Innovation in Scientific Research and Emerging Technologies: A Challenge to Ethics and Law 3030167321, 9783030167325

Table of contents :
Contents......Page 5
1.1 Experimentation on Human Beings......Page 7
1.2 Experimentation on Minors......Page 11
1.3 Experimentation on Women......Page 15
1.4 Experimentation in Developing Countries......Page 19
1.5 Unexperimented Drugs and Compassionate Care......Page 23
References......Page 26
2.1 Research and Biological Samples......Page 29
2.2 Biobanks and Informed Consent......Page 35
2.3 Ethics Committees or Institutional Review Boards......Page 39
References......Page 41
3.1 Research in Neuroscience and Neurotechnologies......Page 43
3.2 Gene-Editing: New Frontiers in Research......Page 48
3.3 Genome Wide-Tests, Direct-to-Consumer Tests, Incidental Findings......Page 53
3.4 The New Medicine: Prevention, Prediction, Personalization, Precision......Page 58
3.5 Citizen Science: New Forms of Participation in Health......Page 60
3.6 Information and Communication Technologies in Medicine......Page 63
3.7 Big Data and Health......Page 68
3.8 Mobile Health......Page 74
3.9 Biometrics, Biosecurity, Biosurveillance......Page 78
References......Page 80
4.1 Converging Technologies: Nano-Bio-Info-Cogno-Technologies......Page 85
4.2 Enhancement (Genetic, Biological, Cognitive): Beyond Therapy......Page 87
4.3 Moral Enhancement......Page 99
4.4 Roboethics and Artificial Intelligence: Beyond Humans......Page 113
4.5 Beyond Humans: Transhumanism and Posthumanism......Page 118
4.6 Emerging Technologies and the Future of Work......Page 121
References......Page 138
5.1 Techno-Scientific Progress, Ethical Pluralism and Governance......Page 142
5.2 The Role of Bioethics Committees: Seeking Shared Basic Principles/Values......Page 144
5.3 A New Regulatory Approach Facing Emerging Technologies......Page 148
References......Page 149

Citation preview

Laura Palazzani

Innovation in Scientific Research and Emerging Technologies A Challenge to Ethics and Law

Innovation in Scientific Research and Emerging Technologies

Laura Palazzani

Innovation in Scientific Research and Emerging Technologies A Challenge to Ethics and Law

Laura Palazzani Department of Law, Economics, Politics and Modern Languages LUMSA University Rome, Italy

ISBN 978-3-030-16732-5    ISBN 978-3-030-16733-2 (eBook) https://doi.org/10.1007/978-3-030-16733-2 © Springer Nature Switzerland AG and G. Giappichelli Editore 2019 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors, and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may have been made. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. This Springer imprint is published by the registered company Springer Nature Switzerland AG. The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland

Contents

1 Scientific Research and Experimenting on Human Beings��������������������    1 1.1 Experimentation on Human Beings����������������������������������������������������    1 1.2 Experimentation on Minors����������������������������������������������������������������    5 1.3 Experimentation on Women����������������������������������������������������������������    9 1.4 Experimentation in Developing Countries������������������������������������������   13 1.5 Unexperimented Drugs and Compassionate Care������������������������������   17 References����������������������������������������������������������������������������������������������������   20 2 Biobanks and Ethics Committees ������������������������������������������������������������   23 2.1 Research and Biological Samples ������������������������������������������������������   23 2.2 Biobanks and Informed Consent ��������������������������������������������������������   29 2.3 Ethics Committees or Institutional Review Boards����������������������������   33 References����������������������������������������������������������������������������������������������������   35 3 Emerging Technologies and Health����������������������������������������������������������   37 3.1 Research in Neuroscience and Neurotechnologies ����������������������������   37 3.2 Gene-Editing: New Frontiers in Research������������������������������������������   42 3.3 Genome Wide-Tests, Direct-to-Consumer Tests, Incidental Findings������������������������������������������������������������������������������   47 3.4 The New Medicine: Prevention, Prediction, Personalization, Precision����������������������������������������������������������������������������������������������   52 3.5 Citizen Science: New Forms of Participation in Health����������������������   54 3.6 Information and Communication Technologies in Medicine��������������   57 3.7 Big Data and Health����������������������������������������������������������������������������   62 3.8 Mobile Health��������������������������������������������������������������������������������������   68 3.9 Biometrics, Biosecurity, Biosurveillance��������������������������������������������   72 References����������������������������������������������������������������������������������������������������   74 4 Converging Technologies and Enhancement ������������������������������������������   79 4.1 Converging Technologies: Nano-Bio-Info-Cogno-Technologies��������   79 4.2 Enhancement (Genetic, Biological, Cognitive): Beyond Therapy������   81 4.3 Moral Enhancement����������������������������������������������������������������������������   93 v

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4.4 Roboethics and Artificial Intelligence: Beyond Humans��������������������  107 4.5 Beyond Humans: Transhumanism and Posthumanism ����������������������  112 4.6 Emerging Technologies and the Future of Work��������������������������������  115 References����������������������������������������������������������������������������������������������������  132

5 Innovation in Techno-Science and Governance��������������������������������������  137 5.1 Techno-Scientific Progress, Ethical Pluralism and Governance ��������  137 5.2 The Role of Bioethics Committees: Seeking Shared Basic Principles/Values ��������������������������������������������������������������������������������  139 5.3 A New Regulatory Approach Facing Emerging Technologies������������  143 References����������������������������������������������������������������������������������������������������  144

Chapter 1

Scientific Research and Experimenting on Human Beings

1.1  Experimentation on Human Beings Experimentation is essential in scientific research for the advancement of knowledge.1 The objective of experimentation is in itself good, insofar as it aims at improving the conditions of human’s health and wellbeing, but it should be adequately justified in relation to the protection of the interests and fundamental rights of the subject being experimented on. The constitutive uncertainty or the incompleteness of knowledge in experimentation (to experiment means ‘to verify’, ‘to test’ or ‘to put to the test’), the difficulty in quantifying and foreseeing the possible risks a priori balancing them with respect to the desired benefits, the certainty or probability that the benefits may not be direct on the subject being experimented on but only indirect or also with the only likelihood of benefits, fill this practice with rather problematic elements that require a specific moral and juridical reflection. Between radical techno-scientism in a libertarian framework that strives for experimentation ‘at all costs’ and extreme anti-scientism that blocks and hinders all research, in recent years bioethical reflection has consolidated its thought on the limitations of the legitimacy of experimentation on human beings. Even in the context of a moral constitutive pluralism in the bioethical debate that continues to raise 1  Starting from the Nuremberg Code (1947), through the Declaration of Helsinki (1964 and successive revisions) and the drawing up of the guidelines for clinical practice (Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Biomedical Research Involving Human Subjects, adopted in 1993 with successive revisions; Good Clinical Practice approved by The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use in 2002), up to the documents of international and community importance, with different levels of bindingness. In particular the following deserve mention: UNESCO (2005); Council of Europe (1997, 2004); Regulation of the European Union No. 536/2014 of 16 April 2014 on clinical trials of drugs for human use, which repeals directive 2001/20/EC. In this context see also: European Medicines Agency (EMA) (2016); World Health Organization (WHO) (2002, 2011).

© Springer Nature Switzerland AG and G. Giappichelli Editore 2019 L. Palazzani, Innovation in Scientific Research and Emerging Technologies, https://doi.org/10.1007/978-3-030-16733-2_1

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theoretical discussions and different practical interpretations, the reflection on the experimentation on human beings has reached some common guidelines at bioethical and biolegal level, making it possible to configure an international and national normative framework of reference. Notwithstanding a number of distinctions, general shared ethical principles and criteria emerge within such normative framework, considered of specific importance in the experimentation on humans. Such principles and criteria guide the ethical evaluation of scientific research with a binding character in the context of ethics committees for drug trials. Primarily, the first element concerns the scientific relevance of research and the methodological correctness of the study.2 The ‘rationale’ of the research and the quality of the experimentation should be evaluated: if the experimentation is not scientifically valid it is not ethically justifiable. The scientific validity of the study should be considered according to the methodological correctness of the research plan (the statistical consideration of the sample, the analysis of the safety and efficacy phase and the epistemological validity of the methodology adopted), the competence of the investigator, the consideration of the data obtained from the pre-clinical experimentation on animals, the relevance of the results published in the existing scientific literature. Attention should be paid to the scientific justification of the inclusion and exclusion criteria from the research, considering that at times for patients who do not have therapeutic alternatives, the participation in clinical trials constitutes an opportunity from which it would be ethically reprehensible to exclude them. Secondly, it is essential to make a reasonable evaluation of the proportionality between the likely risks and foreseeable benefits not otherwise obtainable. Every clinical study or experimentation protocol requires an objective consideration of the proportionateness of the risks/benefits ratio. This means that even if a subject were willing to take unreasonable risks, the experimentation could not be authorised at ethical level. It is necessary to bear in mind that the risks are always referred to the subject of the experimentation, while the benefits can directly concern the subject or, much more frequently, indirectly concern the subject and directly the generality of subjects or specific group of subjects who are or will be affected by the same pathology. The ethical meaning of experimentation is the subject’s choice of participation in scientific research, in the uncertainty of the results, with a gesture of solidarity and altruism towards other patients who can possibly and hopefully be treated in the future thanks to the discoveries brought to light by research. A particularly problematic area is represented by the involvement of healthy volunteers in high risk research, with for example exposure to radiation, recourse to electric or transcranial magnetic stimulation. The ethical need arises to rule out the possibility that the access to experimentation might deprive a patient of the “best therapeutic standard” available. Considering the risks for the subject, the access to experimentation should offer them a better  On this topics see the Opinions of the Italian Committee for Bioethics (1992a, b, 2009, 2010a, c).

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chance with respect to the standard therapy. In this sense non-inferiority trials (with research drugs that are not inferior to the standard therapy) are ethically problematic. Studies should always consist in superiority trials, in the search for a more effective therapeutic outcome than those already existing. Only in this way a level of safeguard is ensured, which is at least equal to the one guaranteed by the existing therapy. This is particularly applicable in the randomisation trials in which the subjects are included randomly in one branch of experimentation or another. It is ethically problematic that in evaluating the effectiveness of a new resource (in a broad sense), the experimentation deprives the recruited subjects of the access to available and validated therapeutic means. A specific problem is related to the clinical trials on drugs which do not present an “added value” in terms of greater efficacy or lower toxicity with respect to drugs already existing in commerce. These trials, unlike the “superiority” or “equivalence” designs, are trials of “non-inferiority” designs. Ethical reflection underlines that only “superiority” testing has an adequate motivation in the interest of the patient, while the “non-inferiority” testing mainly answers the needs of the pharmaceutical industry (less risk, lower costs). A particularly difficult problem is posed by the use of placebo, or ‘fake’ medicines. Often proposed by researchers to reduce the time of the trial and to make it more effective and efficient, such method is ethically unacceptable if efficacious treatment is available (of which the subjects would be deprived, for the experimentation) or if the use of placebos entails suffering, lengthening of illness or increased risk. There is wide debate on the ethicality of the frequent recourse to trials with control groups. The possibility is discussed of increasing the retrospective evaluations, improving the filing modality of the clinical data too. The obtaining of informed consent to experimentation takes on a central ethical role. The informed consent form constitutes a necessary but insufficient element. Informed consent presupposes the information given by means of a dialogue between subject and investigator, suitable for their capacity to understand so as to gain consciousness and awareness of the various aspects of the trial, in order to avoid ‘therapeutic misconception’. At times informed consent is understood in a perspective of defensive medicine, as a detailed technical and exhaustive description of the characteristics of the project (with particular attention to the hypothetical adverse events), aimed at the defense of the investigators rather than of the subjects who have been recruited. Often ethics committees, appointed to evaluate the informed consent in the context of the analysis of the trials, request a simplification and clarifications of the information modalities, so as to account for the real substantial and not only formal meaning of consent. The information and the consent should ascertain the subject’s awareness of the meaning of the trial and what their participation entails also in terms of commitment and responsibility, verify their actual willingness without direct or indirect conditionings (the so called undue inducement), vouch for the realisation of the possible risks and potential benefits, as well as the possible consequences of their

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n­ on-­participation (in cases in which there are no therapeutic alternatives), explain the revocability of consent without any consequence in the treatment of the patient and the possible interruption of the experimentation with justified motives on the part of the investigator. Moreover, informed consent clarifies the condition of confidentiality of data and information, explaining the modality to guarantee them and the legal requirements. An element being debated is the communication of the results obtained during the trial to the recruited subjects, particularly those regarding genetics. Libertarian bioethics considers that the free subjects should decide autonomously whether or not they want to know, even about important information at a preventive, diagnostic, therapeutic level or information regarding reproduction choices. The bioethics that defends intrinsic human dignity retains that communication is obligatory, except in the case that there might be a conscious refusal on the part of the competent subjects. The obligatoriness should be stressed above all with regard to the parents or guardians, when the information concerns the health of the minors or the incompetent. The communication of “unexpected outcomes” (incidental findings) is particularly problematic, in relation to incurable genetic pathologies with a late onset (for example, Huntington’s Corea). In genetic research it is essential to make the subjects aware of the likelihood of such information in order to know their preferences and to arrange suitable genetic consultancies. Another ethically delicate problem is transparency (except what regards patent profiles) on the results of research, particularly in the case of negative outcomes, and therefore different from the sponsor’s expectations. Such results are often not published even though of the utmost importance for future research. Privacy—with regard to personal data and clinical data—is also an ethical and legal requirement of every trial, according to the current regulation of the country where the study takes place. In Europe the reference to the General Data Protection Regulation (Regulation 2016/679 of the European Parliament and of the Council on the Protection of Natural Persons with Regard to the Processing of Personal Data and of the Free Movement of such Data, and Repealing Directive 95/46/EC) is required in the informed consent (generally in a separate form). In short, experimentation on human beings is considered licit insofar as the primacy of the interests of human subjects is respected over the progress of scientific research and above all with respect to the economic interests of the market (pharmaceutical companies or industrial sponsors). If carried out properly and in morally acceptable conditions, experimentation on human beings is not only licit but also dutiful for progress in scientific research.3 Even in the framework of a sharing of general ethical principles, particularly thorny elements arise in the bioethical and biolegal debate in the analysis of a number of conditions of specific vulnerability: minors, women and populations of the developing countries. Such issues need a bioethical reflection and, at times, a compliance and integration of the bioethical reflection on specific points. 3  On this topics see Emanuel et al. (2011); Council of Europe, Committee on Bioethics (DH-BIO) (2012).

1.2  Experimentation on Minors

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1.2  Experimentation on Minors Children are often considered “orphans of therapies”. Drugs experimented on adults are often used for children by quantitatively reducing the dosages. In fact, most medicines used to treat children are off-label, that is outside the authorised indications for use and therefore without proper knowledge of the possible side effects in paediatric use. To consider children as “small adults” means not to take into account that the reaction mechanisms of their organism to the taking of the medicine in paediatric age are qualitatively different from those of adults, considering that they are subjects in a development stage. In this sense, the application of the safety and effectiveness data to children of drugs taken from the world of adults exposes them to the risk of inefficacy or adverse reactions.4 On the basis of the principle of equality and justice, like any other human being, children have the right to receive drugs that will guarantee possible conditions of health in the same way as adults do. It would not be ethical to exclude children from trials since it would mean to discriminate against them with respect to other subjects in the safeguard of their interests and fundamental rights such as life and health. Nevertheless, experimentation on minors raises a number of critical ethical and legal issues. First of all, there is poor recruitment of children in clinical trials. In the methodological planning of a trial it is necessary to take special precautions with respect to experimentation on adults, by virtue of the different age: reduce the number of medical examinations, guarantee an appropriate reception and recreation spaces, reduce to the minimum invasiveness on the body and discomfort in the experimental procedures that might cause pain, fear and suffering. The low number of samples should also be considered, as it is more difficult to reach the number that is statistically needed to guarantee the reliability of the results (nowadays attempts are made to remedy this problem by creating multicentric networks for each pathology). To this are added the poor economic incentives that reduce the interest of the pharmaceutical companies in sponsoring such research. In the consideration of the involvement of the lowest possible number of subjects (given the risk), the research should guarantee high scientific and ethical standards in the justification of the importance of the experimentation, in the relevance of 4  See documents on the topics on an European level: European Medicines Agency (EMA) (2008, 2012); European Commission (2013); European Commission ad hoc group (2008). The main Opinions on the topics in Europe: Nuffield Council on Bioethics (2015); U.K. Medical Research Council (2004); Italian Committee for Bioethics (2012); Working Party of Research Ethics Committees in Germany (2010). On an international level: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) (2000); International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) (2016). In USA: American Academy of Paediatrics – Committee on Bioethics (2016); U.S. National Academy of Sciences (Committee on Clinical Research Involving Children) (2004); U.S. National Academy of Sciences (Committee on Paediatric Studies-Institute of Medicine) (2012); U.S.  National Institutes of Health (2016); U.S. Presidential Commission for the Study of Bioethical Issues (2013).

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measurable results from pre-clinical research on animals and in the analysis of the data gathered from trials on adults, the correctness in being conducted by means of appropriate designs according to the age of the patients, the competence of the investigator, the attention to the detection of side effects or adverse events that take the psycho-physical development of the underage subjects into account. One of the most critical elements of clinical trials in children is consent. The need to obtain the consent of both parents is a consolidated bioethical line of thought and in particular cases of social hardship (for example, neediness, poor education, immigration) the presence of a cultural mediator from outside the family can be foreseen. It is furthermore important that, with regard to the general information prior to consent, the investigator evaluates the real motivations leading the parents to accept the recruitment of their child in a trial, so as to exclude the existence of ethically unacceptable reasons for this: for example, to benefit from medical treatment otherwise not guaranteed or however to obtain greater attention by the doctors in the treatment of the children. The consent of the parents should be accompanied by the assent of the child, which is the proof of their actual involvement in the medical decisions, together with their parents.5 Such assent should be obtained by putting together appropriate information and communication with the child also with the help of psychological and pedagogical studies, suitable for their age and their intellectual and emotive capacity to understand. It is impossible to establish time limits in the formulation of the assent. There should be an approximate separation between pre-school age (with communication by pictures) and early school age (with pictures accompanied by cartoons with short simple explanations), to progressively develop a more complex elaboration up to adolescence or the so-called ‘great minors’. The appropriateness of the information will be evaluated case by case according to cultural and social context but also to the existential context, since each child has a different evolution and maturity and can react differently to illness or pain. It must be said that on a biolegal level, countries may have different regulation of the age of maturity and may recognize the possibility to give consent also to ‘great minors’. The minor should receive information from expert personnel that is proportional to their capacity to understand the risks and benefits and furthermore the investigator is called upon to take into consideration the desire expressed by the minor to take part in the experimentation or to withdraw from it at any moment. The child should be told that their desires will be considered important in the decision, making it clear though that they alone cannot be decisive. Specific attention should be paid so that the involvement of the child is not an indirect insistence on participation, which should always be free and unconditioned by external factors. The conditioning is particularly problematic in a paediatric phase given the child’s vulnerability from the external influences of adults, members of the family and doctors. In the context of assent the child should be helped by doctors to understand the aim of the trial, the procedures foreseen and the experiences that they will have,  Wendler (2006), pp. 229–234.

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always attempting to perceive how much the child has actually understood and what their often unexpressed concerns are, in order to help participants to overcome them. It is important that the researchers together with the parents, always act in the best interests of the children, helping them to develop their awareness and choice, whenever possible. In this sense the informed consent/assent cannot be reduced to a mere procedure, but should be carried out in an interaction between doctor, parents and child, to be realized over time so that there is room for clarifications and the reaching of possible shared decisions (the so called shared consent). Both consent and assent must be in written form. It should be made clear that these records can be withdrawn at any time, without having to give any justification. In the case of conflicts and disputes, suitable psychological assistance and ethical consultation need to be guaranteed. The most delicate part of the assent of children is that of avoiding the imposition of the decision on those who are not able to decide or express a decision for themselves, but also the exclusion from the decision of those who are ready and eager to be involved. A particularly difficult element is the involvement of healthy or sick children as a control group or as subjects of “non-therapeutic”6 experimentation, without any direct benefit but only indirect benefit, that is possible benefit for other children in the future with the same pathology. Non-therapeutic experimentation on minors cannot be excluded, if significant improvements in scientific knowledge were to be achieved from this in the face of a positive will and minimum risk and/or discomfort. The restriction of experimentation to the condition of the existence of a “direct benefit”, even though justified by virtue of the protection of the minor, could preclude some therapeutic possibilities specifically devoted to minors. In the measure in which research is essential to confirm data gathered in clinical trials on persons able to give their informed consent or in the measure in which research is such as to be able to be undertaken only on minors in the absence of experimental alternatives, it can be considered bioethically acceptable. The condition is that the research directly concerns a clinical state that the minor suffers from and which therefore could benefit groups of patients with the same pathology. This problem is not always explicitly dealt with in biolaw, and requires an improvement of the deontological dimension. In this context it is indispensable that a real capacity of informed assent/consent exists to the risk and the entity of the risk. When it comes to a non-therapeutic trial on a child with real capacity of informed assent, supported by the consent of the parents/legal representatives, provided that there are no outstanding risks either for the life or the physical integrity of the minor, the bioethical and biolegal reflection has reached the consideration of the legitimacy of such experimentation. The requisite of the minimum reduction of risk and or discomfort is ethically central to this. Some studies show that young boys and girls/adolescents are motived in taking part even in non-therapeutic clinical trials out of their desire to help others. In the case

 Miller and Nelson (2006), pp. S25–S30.

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of subjects who are unable to give consent/assent, non-therapeutic experimentation should be considered morally unacceptable.7 There is a different bioethical and biolegal evaluation regarding the use of experimental drugs as a last resort in the attempt to save the life of the minor in incurable terminal conditions (maybe also in condition of imminence of death) and in the absence of effective therapeutic alternatives. In such case the ethical decision should be proportionate to the actual circumstances, in order to seek the conditions that are respectful of the dignity of the minor insofar as a human being. In first place, it is essential to gather objective scientific data, in reference to the evaluation of the seriousness of the illness (verification of the condition of impossibility to cure him/her), and secondly the present and foreseeably future suffering should be considered, also taking into account the patient’s quality of life. Those experimental pharmacological interventions which are even aggressive and intensive are considered ethically licit and proper when there is an albeit minimum “therapeutic hope” and when the likely suffering is considered acceptable for the benefits that can foreseeably be gained in relation to the improvement of the quality of life (or at least minimization of suffering), with the consent of the parents and possibly the assent of the minors. The suspension of aggressive and intensive experimental therapies is considered ethically licit and sometimes dutiful, when the life expectancy is short, the prognosis undoubtedly poor and the therapies futile and harmful with respect to the benefits to be obtained. In these cases, only ordinary treatment is given along with palliative care and human caregiving. The use of pharmacological therapies made available by more advanced medicine also in the experimental phase should thus be evaluated case by case during the evolution of the pathology. They are to be considered optional in the absence of other remedies, when, even though not resolutive, they make it possible to alleviate 7  The regulation on international level: UN Convention of the Rights of the Child, 1989; Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, 1997; Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research, 2005. Regulation on European level: Charter of Fundamental Rights of European Union, 2000 (2000/C 364/01); Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data; Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use; Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance); Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (Text with EEA relevance); Regulation (EU) 679/2016 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation); European Parliament Resolution of 15 December 2016 on the regulation on paediatric medicines (2016/2902(RSP)).

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suffering and improve the quality of life even temporarily, with the consent of the parents and possibly the assent of the child. It is also licit to interrupt them, limiting the treatment to ordinary therapy, if they do not give results or if the results fall short of the expectations, presenting high risks and costs in terms of suffering (following medical opinion and the family’s consent). In these cases the forced extension of treatment would be uncertain and distressing, thus becoming “therapeutic insistence or obstinacy” or better, “experimental insistence or obstinacy”.

1.3  Experimentation on Women As well as minors, sexual difference also brings out other profiles of vulnerability which are peculiar to clinical trials.8 Women appear as “weak subjects”, in as much that they are not adequately considered in reference to their specificity.9 The percentage of women enrolled in the trials is low. One can speak of ‘representative inappropriateness’ or ‘female underrepresentation’ in trials.10 The yardstick for the dosage of drugs is referred to men and women are considered a ‘variation’ of such model, but the physical, morphological and physiological difference between men and women determines a notable diversity in pharmacokinetics (or in the different absorption, distribution and metabolization of the drug) and in pharmacodynamics (or in the different concentration of the drug in the blood and tissues). Despite the fact that scientific knowledge of the peculiarity of the female body has made progress, the trial protocols have not been modified with respect to gender difference, with the persisting of non-separated enrolment with respect to the male and female difference, with the consequent undifferentiated data analysis. The lack of specific studies on women, above all in the early stages of research, does not make it possible to measure the real effectiveness of drugs on them, but could also have limited the identification of specific medicines for women.

8  While in 1977 the Food and Drug Administration (FDA) in its General Considerations for the Clinical Evaluation of Drugs and in 1982 the World Health Organisation in its Proposed International Guidelines recommended the exclusion of women from experimentations, it is in 1988 that the FDA in its Guideline for the Format and Content of the Clinical and Statistical Sections of New Drug Application recommends the analysis of data differentiated according to sex in clinical trials. In 1993 once again the Food and Drug Administration issues the Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs, expressing the hope for the inclusion of women in the experimentation protocols so as to guarantee an equal representation. Along the same line are the International Ethical Guidelines for Biomedical Research Involving Human Subjects (1993, revised in 2002), which recommend researchers, sponsors and ethics committees to not exclude women of child bearing age from experimentation, not considering the potential of pregnancy a sufficient reason to limit their participation and recognising women the capacity to take a “rational decision” in taking part in research. 9  Wizemann and Pardue (2001); Mattison (2004), pp. 112–117. 10  Franconi et al. (2007), pp. 81–97.

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The lack of experimental studies that take into account gender difference in the pharmacological field is still even more problematic owing to the recent change in conditions of health/illness of women in the context of the general shift in the female condition, due to the rise in the level of education and in the participation in the working world as well as in the political-social context, but the still ongoing marginalisation. Some of the illnesses considered ‘male’ today tend to be more frequent in women, but the drugs for their treatment are not experimented specifically on women. This is somewhat penalising for women who are greater consumers of drugs than men, as they have more frequent and serious side effects. Consequently women, who live longer than men, have less health. There are different reasons for female underrepresentation and numerical inferiority of participation of women in clinical trials. There are reasons that generally concern the way of considering experimentation and medicine. In experimentation there is a tendency towards ‘generalisation’ and in medicine a tendency towards ‘neutrality’ and to the assimilation of women to men; but these orientations are in conflict with the need for individual specification and gender differentiation. Moreover, there are social reasons due to the difficulties of women to get into clinical trials owing to their lack of time (family commitment or the double work-­ home commitment) or due to low income (unemployment or low salary); psychological reasons due to the lack of attention by the recruiters to practicalities and female needs; environmental reasons owing to lifestyle, the more frequent recourse by women to the use of natural remedies that can affect the experimentation; economic reasons as it is not ‘convenient’ in terms of costs for the pharmaceutical companies to fund experimentation that needs an increase in enrolments in the preclinical and clinical phase, with the inevitable rise in time and costs; biological reasons as women are considered ‘difficult’ subjects by virtue of their physiological, enzymatic and hormonal diversity, due to the variations of childbearing and nonchildbearing age. The possible pregnancy in childbearing age is one of the reasons that has led the pharmaceutical companies to exclude women from clinical protocols or to impose the use of specific hormonal contraceptives as a condition for the participation in research because of the possible risks to the foetus. Bioethical literature is divided on this last point. Some lines of thought, of liberal and libertarian feminism, consider that fertile and childbearing women must be included in the experimentation as a priority ethical need for the potential benefits for women, retaining the possible harm to the foetus as secondary as it is considered as not yet having dignity (at least in the strong sense).11 The exclusion of fertile and childbearing women from clinical trials would produce injustice in biomedical research, insofar as women would not have the same chances as men in treatment. In contraposition to this line of thought, the justification of the defense of the intrinsic dignity of human beings from conception leads to a different consideration in relation to female clinical trials. In the measure in which clinical trials can endanger the life or health of the foetus recognised as the subject of rights, the  This is the theory maintained by feminists. Cfr. DeBruin (1994), pp. 117–146; Sherwin (1994), pp. 533–538; Sherwin (1992), pp. 158–175; and Merton (1996).

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11

non-­participation of women in clinical trials is considered ethically preferable as the risk for the growing life exceeds the potential benefits for the woman. If the woman decided to enrol in the trial for social or personal aims, she should nevertheless be able to choose the modalities freely and responsibly to avoid pregnancy coinciding with her own lifestyle and values, among which abstinence from sexual relations, insofar as she should deem the use of contraceptives illicit owing to the scission between unitive act and procreation (as in the Catholic perspective). As a counterweight to such theoretical contraposition is a third line of thought, according to which following the awareness of the problems by means of suitable information given during the consultancy, the woman could decide to take part in a trial even if the pharmaceutical company requests the use of contraceptives for safety reasons. Provided that they are not potential early abortifacients, the use of contraceptives would be justifiable in the context of an experimental objective (with the intention to take part in a trial and not to avoid conception), also for those who consider the use of contraceptives ethically illicit. In this case the use of contraceptives would not have the aim to separate sexuality and procreation in order to avoid the latter, but only to guarantee the conditions of safety required in the trial, without it entailing the modification of values or behaviour. In other words, a woman who is even against in principle of the use of contraceptives and considers that sexuality is aimed at procreation could use them if requested by the trial without changing her behaviour (that is, practicing abstinence for non-procreative ends). After all, the use of contraceptives can have a therapeutic aim (for example, for the regulation of the menstrual cycle): by analogy it could have an experimental aim (in the case of the study of the interaction between drugs and contraceptives or however to guarantee safety, as it is always possible for the woman to have a sexual union unintentionally, by rape for example). This is a particularly thorny issue that requires a bioethical debate that manages to balance the needs of the trial on the one hand and on the other the values of the subjects taking part in the experimentation. It is therefore bioethically important that the informed consent is always structured by taking into account gender difference and the moral principles of those taking part in the trials, offering women also sexual abstinence among the possible choices and, should that be impossible owing to trial requirements, offering appropriate consultancy so that women can choose responsibly according to their moral and religious values. It is also important to remember that informed consent should  also be undersigned by the partner and could include a variable time frame that can be extended even after the trial. For the purpose of stimulating the awareness of women and increasing differentiated pharmacological experimentation by sex (experimentation on men and women), it could be important to state specifically on the leaflets of medicines whether or not they were experimented on women. It would also be advisable to raise awareness in the healthcare authorities and pharmaceutical companies to support trials separated by sex, even if not very profitable, encouraging research projects on the subject and promoting the participation of women in clinical trials with adequate information on the social importance of female experimentation. A possible proposal also consists in a greater presence of women as investigators and as members of ethics

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committees, as they are more sensitive to female issues in clinical trials. In this sense, it would be advisable to have healthcare training that focuses on the female dimension of pharmacological experimentation, as well as research and treatment.12 A specific bioethical issue in female clinical research involves pregnant women. In this context, physicians often prescribe drugs for pregnant and breastfeeding women, without studies involving women in those conditions, so without evidence of safety and efficacy. Such treatments include medications that may have a serious harm both to the woman and to the foetus. The exclusion of pregnant women from clinical trials is the cause of the lack of data on potential benefits and harms on them and their future children. Therefore, there is a discussion on the necessity to design research for pregnant and breastfeeding women in order to verify unknown risks and potential individual benefits.13 Clinical research on pregnant women needs specific ethical requirements: research that may or may not have a potential direct benefit is allowed only when studies cannot be carried out on other persons, non pregnant and non breast-feeding women; for research with potential direct benefit on the subjects, the risk-benefit assessment should consider the specific situation of pregnancy, and extends assessment on the foetuses or even preconceptional stage. In such research the criteria of minimal risk and minimum burden are compulsory both for the woman and the child. The issue of “minimal risk” refers to the degree of harm or discomfort which should not be greater than those experienced in daily life or during routine physical or psychological examinations. A specific attention and prudence is required by research ethics committees. In any case, relying on evidence from prior animal experimentation is absolutely necessary. Pregnant or breastfeeding women should not participate in non-therapeutic research that carries more than minimal risk to them and to the foetus or infant, unless this is intended to elucidate problems of pregnancy or lactation without any alternative paths.

 On the topics see the Opinion of the National Ethics Council in Europe: Austrian Bioethics Commission at the Federal Chancellery (2009); Belgian Advisory Committee on Bioethics (2004, 2015); European Medicines Agency (EMA) (2005, 2005); Italian National Bioethics Committee (2008). In USA: Columbia University Institutional Review Board (2012); John Hopkins University Center for Communication Programs (2003); The American College of Obstetricians and Gynecologists (2015); The Society for Women’s Health Research – United States Food and Drugs Administration Office of Women’s Health (2011); U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, Office of Research on Women’s Health (2011); U.S. Government Accountability Office (1992); U.S. Government Accountability Office (2001); U.S. Food and Drug Administration (1993); U.S. National Institute of Health (2001). In other countries and on international level: Health Canada (2013); International Conference on Harmonisation (ICH) (2004); World Health Organization (WHO) (1995, 1998, 2010). 13  CIOMS 2016, Commentary on Guideline 19. 12

1.4  Experimentation in Developing Countries

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When a pregnancy has been exposed to more than minimal risk in the conduct of research, the woman should be encouraged to participate in any available follow-up evaluations to assess the effect on her and her foetus or child. As part of the informed consent, the woman should be informed of all types of risks of the participation, with specific consideration for the implication on her health and on the embryo, foetuses, infant. If new scientific information arises during the research, this information should be immediately given to participants as soon as possible. As at any stage of the research, subjects’ right to withdraw consent should be respected. Follow-up of the pregnancy, foetus and child is essential, even for several months after the end of the study. Research on pathological conditions or treatments specifically aimed at the foetus may equally be the focus of research studies. The primary goal of these interventions is to improve the health of children by intervening before birth to correct or treat prenatally diagnosed abnormalities. This leads to consequences for the woman’s health and bodily integrity, so it cannot be carried out without her explicit consent.

1.4  Experimentation in Developing Countries The globalization of research would increase the conditions of justice and equality in the distribution of drugs. Although the globalization of clinical studies hides, often, the objective of ‘outsourcing’ the experimentation, in order to reduce costs, simplify and accelerate procedures. The reference is to the experimentations that involves those populations that are particularly ‘vulnerable’ mainly because of economic underdevelopment that slows down the progress of science and technology or, even if economically developed, unaware of ethical issues. These conditions may expose some populations to a risk of exploitation for scientific interests, which may hide commercial interests. It may be considered as a form of bioethical ‘colonialism’ and ‘imperialism’ (or, in a moderate expression, ‘paternalism’), unfair exploitation and manipulation due to the differences in scientific-technological knowledge and socio-economic and cultural inequalities. The general ethical standards which must be considered mandatory, as substantive ethical requirements for clinical trials on international level are: the protection of all human subjects regardless of ethnical belonging, culture, religion, socio-­ economic status, country of birth or residence and the guarantee of the conditions of justice, respect of equality (in the equal access to health) and of different cultural contexts. The respect of dignity, physical integrity, autonomy of participants and justice between subjects in accordance to the good clinical practices are ensured through: preliminary verification of scientific relevance of research; protection of safety and well-being of participants; equity in the enrolling and selection of participants; balance of reasonable risks compared to potential benefits; expression of informed

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consent; appropriate treatment during and after the trial; compensation for direct damages to health; distribution of equal burdens and benefits. The application of general ethical standards of clinical trials to the different cultural context, in particular to developing countries, needs an activity of interpretation and specification. In an ethical framework that recognises the priority of the human dignity and justice emerges the necessity of additional standards of safeguard to avoid exploitation or abuse of particularly vulnerable population because of poverty, lack of education and understanding of scientific issues, lack of technical skills, scarce resources, disease, inability to have access to the most basic and essential health products and services.14 The process of interpretation might be helped by a community consultation to acquire better knowledge of local culture and involving community representatives in the elaboration of research projects. In this context, the role of the cultural mediator is important. The aim is neither to impose foreign ethical standards nor to adapt to local standards, but to apply generally recognised principles and values taking seriously into account the conditions and needs of the specific culture. The Universal Declaration on Bioethics and Human Rights of UNESCO (2005) constitutes a reference point for the protection of human beings in transnational research, in order to avoid economic interests prevailing over respect of dignity, autonomy and justice. There is a need for Western Countries to realise that advances in scientific knowledge do not mean that they can use them to exploit poor countries for one-way benefit. The intrinsic value of this obligation should be the same for each country and ensure that each country may benefit from the positive results of clinical trials regardless of the level of literacy, wealth, social advancement, techno-­ scientific progress. This is one of the concrete paths to deliver global justice in health and welfare. The Universal Declaration on Bioethics and Human Rights of UNESCO expresses the general framework of reflection with references to human dignity (Article 3), the direct and indirect benefits for patients participating in the research (Article 4), informed consent (Article 6), respect for human vulnerability and personal integrity (Article 8), equality, justice and equity (Article 10), non-­discrimination (Article 11), respect for cultural diversity (Article 12), solidarity and cooperation (Article 13), social responsibility and health as a fundamental human right (Article 14), international cooperation (Article 24), promoting the international dissemination of scientific information, freedom of movement and sharing of scientific and technological knowledge. The Declaration recalls the general ethical principles of experimentation on human subjects, recognized in international documents, affirming that they should be applicable everywhere, without making a distinction between more or less  On the topics see: French National Consultative Ethics Committee for Health and Life Sciences (2003); Italian Committee for Bioethics (2011, 2017); European Group on Ethics in Science and New Technologies (EGE) (2003); Nuffield Council on Bioethics (2005); U.S.  Food and Drug Administration (2013, 2016); U.S. National Bioethics Advisory Commission (2001); U.S. National Institute of Health (2001); Marshall (2007); Neves (2009).

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developed countries, avoiding unequal treatment and recognizing the universal justice. This does not mean accepting a ‘double standard’ of ethics (also called ‘ethics dumping’). On the contrary, it means reiterating that the ethical standard should be ‘unique’ as concerns principles. Trials in developing countries should  meet the same ethical standards of developed countries (Article 21 b). The specific additional standards ethically required, explicitly or implicitly, are the following: direct relevance of the clinical trial, equity in enrollment, tailored informed consent, proportionality and compensation for risks/damages, training and assistance in order to develop a ‘collaborative partnership’. Responsiveness and direct relevance of the clinical trial to real health needs is a specific requirement with regard to the vulnerable population of the host country. International testing should be considered as a priority in relation to the specific interests and priorities of health of the populations of the host country. In this sense, the right to health care as protection of the objective good of a person should be considered a fundamental international right. Enrollment of the subjects should guarantee equity considering the possible advantages of participants in relation to the population and ensuring benefits both to participants and to the population as a whole. The balancing of risks/benefits should be commensurate with the basic conditions of the population (including nutritional, epidemiological and health conditions), in reference to each individual, but also to the community. Commensuration of risk for the individual and the population in relation to the benefits for ‘third parties’ (with reference to the Countries performing the trials) is ethically unacceptable. Research is ethically justified if it provides reasonably direct benefits to participants and indirect benefits for the overall population, with the minimization of risks to people participating in the research, but also for the vulnerable population as a whole. Informed consent should be tailored to local customs, verifying that it is voluntary and freely given without coercion, incentives or ‘undue inducement’. It may be oral and witnessed for the illiterate, with permission of community leader or family involvement when needed in specific circumstances. With regard to voluntariness and lack of ‘undue’ influence, it should be noted that in developing Countries participation in a trial could be an advantage for those who have difficulty in obtaining food and basic health care. The socio-economic conditions could push to participate without an adequate awareness of the risks in the research. Another problem could be the difficulty of some populations to grasp the concept of research, which tends to be confused with care and assistance (the so called ‘therapeutic misconception’). The involvement of other persons in the expression of informed consent is acceptable only if there are ways to verify the actual awareness of individual participation (as well as the possibility to withdraw it) and the absence of direct or indirect external pressure. This awareness should be verified as being personal and cannot be replaced by others. An issue connected to informed consent is confidentiality. Confidentiality may be weakened (if not obliterated) given the family’s possible involvement in the process of granting permission to carry out research. The fact that in some cultures there is a lack of the concept of ‘privacy’ should also be considered. This raises an

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ethical problem: the participation in research may mean, for vulnerable populations, the risk of the stigma of being sick. In this context, cultural associations may play a supportive role, helping the patient not to be marginalized. Appropriate treatment should be guaranteed, ensuring that participants enjoy potential benefits and is compensated for any harm directly related to participation, helping health care infrastructure to support proper distribution and guaranteeing continued access to post-trial benefits and treatment to participants and to the population outside the research context of the country where the trial is conducted, as expression of international cooperation and solidarity. This means also that protection should be provided through arrangements a mandatory insurance in view of possible damages, where the premium is assessed in relation to the local economic state. This could be guaranteed also by independent organizations that are non-­ profit and internationally accredited, which may have the role of monitoring this ethical requirement. An ethical requirement is the need to assist developing Countries in building the capacity to become fuller partners in international research both on scientific and ethical levels, enhancing collaboration and creating an atmosphere of trust and respect. Assistance should be guaranteed to developing Countries during the experimentation without inflicting on them the burden of the ‘indirect costs’ of the trial, on an already precarious local health system, and helping them to become active partners in international research, stimulating the improvement of the local health system and transferring technical and scientific skills, involving also doctors and representatives of the host Country, to monitor compliance with ethical standards and avoid abuse. It is an ethical requirement of experimentation that the investigators assume responsibility and solidarity in the framework of international cooperation which continues even after the trial, so that research participants do not feel abandoned. In this sense, experimentation is justified to the extent that the product, if it proves effective, can become available to the entire population. There is considerable international debate, even as regards the ways in which this ethical requirement can actually be met. There should also be specific training for doctors and the medical staff conducting this experimentation as well as education involving local doctors and health personnel, often in particularly fragile conditions, so that care becomes a ‘collaborative partnership’ and enables to develop in the host Country the skills required to independently conduct clinical trials and ethical assessments (also, possibly, with the institution of Ethical local Committees).15  In the context of international guidelines the ethical criteria of experimentation with particular reference to developing Countries have been elaborated in  International Ethical Guidelines for Biomedical Research Involving Human Subjects 2002, which updated the 1993 guidelines of the Council for International Organizations of Medical Sciences in collaboration with the World Health Organization; Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects, in its most recently developed form by the World Medical Association (adopted in 1964, revised in 1975, 1983, 1989, 1996, 2000 and 2008), Working Party for the Elaboration of Guides for Research Ethics Committee Members (CDBI, 2010, Rev. 1. 2).

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1.5  Unexperimented Drugs and Compassionate Care

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1.5  Unexperimented Drugs and Compassionate Care There is wide debate in bioethics on the limits of legitimacy of the use of drugs or technologies that are unexperimented or being experimented for their effectiveness and safety.16 This is an issue that arises in the debate sparked by ‘cases’ that attract the attention of public opinion, as happened with some oncological treatments (cures for oncological patients made up of a mix of off-label drugs, or used outside medical prescription, with different indications, dosage and modalities) and the case of the taking of mesenchymal stem cells present in bone marrow, with variable combinations, proposed to treat a range of heterogeneous illnesses, associated by the absence of effective remedies offered by medical science and poor prognosis. The move towards the use of drugs with unauthorised unexperimented treatments is on the rise, the so called ‘early access’ to innovative treatments, unproven (alternative medicines) or not yet proven. Such cases have also led to social conflicts, with the claim of the right to treatment by patients and families to the national healthcare system, which has involved the intervention of judges (the so called ‘right to try’ or ‘right to hope’). This is an issue with international dimensions. Generally in bioethics the generic expression “compassionate use” is employed for a plurality of cases, having in common the will/request/desire to use unexperimented drugs or technologies. The request for compassionate use arises from a number of factors: on the one hand from the slowness and rigidity of the experimentation procedures (slowness, proceduralisation and rigorousness are also a guarantee of precision) and authorisation for the marketing of the drug by the regulatory authorities; on the other hand, from the increase in knowledge, also through the information and communication technologies, of the patients and family members that come to know about new products that have still not been validated and, in the tragic nature of the condition of the illness, do not want to leave any stone unturned. In the age of techno-scientific progress death and illness are even less accepted, and one tries to do everything possible to recover and get better. This is out of an excess of trust in science and medicine, but at times out of a mistrust for ‘traditional’ medicine, preferring innovative and yet still unvalidated treatments. It is necessary to distinguish between the compassionate use of drugs and the so-called “alternative medicines” or complementary medicines that concern the practices whose effectiveness has not been ascertained with the criteria adopted by scientific medicine and is not “ascertainable”. Instead, compassionate use regards cures and treatments not yet ascertained de facto but ascertainable in principle, on the basis of the experimentation procedures. This is often the condition of patients with rare pathologies which, owing to the time and costs of the treatment, have no drugs (the so-called “orphan drugs” or “orphan diseases”). Many patients with rare pathologies do not therefore have courses of treatment and there are very few medical experts able to accept them as patients.

16

 Italian Committee for Bioethics (1992a, b).

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The requests for “compassionate use” pose many questions in bioethics. To what extent does a right to the freedom of treatment, a right to hope exist? When does the hope become illusion, with negative consequences on the health of the patient and for the whole society?17 In order to give an answer to these questions it is essential to make some preliminary distinctions. The formulation “compassionate use” groups together different types of situations in a shade of intensity, from the minimum to the maximum: the use of off-label drugs (outside prescription for indications, dosage and directions for use, but validated for effectiveness, safety and tolerability) to the use of unvalidated drugs undergoing validation (early access, in controlled conditions), to the use of drugs without validation (of which not even the absence of harmfulness is known). In the first case the risks are sufficiently controlled: it is the case that generally arises for the use of drugs on children which have been experimented on adults. In the second case the risk margin increases, as the clinical trial process has not been concluded. The latter is the most problematic case since no data exists even on the harmfulness of the drug: it is the case of the “journeys of hope” for cell therapies, in the case of diseases with a poor prognosis. Another one is the “Ebola case”, a disease that per se is rare but to which is added the danger of contagion and rapid spread (pandemic), which can transform it into an epidemic with high levels of mortality, making it more urgent to try and find a solution, not only in the interest of the single individual but also of the community18: in this case the risk and uncertainty should be balanced with the benefit for the whole society as well as for the single person. Moreover, the very expression “compassionate” is ambiguous. It evokes feelings of compassion, empathy towards patients with serious and incurable illnesses which implicitly presuppose the ethical legitimacy: who could be opposed to feelings of empathy, without being considered indifferent or selfish? These are alternative  See art. 37 of the Declaration of Helsinki (updated in October 2013) that provides for the possibility of “unproven interventions in clinical practice”. It allows the use, under the responsibility of the doctor and with the consent of the patient or his legal representative, of “an unproven intervention”, when there are no proven treatments or other known interventions have proved ineffective, and after seeking expert opinion on the subject. The doctor must be convinced that this drug could “constitute a hope to save the life, restore the physical integrity or alleviate the suffering of the patient”. The article adds that “this intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information should be recorded and made publicly available when appropriate”. In one of the many drafts of the Universal Declaration on Bioethics and Human Rights of UNESCO, art. 16 of Scientific and Rational Method, after pointing out that every decision and practice should be based on the best scientific information available, stressed that (v) “be considered individually, allowing for the possibility of exceptions to general rules and practices”. The article was then removed from the final version, but it is the sign of a debate within the international community itself. 18  ‘Expanded access’ refers to treatment offered to patients in the absence of other effective treatment, emergency for individual and public health. Nevertheless, the spread of contagion cannot be sufficient to allow compassionate treatment only in these circumstances and thus result as being an advantage for these patients. If one considers the point of view of the person affected by a rare disease, with high mortality but not contagious, the lack of danger of its spread would paradoxically deprive these patients of an opportunity that others instead have in trying a treatment. 17

1.5  Unexperimented Drugs and Compassionate Care

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expressions proposed, in order to avoid this ambiguity, as the expression “non-­ validated treatments for personal and non-repetitive use”, which covers the elements common to the different typologies described. These are exceptional treatments, to which it is possible to guarantee access to patients in the absence of validated alternative therapies, in serious cases of urgency and emergency in life threatening cases, when the existing therapies have been ineffective (both in relation to recovery and improvement of quality of life, but have rather worsened the condition). Access should however be subordinate to a reasonable, robust and solid scientific basis, with data published in international journals, with scientific evidence at least on animal models and possibly with the results of phase I clinical trials. The prescription for these lies with committee of experts (with the evaluation of the ethics committee of the clinic practice, even if non-binding), designated by public healthcare facilities, in conditions of transparency: absence of conflicts of interest, publication both of the composition of the products and the results of the treatment, exhaustive explanation to the patients of the potential dangerousness of non-­ validated treatments, responsibility for the drugs borne by the manufacturers and monitoring carried out by national healthcare bodies. Only under these conditions can “compassionate” treatments be considered ethically licit and be included in the general right to health. The access to unexperimented therapies should not be a ‘hidden’ or ‘fake’ trial, which, by means of the compassionate use, obtains results by bypassing the usual long trial procedures. Furthermore, the access to treatments should not be coercive to the extent that, owing to pandemics, there is danger for public health. The right to treatment should always be balanced with the economic sustainability of healthcare and with medical accountability (insofar as it is the doctor that prescribes and administers the drug). Consent should be suitably informed, covering the uncertainties, the limits to hope and possible harmfulness or even lethalness. Risk-taking should always be personal, not substitutable and conscious.19 The treatment of minors represents a particularly delicate area, and understandably so if requested by parents who persist in removing the imminence of death of their child. Compassionate practices should never be miraculous illusions but need  The expression “compassionate use” can be traced in art. 83 of EC Regulation no. 726/2004, that authorizes individual states to derogate from the Community rules for the marketing of drugs in the event that a group of patients with a chronic, seriously debilitating or life-threatening illness, cannot be treated satisfactorily with an authorized medicinal product. EC Regulation no. 726/2004 was amended by Regulation no. 1394/2007. The latter introduces for the first time the definition of “advanced therapies”, including not only gene therapy and somatic cell therapy, as well as tissue engineered products. The main innovations introduced by the Regulation include: the establishment of an expert committee (Committee for Advanced Therapies), within the European Medicines Agency (EMA); the adoption of new requirements for quality, safety and traceability of the donation, procurement and control; the adoption of new regulatory procedures for classification and certification; support for small and medium businesses with incentives to promote entrepreneurship. In addition, Regulation stipulates that each Member State should standardize the production and use of advanced therapies for individual patients, treated in national public facilities, and therefore not aimed at placing on the market and commercialization.

19

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to be based on scientific reasonableness, so as not to give false hope thus causing even more pain and suffering. Associationism gives important support to families in this sector. The doctor should be recognised as having the possibility to abstain from prescribing drugs or technologies for compassionate use, insofar as, to the best of his knowledge and his own conscience, he considers them dangerous treatments and too risky for the patient (a sort of “experimental obstinacy”). The right to autonomy and professional deontological responsibility prevail over the possible need to guarantee therapeutic continuity. This is not a case of conscientious objection, since the physician does not find himself before a conflict of values or different views on life, but a case of ‘scientific objection’ before the respect of those fundamental principles that are at the basis of medical practice.

References American Academy of Paediatrics  – Committee on Bioethics. (2016). Informed consent in decision-­making in paediatric practice. Pediatrics, 138(2), e20161484. Austrian Bioethics Commission at the Federal Chancellery. (2009). Recommendations with gender reference for ethics committees and clinical studies. Belgian Advisory Committee on Bioethics. (2004). Opinion No. 31 of 5 July 2004 regarding experiments on pregnant and breastfeeding women. Belgian Advisory Committee on Bioethics. (2015). Opinion No. 62 of 12 October 2015 on the ethical implications of the “Statute” of the pregnant partner of a male participant in a clinical trial. Columbia University Institutional Review Board. (2012). Clinical research involving pregnant women. Council of Europe. (1997). Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: Convention on human rights and biomedicine. Council of Europe. (2004). Additional protocol concerning biomedical research. Council of Europe, Committee on Bioethics (DH-BIO). (2012). Guide for research ethics committee members. DeBruin, D. A. (1994). Justice and the inclusion of women in clinical studies: An argument for further reform. Kennedy Institute of Ethics Journal, 4, 117–146. Emanuel, E. J., Grady, C. C., Crouch, R. A., Lie, R. K., Miller, F. G., & Wendler, D. D. (2011). The Oxford textbook of clinical research ethics. Oxford: Oxford University Press. European Commission. (2013). Report from the commission to the european parliament and the council. Better medicines for children – From concept to reality. European Commission ad hoc group. (2008). Recommendations of the Ad hoc group for the development of implementing guidelines for directive 2001/20/ec relating to good clinical practice in the conduct of clinical trials on medicinal products for human use. Ethical considerations for clinical trials on medicinal products conducted with the paediatric population. European Group on Ethics in Science and New Technologies. (2003). Ethical aspects of clinical research in developing countries. European Medicines Agency. (2005b). Guideline on the exposure to medicinal products during pregnancy: Need for post-authorisation data. European Medicines Agency. (2008). Ethical considerations for clinical trials on medicinal products conducted with paediatric population.

References

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European Medicines Agency. (2012). General report on the experience acquired as a result of the application of the paediatric regulation. European Medicines Agency. (2016). Guideline for good clinical practice. European Medicines Agency (EMA). (2005a). ICH  – Gender considerations in the conduct of clinical trials. Franconi, F., Brunelleschi, S., Steardo, L., & Cuomo, G. (2007). Gender differences in drug responses. Pharmacological Research, 55(2), 81–97. French National Consultative Ethics Committee for Health and Life Sciences. (2003). Disparity in access to health care and participation in research on a global level – Ethical issues. Health Canada. (2013). Guidance document: Considerations for inclusion of women in clinical trials and analysis of sex differences. International Conference on Harmonisation (ICH). (2004). Sex-related Considerations in the Conduct of Clinical Trials (revised in 2009). International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). (2000). E 11: Clinical investigation of medicinal products in the paediatric population. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). (2016). Addendum to E 11: Clinical investigation of medicinal products in the paediatric population (Step 1 version). Italian Committee for Bioethics. (1992a). Ethics committees. Italian Committee for Bioethics. (1992b). Drug experimentation. Italian Committee for Bioethics. (2008a). Pharmacological trials on women. Italian Committee for Bioethics. (2009). Information and consent related to medical acts, bioethical problems in clinical trials with non-inferiority design. Italian Committee for Bioethics. (2010a). Secrecy in drug regulatory system procedures. Italian Committee for Bioethics. (2010b). The improper use of placebo. Italian Committee for Bioethics. (2011). Pharmacological trials in developing countries. Italian Committee for Bioethics. (2012). Clinical trials in adult or minor patients who are unable to give informed consent in emergency situation. Italian Committee for Bioethics. (2017). Migration and health. John Hopkins University Center for Communication Programs. (2003). The gender guide for health communication programs. Marshall, P. (2007). Ethical challenges in study design and informed consent for health research in resource-poor settings. Geneva: World Health Organization. Mattison, D.  R. (2004). Sex matters in pharmacology: Principles of pharmacology for women. In P. C. Leppert & J. F. Peipert (Eds.), Primary care for women (pp. 112–117). Philadelphia: Lippincot Williams and Wilkins. Merton, V. (1996). Ethical obstacles to the participation of women in biomedical research. In S. M. Wolf (Ed.), Feminism & bioethics. Beyond reproduction. Oxford: Oxford University Press. Miller, V. A., & Nelson, R. M. (2006). A developmental approach to child assent for non therapeutic research. Journal of Pediatrics, 149, S25–S30. Neves, M. P. (2009). Respect for human vulnerability and personal integrity. In H. ten Have & M.  Jean (Eds.), The UNESCO universal declaration on bioethics and human rights. Paris: UNESCO. Nuffield Council on Bioethics. (2005). The ethics of research related to healthcare in developing countries. A follow-up discussion paper. Nuffield Council on Bioethics. (2015). Children and clinical research: Ethical issues. Sherwin, S. (1992). No longer patient. Feminist ethics and health care. Philadelphia: Temple University Press. Sherwin, S. (1994). Women in clinical trials: A feminist view. Cambridge Quarterly of Healthcare Ethics, 3, 533–538. The American College of Obstetricians and Gynecologists. (2015). Ethical considerations for including women as research participants. Opinion n. 646, Committee on Ethics.

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The Society for Women’s Health Research-United States Food and Drugs Administration Office of Women’s Health. (2011). White paper on dialogues on diversifying clinical trials. Successful strategies for engaging women and minorities in clinical trials. U.S.  Department of Health and Human Services, Public Health Service, National Institutes of Health, Office of Research on Women’s Health. (2011). Enrolling pregnant women: Issues in clinical research. U.S. Food and Drug Administration. (1993). Guideline for the study and evaluation of gender differences in the clinical evaluation of drugs. U.S. Food and Drug Administration. (2013). FDA report. Collection, analysis, and availability of demographic subgroup data for FDA-approved medical products. U.S. Food and Drug Administration. (2016). Collection of race and ethnicity data in clinical trials. U.S. Government Accountability Office. (1992). Women’s health: FDA needs to ensure more study of gender differences in prescription drugs testing, HRD-93-17. U.S. Government Accountability Office. (2001). Women Sufficiently represented in new drug testing, but FDA oversight needs improvement, GAO-01-754. U.S. National Academy of Sciences (Committee on Clinical Research Involving Children). (2004). Ethical conduct of clinical research involving children. U.S.  National Academy of Sciences (Committee on Paediatric Studies-Institute of Medicine). (2012). Safe and effective medicines for children. U.S. National Bioethics Advisory Commission. (2001). Ethical and policy issues in international research: Clinical trials in developing countries, report and recommendations, Bethesda, Maryland (Vol. I). U.S. National Institute of Health. (2001). NIH policy and guidelines on the inclusion of women and minorities as subjects in clinical research. U.S. National Institutes of Health. (2016). Research involving children. U.S. Presidential Commission for the Study of Bioethical Issues. (2013). Safeguarding children. UK Medical Research Council. (2004). Medical research involving children. UNESCO. (2005). Universal declaration on bioethics and human rights. Wendler, D.  S. (2006). Assent in paediatric research: Theoretical and practical considerations. Journal of Medical Ethics, 32, 229–234. Wizemann, T.  M., & Pardue, M.  L. (2001). Exploring the biological contributions to human health: Does sex matter?, Committee on understanding the biology of sex and gender differences. Washington (DC): National Academy Press. Working Party of Research Ethics Committees in Germany. (2010). Ethische Aspekte der pädiatrischen Forschung. World Health Organization (WHO). (1995). Women’s Health: Improve our health, improve our world (WHO Position Paper, Fourth World Conference on Women). World Health Organization (WHO). (1998). Women’s health and development family and reproductive health, gender and health: Technical paper. World Health Organization (WHO). (2002). Handbook for good Clinical Research Practice (GCP) guidance for implementation. World Health Organization (WHO). (2010). Gender, women and primary health care renewal: A discussion paper. World Health Organization (WHO). (2011). Standards and operational guidance for ethics review of health-related research with human participants.

Chapter 2

Biobanks and Ethics Committees

2.1  Research and Biological Samples Experimentation is almost always strictly connected to the use of biological samples and to biobanks. Experimentation of drug on human beings generally imply the research on biological samples and their genetic materials. It is not easy to find a clear definition of “biobanks” or “biological/gene banks”. This expression usually indicates operative service units, assigned to collect, preserve, classify, manage and distribute human biological materials, biological samples or human body parts (cells, tissues, DNA) donated by individuals or groups of healthy or sick individuals, for biomedical purposes (research, diagnosis, prevention or treatment), inside hospitals or research centres. Biobanks also provide for the collection of information (i.e., a range of data: personal, genealogical and clinical) and data storage into a computer to facilitate their rapid retrieval, as well as data connections, comparisons and updates. Biobanks, therefore, consist of biological samples and (individual and collective) associated data/information. These structures have been embedded in an increasingly wider dimension, also with regard to populations related to national and international dimensions. It is easy to imagine the huge interest in such valuable resources for biomedicine, however, it is equally possible to foresee problematic scenarios that may arise. Given the rapid and relentless development of knowledge in genetics, it is considerably important for scientists to collect human biological and genetic material (especially a wide range of records allowing them to study variability factors), in order to continue conducting research and clinical trials, to discover new drugs, new diagnostic methods, alongside preventive and therapeutic possibilities. Carrying out an ethical reflection on the limits of acceptability of the use of human biological material has emerged as important, in the light of the values at stake: scientific progress, the dignity of the body and its parts, personal identity, autonomy, privacy, the collective good, justice and solidarity. This reflection should © Springer Nature Switzerland AG and G. Giappichelli Editore 2019 L. Palazzani, Innovation in Scientific Research and Emerging Technologies, https://doi.org/10.1007/978-3-030-16733-2_2

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also consider the ways of providing for legal regulations governing the behaviours of citizens at national and international levels. As so often in recent decades, during which we have witnessed an increasingly rapid evolution of science and technology in biomedicine, practices—that are progressively taking shape, being consolidated and enhanced, alongside progress— stimulate the bioethical discourse triggering a pluralistic debate. Ethical pluralism delays and hinders biolegal regulation, looking for standards targeting all citizens. The regulatory slowdown creates, in fact, a ‘far-west’ situation or the emergence of occasional, temporary, fragmentary rules (soft laws). A vicious circle that tends to repeat itself, resulting in negative effects on science, society, individuals. This is what is happening today with biobanks where there is a lack of a systematic, overall and global regulation or the existence of a not sufficiently balanced regulatory system, with respect to the different requirements at stake, involving science, individuals and society. The main ethical challenge is the status of detached human body parts, between individual rights and duties of solidarity. Biological and genetic samples are parts factually detached from the human body, but closely related, at the informational level, to the identity of the subject from which they originate. This raises a preliminary philosophical question: what relationship exists between the body and its detached parts? Can we speak of bodily cells and tissues? Are biological samples available? Who has the ownership: donors, researchers, biobanks, society? In what ways, to what extent and with what obligations? In order to answer these questions, we need to go back to the anthropological notion of the body within the context of the overall relationship between science, individuals and society. Several possible paths have been envisaged in bioethical reflection and biolegal practices. The liberal-libertarian view grounded in an individualistic anthropological concept, which features a strong focus on the subject and his autonomy or self-­ determination, paves the way to the ‘availability’ paradigm. In the context of regarding the body as a biological object (reduced to mere matter), the biological samples removed from it are considered molecular aggregates and, combined with the related informational data, they ‘belong’ to the person who owns them. The subject ‘has’ his/her body, ‘has’ biological samples/informational data. The subject considers the body and its parts/data, as objects of ownership. The body/object is not a constraint or a limit to human’s action. A human being is free to dispose of it, in a self-referential, arbitrary manner. He can confer value upon it; he can protect it for extrinsic, conventional or prudential reasons; he can use it and exploit it. The body, as well as its parts/data, become usable objects in this perspective. The libertarian argument, the most radical one, claims that the body, as its parts, are objects giving rise to property rights. As such they can be transferred, but also sold or purchased (to/from biobanks) based on self-determined choices, according to free market competitive logic and contractarian logic of exchange and transition. The donor, it would be better to say the ‘giver’, can receive direct compensation (not only an indirect remuneration, for expenses incurred) for its ‘bestowal’. Through

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this act property would be transferred totally in the hands of researchers and the biobank that could legitimately benefit from its economic exploitation, even reaping financial advantages in relation to intellectual property and patentable inventions, according to the logic of utilitarian benefits. Following this approach, the body is exposed to the risk of manipulation and exploitation by the individual himself or other subjects. The body and its parts, reduced to ‘means’, no longer an end, have a ‘price’, and lose their dignity. But, above all, the subject runs considerable risks, given the close correlation between material parts and informational data. There are possible forms of discrimination, insofar as the biobank allows access to data and information to third parties, insurers or employers. Moreover, the expropriation of the subject of a part, albeit detached, of himself and appropriation by researchers, leads the latter into economic and trade “temptations”, with purposes significantly far from those of medical research. The recognition of property rights of these facilities would trigger a competitive mechanism between biological banks to collect tissues and related research funding. Hence, the option of recognizing property rights of biobanks or researchers would legitimize a complete ‘alienation’ of donors from research and scientific advances aimed at improving community wellbeing. The more moderate form of liberal approach draws a distinction between ownership (as an economic category) and transfer (as a legal category), arguing that the availability is limited to transferring body parts and related data, but not to sell them. The donor does not donate in the proper sense, but detaching a part of the person’s body, he may decide to transfer it to a structure, retaining the right to ­constantly and continuously control it. It is necessary to be regularly and specifically informed about research places and timelines, the use and results obtained (the so-­called restricted informed consent), requiring a re-expression of consent whenever research changes its core focus, revoking the transfer, at any time, while claiming the destruction of the material sample and the cancellation of informational data, to preserve and avoid disclosing to others the knowledge gained (even to family members or society and if this might involve their interests). This perspective emphasizes the importance of privacy, confidentiality and secrecy, setting individual rights above collective interests, thus, inevitably undermining scientific research. Progress would be subject to individual will resulting in the impossibility of obtaining informed consent, given the inherent unpredictability of research, due to the constant dynamic evolution pertaining to scientific research. Researchers are not always able to provide donors with a complete and detailed picture of the possible future uses of the biological material (in relation to the type of research and its timelines), at the time of collection. Moreover, donors do not have adequate knowledge to understand such specialized information. The biobank itself, as third party with respect to the researcher, can transfer a part of the samples and related information to external researchers, even in the future, for research purposes. The option of assuming the duty to re-contact donors would create excessive bureaucracy, while the possibility of a sudden interruption of the availability of samples would jeopardize the planning of research activities requiring a significant amount of permanent data stored for long periods of time.

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The two paths (the libertarian and the liberal), moving in the direction of the claim of ownership and privacy, are both an expression of the individual’s right to autonomy, meant as protection, in the negative sense, of non-interference or ­intervention by third parties (state, society) in the public dimension and as protection, in the positive sense, of the sphere of individual freedom. Ownership is individual autonomy with regard to the owned good (the biological sample in a material sense); privacy is intended as individual autonomy in relation to subjective identity (the biological sample as data, in the sense of information). These trends show—albeit through different ways and arguments—a poor and marginal interest in the community. The protection of property and confidentiality prevail over social needs. The self-determination of individuals in the management of samples/data outweighs the interests of society. It is up to individuals to decide, arbitrarily, on goods to be deemed valuable for scientific advancements and public health improvement. An individualistic stance, according to which individual will has a central role. Individuals are relieved of responsibility towards others, they decide for themselves, having no restrictions and obligations whatsoever to contribute to scientific and social progress (also in the event of a minor or even lacking interest in one’s sample). It deals with balancing the relationships between individual and social interests within the context of a different anthropological concept of the body and its parts, both in the material and information sense. In the framework of the phenomenological view, a de facto distinction between bodily subjectivity and objectivity comes to the fore yet alongside, in principle, the non-distinction in the body between object-body and subject-body since they are naturally integrated in the human being, as constitutive elements. The extended and measurable body, that one sees and touches, is distinguishable from the human subject that expresses himself through the body. The phenomenology of the body enables us to give an account of the co-­ extensiveness of personal subjectivity and biological corporeity. We ‘are’ our bodies; we are ‘embodied’ beings. We are our bodies, our cells, tissues and organs. The body/subject we feel under our skin, is also body/object. The coexistence of objectivity and subjectivity, to be and to have, is the paradox, but also the peculiarity of our humanity. Of our bodies we can say to “be” and to “have” a body as inextricably tied up, being the inseparable point of convergence of somatic and psychic processes. On these grounds, the personalist perspective recognizes the human body’s personal status in its synchronic and diachronic dimensions, considering the body as a manifestation of subjectivity as a whole (which is more than the sum of its parts) and in its parts. In this perspective, also the parts removed from the body retain a structural link with the subject. Every part of the body, including tissues and cells, maintain a close (genetic) relationship, after their detachment, with the original body and its identity. Detachment enables their separation and distribution, yet belonging, in principle, to individuals on the genetic level, connected with and inseparable from the body where they come from. In this sense, a constitutive relationship of belonging stems

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from the body and its parts. This does not, of course, imply that body parts have the same dignity of the body, as an expression of the person’s subjectivity, but that even if detached from it, thus no longer part of the organism as a whole, they are not reducible to mere waste material, as a whatever thing (res) available according to one’s needs. In short, in this view biological samples are not only molecular aggregates, but also biological matter conveying personal identity, at least at the information level. Recognizing genetic data’s importance and significance does not imply sharing an approach of biological reductionism, according to which individuals identify with genetic information. It is appropriate to recall the complexity of the human being, whose genetic phenomenology is shaped by a number of factors. Each subject is determined by the interaction of multiple elements, which give rise to comprehensive characteristics, irreducible to the sum of its parts or components, or to the underlying rules governing their interactions. Individuals turn out to be the result of the interaction of historical aspects, social and cultural relations. This interpretation leads us to consider them as not reducible to their single components, therefore, their worth is greater than the sum of the parts. The personalist approach focuses on the subjective status of the body, within the context of recognizing the value of responsible freedom and solidarity. The personalist anthropological view considers human being  as a constitutively relational being, placed in a co-existential relationship. His freedom cannot be a purely self-­ referential act. Every human being lives inevitably ‘with’ others; alterity precedes us, as we are born from others, whilst being the constitutive condition of our identity: we live in the family, in society. According to this interpretation, freedom falls within a universal perspective that allows us to understand the true meaning of freedom in relation to the responsibility dimension. We must give up our ‘entire’ freedom, if freedom is to belong to ‘all’. This perspective justifies overcoming self-referential individualism, while recognizing the body as a limit and duty, in the direction of a conscious involvement in taking responsibility and promoting solidarity towards society and future generations that may benefit from scientific research developments. This line of thought justifies donation, in its proper meaning, as a spontaneous, supererogatory, free and impartial act, giving to others according to an asymmetrical and non-reciprocal logic, without calculating benefits and trade negotiations, but offering to others for their own good. In this context, there is an emerging need for a framework to regulate the use of biological samples, saving them from individual will, in order to protect their social and scientific value. Overcoming the limits of individualism is marked by the transition from the ‘ownership model’ to the ‘custody model’, according to which, at the time of transfer, samples no longer belong either to individuals or researchers, but become part of the ‘community heritage’, ‘commons’ or common good, removed from individual will, in order to optimize scientific research, corresponding to social good. In this sense, body parts, as well as the body, are available to the subjects for donation purposes. This perspective is articulated in a set of bioethical theories: virtue ethics, recognizing the duty of a constant and active commitment to each other; caring ethics,

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identifying ‘care’ as empathy, regard and concern for others; responsibility as a synchronic (global) and diachronic (intergenerational) moral principle and obligation; communitarianism which re-thematizes the common good; the egalitarian theory of justice acknowledging the good of all as a priority. These are theories that, despite the conceptual differences, fall in the ‘communitarian turn’, i.e. the anti-individualistic theoretical breakthrough. Another term has been recently appearing in literature to define these peculiar repository facilities, considered more appropriate than the one commonly used for biobank: “research bio-repository”. This neologism aims at overcoming the consequences of a metaphor, such as that of “bank” which implies a negative connotation linked to the purpose of realizing a profit or gain, that proves to be not in line with the solidarity goals set by these facilities. Different approaches are outlined, also in this context. A donation and altruistic approach, in the strong sense, requiring individuals to give up any form of control over their donated goods. This sense of solidarity is expressed through free and inherently unselfish donation. Donating biological samples for research purposes means giving up little or nothing of oneself, in view of a possible future good for the many, without asking or expecting anything in return. This approach is in favor of a ‘blanket consent’, at the time of donation. An a priori donation which does not entail being aware of future research options or receiving information on research outputs likely to have preventive, diagnostic or therapeutic effects for donors. An availability to complete anonymization is also provided for, separating samples from related data. It moves beyond the exchange-­ based logic of contractualism and the instrumental mutual benefit argument of utilitarianism, while achieving a final and irreversible donation and solidarity-based logic, directed to individuals, as well as present and future society, giving up on personal benefits. This is a perspective that ends up forgetting individuals, while enhancing solidarity and altruism, with a series of negative consequences for human subjects and research itself. Concerning individuals, they are excluded from research possible fruitful outcomes in diagnostic, preventive and/or therapeutic terms. Regarding research, the researchers can not correlate samples to personal, clinical and health data, which is essential for advancement of knowledge. Some criticize this donation system defining it a ‘misinformed naivety’ and suspect that the exaltation of an unselfish logic, alongside the concern for a complete anonymization, such as deletion of personally identifiable information, are inspired by a hidden desire to stimulate the market. One should recall that human cells and tissues can also be used when studying and implementing advanced regenerative therapies and biopharmaceuticals, which could lead to substantial gains by pharmaceutical companies discovering, patenting and marketing such ‘therapeutic products’. Paradoxically solidarity is likely to conceal commercialization. Donors would become free sources of cells and tissues that, once exploited by pharmaceutical companies, could turn into biopharmaceuticals targeting the same donors, as possible users in the competitive market. Donors would be expropriated from any role, control activity and opportunity to claim interests through anonymization. Biological

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materials would be ‘abandoned’ and undergo undue appropriation by market operators. It is, thus, important to seek a balance between the needs of the person and society, the necessity to protect the dignity of the body as a non-marketable good and advocate the value of scientific developments to advance social good, avoiding the annihilation of society for the individual and of the individual for society. The value of a human being should always take priority over scientific progress, such a principle being frequently upheld in international regulations. This balance can be achieved by favoring the collective dimension from a “participative” and “democratic” point of view, without neglecting the donor/person. The “participatory-democratic” model thematizes the need for a dialogic and aware donation. This participatory dimension related to research is possible through appropriate counselling, allowing donors to freely and consciously express informed consent, without direct and indirect incentives, as a result of the description of possible risks and damages.

2.2  Biobanks and Informed Consent Biobanks should report transparently to donors on the methods and goals set for the use of samples, drawing a clear distinction between research and therapeutic applications. Transparency is an essential condition for gaining the trust of donors. Information should concern the places, timelines and potential research options, while retaining flexibility, guaranteed by a direct or indirect connection with the initial research. A free choice regarding the type of consent (i.e. multi-layered consent) may be envisaged for donors, at the time of donation, as long as the subject is aware of the moral value and consequences of his/her choices. The option for a specific consent or restricted to specific research activities and deadlines, falling within the ‘forms of concession for use under certain terms’, enables a greater control over samples, the type of research and storage duration for materials, but hinders certain options and potential developments of research itself. Concerning restricted consent, any change with regard to its goals involves requesting a new consent, entailing a risk of excessive bureaucratization and proceduralization in research processes. Moreover, restricted consent confines the use of samples to specific research activities, also with a limited number of cases involved. The option of a broad or general consent (i.e. ‘real, definitive and irreversible donation’), which encompasses unspecified types and indefinite timelines, fosters freedom of research, at the cost of giving up individual control. A choice in favour of a partially-restricted consent— allowing research directly or indirectly connected with agreements—turns out to be the most balanced choice, as it accommodates a reconciliation of individual and social needs. What should also be guaranteed, in order to achieve a dialogic and participatory approach to consent, is the detection of a possible explicit dissent with

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regard to specific research activities donors may refuse on moral and/or religious grounds. The choice of donors should be free even in relation to partial identifiability/ anonymization, the so called ‘codification’ or ‘pseudonimization’ (in the European General Data Protection Regulation), and complete anonymization. They should also be given an explanation of the advantages/disadvantages of each option. On the one hand, identifiability enables researchers to perform an immediate correlation between research/clinical data, exposing the subject to possible abuse of personal information; on the other hand, complete anonymization protects privacy, but impoverishes research, since it does not allow a comparison of samples with the medical history of the subject, whilst eliminating the possibility for the latter to know research findings, both expected or unexpected, related to his/her personal condition. Partial anonymization, involving a traceability system based on a confidential code available to researchers, facilitates, on one hand, the protection of confidentiality of donors, along with their right to be informed (if desired) about any discovery related to their health condition stemming from research activity; on the other hand, it leads to research developments. Donors should be granted the opportunity to withdraw or access samples/data, and to be assured of their physical destruction or information deletion, if desired. The possibility of withdrawing consent, on one side, undermines research, depriving research of statistical numbers, on the other, it is vital to building up trust and enhancing involvement in research activities. A limited access to data should be ensured, in order to protect the privacy and confidentiality of individuals and their families. Data protection is expected to prevent the risk of a possible use of the information for discriminatory purposes (i.e. in the field of insurance or employment), minimizing the possibility that stakeholders other than donors, family members, researchers and the scientific community might access personally identifiable information collected and stored for scientific purposes. Genetic discrimination is a possible consequence of privacy violation of genetic information belonging to individuals to whom data relates. Those responsible for managing biobanks, therefore, play a pivotal role. They shall take all appropriate measures to prevent the misuse of confidential information and genetic data, alongside ensuring effective monitoring action. Among the foreseeable measures, it is essential to provide for proper registration, storage and a secure system of records related to data in print or electronic format, with code-secured procedures. Donors should be informed of expected or possible unexpected results, with regard to genetic information relating to the diagnosis of ongoing diseases, the susceptibility/predictability of possible future diseases, also involving family members. The subject should express by consent his/her willingness to know or not know this information (in the case of adults), provide an authorization to disclose or not disclose those results to family members. It should be ensured that physicians have the opportunity of a discretionary assessment as to whether and how to communicate any information, even apart from the will of the donor, to the subject/family

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members, depending on the possibility of preventive and/or therapeutic interventions or reproductive choices. The establishment of an ethics committee in each biobank, in charge of supervising research ethical conditions and carrying out surveillance on ethical standards, alongside compliance with donors’ consent and will, is considered essential. The key requirements for setting up such a structure is expertise, high standards of quality and adequate staff training. Regarding ‘historical collections’, or occasional sample collections of remaining biological material obtained from diagnostic and therapeutic interventions, the chance to use this heritage for research purposes is advisable. In this case informed consent is generally not given and difficult to be tracked retrospectively, re-­ contacting donors, due to organizational problems in getting back to them. These collections of biological samples are suitably not to be managed according to the current criteria, provided that the ethics committee recognizes the significance of the research activity, the impossibility to conduct research without the samples, thereby avoiding harm to the interests of donors, retaining anonymization, ensuring there is no explicit objection to donation. Samples deriving from minors or those incapable of expressing consent, can be used only if the research project is directly related to the health condition of the subject, it does not expose subjects to risks and burdens and it brings about possible benefits. The legal representative has expressed consent or, if possible, the subject himself. Donors should be informed about any possible commercial exploitation of the product and about the fact they are not allowed to earn profits. It is important that citizens’ awareness is raised and their education adequately provided for, in order to understand the scientific value of collecting samples based on a perspective of civic solidarity. Pluralism dominates the bioethical debate, involving liberal-libertarian, solidarist or intermediate models aimed at balancing individual protection with promoting the common good. Ethical pluralism reverberates in the approaches outlined in biolaw. The US case-law initially favoured ownership rights over biological samples. One should recall the case of Mr. Moore dating back to the late 80s but also, most recently, the case of Dr. Catalona in 2006. In this context, research interests are put before individuals’ interests, therefore, privileging the interests of the market in general, either by assuming the abandonment of the samples or through recognition of intellectual property rights, ousting individuals from the fate of their samples. A set of opposite orientations are to be found in some European regulatory stances, that have placed a specific focus on the protection of individuals’ privacy rights. The fate of tissues tends to be closely linked to the future of data, as mere material objects owned by the subject. The management of the material tissue is embedded in the relationship between the subject and personal data contained in the tissue. The sample becomes a mere data support, belonging to the subject. This

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leads to a shift from ownership rights (with regard to the sample intended as matter) to the right to privacy and self-determination (concerning dematerialized data).1 Despite some conflicting orientations, a number of common regulatory stances may be devised, at the international level: the recognition of non-marketability of the body and its parts (not to be degraded to a mere source of profit), the primacy of the good of man and society in connection with freedom of scientific progress, the protection of privacy and genetic information non-discrimination, informed consent and transparency. This is the orientation of the main norm, such as: Council of Europe, Convention on Human Rights and Biomedicine, 1997; Directive on the Legal Protection of Biotechnological Inventions, 1998; Charter of Fundamental Rights of the European Union, 2000. At the regulatory level, the existence of a biolegal approach aimed at highlighting the overcoming of individualism in the direction of solidarity, is increasingly clear. In the perspective of a participatory and democratic dimension, the subject is invited to consciously participate in research projects, in order to actively engage in biobank governance. This field is giving rise to new regulatory schemes governing the relationships between donors, researchers and facilities, with regard to trust aspects, aimed at the protection of collective or public interests, with the purpose of enhancing solidarity and sharing. ‘Donation agreements’ and ‘charitable trusts’ are an example of such tools.2 A donation agreement is a formal act of donation whereby the donor expresses his/her willingness to donate, under conditional or unconditional terms: the former provides for an unfettered use of biological materials; the latter sets a number of restrictions falling within the subject’s discretion. In the case of a charitable trust, individual interests in tissues are entrusted to a fiduciary (trustee) that, on one side, holds individual rights and, on the other, is accountable by mandate for the use of the property to the benefit of others (other current or future patients, or society in general), according to the agreed purposes. The trustee has a duty of transparency in handling the goods received. The donor engages in the activities and objectives of the donated goods. Thus, this regulatory scheme combines individuality and solidarity elements of public and private interests. In this sense, the expression “participatory turn” refers to a biobank governance with an “open” approach. The notion of benefits sharing (already part of the bioethical language with regard to plant or agriculture biotechnologies, as well as in the field of genetics research) and the reference to open data applied to biobanks express the need to compensate, in a reciprocity perspective, participants involved in scientific research for their donation. If one considers the human genome as “common heritage of mankind”, public sharing of research findings, along with the benefits 1  The Recommendation 2006/4 of the Council of Europe on research on biological materials of human origin and the Italian Data Protection Authority, General Authorization for the processing of genetic data (2007), both move in this direction. 2  Council of Europe (CoE) (2016) and European Commission (2012). See also: French National Consultative Ethics Committee for Health and Life Sciences (2003) and Italian Committee for Bioethics (2006, 2009, 2014).

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stemming from research on biological materials, intended as valuable resources for humanity as a whole, becomes inevitable.3 It is a humanistic-centred view ­recognizing genetic data as a global public good, emphasizing the negative effects deriving from a solipsistic closure. Research actors or stakeholders (pharmaceutical companies, sponsors, industries), as well as researchers, should separate research from economic interests, or should invest at least part of profits in services and research activities for the benefit of the community. The “return of benefits” should target not only individuals engaging in research activities, but also humankind as a whole, through different tangible forms: technology transfer, access to medical treatments or research-developed drugs, healthcare. Education—despite ongoing progress—is still inadequate, fragmented and diverse in this area. A regulatory delay is strongly perceived in the face of a discordant development of practices, given the lack of common standards. There is a growing need to seek common ground to achieve a regulatory harmonization, due to a phenomenon which is increasingly assuming an international, if not global, dimension.4

2.3  Ethics Committees or Institutional Review Boards Ethics Committees5 have for some time now been set up in healthcare research facilities as places for interdisciplinary and pluralistic debate, aimed at the evaluation of experimentation, clinical practice and research. This phenomenon appeared spontaneously and was only regulated and institutionalized later, at least in some areas (above all after the Belmont Report, 1978). Generally speaking, the committees have a twofold function: the evaluation and/or consultation and the training of operators in the facility where they work. The committees for clinical trials6 are made up of experts in the medical field with specific competences also in relation to the type of protocols being analysed,  At the international level, the concept of benefit sharing is found in the Universal Declaration on the Human Genome and Human Rights of UNESCO (1997) which states that the main goal of studying the human genome (generally speaking, the applications in biology, genetics and medicine) is to improve the health of individuals and humankind as a whole (Art. 12) according to the principle of solidarity (Art. 17). UNESCO reiterates the importance of benefit sharing also in the International Declaration on Human Genetic Data (2003) which sets forth that benefits resulting from the use of human genetic data of biological samples collected for scientific research should be shared with society as a whole and the international community (Art. 19). 4  Cambon-Thomson (2004), pp. 866–873; Dabrock et al. (2010); Dierickx and Borry (2009); Elger et al. (2008); Hansonn (2001); Knoppers (2006). 5  Italian Committee for Bioethics (1992, 1997, 2017). 6  A change is taking place in the regulation of committees for experimentation with the implementation of EU Regulation No. 536/2014 of the European Parliament and of the Council of 16 April 2014 on the clinical trials of drugs for human use and which repeals directive 2001/20/EC. Cfr. Italian Committee for Bioethics (2015). 3

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with experts in scientific, clinical, medical, ethical and juridical subjects.7 There are regional ethics committees which act as single ethics committee or committee of reference and supervision and local ethics committees. The task of the committees for the evaluation of clinical experimentation is the analysis and discussion of protocols with the aim of safeguarding the health and wellbeing of patients, according to ethical values and principles and in conformity with national and international regulations. The committee should be independent with respect to the facility to which it belongs and its members should always declare possible conflicts of interest at the moment of the evaluation. It is not possible to carry out any experimentation on human beings without the approval of an ethics committee, with the evaluation of proven scientific facts, feasibility, respect of norms and ethicality. The committee also examines the informed consents and the privacy requirements. During the experimentation phase, the ethics committee has the obligation to check the progress of the research, monitor the adverse events and maintain relations with the public organisms which by law must be informed of the existence and the state of the studies. This part of the monitoring represents the most critical time owing to the difficulty in the correlation with the researchers conducting the trial. The local ethics committee must also ensure that the patient has an adequate insurance cover, is not subject to any additional expenditure should they decide to volunteer to enrol in a clinical trial and that any reimbursements and payments are reasonable. The committee can approve a trial or suspend it definitively or temporarily: the opinion is binding for the investigators. The application of the Regulation No. 536/2014 of the European Parliament and of the Council of 16 April 2014, on Clinical Trials on Medicinal Products for Human Use inevitably leads to a reduction in the number of committees, a considerable increase of work and the need for national and international coordination. Jointly or separately, the committees for clinical practice were also created. Set up by spontaneous initiative, with no specific regulation and without any coordination, an increase in trend can be seen of their institutionalisation owing to the increase of ethical issues emerging from practice and an ever greater need for qualified experts for their evaluation. In these last decades significant changes have occurred within the context of biomedical research. The vague boundaries between research and practice (see the compassionate use), the emergence of new vulnerabilities, the potential harms to communities, the importance of transparency. These issues need to be taken into consideration by ethical committees, considering the evaluation process dynamically.8

7  The committees are made up of at least two clinicians, a general practitioner, a biostatistician, a pharmacologist, an expert in juridical-insurance matters or a medical examiner, a nursing representative, a volunteering representative, a chemist, the chief medical officer (the IRCCS scientific director) and an expert of ethics. 8  Friesen et al. (2017).

References

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In the context of clinical ethics, the ethics of the consultation is essential, also in consideration of the increasingly extensive and complex relationship between patients and doctors in the light of techno-science developments. Ethical consultancy can be given not only by means of clinical ethics committees but also by ethics consultants, bioethicists who are employed by the healthcare facilities. This is an activity that can be carried out autonomously and/or be integrated with the ethics committees, as a service in the healthcare facility. The consultants make it possible to discuss the cases ‘at the patient’s bedside’, with their family too; while the committees offer a reflection generally maintaining a critical distance from the case by means of an interdisciplinary internal exchange, with a constant interaction with the attending physician and external experts. By means of committees or consultants, clinical ethics allows a mediation between patients and doctors, supports both in the search for a solution to complex problems arising in the context of the assistance to patients and therapeutic practice, in relation to delicate situations with subjects in conditions of particular vulnerability. Committees and consultants do not overlap, nor do they substitute medical accountability. The clinical ethics committee and the consultants can give a non-­ binding orientation. There remains the still not fully debated problem of the configuration of the profession of the ‘ethics expert’ or ‘bioethicist’, essential to be able to have the bases of a definition of such competence in clinical consultancy. Along with the ethics committees for clinical practice, committees for research ethics are also appearing, not necessarily only biomedics but from every area of knowledge. In the context of the proliferations of initiatives, the European Code of Conduct for Research Integrity of the European Science Foundation-All European Academies (ESF-ALLEA) issued in 2011 is of great importance. The document identifies the ethical principles of conduct in research without making any reference to research (therefore applicable to any context of both scientific and humanistic disciplines) and the practices that encourage a ‘good’ conduct in research: honesty, diligence, reliability, objectiveness, impartiality, independence, absence of conflicts of interest, transparency, openness, accessibility, effectiveness, efficiency, cooperation, competence, updating and knowledge diffusion. The task of the committees is to evaluate the internal protocols of research and contribute to improving the ethical conditions for research at both the consultation and education levels.

References Cambon-Thomson, A. (2004). The social and ethical issues of post-genomic biobanks. Nature Reviews Genetics, 5, 866–873. Council of Europe (CoE). (2016). Recommendation CM/Rec(2016)6 of the committee of ministers to member states on research on biological materials of human origin. Dabrock, P., Taupitz, J., & Ried, R. (2010). Trust in biobanking: Dealing with ethical, legal and social issues in an emerging field of biotechnology. Dordrecht: Springer. Dierickx, K., & Borry, P. (2009). New challenges for biobanks: Ethics, law and governance. Cambridge: Intersentia Publishers.

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Elger, B., Mauron, A., Capron, A. M., & Andorno, R. B. (2008). Ethical issues in governing biobanks. Global perspectives. London: Ashgate Publishing. European Commission. (2012). Biobanks for Europe. A Challenge for Governance. Report of the Expert Group on Dealing with Ethical and Regulatory Challenges of International Biobank Research. French National Consultative Ethics Committee for Health and Life Sciences. (2003). Ethical issues raised by collections of biological material and associated information data: “Biobanks”, “Biolibraries”. Friesen, P., Kearns, L., Redman, B., & Caplan, A. L. (2017). Rethinking the Belmont Report. The American Journal of Bioethics, 17(7), 15–21. Hansonn, M. G. (Ed.). (2001). The use of human biobanks. Ethical, social, economical and legal aspects. Uppsala: Uppsala University. Italian Committee for Bioethics. (1992). Ethics committees. Italian Committee for Bioethics. (1997). Ethics committees in Italy: Recent issues. Italian Committee for Bioethics. (2006). Biobanks and research on human biological material. Italian Committee for Bioethics. (2009). Collection of biological samples for research purposes: Informed consent. Italian Committee for Bioethics. (2014). Paediatric biobanks. Italian Committee for Bioethics. (2015). Motion on the implementation of regulation (E.U.) no. 536/2014 of the European Parliament and the Council of 16 April 2014, in the subject of clinical trials on medicinal products for human use, repealing directive 2001/20/EC. Italian Committee for Bioethics. (2017). Clinical ethics committees. Knoppers, B. M. (2006). Biobanks: New challenges for bioethics and biolaw. Iustitia, 1, 47–53.

Chapter 3

Emerging Technologies and Health

3.1  Research in Neuroscience and Neurotechnologies The exponential growth of neuroscience opens up new opportunities for knowledge and its application on human being, forcing us at the same time to rethink some traditional categories of ethical and legal thought, such as freedom, responsibility, conscience, will, intention. It gives rise to a new discipline, called neuro-ethics as the ethics of neuroscience and the neuroscience of ethics. Neuroethics is referred to as the area of bioethics that focuses attention on relevant aspects emerging from neuroscience and neurotechnologies.1 Neuroscience encompasses neurology, in addition to neurosurgery, psychiatry and psychology, as well as a series of scientific disciplines (neuroanatomy, neurophysiology, neurobiology and neurogenetics) which intertwine with cognitive sciences and philosophy of the mind, in the interdisciplinary study of the functioning of the nervous system, especially the brain and the brain/mind relationship. The analysis of neuroscience cannot be separated from the use of neurotechnology (i.e. so-called diagnostic imaging techniques or neuroimaging). These new techniques allow us to acquire knowledge about brain function in a non-invasive and more precise way than ever before by visualizing ‘in vivo’ brain activity in healthy subjects (not only those affected by disease) during the execution of tasks. This research, some of which is still in the experimental phase, is aimed at studying the correspondences between activation of brain areas, mental cognition and behaviour. In the moral and legal sphere, of particular importance is the research of neuroscience and of neurotechnologies on the impact of emotions and rationality in decision-­making, evaluation of limits in the assessment of mental capacity, the distinction between truth and falsehood, the elaboration of judgment for identification of violent or antisocial behaviours. In this context, neuroscience constitutes an  Bird (2005), p. 1310; Wolpe (2004), pp. 1894–1898.

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empirical challenge to philosophical reflection, providing stimulation to rethink old problems (the brain/mind relationship) and traditional categories (truth/falsehood, freedom/responsibility). Neuroscience, in recent decades, has interacted closely with moral philosophy on two levels: the neuroscience of ethics (also ‘neuroethics’), a field that studies the neurological foundations of morals and the ethics of neuroscience, a field that deals with the ethical implications of neuroscience. Alongside and together with moral philosophy, there is increasing consolidation of legal philosophical reflection, equally distinguishable, in the ‘neuroscience of law’ or ‘neurolaw’ and ‘law of neuroscience’. Neurolaw deals with research into the neurological foundations of law, i.e. the existence of brain mechanisms and neural circuits that have led man (in history, from his origins to today) to elaborate legal rules functional to selective adaptation to the environment. In the context of a perspective inspired by sociobiological evolutionism (which applies the evolutionary theory to social action) and neurological reductionism (which reduces the mind to brain), this field of study intends to verify if the legal rules of behaviour derive from our neuronal configuration in addition to the stratification of advantages obtained through practices, which are initially random and then chosen as best from an adaptive point of view. The ‘law of neuroscience’ addresses the legal implications of neuroscience and neurotechnology in different fields. In the field of criminal law, there is the analysis of the reliability of neuroscientific and neurotechnological tests (in particular, the brain scanner) in determining mental capacity, with reference to the imputability of offenders, the reliability of testimony and judgment, the social policies of control of social danger with regard to non-offenders who are carriers of the brain characteristics indicative of a predisposition to aggression and violence. In the field of civil law, the use of neuroscience is investigated to ascertain the capacity to act (e.g. in determining brain maturity in adolescents with regard to responsibility, in assessment of competence in transactions or in the expression of consent). The ‘law of neuroscience’ also marks the boundaries and legal discipline of neuroscience, such as the regulation of neurotropic drugs, interventions and transplants on the brain, use of cranial stimulators and copying of cerebral information into files, the discipline on the use of neurotechnologies for the assessment of pain, persistent vegetative state and brain death, the determination of medical responsibility in trials (use of results, informed consent, incidental discoveries with possible social consequences, use of brain tests for selective purposes in the social sphere, etc.). One of the main bioethical issues in discussion is the role and meaning of freedom and responsibility in neuroscientific and neurotechnological context. The ontological or gnoseological debate on the existence and knowability of freedom has always been outlined in philosophical thought from determinism, which states that every event is the effect caused by a set of other events which necessarily produce it and each action is automatic as it is governed from causal laws, and indeterminism, which brings everything back to chance recognizing the room

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for choice. Recent neuroscientific experiments have cast empirical  doubt on the existence of free will, which has always been considered the prerequisite of the same possibility of morality and law. Some experiments have shown that “readiness potential” (i.e. activation of neuronal circuits) precedes voluntary movement by less than one second (0.5 second); the subject is conscious of wanting to perform an action only after starting to do it. This would show that the decision is apparent, with consciousness following the decision. The denial of freedom is not due to the philosophical justification of determinism, but to the empirical demonstration that consciousness is not the direct cause but the indirect cause of voluntary behaviour. Other studies and experiments have tried to verify the compatibility of these experimental results with the existence of free will and responsibility, showing the conscious possibility of blocking an action (so-called ‘free veto’). Libet’s experiment2 consists in asking the subjects involved in the experiment, whose brain activity is monitored, to flex the wrist up or down as desired. It has been found that the “readiness potential”, that is, activation of the neuronal circuits related to the movement in question, precedes by about one second the voluntary movement as conscious intention to perform a specific movement. In other words, it is only after having begun to carry out the action that the subject is conscious of wanting to perform it.3 An experiment which questions the moral and legal responsibility of the agent. As noted by N.  Levy, “Libet’s experiment was considered by many to be an empirical demonstration of the non-existence of free will […] because it showed that the consciousness of the decision to act or of volition comes too late to be causally effective. Consciousness is informed of the decision, it does not create it”.4 In this perspective the same ethical decision is interpreted in terms of a reflected arc. In the presence of adequate stimuli the brain reacts, in a completely automatic manner, with appropriate responses. In his work, Libet proposes a so-called “compatibilist” interpretation, in the sense that he considers the results of his experiment compatible with the reality of free will and responsibility, since, in his opinion, it is true that we do not consciously will a certain action, but we still have the possibility of blocking it once we realise that it is illicit.5 The point that should be clarified is if coexistence between determinism and subjective freedom is possible. Generally the free self is interpreted as being capable of consciously controlling one’s own body, as characterized by a constant  Libet (1999), pp. 47–57; Libet et al. (1983), pp. 623–642; Libet (1985), pp. 529–566.  Cf. Levy (2007). 4  Cf. Spence (1996), pp. 75–90; Pockett (2004), pp. 23–40; Tancredi (2005); Greene and Cohen (2004), pp. 1775–1785. In this last essay it is explicitly stated that neuroscience is progressively undermining the concept of legal responsibility. 5  In this sense the criticism of Clarke (1999), pp. 279–293. It should be noted, incidentally, that the denial of temporal-causal isomorphism highlighted by Libet’s experiments can also be understood as a denial of reductionism: the rules of the mind do not identify sic et simpliciter with those of the brain. 2 3

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identity, stable in its clarity and differentiation. Probably the truth is that subjectivity is not as strong as is generally believed, while man continues to be a subject. Perhaps a weaker subjectivity would paradoxically be more able to stand comparison with the new discoveries of neuroscience. On an ethical level, therefore, neuroscience makes at least some of our traditional visions of personal freedom and morality less problematic, and this, according to some, leads to the denial of plausibility of ethical and legal imputation, instead according to others it leads to a utilitarian view of morality, which does not consider others as people, but as objects of some kind.6 Many authors propose a downsizing of the alleged neuroscience revolution. There are three possible reactions to the negation of free will by neuroscience: denial of its value (this refusal could be interpreted in itself as an expression of free will), especially by Western culture, against whose presuppositions, in particular, the denial of free will seems to act; a second possible reaction is to isolate neuro-­ scientific knowledge, to accept it on the theoretical level, but to neglect it on the practical level, a phenomenon defined by social psychology; a third possibility is to reconcile the affirmation of neuroscience with determination of the mind by neuronal processes with free will in a compatibilistic perspective (according to which determinism does not imply the negation of free will). For compatibilists what matters in order to be free is the absence of external constraints. The philosophically relevant point of the compatibilistic interpretation is the distinction between external causation and external control. When the subject is free from external control, he is able to act according to what he desires or on what he deems worthy of attention. The causal relationship determines his actions through his desires: his values and desires are themselves determined by the neural causal relationship, but being caused is different from being manipulated. The action, albeit caused by external factors, is nevertheless identified with the agent in his motives and his performing it. Within the framework of neuroscientific studies and experiments, a conceptual paradigm is outlined which tends to propose and interpret the brain/mind/behaviour relationship in a reductionist and deterministic sense. It is the neurobiological paradigm that considers the relationship between brain areas/thoughts/actions as a direct and univocal causation relationship. This interpretation assumes that human identity coincides with neurological identity and human behaviour can be explained on the basis of neural knowledge, as a mere automatism. In this perspective behaviour and thinking would depend on the structural and functional anatomical predisposition of the brain, annulling free consciousness and personal responsibility.7 This reductionist interpretation has been criticised. First of all, it does not adequately explain the complexity of the neurobiological phenomenon. It is scientifically now accepted that the brain, similar to the genome, 6  Cf. Farah and Heberlein (2007), pp.  37–48: Farah (2002), pp.  1123–1129; Farah (2007), pp. 363–364. 7  Vincent (2010), pp. 77–98; Damasio (2005); Damasio (2007), pp. 3–7; Illes (2006); De Caro and MacArthur (2004).

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is not a rigid structure but a plastic organ which, through socio-cultural and environmental factors, changes and moulds itself, exerting an important role in the genesis of mental states/dispositions and behaviour. It should also be emphasised that neuroscience speaks of ‘neural correlates’ of thought and behaviour. The correlation is not a univocal causation, rather it is a statistical survey and association that is to some extent significant among elements, which allows for the possibility that an effect may have multiple causes or concauses, not always foreseeable a priori. In this sense, the correlation between brain areas/mental states/actions does not make it possible to ‘read the mind’ with a brain scanner (to know if someone is telling the truth or lying) or to ‘predict certain behaviours’ (to automatically connect intentional or unintentional behaviour), but rather only to foresee them with a more or less precise approximation threshold, that is never constitutively certain. These considerations allow us to justify personal identity in the metaneural and metabiological sense. Criticisms have also emerged regarding the reliability of the experiments that underlie the reductionist-deterministic theorization. These criticisms question their scientific consistency in relation to the revision of traditional categories. In particular, it is emphasised that such experiments are carried out under “controlled” and artificial conditions in laboratories, far from the concreteness of reality and spontaneity of action, with a limited number of specially trained predetermined experimental subjects who are not always representative of the population. Alongside the scientific and epistemological critiques, on the philosophical level, there has been dispute between compatibilists and incompatibilists in arguing the existence or illusion of freedom in the context of deterministic reductionism. Compatibilists, while accepting determinism, believe that human will can be considered free because actions depend causally on our will; incompatibilists deny any room for human freedom. This is a philosophically central point: if the brain/mind/behaviour coincidence were truly empirically demonstrated and free will denied, there would also be denial not only of the sense of punishment (there not being imputability of actions to their agents) but also the denial of law and ethics themselves (the condition of possibility and thinkability of both law and ethics refers to the existence of free subjects).8 In this sense, neuroscience challenges moral philosophy and philosophy of law on the empirical level, urging the rethinking of traditional categories and justification of assumptions.

 Garland (2004); Gazzaniga (2008), pp. 412–415.

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3.2  Gene-Editing: New Frontiers in Research The debate on genetic engineering on human and non-human organisms dates back to the 1970s. The alarm led scientists to elaborate and share a code of self-­regulation, in order to guarantee security.9 Genetic engineering has seen the emergence of highly innovative techniques with the possibility to modify the DNA sequences of living organisms (humans and non humans) with high precision and efficiency, relative simplicity and easy accessibility and low cost. Gene-editing or genome-editing, means modification, correction, revision applied to genetics. It deals with techniques that use “molecular scissors” to cut DNA in order to eliminate some parts (that are defective), correct them and/or replace them with ‘normal’ ones. CRISPR-Cas9 (Clustered Regularly Interspaced Short Palindromic Repeats) is the most well-known technique. Gene-editing is object of great attention by researchers in the international framework, because of the potential in terms of advancement in basic knowledge of cellular organization and development, and of possible applications to the human being and in the field of agriculture, animal breeding, industrial biotechnology on plants and biosphere and, in general, life sciences. Many authoritative scientific journals have broadly debated these issues, as “Science”10 and “Nature”.11 The bioethics debate focuses on the use of this technique on human somatic cells, human germ cells (or gametes), human embryos at early stages of development. Specific attention of bioethics is related to the possible implications of hereditary genome modifications for immediate and future generations (for the interventions on germ line and embryos), the safety and efficacy of genetic preventive and therapeutic intervention (uncertainties of the risk/benefit analysis), the blurring lines between therapeutic purposes and enhancement.12 Meanwhile, some experiments on human embryos (without implantation) have been authorized in Stockholm (2015), in London and in Japan (2016). An experiment with the implantation of healthy twin genetically modified embryos has been realized in China with the aim to prevent HIV (2018). Other experiments are announced in Russia. The community of scientists agrees on the need of experimentation on animals in order to refine the technique, starting with animal models. The ethical limits of genetic testing on animals need to follow the common ethical requirements of all animal experimentations, shared in the international and national legislation (the so called 3 R, or reduction of the number of animals, refinement of technologies and replacement of animals with alternative methodologies).

 Asilomar (1975).  Baltimore et al. (2015), pp. 36–38. 11  Lanphier et al. (2015). 12  The document on Human Genome Editing: Science, Ethics and Governance addresses different aspects of the applications of gene-editing on human subjects, from laboratory experiments on somatic cells and germ cells and embryos to possible clinical trials in adults. Committee on Human Gene Editing (2017). 9

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The ethical discussion on gene-editing on somatic cells, or cell correction/ replacement on a part of the body in a controlled way, follows the same ethical conditions of experimental practices for therapeutic purposes: the evaluation of risk/ benefit proportionality of the intervention, informed consent with detailed and adequate information on the uncertainty of risks and justice or equity of access. In this case it deals with high risk therapies, but they can be ethically justified in the absence of therapeutic alternatives (at least, less risky therapeutic alternatives), in severely ill incurable patients. This technique will improve the so- called “precision medicine” on somatic cells and it would be a loss for scientific progress to suspend experimentation. The main objection raised to the application of gene-editing to somatic cells is the possibility that the modified vectors not only reach the target cells of the therapy, but also other cells and tissues, with the possible consequence of colonizing the germ cells13 and the possibility that the genetic alteration might induce unpredictable pathological forms. Despite these risks, this kind of intervention is different from the programmed modification of germ cells and human embryos, as the possible consequences are non intentional. It is a situation that can be considered similar to the ‘compassionate care’: in case of untreatable pathologies, the risk (and the uncertainty of the risk) is acceptable in view of the therapeutic potential, with the appropriate information of the patients and evaluation and monitoring of the ethical committee. In the international debate, there is a point of convergence in the attitude of prudence in the clinical use of gene-editing on gametes to be used for fertilization and human embryos to be implanted, due to the high risks for the unborn child, at least at the present state of development of scientific research. The risk is the one of not correcting the genetic defect and/or introducing unintentionally modifications that can transmit serious diseases, even more serious than the ones aimed to be cured. That is why many scientists and bioethicists agree with the opportunity and need of a moratorium (2015, 2019) on the research leading to the use of the modified gametes to produce embryos and of the transfer of a modified embryo into the uterus, with the following pregnancy and birth. It is necessary, from a bioethical point of view, to make clear the distinction between ‘clinical research’ (on humans) or ‘in vivo research’, from ‘basic research’ or ‘in vitro research’: the first must comply with the stringent regulatory criteria of clinical trials (benefit/risk proportionality); the second has an exclusively cognitive purpose. There are different positions in the present discussion, depending on the statute recognized or conferred to human embryos. Those who support the legitimacy of basic research on gene-editing, consider it ethically justified to experiment on embryos in general considering the priority of scientific research on the right of protection of embryos or the moral duty to protect embryos. More moderate the position of those that justify the experimentation only on residual embryos derived from in  vitro fertilization techniques (because of 13

 Kaplan and Roy (2002).

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overproduction and cryopreservation) which, for biological reasons or because permanently in a state of abandonment, are unable to be implanted. This position is based on the recognition that prohibiting basic research on gene-­ editing, in addition to the moratorium on clinical research, would result in a total ban on germline research. It is reasonable to protect human health from experiments which involve an unacceptable risk, but not at the risk of precluding direct research to perfect the technology and advancement of knowledge.14 Basic research on in vitro gametes and embryos is considered necessary in order to acquire knowledge on the early stages of embryonic development (up to the 8th day after fertilization), to search for some of the causes of early abortion and infertility and to decide in the future about possible clinical applications. This position recalls the remarkable scientific opinions about the importance of basic germline research, for cognitive purposes and for potential therapeutic applications. The National Academy of Science and the National Academy of Medicine conclude the chapter dedicated to Basic Research Using Genome Editing in the document Human Genome Editing: Science, Ethics, and Governance of January 2017,15 underlining this aspect. Even if at the moment there is uncertainty about the safety and efficacy criteria necessary for clinical trial application, this kind of experimentation is considered necessary for the potential benefits. While somatic gene therapy may cure the ill patient, but does not eliminate the genetic defect, gene therapy on the germline (both gametes and embryos) would potentially eradicate in a definitive way mutations in the interest of future generations and the interest of scientific research aimed at the protection of individual and collective health. Another line of thought expresses doubts about in vitro experiments involving gene-editing of gametes intended for reproduction and human embryos not intended for implantation. The question is not only about the statute of the embryo (whether it is ethically licit to experiment on embryos, on residual or abandoned embryos), but also about the impossibility to verify the safety and efficacy of the techniques. Regarding human gametes, this perspective considers not scientifically and ethically justifiable experimenting on them for the high risks that it may involve (i.e. introduction of new mutations on embryos produced by gametes) and non-utility as the selective purposes can be achieved in a less risky way, by orienting research towards the selection of gametes for the production of human embryos. In vitro research on gametes for non-reproductive purposes remains licit. Regarding research on human embryos not intended for implantation, the ethical doubts about the legitimacy of the technique are connected to the lack of safety and  Cf. Citi GPS Global Perspectives and Solutions (2016), p. 935.  In the text (p. 60) it states: “Important scientific and clinical issues relevant to human fertility and reproduction require continued laboratory research on human gametes and their progenitors, human embryos and pluripotent stem cells. This research is necessary for medical and scientific purposes that are not directed at heritable genome editing, though it will also provide valuable information and techniques that could be applied if heritable genome editing were to be attempted in the future”.

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the impossibility to verify its effectiveness, and the problems of justice concerning the distribution of scarce resources. While recognising the relevance of experimental research on the embryo for preventive and therapeutic purposes for the interest and benefit of the same embryo (in the absence of therapeutic alternatives and with informed consent of parents), the attitude of caution towards gene-editing is mainly motivated by the high risk and unpredictability of risks. The minimal ethical criterion for experimentation may be considered the presence of a reasonable proof that the genetic modification intervention on human embryos induces less damage than that caused by the disease which it is intended to correct. In order to be sure of the results of gene-editing and of the efficacy of the technique it is not necessary research in laboratory, but it is necessary to verify the functional effects on the modified genome, also taking into account the off-target effects, any unwanted modifications. It would be necessary to implant the embryo into the uterus, to monitor embryo-fetal development, and to check the condition of the baby, to follow his/her development and to carry out a transgenerational follow-up. The only possibility to verify it is to accept the birth of ‘genetically modified babies’ potentially at risk of carrying undesired mutations induced by the technique. This would mean newborn babies used as means in order to improve a technique, probably for the benefit of possible future children. The birth of subjects with possible “defects” caused by the new technique makes it ethically problematic at this moment. The research on embryos in vitro without the hypothesis of implantation in the uterus (i.e. without the possibility of verifying its effectiveness) is therefore an end to itself and not useful. Altering the genomes of our offspring—not just the first generation but all later ones—means irreversibly changing every cell in their bodies, for the present and the future. It is a biologically extreme experimentation that may have huge risks, from the early stages of embryonic development through the life span. Even with the latest gene-editing techniques, off-target effects are an unsolved problem, and even if genes can be added or deleted in the right place, we cannot predict what those added or deleted genes might do in the cell or the organism. Furthermore, human germline modification is often presented as a way to prevent the transmission of inherited diseases. But it is not really true: it is not a form of prevention in the authentic sense. People at risk of transmitting genetic diseases can have healthy genetically related children without manipulating genes of gametes or embryos, by using the embryo screening technique, that is preimplantation genetic diagnosis and embryo selection. This is a methodology debatable in a moral sense, for whom considering embryo as a subject. This argument underlines the fact that there are alternatives to gene-editing. Also adoption can be considered an alternative to gene-editing, in order to have babies without transmitting diseases. Another ethical problem is the absence of informed consent. It is not ethically legitimate to undertake non-consensual experimentation on someone else’s body. Parents and physicians/researchers have no right to decide the biological future of

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another human being. In this sense we should preserve the human right to bodily integrity and the right to an open future, without being the object of manipulation. Our shared humanity is the starting point for every struggle for equality. Moreover, within the framework of the criterion of justice in the distribution of resources, it is ethically problematic to invest in research applicable to a small number of cases on not yet existent individuals, compared to research on therapy for individuals who are already severely ill. Scientists working on gene therapy and regenerative medicine are rightly worried that attempts to change the genetic inheritance of our species will provoke a backlash against important scientific efforts to treat disease in people who are suffering today. We can and should encourage ­beneficial applications of genetic technologies, and condemn pernicious ones. The determination of “bad” genes that need to be replaced and “good” genes to be introduced would reflect criteria set by the economically and socially privileged. The social and commercial dynamics in which human germline modification would necessarily develop could easily exacerbate global disparities, and take structural inequality to a whole new (molecular) level. There are recent documents on this topic. The UNESCO’s Universal Declaration on the Human Genome and Human Rights (1997) declares that the “human genome underlies the fundamental unity of all members of the human family, as well as the recognition of their inherent dignity and diversity”. This statement was successively confirmed in the conclusion of the 2003 International Bioethics Committee Report on international bioethics regulations, while the UNESCO Universal Declaration on Bioethics and Human Rights (2005) states in Article 16 on Protecting future generations: “The impact of life sciences on future generations, including on their genetic constitution, should be given due regard.” The 2015 Report of the IBC on Updating its Reflection on the Human Genome and Human Rights supports the moratorium and calls for “states to agree on a moratorium” on germline gene-­ editing, recalling the value of the human genome as the “heritage of humanity”, considering this technique to be problematic even from the point of view of the principles of equal dignity of human beings and of justice that is, of sharing the possible benefits of research. The European Group on Ethics in Science and New Technologies has approved a Statement on Gene Editing (January 2016) underlining that the issue requires “careful consideration, given the profound potential consequences of research for humanity” and adheres to the moratorium on genome editing for reproductive purposes of embryos and gametes, considering further technological development to be needed before moving to clinical trials.16 The Council of Europe’s Bioethics Committee (DH-BIO) issued a Statement on Genome-editing Technologies (November 13, 2015), recognizing the potential of this research. In the Statement, the extensors referred to art. 13 of the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the 16  See also: Nuffield Council on Bioethics (2016, 2018); Italian Committee for Bioethics (2017a). The European Group on Ethics in Science and New Technologies is currently working in order to elaborate an Opinion on the topics.

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Application of Biology and Medicine (1997) that states that germline interventions affecting the genome of any descendants are considered as violation of human dignity, i.e. contradicting the required respect for the rights of any human being. (“Interventions on the human genome: An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants”. The Statement considers art. 13 as a “benchmark of the international debate” on the fundamental problems raised by new technologies and recalls that this debate was envisaged in the same Convention in art. 28 (public debate and consultancy).17 The biolegal regulation on the topic is under discussion. One of the more restrictive legislation is found in the German Embryo Protection Act (1990), which explicitly prohibits germline modification for reproductive purposes. The overall EU position on human embryo research takes a middle path between prohibition and permission: it does not exclude embryonic research as such and permits, under strict regulation, funding by the EU, for example, for research with embryonic stem cells. However, it deliberately excludes research that involves modifications of the human genome for reproductive purposes, which would not only affect a specific individual (somatic gene therapy) but also  future generations. Given the new technological developments and lacking regulation in some countries, the rationale for this restrictive position on human germline modification needs to be explained and analysed in view of the new technological possibilities.

3.3  G  enome Wide-Tests, Direct-to-Consumer Tests, Incidental Findings The rapid acceleration of genetic technologies of genomic sequencing18 have outlined a new configuration of medicine, with uncertain contours, embracing dynamic development and change. If in the past genetic tests allowed us to analyse only segments of DNA, today with genomic sequencing techniques it is possible to analyze all, or almost all, the genes of different individuals of a given species to verify genetic variations. With reduced times, relatively low costs, greater ease of access. These techniques are increasingly being used in research and in clinical settings. There is substantial diffusion via the internet, the so-called direct-to-consumer genetic test (DCT): many websites offer genetic susceptibility tests for diseases, personalized diets, physical attitudes, choice of partner. The objective is to define the genetic inheritance of diseases and understand environmental modulation on the genome in different individuals: in order to “personalise” medicine and therapies, measuring in a precise way the susceptibility and 17 18

 Araki and Ishii (2014) and Jasanoff et al. (2015).  See the Opinions of the Italian Committee for Bioethics (1999, 2006, 2017b).

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resistance of each person to common diseases. To date, knowledge is still fragmentary as the mechanism is extremely complex, but steps are being taken in this direction. The suffix “omic” is used with reference to non-static but dynamic disciplines which evolve in research, in the genetic and biomolecular fields (genomics, proteomics), to indicate the study of specific aspects considered as a whole and/or on a large scale, on the collective level. The “omic” disciplines arise from the fact that enormous volumes of data are available for the different levels of biological complexity (DNA, mRNA, proteins, metabolites, etc.). There is a shift from reductionist approaches (understanding of complex phenomena through their disaggregation into single, simpler aspects) to approaches that are more oriented towards a systemic and “holistic” vision; from the study of genetic sequencing to genomic structure, through a complex and always dynamically evolving approach. The objective is to explore the functions, relationships and actions of different types of molecules that make up the cells of an organism. Genomics is constituted by large-scale genetic sequencing and bioinformatic analysis; proteomics involves the massive analysis of protein data. Massive analyses of biological data are correlated with lifestyle data, using algorithms. On the basis of the analysis of huge amounts of data (correlations between genetic sequencing, lifestyles, environment), with comparison between the healthy and the sick, there can be identification of different risk factors and susceptibility to diseases. Algorithms allow for the prediction of pathologies or progression of pathologies. This new approach requires an interaction between researchers in the biomedical field (biologists, geneticists, physicians) and physicists, mathematicians, engineers, computer scientists. Post-genomic medicine increasingly highlights the relevance of the complex and dynamic interaction between genome and environment in the context of individual lifestyle. The spread of genetic and genomic tests, diagnostic and predictive as well as susceptibility tests, in the process of boosting commercialisation, means that they are often sold without adequate verification of scientific validity (even directly to the consumer without adequate counselling), giving rise to ethical problems in relation to the right to know/not to know, how to manage their use and the results of the tests, in a society that is moving towards direct-to-consumer testing without the mediation and advice of a doctor.19 Consider the fact that the sequencing of the genome today is increasingly more easily accessible in terms of costs, time, availability of technologies. The challenge, rather, regards: on the one hand, faced with this huge production of data, the difficulty in processing them (there is a lack of processing tools, there is a lack of close collaboration between doctors and informatics professionals); on the other hand, however, they offer individuals results with reference to specific variations and risks that are not always reliable (sometimes different companies give different results), consequently there is often the problem of understanding how to behave in relation

19

 Van El et al. (2013).

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to the results in order to address these risks. The only option is to adopt a preventive lifestyle: a solution dictated by common sense, rather than the test itself. Genetic counselling is needed in the sphere of post-natal genetic testing, should be differentiated according to whether it is aimed at adults, minors or the incapacitated. The user should be aware that the reliability of some genetic tests is difficult to evaluate and that certain choices may be inappropriate, due to the possible occurrence of false positives and false negatives. The user should be informed that the test may lead to acquisition of unsolicited information (the so-called “incidental findings”), that is not requested at the moment of expressing willingness to undergo the test (e.g. information on paternity and filiation or a diagnose of another illness), and possibly ensuing legal and psychological implications of a personal and family nature. Often the predictive value and reliability of genetic testing are difficult to evaluate, so there is the risk that the user might undertake inappropriate actions in the light of a result which later could be proved wrong. In the presence of a recognised genetic risk of pathology it is important, in the sphere of genetic counselling, that the doctor should inform the patient that predictive susceptibility or predisposition tests fall far short of proving accurate predictions, in order to avoid fatalistic attitudes (in the case of high risk) or a sense of invulnerability (in the case of low risk). The user should be informed that often the diseases diagnosed or predicted by genetic tests are incurable or unpreventable diseases, therefore, the patient could also consider the possibility of not undergoing any tests in so far as he/she may not feel able to cope or live with an existential situation resulting from information regarding an illness that is neither preventable nor curable. According to the autonomy model, in the sphere of genetic counselling aimed at adults, the doctor is called on to clearly explain to the test subject the possible outcomes and possible implications (recognising the subject’s full freedom to decide whether or not to undergo the test), in addition to the possibility that the result may reveal the diagnosis, (probable or certain) prediction or susceptibility to a disease that is curable or incurable, non-transmissible or transmissible genetically, and explicitly asking about the subject’s willingness to know or not know. In the case in which the subject expresses the preference to know, the doctor will still communicate the test result gradually, adapting to the individual’s cognitive-­ emotional ability to receive the truth. In the event that the subject distinctly prefers not to know, the doctor can accept this request, without influencing this decision. For reasons that vary from one individual to another, a patient may wish not to know about certain aspects regarding their health and this should be respected. The problem emerges in relation to the possible ‘harm’ to others: liberal bioethics believes that the limitation on individual freedom is mutual respect for the freedom of others, therefore in so far as the choice not to know (the right not to know) constitutes a limit to the right to know of others, it may be subject to a restriction, to be evaluated on a case-by-case basis.20 20

 Knoppers (2014), pp. 6–10.

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According to the relational model in the genetic counselling aimed at adults, the user should be informed that the decision whether or not to undergo the genetic test should be taken together with the doctor, based on actual objective indications and not on the basis of a mere subjective choice (given the personal, social and economic implications of this choice). The user should be informed about the methods, risks and timing of the test, also with respect to the communication of results. In the area of counselling, the right to know and the right not to know should be balanced, recognising the legitimacy and the need for restrictions both in the interest of the actual patient and in the interest of a third party or the community. The right of the data subject to restrict access to the results should be recognised, with explicit indication of whom has or may have access to the data to be stated at the time of giving informed consent or subsequently to this. The personnel involved in the management of a genetic test is required to observe the duty of professional secrecy and to refrain from providing any kind of information about the test to anyone, without the explicit consent of those involved. Privacy must be respected, The main problem is the possibility for employers or insurance companies to have access to genetic information under certain conditions. Access to information is undoubtedly excluded if it is motivated by economic reasons. The only limitation to data privacy should be recognised to the extent that (existing or predictive) diagnosable diseases may endanger the life and health not only of the individual, but even of society. Consider the case in which an individual may decrease the risk of disease by changing type of work or an individual whose job involves high social responsibility who could (at the onset and manifestation of the disease) endanger the lives of others. Selective access to genetic information could be allowed in the event that the employer has no discriminatory intent, but whose ultimate aim is to protect the health of the worker, to develop a healthier work environment or to avoid his performing dangerous tasks, for the purpose of protecting personal and social security. The use of genetic tests by insurance companies raises important problems both from the ethical and the legal perspective. Insurance companies cannot use genetic data for discriminatory purposes, to calculate policy premiums or to exclude those with higher genetic risks, i.e. to deny insurance coverage to those most likely to get sick. In particular, as regards predictive tests, an individual cannot be compelled to undergo a test for purposes other than medical care or medical research, and not simply because it is an insurance company requirement. Furthermore, it is not possible to set the insurance premium on the basis of genetic characteristics, for diseases that are only predicted and foreseen and not actually existing and certain, based on a presumption of risk that is not ascertainable, and which may never materialize. The individual’s right to privacy must be recognised, but subject to the duty of social responsibility in the transparent and correct or even public communication of results of collective importance. The right to know is the condition that guarantees the possibility of an autonomous decision. Only in the case of diagnosis of (existing or future) incurable disease is there discussion on the possible “right/duty not to inform” of the doctor or the subject’s “right not to know”.

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In the case of minors and adolescents, particular caution is required. Predictive test results may have negative repercussions on individuals who are not yet mature. Genetic counselling should involve the whole family, evaluate the relationship between benefits and potential harms of the test, and the capacity for understanding and responsible decision-making of the child. If the balance between benefits and potential harms highlights the prevalence of harms or remains uncertain, the precautionary principle prevails and the test is to be avoided. Presymptomatic genetic tests can therefore be carried out on minors only if they are at risk of diseases for which it is possible to intervene with effective preventive treatments, and in any case the informed consent of the parents is always required. The problem is particularly important especially with regard to the reproductive choices of couples, who can avoid conception or terminate pregnancies after learning from genetic tests that there is a risk of conceiving a sick child. The spread of direct-to-consumer testing surpasses counselling, and overloads the individual with an excess of information, that is often neither rationally controllable nor emotionally manageable. If we specifically consider the spread of genomic tests in the context of research and in the clinical field (often both inextricably intertwined), some specific bioethical problems arise. In particular the question of “incidental findings”, i.e. accidental findings, random information, that is not expected, also not related to the original diagnostic question. The strong push of research leads more and more frequently to such findings that can be a source of stress for the patient, the subject and the family.21 From this perspective there emerges a need for caution in the medical field with regard to the application of these tests, balancing the aims of research and the need for clinical utility for the patient (application of tests to identify treatable or preventable diseases and non-application of tests for untreatable disorders and with an uncertain clinical outcome). It is necessary to rethink genetic counselling and information in view of preparing the subject undergoing the test for the possibility of knowing some incidental information,22 scenarios of complexity and uncertainty. Also the subject of discussion is the way in which to truly guarantee to those who donate biological samples the possibility of a return of information insofar as being relevant to health in terms of preventive, diagnostic, therapeutic or reproductive  Christenhusz (2013), pp. 248–255; Hehir-Kwa et al. (2015), pp. 1601–1606; Hellenic National Bioethics Commission (2015). In the Meeting Report it is stressed that the use of the expression incidental findings includes (1) unexpected positive findings, but also (2) the intentional search for pathogenic variants not associated with the primary diagnostic query. It is considered that the use of a different term, for example, “unexpected” or “secondary” or “unsolicited” findings, is just as problematic and therefore it is advised to keep to the most common use of ‘incidental findings’. 22  Presidential Commission for the Study of Bioethical Issues (2012, 2013). The Commission distinguishes between “primary”, “secondary” and “discovery findings”: “primary findings” refer to a result that is actively sought, using a test or procedure designed to find such result; the “secondary findings” refer to the results that are actively sought by a professional, but which are not the “primary target”; the “discovery findings” refer to the results of wide tests, aimed at detecting any potentially interesting data. 21

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choices. The huge amount of data and the possible difficulty in contacting the original donors seem to highlight the main obstacles to the “right” to be informed. There is a study of the computerised possibilities of ensuring and maintaining communications through websites, social forums. There is discussion about the duty of communication by doctors and researchers also against the right to ignorance of the subjects. The problem concerns in particular late-onset and untreatable and/or preventable genetic diseases, particularly for minors. There is a need for a balance between the possible benefit for parents deriving from knowledge of their genetic risk and potential damage to the minor with the questioning of his future autonomy and his right to an open future. Faced with the rapid advances in genetic and genomic research, the UNESCO23 International Bioethics Committee has called for the development of internationally agreed rules to avoid inequalities in life and health expectations, new dangers of discrimination and/or stigmatisation of people and/or specific groups.

3.4  T  he New Medicine: Prevention, Prediction, Personalization, Precision In the context of the most recent advancement of scientific discoveries and technologies above all in neuroscience and genomics, linked to mathematical and computational tools (bioinformatics), there is a strong emphasis increasingly put on a ‘new paradigm of medicine’, the so-called “P4 medicine”, that is preventive, predictive, personalised, participatory medicine.24 It is aimed at healthy not unhealthy citizens, identifying early on individual susceptibility to certain diseases, with precision and the direct active involvement of the subject (through knowledge, and the adoption of lifestyles). So-called “personalised medicine” or “individualized medicine” or “stratified medicine” or “precision medicine” or “systemic” or “tailored medicine”25 (all these terms and expressions are used interchangeably, even if there are some distinctions to be made) has the objective of analysing individual variability in the relationship between genetics and the environment, with reference to the biography of the individual and lifestyle (so-called individual profiling) as well as increasing the effectiveness of treatments, reducing the risks of taking a certain drug, and possibly the costs. The “precision medicine” aims to deliver the right treatment for the right patient at the right time in the right moment, by integrating genetic, physiological, behavioural and environmental data, with preventive and interventional strategies targeted to specific patients. The US National Academy of Sciences in the report Towards  UNESCO, International Bioethics Committee (2015).  Flores et al. (2013), pp. 565–576; Hood and Flores (2012), pp. 613–624; Prainsack (2018). 25  Collins and Varmus (2015), p. 26; Shringarpure and Busamante (2015), pp. 1–18. 23 24

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Precision Medicine (2011)26 makes the analogy between this new field of study and Google Maps. In order to help us get to the place we choose, Google Maps integrates data drawn from diverse sources into a set of instructions. In the same way, collecting, integrating and synthetising data from large patient cohorts and healthy populations should lead to more “precise” health diagnosis, treatment, prevention. That is why this new medicine combines different words: prevention and prediction (anticipation of knowledge of possibilities and probabilities of illnesses); participation (as the condition of possibility of this change in medicine depends on the willingness of citizens to be involved/engaged, to share health or “open data sharing” and other personal data with researchers and doctors). In this sense medicine could become “personalized” or tailored to the specific need of the patient in a specific context. The concept of precision medicine is not completely new but it is recent because of the advances in genome sequencing (genome-wide tests), informatics and wireless/mobile technologies applied to health and the convergence of scientific disciplines and technologies. In 2012 the European Alliance for Personalised Medicine (EAPM) was established with the aim of personalising healthcare to European citizens. In October 2013, the European Commission published a document,27 detailing the possibilities and challenges for healthcare by the rise of personalised medicine. In January of 2015, President Obama announced a high investment in research initiative in precision medicine.28 The National Institute for Health (NIH) is leading an initiative engaging individuals as “research partners” rather than “research participants”. The promise of precision medicine is, collecting and combining biological materials, behavioural data and electronic data, to identify risk of developing disease in healthy individuals, in order to predict and prevent diseases. The significant investment in precision medicine is not however without its critics.29 The first objection is about the novelty. Doctors have always applied their general knowledge to every patient as unique, and doctors have always tailored their treatments in the measure possible. The novelty is not in the aim of medicine but in the new technological tools offered by scientific advancement. Second objection is related to the ‘hype’ on precision, as medicine is and will be, even with new technologies, always “imprecise”, precision being—at least in medicine—a false promise not fully realizable. Other critics focus on prevention/prediction and the possible negative consequences on people: healthy become ill just knowing predictions, which may become the cause of illness and not the prevention of it. Participation may also become a form of exploitation hidden behind the request of engagement and involvement, transforming the autonomy in new forms of heavy responsibilization of patients.  National Research Council (2011).  Commission staff working document (2013), p. 436. 28  President Obama State of the Union Address, January 30th 2015. 29  Weber (2014), pp. 2–3; Joyner and Paneth (2015); Coote and Joyner (2015). 26 27

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Disease becomes a sort of ‘guilt’ of the patients, being the consequence of his/her behaviour; the impact of social determinants of health on illness decreases. The strongest argument against precision medicine30 argues that the investment on precision medicine could produce new inequalities, as investments on precision medicine will diminish resource allocation on health inequalities, investments on prevention will diminish resource allocation on treatments. It is a fact that health is non equal as there is a ‘social gradient of health’ (the lower a person’s social position, the worse his/her health). There are different opinions on whether precision medicine will result in cost savings to the healthcare systems. On the one hand, it is argued that tailored effective treatment with less side effects will result in better health outcomes and overall treatment costs will fall. On the other hand, it is argued that developing treatments for small groups of patients will increase the costs of drugs because developmental costs will be borne by fewer patients taking them.31

3.5  Citizen Science: New Forms of Participation in Health Participation is becoming one of the main aspects of new medicine. The expression “citizen science” has recently become more widespread, and encompasses different levels of meaning. In a broad sense, it indicates the phenomenon of propensity and willingness on the part of citizens (citizenship includes all individuals, digital users of the global network) to participate, at different levels, in the development of science (understood in the general sense as scientific knowledge), in two directions: from the bottom, i.e. citizens construct as scientists or contribute with scientists to scientific production; from the top, citizens are actively involved in scientific progress in different ways to scientists, from public policies to the identification of applications/ implications of scientific discoveries. It is a phenomenon that forms part of the wide movement towards ‘open science’, a science open to all (therefore also to non-­ experts, citizens) and to data sharing for the implementation of science, which includes large geographical areas or over long periods of time, and above all inclusion of a potentially huge amount of people. The most extreme and restrictive version of citizen science indicates the propensity of citizens to become researchers, to acquire the role of scientists, replacing scientists and imitating them in designing, coordinating and conducting research. The more moderate and broad version involves participation, through the provision of personal data on a voluntary basis or participation in experiments or the scientific analysis of scientific project experiments or the formulation and political regulation of science, or consultation. Citizens ask questions on important scientific issues or direct public attention to environmental issues, public health or management of

30 31

 Bayer and Galea (2015), pp. 499–501.  European Group on Ethics in Science and New Technologies (2015).

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natural resources, encouraging collaboration between communities of citizens and scientific institutions. This phenomenon is called ‘participatory turn’ with implications also in the field of health. In this field, citizens can participate as data providers, as research participants, as experimenters, as protagonists or co-protagonists. This orientation is delineating new forms of collaboration between citizens (professionals and non-professionals, experts and the inexperienced) and scientists, with the involvement or engagement of citizens, also through technologies of information and communication (ICT). Many new expressions are used to mark citizen participation: crowd-sourced science; networked science; civic science; community science.32 We can distinguish between: contractual projects, where citizens ask researchers to carry out a specific piece of research useful to the community; contributory projects, in which citizens offer contributions to research designed and built by scientists; collaborative projects, where citizens offer data, contributing to the project, in particular in analysis and dissemination; co-created projects, built together by scientists and citizens, where citizens actively participate at different levels of research; and collegial contributions, where non-scientist individuals conduct research independently, expecting recognition from scientific institutions. Citizens can also be involved in the political sphere in the definition of the research agency, priority of funds, risks. It is necessary to distinguish between: citizens as producers of science, or citizens ‘creating’ science, with a direct role in the generation of knowledge, in research and experimentation; and citizens as contributors of science, both consciously or unconsciously; citizens as users of science (in the case of self-diagnosis). The term citizen is used not in the political sense of citizenship, but in the sense of active participation in society (citizenship as participation). In the field of health, there are many examples of ‘citizen science’, from citizens as experimenters, citizens as patients and data providers, with patients reporting to scientists and researchers the results of the off-label use of drugs or medicine being tested or reporting data on the internet in patient-centric initiatives directed at patients and not doctors. Some patients in incurable conditions organize websites to report the results of new self-administered treatments: self-experimentation in patient groups: e.g. the effect of lithium in patients with amyotrophic lateral sclerosis (ALS). ‘PatientsLikeMe’ is a platform dedicated to information sharing and aggregate use of data to conduct research.33

 Mueller et al. (2013), Prainsack (2014) and Seife (2013).  PatientsLikeMe is a platform for sharing information and disease experiences; it enables patients to connect with patients of the same illness and encourages patients to share data and information. Members (more than 300,000) may choose different privacy settings that may be changed in time: shared data are accessible to third parties, non-shared data are not. The website reports aggregated data on symptoms and treatments that may be useful to patients. It is founded on an ‘openness philosophy’.

32 33

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There is collaboration also between patients and researchers, with patients providing data and researchers analysing them and deciding whether or not to confirm the hypotheses proposed by patients. This provides momentum for the acceleration of the trial or use of drugs not yet validated (compassionate use, expanded access are examples of patients as promoters of science). Patients and their families are looking for new ways, including using social networks, to experiment treatments and therapies, even through self-experimentation, with the intention of overcoming strict protocols, to accelerate the use of non-validated therapies or not-yet validated therapies. A further phenomenon is the so-called ‘citizens’ veillance on health’, similar to epidemiology and surveillance of public health, in which local communities of citizens launch epidemiological research projects with the aim of soliciting public policies with attention to the health of citizens and the environment, and raising civic awareness of problems. Even the voluntary collection of biological samples to monitor genetic changes as health indicators is another example. “Personal Genome Project”, at Harvard University, requests the voluntary participation of citizens for the donation of samples and genomic analysis. The project is based on public participation through the donation of samples and data for creation of a public resource, the approach is “to invite willing participants to publicly share their personal data for the greater good”.34 It provides ‘open consent’ that intentionally excludes privacy protection.35 The participatory breakthrough opens up scenarios for new opportunities as well as complexities.36 The opportunities are identified in the so-called ‘empowerment’, i.e. strengthening the autonomy of subjects/patients, which increases their capacity for knowledge and their active participation in science. These subjects are not just passive receptors, rather they are becoming increasingly the active promoters and partners of science. They are more informed and able to have greater control over their health. There is an increase in the opportunities to interact with scientists and political institutions with regard to decisions on individual and collective health. The moving of science closer to citizens and citizens closer to science is a fact: the scientific training of citizens and civic consultation on scientific issues are new forms of the so-called “democratisation of science” and “scientification of democracy”. There are increasing opportunities for science to develop large-scale spatial and temporal monitoring by collecting a considerable amount of data (not comparable to what could be done in the past), at a lower cost. Information and education is moving closer to participation in scientific citizenship, with beneficial effects with regard to the individual and the community, developing a form of citizenship that is more respectful of the environment and health. However, several complexities also emerge: the expression ‘citizen science’, apparently positive, hides some ambiguity and rhetoric. The rhetoric of health for  PGP website: http://www.personalgenomes.org/.  MIT Technology Review (2013). 36  Frost et al. (2011); Kaye et al. (2012), pp. 371–376; Vayena and Tasioulas (2015), pp. 479–485. 34 35

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all and of all, can hide forms of instrumentalisation. Increased knowledge also leads to an increase in responsibility with regard to one’s health. Maintaining a certain lifestyle as a preventive condition, leads to the belief that individual behaviour is an element charged with greater responsibility than diseases themselves. With the aim of participating, more and more data are being used without being able to guarantee confidentiality, with the risk of potential misuses from which citizens are not always protected. There is also an epistemological limit and data reliability: the lack of authenticity control. Although data collection procedures, statistical tools, and computational techniques are increasingly sophisticated, and reliable quantitative methodologies utilised, some contest the practice of citizen science making specific reference to data quality, believing that it is not enough for scientists and researchers to equip themselves with specific tools to reduce errors. In the ‘bottom up’ cases, there is also an epistemological problem: the patient-­ expert is not a scientist, therefore both a rigorous method and qualified scientific competence are lacking. Their research is not subjected to review and evaluation, on the scientific and ethical level. They are often amateurs, who have only experience and no valid scientific preparation. In the ‘top down’ cases, there is the risk of data exploitation, also for commercial purposes. This is accompanied by the problem of property ethics: the members of the group become co-producers of information, co-owners of data, this inevitably raises the question of copyright and intellectual property or “data ownership”. Scientists consider themselves to be the sole owners of their data. Participants would like some kind of return, but it is often seen by researchers as a public commitment or as an opportunity to learn, to get a close-up on scientific research, to have fun together with other people. But this is not enough, the public also needs to receive something tangible in return. Lastly, another difficulty is recruitment. If at a national level it is easier to have volunteers, at a local level this is less the case. It often happens that groups abandon a citizen science program due to lack of motivation, also in relation to the means of recognition of the commitment undertaken.

3.6  Information and Communication Technologies in Medicine Citizen science is strictly connected to digitalization. The digital revolution has been experiencing an impressive acceleration in recent years: think of personal computers, internet, cloud computing, social networks. This is a revolution that has a considerable impact on the political, economic, health, educational level, etc. We have become accustomed to the prefix ‘e’ before many names, the official language of the web: e-governance, e-commerce, e-health, e-learning. It is a signal of the intrusion of the electronic-informatics dimension in our daily life. A revolution

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which brings with it an inevitable change in the way of conceiving personal identity and interpersonal relationships. Digital identity takes on peculiar connotations: on-line identity may not correspond to off-line identity, as it is a disembodied, dynamic and plural identity. An identity that is built by adding fragments (photos and videos) shared on the network, which risks eroding the substantial dimension of the authentic person. Interpersonal relationships change: it is possible with the computer to connect with several people at the same time in every place in the world, without barriers of space and time. The quantitative increase in digital relations risks being inversely proportional to the qualitative dimension: face-to-face relationships in the sharing of interests and responsibilities are replaced by virtual relationships, often superficial, episodic, fungible (there are hundreds of virtual friends). What are the consequences? Some are certainly positive: stimulus to creativity, expansion of free expression, facilitation and speeding up of services. Others, not yet completely predictable, may be negative: superficiality and uncertainty in relationships, insecurity in transactions, erosion of privacy, possible uncontrolled use of data. What is becoming increasingly clear is that the new information and communication technologies do not constitute a ‘neutral’ sphere: there is growing awareness of the current and possible implications that can harm the individual and the community. It is still a poorly regulated area that requires more specific and articulated standardisation, embracing, in a harmonious way, the global digital society, placing the dignity of the person and his fundamental rights at the centre.37 In the specific field of health many opportunities open up: the possibility of expanding knowledge, thanks to the increase in information, the speed and global expansion of communications; improvement of health system efficiency, reduction of costs and waiting times for some health services, with delocalisation of the provision of services (telemedicine, remote medicine), the possibility of comparing different points of view and medical opinions; facilitation of access to treatment, contacting distant organisations/groups/individuals, offering higher-level consultancy services to residents in areas less served by the organisation of health services, especially if linked to telemedicine services; improvement in the organisation of health facilities (greater usability of services, patient appointments, fewer queues at desks, reduction of costs and waiting times); simplification and intensification of both monitoring and patient monitoring; facilitation of health education for people (doctors, patients, citizens) and actions to support the sick and families. The possibility of creating electronic health records would allow individual and collective information gathering, making them usable in real time to citizens and doctors. However, certain problematic aspects also arise.38 First of all, there is the problem of the difficulty in discerning correct and incorrect information by the digital user. The quantitative increase in information does not coincide with the quality of contents. A selection filter is missing; there is no  The European Group on Ethics in Science and New Technologies (2012) has identified some ethical guidelines for the establishment of rules in this sensitive sector. See also (1999). 38  UNESCO (2011) and Italian Committee for Bioethics (2006). 37

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clear guarantee of certification of the quality or truthfulness/authenticity of the information, which may be false, partial, approximate, inaccurate, equivocal, triumphalistic, falsely reassuring, sometimes intentionally misleading also due to commercial interests. Untruthful information can provoke in users a reaction (misunderstandings) that leads them to behave incorrectly or inadequately (putting their health at risk), resulting in superficiality with regard to serious illness or anxiety and disorientation in the case of treatable disease. There is a need for correctness and authentication of information, in order to guarantee a right to access correct health information. There are, to date, no “quality certification” measures or sites accredited by health institutions that attest to the patient the veracity of contents. Certification measures have been proposed but not activated/or limitedly activated (spontaneous adhesion to codes of conduct-self-­ regulation; recognition of authoritative certification bodies with external audits/ checks with revisions and site reviews; adoption of labels for quality certification).39 The problem concerns providers as well as active users of sites: tools should be found to encourage control and accountability, through accessions to codes of self-­ regulation of the “quality” of messages (hopefully on the basis of uniform criteria), the explicit adherence to which should constitute reliability for both operators and users in the health sector. The transparency of sources (name of the compiler, individual or organisation, date of compilation, possible update) would also be desirable as a necessary condition for data control, with information on whom is collecting the data, how, for how long, why. Secondly, there is the possible danger of depersonalisation of the doctor-patient relationship. The virtualisation and digitalisation of communication, on the one hand speed up and globalise communication, however, on the other, it can create a spatial ‘distance’ between doctor and patient. The doctor risks practicing “remote” medicine for unknown patients, without an objective physical examination, without face-to-face “interpersonal communication”, a form of communication made up of not only verbal expressions, but also visual perceptions and attitudes. The tendency to self-diagnosis and medical self-referentiality by patients emerges, both as regards diagnosis as well as therapy, without any indications, advice and controls, and many health risks. Sometimes patients turn to the internet because they have not had enough information from the doctor or they suspect the information received to be inadequate in relation to the problem. Information technologies could lead to an impoverishment of interpersonal communication, but lack of ‘closeness’ between doctor and patient, despite the availability of a huge amount of digital information, highlights the lack of verbal expression, visual perceptions, emotional perception that help the doctor to make a diagnosis. Medicine that is only digital tends to transform the doctor/patient relationship into a contract between user-consumer/doctor, providing services. We should first build a relationship of trust between patient and doctor through thera In sites: national (health ministry, Scientific Societies, University) or international (WHO, EMEA, NIH, Medline, FDA; pharmaceutical industry sites; patient association sites).

39

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peutic alliance, with a subsequent and integrative use of Internet, aimed at increasing collaboration, participation, interaction “with” the doctor and not “without” him. A specific problem is the selling of medicines online or any other form of incentive for self-medication or self-diagnosis (such as genetic tests for the consumer, but also for body imaging). There is a serious risk of abuse or incorrect use of tests and medicines. For the sale of medicines online there is the difficulty of verifying whether or not the drug has obtained authorisation (in the country that sells it, and in the country of residence of those who buy it); the lack of indication and prescription by the doctor, the absence of direct contact with the pharmacist leads to p­ ossible undesired consequences (due to possible interaction with other drugs, incorrect methods of administration, lack of control over the state of preservation of drugs, lack of clarity regarding active ingredients). A further problem is constituted by potential invasiveness with respect to privacy. On the one hand internet allows for the free expression of thought and knowledge by others, but, on the other, the risk of invasion of privacy becomes increasingly evident above all with reference to health information, personal data, sensitive data. In this context the ambiguity and problematic nature of informed consent emerges. ‘Digital informed consent’ should not be reduced to an automatic procedural registration (often leaving no possible alternative), but there should be explicit verification of the user’s actual awareness of the consequences of his choice, manifest willingness for the collection of data under certain conditions (individual control, identification conditions with full or partial traceability or anonymity). In informed consent there should be clarified the right to rectify, integrate, delete data (even in a definitive manner); respect for privacy and the protection of confidentiality (use of pseudonyms, encryption of content), the exclusion of direct access by third parties (above all insurance companies, employers). There is a new right: the ‘right to erasure’ or ‘right to be forgotten’ by a network that generally does not cancel anything, exposing especially the young to potential future risks in the workplace. In particular minors, the greatest users of the network, are often unaware of the risks they might face. For them, for example, informed consent should provide simple, concise, easily understandable language with effective age verification mechanisms (to prevent access to inappropriate websites) and tools that make them aware of dangers to health, in addition to, the right not to be informed. Furthermore ICT can create different forms of dependency: so-called Internet addiction disorder (IAD). This condition has implications on personal identity and the relational dimension, hindering interpersonal relationships in everyday life. It is being investigated whether this condition constitutes a standalone illness. The negative effects of the compulsive use of the internet have been assessed with reference to specific online activities, such as pornography and gambling; subsequently the hypothesis was put forward that these effects also concern uncontrolled surfing in general, carried out in the most diverse fields.40 There are seven symptoms that could indicate some form of disturbance related to the use of the Internet: personal satisfaction derived from time spent browsing, 40

 Cf. Müller et al. (2016), pp. 172–177.

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low interest in other activities, anxiety and depression in the absence of internet access, overwhelming need to check events on the web, increasing frequency of use of the net compared to usual habits, long connection times and use of internet even in the presence of physical, work and social impediments. Examples include: information overload (spasmodic searching for information), cyber-relationship addiction (abuse of social networking) and computer addiction (excessive use of online games). A further problem concerns the “digital divide” and inequality of access to new technologies. Everyone should be allowed to acquire the tools, skills and motivation to use new information technologies in order to participate fully in society and not be marginalised by the network. The digital divide due to age, socio-economic status, belonging to a geographical area should be bridged as far as possible: the elderly, the less educated, the poor, the inhabitants of developing countries are the most vulnerable subjects of the digital age. At the same time, an alternative access to services (in particular, specifically, to health services) should be guaranteed for those who prefer not to enter the digital sphere, without being discriminated against for their choice. The promotion of access for all should be accompanied by an adequate education in ‘digital skills’ or ‘digital literacy’, motivated, even for those who do not want to use it, by the right to be informed about health, and the basic ability to critically evaluate information. The ethical requirement arises for the user to be able to recognise ‘reliable’ information and have the tools to judge and evaluate the quality of a site: websites themselves can help the user to understand the quality of sites, providing the instruments to select independently. Information should be proportionate to the capacity of comprehension of the average consumer: provide different levels of complexity depending on the user to whom it is directed with the aim of encouraging awareness of possible dangers/responsibilities. In the context of online medicine, with direct and immediate access to anonymous impersonal medical services, there is a need for specific legislation to repress fraud and set rules for the identification of those responsible. The structural delocalisation of news by internet prevents clear identification of the applicable legal regime (whether to invoke the regulations pertaining to where the service is offered or those where it is required); even if abuses were identified, there is often  an absence of repressive instruments. If we consider the diffusion of news via the Internet, we need to verify: content providers, those who have networked content, network providers, the owners of communication infrastructures, access providers, those who offer the possibility to access the network and use services, service providers, the service provider that allows the user to connect to the network. It is difficult to reconstruct the chain: the steps are closely linked, as each provider can operate in a different country ignoring the work of others. Our legal system lacks a specific monitoring obligation on the part of the provider regarding the information disseminated. The problem arises in relation to the huge mass of data and its rapid mutability. Difficult preventive control or immediate subsequent control of data entered into the network, the identification of those responsible, immediate removal of information

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that is dangerous to health, deterrence of providers (network, access, service providers) from hosting news that is harmful to the user’s health. It is a challenge, launched by the new information and communication technologies, to which countries, through law, are called to urgently address, in order to allow progress to accompany the development of the human person and society in an appropriate manner.

3.7  Big Data and Health The ‘new wave’ of health technologies is characterized by the transformation of medicine, going towards the ‘P4 medicine’ and the convergence/confluence of traditionally different disciplines (medicine, biology, informatics, engineering, computer science). The advancement of ICT, with the increase and acceleration in the collection, storage and processing of information, and the development of data science (i.e. the use of computing and mathematics with statistical techniques and algorithms) are opening up new possibilities of knowledge, use and application in various fields, including healthcare.41 The collection and analysis of a huge amount of data, in the era of ICT, has health care applications, such as ‘model data-driven medicine’. In this context, the ‘model-­ driven health data repository’ is a form of ‘health data-driven medicine’ (yet the object of study and research, currently not extended to all aspects of biology and medicine), which offers the possibility to make predictions and simulations of diagnosis and treatments for patients in specific contexts or for stratified groups of patients on the basis of an amount of data collected, and transferred from the clinical arena to digitalization. ‘Big data’ is an exponentially growing and evolving phenomenon, transforming medicine and health, both as a concept and as a practice. Big data refers to massive digital data, which is characterized by the so called ‘5 Vs’: volume or huge amount of data and the quantitative increase of data (it is becoming increasingly difficult to keep up with the updating of the unit of measurement, terabytes, petabytes, exabytes, etc.); variety or heterogeneity of sources (different types of digital data and diverse supply sources, as computers, mobile phones, the Internet, mobile devices and sensors, etc.); velocity or speed of collection, processing and application; veracity or quality of data; and value or meaning of data. The novelty of the phenomenon, combined with its complex manifestation and dynamic development, requires new approaches also in ethics and law. Traditional ethical categories (dignity, integrity, autonomy, privacy, equality, justice) need to be reinterpreted in light of the new issues emerging from the fast developing technologies. Existing legal norms at international, regional, national levels,

 Mayer-Schönberger and Cukier (2013); Bowker (2014), pp. 1795–1799; Mittelstadt and Floridi (2016), pp. 303–341; Cohen et al. (2018).

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often prove outdated, inadequate and not applicable to the new and emerging problems, which require new forms of governance. Big data and big digital repository could be considered a ‘big opportunity’ for personal and social benefits as regards health. The management of large amounts of diverse types of information, the conversion of these data into hypotheses about health and disease, as well as their transformation into usable knowledge, offers a ‘big promise’. The goal of this project, the elaboration of a model-driven patient-­ specific predictions and simulations and personalised diagnoses and treatments, is unquestionably good from an ethical point of view. It also envisages promising future possibilities in medicine, both for individuals and for society, including present and future generations. But ‘big challenges’ to ethics are equally likely. Challenges are not a sufficient reason to limit or even stop the development of techno-science in medicine, but they should be taken into account in the ethical evaluation and legal governance of these emerging technologies, in order to balance the human fundamental rights and the advancement of progress. The main ethical challenges include: the quality of data, transparency, privacy, informed consent, and equality.42 Possible inaccuracy and doubtful veracity in data collection (the challenge of the so-called ‘big bad data’), due to the quantity, complexity, heterogeneity of data sources, as well as its possible non-authenticity or untruthfulness, represent a scientific and ethical challenge. The curation of data including cleaning and monitoring of data, serves to bolster the veracity of data and the ‘quality’ of collection. Large amounts of data are continuously and rapidly accumulating. This explosion of information requires reliable tools to build an accurate collection, evaluation of change in clinical parameters to preserve high standards of healthcare. In this regard, artificial intelligence may be helpful in achieving this goal: computerized patient records may be analysed by appropriate programs developed to yield important clinical information or construct algorithms helpful in diagnosis, prognosis and monitoring therapy. Biases should be identified and eliminated, as far as possible. However, the quality of datasets used may be at stake. It is necessary to make a clear distinction between quality big data and big data of poor or dubious quality. This also raises the question of robustness and the need for research purposes to access raw data aimed at checking, meta-analysis and reinterpretation. If bias is detected in the data collected, its analysis and use become irrelevant and even damaging for scientific progress, as well as dangerous for individual and public health, entailing a needless and erroneous exposure to risks (to their integrity). Incomplete collections of data or miscoded data are not uncommon, for various  There is no consolidated literature on the topic. There are documents and opinions of international and national ethics committees, which may contribute to the development of an ethical framework in this analysis. Among the main documents, it is worthwhile recalling: European Group on Ethics in Science and New Technologies (2015) and Opinion 7/2015 from the European Data Protection Supervisor on Meeting the Challenge of Big Data; UNESCO International Bioethics Committee (2017), OECD (2013, 2017), Italian Committee for Bioethics (2016) and Nuffield Council on Bioethics (2015).

42

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reasons: e.g. because of the increase in physicians’ documentation burden, lack of education and accuracy and/or knowledge of the correct methodology in registering data, lack of updated international classification of diseases or knowledge of them, difficulties in selecting essential and specific information of a patient’s history, incorrect registering of the patients unaware of the possible/future use for analysis purposes, lack of proper oversight and selection for authenticity, lack of standardisation, interoperability and data harmonization as regards terminology. There can be biases in the automated processes used for collecting and assessing the data, often due to the algorithms (and their designers) including a lack of human checks in analysis, lack of education and the competency of analysts. If data quality in the collection and analysis process is not checked, monitored and guaranteed, invalid conclusions may be drawn, on a scientific and clinical level, with possible negative consequences both for individuals (anche their health) and society.43 The second ethical issue regards transparency and the possible ‘opacity’ of algorithms in data selection/classification. Using these technologies for data collection makes it possible to combine biological, social and/or environmental information. Big data may show correlations and interactions of complexities in health and disease, that could not be identified before. The key challenge hinges upon transforming biological-social-­environmental information into predictive abstract models. Although, some ethical challenges come to the fore: which are the selection criteria of the most relevant data (criteria of data exclusion or inclusion)?  Are the ­criteria that establish correlations between data  objective or subjective? To what extent is it possible to transform bio-socio-environmental data in numbers? There are also possible difficulties in finding objective criteria with regard to data selection, elaborating criteria, categories, typologies, clusters. Data selection is not an automatic mechanical tool, but requires a subjective and discretional intervention of researchers in the arbitrary creation of algorithms, the so-called ‘ethics of algorithms’. We should be conscious of the fact that algorithms construct correlations and predictions regarding (mathematically calculated) “probability”, which should not be confused with “causality”. Profiling identifies the major and minor probability or propensity of certain stratified groups of individuals. What criteria form the basis on  Raghupathil and Raghupathi (2014). There is a discussion on what forms of regulations could provide for data quality monitoring (collection, storage, analysis), as a requirement of data use, with flexible and updatable tools (as code of conducts), ensuring a control on competences and correctness of operators (clinicians, analysts, as engineers, statisticians, bioinformaticians) and correct interactions among them. Proposals include ‘soft regulation’ such as an updated code of practice for clinicians or other professionals involved in collecting health-related data. Others aim to foster interdisciplinarity between clinicians/researchers and engineers working together to translate and extend their existing and advanced data analysis technology (including on the one hand the clinically trained human mind), into targeted big data analytical approaches that will achieve clinically effective outputs. Although engineers and clinicians have long collaborated successfully, development work on “Big Data Healthcare” will particularly require mutual understanding by each disciplinary culture of the other. This will resort to further cultural development in both areas.

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which algorithms are constructed? An important aspect, therefore, concerns the full publication of all the factors, which research algorithms take into account. The opacity of the factors upon which search engines are based does not allow the monitoring of information quality. Another ethical question concerns privacy and confidentiality. The protection of privacy and confidentiality is facing several challenges in the era of big data. Full anonymization of personal data no longer provides sufficient guarantees. Partial anonymisation, also called pseudo-anonymisation, or the replacement of identifiers with a code in order to guarantee re-identification when necessary or desirable (for example, to give information to individuals when serious illness or specific risks are discovered), entails possible vulnerabilities, including potential access by third parties (i.e. employers, insurances). Re-identification should not only be considered as a theoretical possibility, but also as a practical and real one in the context of big data. For this reason, effective anonymisation preventing all parties from identification becomes a real challenge. By integrating large amounts of data from different kinds of sources, it is often possible to re-identify an individual. “Privacy” in the sense of a right to respect for private life (which is more than personal data), in relation to those areas of life or the data that individuals want to keep confidential, is at stake. Problems are likely to emerge in ensuring an effective anonymization of data: gender, age, date of birth are sufficient to identify participants. The so-called phenomenon of the ‘evaporation of privacy’ or even ‘end of privacy’ reveals the difficulty or even impossibility, in an age of big data, to completely defend the confidentiality of the patient, who is the data owner. The risk for the patients is the possible/probable loss of control over their private information in this virtual space, through the expansion of data.44 The challenge lies in informing the patients and gaining critical awareness of the problem. The challenge is to raise awareness without losing trust in the governance of health data. There is a loss of trust in confidentiality caused by the awareness of large-scale data disclosures, as well as revelations regarding intrusions by government agencies and commercial companies, including inappropriate data sharing by social media organisations. In this sense, there is a need for designing new forms of governance in data collection systems. There should be an improvement of technical measures—as concretely as possible—in order to prevent the identification of subjects and reduce the risk of privacy infringements whenever possible (the so called ‘privacy-­by-design’ or ‘privacy-in-design’). On this point, discussion should be taken forward, at a normative level, on how to guarantee transparency at the moment of data collection and find additional measures to prevent identification of individuals, as standardised anonymisation protocols are insufficient in specific contexts.  The information requested is of an heterogeneous nature. With specific regard to health-related data, consideration should also be given to the fact that boundaries between the strictly medical and non-medical spheres are becoming increasingly blurred, like those between health and society; information on lifestyles and behaviours tends to become increasingly more relevant to health even within the perspective of prevention. In this sense, health information is not only deemed to be the outcome of laboratory tests or epidemiological data, but also the general news that comes from social networks.

44

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Furthermore, in the age of big data, there is a radical digital transformation of informed consent. We witness a “challenge” to informed consent as it has been traditionally understood. It is, sometimes, almost impossible to specify who is collecting the data and who will use it, which data is involved, how the data is collected, where it will be stored, for how long and for what reason and purpose. It becomes difficult to guarantee the right to access, modify and delete personal data, to revoke consent or to dissent. Informed consent, in the field of big data, cannot be specific. It, inevitably, calls for characteristics of “broadness” given the impossibility of accurately anticipating the paths of research or application in healthcare (similar to what occurs within the framework of biobanks). It is therefore a “dynamic” and “flexible” consent, which identifies similar areas of research directly or indirectly related to the original path. Broadness, dynamism and flexibility do not mean “blind” or ‘blanket’ consent to whatever research. Broad consent implies asking individuals transparently to consent not only to the immediate purpose for which their data has been collected, but also to unforeseen uses of their data. Dynamism and flexibility mean engaging the active participation of the data subjects, allowing a constant control of data access by individuals, through consent portals. In a context of greater participation and citizen involvement in science/medicine, concerns centre around the risk that individuals may also be willing to actively participate in research and express their consent to donate and share data to ‘open source’ platforms. This may be explained as a form of altruistic and solidaristic behaviour, expressed in the willingness to give unlimited permission regarding the use of data in a collaborative or cooperative context (as in ‘citizen science’). Some criticise this kind of consent to ‘data donation’, defining it as misinformed naivety and suspect that the exaltation of an unselfish logic may be inspired by a hidden desire to stimulate above all the market. One could perhaps rethink the very expression “informed consent” in the digital world, limiting it to an “awareness” or “acknowledgement” (as a sort of declaration) that the data will be collected, with a critical consciousness of the difficulty/impossibility of anonymity, based on the non-precise a priori determination of the method of use, storage, and analysis of data, and the impossibility of guaranteeing security and confidentiality in all circumstances. In this context, the protection of personal data (confidentiality, discretion, privacy) should be combined with the protection of personal freedom,45 in order to avoid or at least mitigate the “social risks” of new technologies, namely the abuse and misuse of data for discriminatory purposes (in the field of insurance companies or workplace). That is why another ethical requirement for governance of big data is the respect of the principle of equality, as non-stigmatization and non-discrimination. There are no specific regulations of the phenomenon of big data in national and international legal frameworks. Regulation of data protection is provided for in many legal systems, numerous rules thereof could be applicable to the area of big 45

 Bock (2016), p. 9.

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data: even though big data is a new reality and may require new regulation. While there is a broad consensus on the core data protection principles at the heart of most national laws and international norms, the main challenge is the divergence in the implementation of these principles, as well as in the detailed data protection laws of the world.46 The legal framework applicable to data use in biomedical research and health care recognises, broadly, two sorts of measures that may protect the interests of citizens against potentially injurious misuse of data. First, it recognises operations that alter the data in order to de-identify it, so that its use would no longer pose a direct risk to data subjects through person identification. Second, it sets out controls over access to data in a way that the data is only made available to authorised users, under circumstances in which it is expected not to be misused or otherwise result in harm to data subjects. These measures are often used in combination. In the framework of the UN Declaration of Human Rights (1948) and the European Convention on Human Rights (1950), there are other documents and regulations. Both are the main binding legal instruments at international level, which address privacy. The European Region has a more developed legal protection of health-related data than other regions.47 In the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the Protection of Natural Persons with Regard to the Processing of Personal Data and on the Free Movement of such Data, and Repealing Directive 95/46/EC, General Data Protection Regulation is of great importance for information and communication technologies, because it provides the basis for the exercise of new rights and defines limits with regard to the automatic processing of personal data. The Regulation states that the persons involved in the processing of personal data should be informed of their right to revoke consent to certain processing, and the right to “be forgotten”, or the cancellation of their personal data. Furthermore, the Regulation introduces the “right to portability” of one’s personal data to transfer from one data controller to another. The Regulation confirms the transfer ban on personal data to countries located outside the European Union or to international organizations that do not meet the required standards on data protection, in relation to which the Regulation introduces more stringent evaluation criteria. Also significant for information and communication technologies is the principle of “privacy by

 Wyber et al. (2015), pp. 203–208.  WHO (2012), p.  27. Among the most significant documents on the subject adopted by the Council of Europe: Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data, Council of Europe, 1981 and additional protocol (Additional Protocol to Convention ETS No. 108 on Supervisory Authorities and Transborder Data Flows); Recommendation CM/Rec (2010)13 of the Committee of Ministers to Member States on the Protection of Individuals with Regard to Automatic Processing of Personal Data in the Context of Profiling (23 November 2010); Recommendation CM/Rec (2012)4 on the Protection of Human Rights with Regard to Social Networking Services; Recommendation CM/Rec (2014)6 on Human Rights for Internet Users; Recommendation CM/Rec (2016)1 on Protecting and Promoting the Right to Freedom of Expression and the Right to Private Life with Regard to Network Neutrality.

46 47

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design”, whereby it is necessary to ensure the right to data protection from the initial stage of conception and design of a process or of a system. This goal could be reached through: transparency of database purposes, arrangements for the control of accuracy and transparency of procedures (collection, use of algorithms, consent), arrangements for the protection of privacy, at least declaring the limits of privacy protection, arrangements for the duration of data storage, concerning data ownership,48 data sharing and criteria for access, including the prioritization of research and data users. It is important to be cautious and to avoid exaggeration of the current state of scientific knowledge and the potential benefits of big data and precision medicine for healthcare. The bio-optimistic ‘hype of big data’ can lead to overstatements and unrealistic estimations. On the other side, the bio-pessimistic underline threats, potential risks and damages that may lead to neglect the potentials of big health data. A balanced way of dealing with hopes and promises, opportunities and challenges, is very important in order to protect human values and rights in the context of the advancement of techno-science in medicine.

3.8  Mobile Health One of the emerging technologies strictly linked to big data is mobile-health. The term ‘mobile-health’ or ‘m-health’ refers to mobile technologies (i.e. the use of wireless communication such as smartphones, tablets, digital devices, wearable sensors), related to health.49 There are a lot of applications for well-being or wellness-fitness (counting calories, measuring steps and movement, monitoring emotions)50 and medical applications for prevention (recording physiological functions such as heartbeat, breathing, pressure, temperature, brain activity),51 for diagnosis (e.g. melanoma), in the treatment of diseases (e.g. medical remainder to improve adhesion to treatment), for assistance (e.g. care for disabled people with limited mobility). Mobile applications in healthcare open new opportunities: the improvement of technologically innovative organizational models, redesigning services in multidisciplinary interventions, improving the efficiency of the healthcare system, with reduction of costs for care and hospitalization by the use of remote monitoring and  Hoeren (2014), pp. 751–754.  The delivery of healthcare services via mobile communication devices (2010 mHealth Summit FNIH) applies to both software and hardware, “Healthcare delivered wirelessly”. 50  Bert et al. (2014), p. 9995; Giacometti et al. (2013), pp. 249–259. 51  Examples of medical applications for health: ‘Welp’ to detect the paralysis often characterizing seizures; applications for preventing falling of older people; applications to identify the first signs of Parkinson’s disease; applications to manage certain diseases (HIV, diabetes, chronic conditions). 48 49

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telemedicine; the empowerment of citizens in their active and aware participation in health and promotion and motivation of a healthy lifestyle; the enhancement of doctor/patient communication and personalization of treatments, facilitating individual and environmental data collection, useful for the individual as well as the community (i.e. epidemiological research). There are also some ethical concerns. The fundamental ethical aspect regards the protection of health of the user or safety, above all in the determination of criteria for the distinction of m-health applications that come and do not come under medical devices. Medical device refers to any instrument, apparatus, software, material, intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease. This distinction is important because the medical applications on health, before being commercialized, must comply with international and European regulations, the rules governing how the devices should be used, by whom, and which their applications are. In the case of non medical applications/devices, there is no specific regulation, but only the general protection of the consumer. While the testing of medical devices has a precise and detailed regulation (as drug experimentation), there is no regulatory requirement for testing apps as they are not considered medical devices. There is a tendency of developers and of companies to circumvent the regulation (which is often long and burdensome) of medical devices by presenting as a simple method for verifying well-being what in actual fact is a genuine medical device. In this sense there is an ambiguity in the supply of health applications. The criteria of evaluation in this area is the real impact on users, judging from the number of downloads and the views and comments expressed on the network. What drives users to install an app is not a scientific validation of experts rather than the approval expressed in the network by consumers. The consequence is that some applications on the market are potentially dangerous for the consumers themselves.52 Some health related applications with clinical use do not provide training for doctors using them and they do not involve doctors in the design and development process.53 Often the developers and designer of health apps have only technological knowledge, with no medical expertise; the doctors may know little about technology; the users tend to rely on technology, often without being adequately informed about the limits of safety and the possible risks. Another ethical problem concerns privacy. The intensive generation of data, rapidly and continuously collected and stratified through the monitoring of physiological and psychological parameters are correlated with algorithmic models. This  On these issues, there is already a wide-ranging debate: McCartney (2013), p. 181; Buijink et al. (2013), pp. 90–92; Haffey et al. (2013), pp. 111–117; Wolf et al. (2013), pp. 422–426. The problem that remains open on the practical level concerns the fact that the exponential rate of designing new apps makes it difficult to carry out the evaluation of the risk/benefit. Medical apps can work with different operating systems, so it is not possible to test them all for safety. 53  E.g. some applications for asthma, food diary, ‘my recovery’ applied to preparation management for operations and after surgery, for rehabilitation; use of games to control panic attacks; home HIV testing, sexual diseases, streptococcus. 52

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explosion of information raises some controversial aspects regarding data collection. Any information may be relevant, but at the same time may become discriminatory when connected and “profiled” to individual users. The collection of data relating to health, but also beyond health (lifestyle, habits, preferences), may give rise to elements of relevance for the market of pharmaceuticals, insurance and labour. Profiling system may be discriminatory: how is it possible to avoid, for example, that those buying apps for heart problems, being classified as possible cardiopaths, have possible consequences in workplace or insurance? These phenomena frequently occur without the person’s awareness. The problem not only affects health and medical data, but also the data on wellness and lifestyles. These data are called “raw data”: even if they are not directly medical, combined with other data, they may have a medical relevance and allow for the definition of a health profile of the user.54 There is a lack of transparent information to users, before downloading the application of data, on what and how much data are used for possible research; who uses data and manage them (data controllers); where the data are stored, for how long (data repository). There is a lack of information as to whether the data are to be combined with other data from which health-related information can “reasonably” be inferable; absence of information on the risk of identification and of data access by third parties (insurance companies, employers, etc.) and the possibility that those who store data may ‘sell’ them to form research databases (commercial/scientific). Emerging in the ethical debate is the requirement of privacy as a condition of the very legitimacy of the app. It indicates the possibility that the issue of privacy is already considered at the design stage of the application, therefore from the beginning of the technological project. One of the ethical issues under discussion in this context is informed consent or ‘informatic consent’. The Warsaw Declaration on the “appification of society” (September, 2013), in the context of the meeting of the Data Protection and Privacy Commissioners, 35th annual international conference, proposed the so-called “granular consent”: it consists in a detailed consent given specifically for each information.55  E.g. if one collects data of the counting of the number of steps taken once only, such data reasonably will not lead to any inference. These are not data in a medical context and are not correlated with other data, therefore not relevant for research. But if they are systematically collected and combined with other data (e.g. gender difference, age, habits) they can become important for research. 55  This is the line of thought based on the interpretation of para. 107 of the Explanatory Memorandum Recommendation N° 97) 5 on the Protection of Medical Data: “But even in cases where his/her consent is not required—that is, when the collection and processing of medical data follow an obligation under the law or under a contract, are provided for or authorised by law, or when the consent requirement is dispensed with—the recommendation provides that the data subject is entitled to relevant information”. Also Article 29 Working Party has recently published a document On apps on smart devices, which emphasizes the need to inform in a clear and unambiguous way the way in which the data are used (data type, purpose, period) before installation of the app. The right to be informed is also expressed in art. 10 Directive 95/46/EC; art. 5.3 of the ePrivacy Directive 2002/58/EC. 54

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Informatic consent is often written in small characters on small screens, sometimes without the alternative to dissent. Consent risks to become a mere ‘click’ without sufficient time for making an informed and aware choice, without any kind of relation.56 This consent becomes even more sensitive when the apps are used by children, even if it is difficult to know whether the medical app is used by an adult or a minor. There is a need to provide, precisely for minors, simple, and concise information that also includes educational references which encourage awareness. There is a tendency to incorporate technology in everyday life with the recording of human behaviours: measurement of food eaten, kilometers covered, calories consumed, registration of the emotional state. This phenomenon has been interpreted as the application of the scientific method to the personal sphere, with the aim of quantifying oneself. The urge to ‘datify’ one’s corporeal, psychical and emotional functions can arise from the desire of self-control and self-measurement, as a way to feel able to exercise power over themselves and of being masters of one’s own destiny in an era, marked by uncertainty. The difficulty or impossibility to control the world and what is happening around us urges to fill with a sort of ‘compensatory mechanism’ such a lack with the will to control what becomes technologically controllable. But the quantification of the self may contribute to exacerbate forms of health fanaticism and the medicalization of life, as well as consumerism (market pressures to buy new apps to improve physical and mental performances). The existence of increasingly complex technology without a corresponding rise in the level of awareness and culture is ethically problematic. Someone says that Google is now the first doctor for Americans. New technologies can change the way in which citizens manage their own well-­ being and health, involving citizens more actively. The active participation by citizens on their own health is positive, but it can have negative implications: the citizen/patient may feel able to cure oneself and be responsible for his own health (self-medication), without any need for a doctor. This can be positive in the prevention of disease and the maintenance of appropriate lifestyles.57 The ethical problem emerges in relation to diagnosis and treatment of pathologies, when the patient does not have sufficient skills and information to make a direct medical assessment alone. It can become a form of de-­ responsibilization of the doctor, ‘passing’ it to the patient, reducing the interpersonal relationship impoverishing or even eliminating the relationship with the patient. It is essential to reflect on a fair distribution of technology—proven safe and efficient—and the access to new technologies for all, including disadvantaged and vulnerable groups (the elderly, the disabled people, the indigent and those not sufficiently competent to actually use technology). Non-discrimination should also be ensured towards those who can not or will not be able to access these medical technologies, guaranteeing the provision of alternative solutions for health treatment.

56 57

 Mantovani et al. (2013); Parker (2012), pp. 50–52; Siòlberman and Clark (2012).  Cf. Italian Committee for Bioethics (2014).

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These ethical challenges could be solved with different actions: promoting interdisciplinary research between computer scientists, engineers, informatics together with ethicists, in the phase of design, testing the applications in order to ensure the protection of safety, privacy, and autonomy; encouraging developers and industries to produce apps reliable for the health of citizens; identifying the responsibility of companies that produce apps, placing as ethical requirements to design the safety and privacy (minimizing data collection); establishing an observatory to monitor health apps in order to devise potential risks. Specific attention should be devoted also to the elaboration of informed consent, in particular for vulnerable groups, such as children, the elderly, the disabled persons, in order to ensure non-discrimination and enhance inclusiveness of the advantages in the use of the new technologies. It is relevant to improve the social promotion of a critical awareness in the use of the new applications for health, avoiding forms of ‘healthism’.58

3.9  Biometrics, Biosecurity, Biosurveillance The possibility to observe, monitor and measure oneself and the other is strictly connected to “biometrics”. It deals with a scientific field and the technological automation of the procedures of identifying human beings through the assessment and verification of the physical, psychological and/or behavioural properties and characteristics acquired by electronic sensors, elaborated by mathematical algorithms. The requirement is that the characteristics should be easily measurable, should be unique and specific to a particular person, and must remain stable and constant over time. The new technological tools for biometrics increase the opportunities, but at the same time open new possibilities for social or personal control. Biometric authentication (both in the sense of identification and verification of identity)59 require: universality (each individual should have the biometric feature); distinctiveness (the element of biometric reference should allow to distinguish each individual from all others); permanence (the element used for biometric analysis should be stable in time); collectability (the biometric feature should be quantitatively measurable in a stable system of detection). The body has become a ‘password’60 or a living code that may be measured and interact with machines. Individual unique characteristics can be recognized from our body: facial characteristics, hand geometry or vascular structure, voice  See Italian Committee for Bioethics (2015).  Identification (“who is this person?”) is the determination of a subject’s identity by comparing a measured biometric in a database of records (a one-to-many comparison); verification (“is this person who he claims to be?”) corresponds to a one-to-one comparison between a measured biometric and a particular person. All biometrics can be used for verification, only some may be used for identification. 60  Davis (1997) and Jain et al. (1998). 58 59

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modalities, iris patterns, vascular structure of the retina, signature dynamics, keystroke dynamics, DNA61 and our behaviour (movement, expression etc.). Both physical and behavioural characteristics may be associated with other personal information. The stages of a biometric process include: acquisition of the biometric feature through a sensor; transmission of data; processing of data; storing the template; comparison; validation/matching. Evaluation is on a statistical basis and is a f­ unction of a great number of parameters, that can include margins of error, such as changes in environmental conditions, data collection, physical and behavioural changes (temporary or permanent). Biometric technologies involve interdisciplinary knowledge that includes electronics, computer science, statistics, medicine, psychology, ethics and law. These elements linked through computer networks and ICT, may become a technological instrument of stigmatisation and discrimination.62 The problem of the protection of individual identity and privacy is particularly relevant, as there is the real risk that the individuals can lose control on their identification processes. The areas of application of biometrics involve large spheres of social life, beyond criminal investigation: access to certain places, enjoyment of particular services, traceability, with an expansion of the market. The requirement of accountability and reliability concerns the management and control of data collected nationally and internationally. Technologies in this field are becoming more pervasive and intrusive, affecting individual behaviour. The individual runs the risk of assuming social importance only for the traces he leaves. Technologies are bringing new and subtle forms of control, and consequently, they may affect their personality, at least to “remain” in a biometric system and to “maintain” biometric data. On the one hand biometrics can enhance and improve security and biosecurity, on the other hand constant control of everyday activities can become an insidious form of biosurveillance, and interfere with personal identity, safety, security and freedom. First of all, in biometrics, the body becomes an instrument of recognition and, therefore, to guarantee authentication specific measures are needed. Beyond the rules of neutrality and standardisation, it entails a sort of duty for permanence and maintenance of the characteristics of the body (no alteration of fingerprint or facial characteristics). Voluntary alteration of the body is therefore limited with reference both to non-permanent changes (cosmetic, ornaments, etc.) and to permanent ones (tattoos, piercings, surgery, etc.). The appearance could become the predominant way of unicity of being strictly linked to the ability to be recognized by biometric systems. The damaging of one’s biometric characteristics could alter or hinder the  DNA analysis does not allow authentication in real time, as the other biometrics technologies. The temporal criterion is not covered in the definition of biometric technologies and therefore does not prevent to include DNA analysis among them. 62  Cf. Mordini and Petrini (2007), pp. 5–11. See also European Group on Ethics in Science and New Technologies (2014). 61

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possibility of recognition, in a similar way to what happens in the case of deteriorated documents. This would create a sort of biometric inability for that physical feature. Confidentiality and anonymity are at stake. There is no absolute right to anonymity, which is guaranteed in many different circumstances. Another ethical challenge is the possibility of discrimination of certain groups of users. ‘Biometric disability’ is a new expression referring to the condition of impossibility to use biometric technologies, encountered for certain categories of users (as minors, old people, disabled persons). For example, the use of biometrics raises a number of technical issues with reference to children, as body parts for the ­acquisition of biometric data are undergoing rapid development; if we refer to fingerprint, the gradual drying and thinning of the skin in the old age, may alter biometrics identification. Another ethical issue concerns the centralized repository of biometric data, that increases the risk that such data are used to connect to other aggregates of personal data creating a profiling of the subjects concerned. The interoperability of databases generates efficient systems, but it can introduce possible associated hazards. The use of technologies based on biometric features that leave no tracks, and that minimize archiving and interoperability, could mitigate these moral issues. The ethical requirement of necessity, proportionality and relevance of data collection is necessary for a balanced governance in biometrics. There should be a recognition of the right to access to the biometric database, in order to know what data have been collected, by whom and for what purpose, since when and for how long, and with what other data this has been associated. There should be a recognition of the right to oblivion, as a right to be cancelled, or a right to modify data and their traceability, in order not to be discriminated.

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Chapter 4

Converging Technologies and Enhancement

4.1  Converging Technologies: Nano-Bio-Info-Cogno-Technologies The expression “converging technologies” refers to the combination of four scientific sectors: nanosciences and nanotechnologies, biotechnologies applied to living systems in the biomedical field and genetic engineering, information and communication technologies, cognitive sciences and neurosciences (generally indicated with the acronym NBIC).1 The innovation of converging technologies is not given by the sum of the results in the different scientific sectors, but from the systems interaction and synergic integration at the confluence of different methodologies. The deep innovation and unprecedented transformation is identified with the interface between the biological and the informational level, both levels at the intersection of nano-, neuro- and cogno-. The continuous, rapid, dynamic progress both in scientific knowledge and in technological applications makes it difficult to provide an updated description of emerging converging technologies. Each attempt to update is inevitably incomplete, and needs to be constantly revised. It is possible to identify major trends of this new techno-scientific advancement in the process of ‘biologization of information’ and ‘informatization of biology’.2 The first trend “from biology to technology” identifies with the progressive technological and informational transformation of the body and its parts: bioengineering of biological living complex systems, genes, cells, tissues, organs, brain; ‘neuro-­ engineering’ with nano-neuro-implants; interactions between neurosciences and

1  Roco et al. (2002) and Antón et al. (2001). A European reflection followed: Nordmann (2004), Berloznik et al. (2006), van Est et al. (2010a, b) and van Est and Stemerding (2011). 2  van Est (2014).

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artificial intelligence, informatics and robotics; brain/computer interfaces, wearable sensors and computers, reverse engineering the brain, artificial life. The second trend from “technology to biology” coincides with the interconnection of informatics and cognitive processes, with the creation of machines similar to living beings, able to self-repair, think and act intelligently: the so called ‘living technology’, ‘living artefacts’, bio-inspired or socio-inspired artefacts, social robots. The increasingly exponential acceleration of techno-scientific progress in the convergence of nano-bio-info-cogno, sets an ethical challenge not just in number, scope, depth of issues but also in the very form the ethical reflection takes. Ethics should be dynamic and integrated, in the ongoing process of techno-science since the beginning of the research project, during the process, until the application at every stage in a case-by-case methodology. Convergence of technologies requires ‘convergent ethics’. Not only in the sense of finding common minimum values in a pluralistic society, but also in elaborating a synthetic view dealing jointly with the different levels of analysis (nano-ethics, biotechnology ethics, ICT ethics, cognitive sciences ethics). Ethics should also be integrated with social sciences, that deal with the societal impact of new technologies. There is a preliminary ethical distinction to be made between the technologies on human beings (intervention on the body and on the mind), the technologies involved in the interaction between human bodies/minds and artefacts, and the technologies producing artefacts with the robotization of the body/life and artificialization of intelligence. The technologies intervening on the human body/mind give rise to many emerging ethical challenges: the definition of health and illness, the distinction between cure/care of the patients and enhancement of capacities (physical, psychological, emotional, social) of the healthy subjects, increasing in a quantitative sense and/or bettering-improving in a qualitative sense performances. Medical and non medical purposes challenge the ‘traditional’ values, such as respect of human dignity, integrity and identity. Technologies producing artefacts (interaction between bio and techno-info-digital, cognitive and behavioural sciences, robo-ethics) trigger anthropological dilemmas involving the interpretation of human nature facing the new possibility of hybridization and artificialization of human beings (disembodiment, functionalism). The ethical distinction between invasive/non-invasive technologies, possible non serious or serious harm, immediate and long-term effects, reversible or irreversible damage, require a deep reflection on the ethical values of security, efficacy, dignity, autonomy and justice. All these values need to be re-interpreted in the light of the main goal of converging technologies, that is human enhancement, enhancement of human capacities and enhancement of humans.3

 van Est et al. (2014) and Strand and Kaiser (2015).

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4.2  E  nhancement (Genetic, Biological, Cognitive): Beyond Therapy The term “enhancement” is increasingly used in the bioethical debate, often involved also in converging technologies, to characterize a set of interventions going ‘beyond’ therapy, the latter being understood as a medical treatment necessary to prevent, sustain and restore good health. Enhancing means intervening in the human body and mind of a healthy individual, in order to alter existing physical, mental and emotional capacities or create new ones, designed to achieve a quantitative increase and qualitative improvement in human beings.4 To a certain extent, cosmetic surgery, namely those interventions meant to correct, in the sense of improving the aesthetic appearance of the body, and doping in sports, i.e. the use by athletes of drugs and practices aimed at artificially enhancing performance to ‘win at all costs’, both fall within enhancement. In addition, other types of interventions occur: genetic, biological and neuro-cognitive enhancement. ‘Genetic enhancement’ generally refers to the use of intervention techniques to improve the genomes of healthy individuals (ameliorative genomics or gene doping), performing interventions on gametes, embryos, fetuses, but also on infants, children, adults. It is the case, beyond eugenic selection (both in a negative and positive sense, or selection of the sick or selection of individuals with preferable/desirable traits), of genetic alteration of the individual or species, through gene-editing. ‘Biological enhancement’ indicates the possibility to intervene in ageing mechanisms to curb physical and psychological deterioration (as anti-aging medicine) to obtain rejuvenation, alongside an indefinite healthy and youthful life-extension, with the far-reaching prospect of a sort of “earthly immortality”. ‘Neuro-cognitive enhancement’ refers to interventions designed to improve mental and emotional performance, thanks to recent advances in neuroscience and neurotechnology involving the brain, as well as the neurophysiological mechanisms that govern cognitive functions: psychotropic drugs affecting mental processes, neuro-imaging technologies that allow us to explore the human brain in vivo for diagnostic and therapeutic purposes, but also to assess or alter brain function, such as deep transcranial magnetic stimulation over the cortex, placing brain implants and employing a brain-computer interface. It deals with diverse methods of intervention, more or less invasive with regard to the body, that despite differences share common goals of intervention, which can be identified with enhancing human capabilities.5 In the context of a pluralistic debate, arguments for and against enhancement are compared, according to their various articulations. This analysis will not delve into single applications; it outlines the different contrasting stances, in an effort to reach a balanced critical position.

 Juengst (2000), pp. 1–28.  Italian Committee for Bioethics (2013a, b).

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Many arguments, in the framework of the libertarian and utilitarian theories, are in favor of enhancement. The impossibility to starkly distinguish between therapy and enhancement emerges from a subjectivist view of health, based on a state of complete physical, mental and social well-being.6 In this perspective, enhancement is equated with therapy, insofar as a reduced capacity is subjectively, socially and culturally perceived as a source of discomfort. According to this stance, enhancement and therapy are interchangeable, contiguous and equivalent. The equivalence between therapy and enhancement also stems from the common aim of the two types of intervention. The goal set for any pharmacological or technological activity is and must be ‘change for the better’: what matters is reducing risks and harm, while increasing benefits, this is a preeminent moral imperative, regardless of whether or not it has been achieved through tools classified as therapies or enhancements. In this perspective, human body and mind modifications are justified every time that the intervention does not cause harm weighted against benefits, in the broad sense. If harm results from the latter, it should be deemed acceptable for subjects on whom the intervention is performed or by subjects deciding to intervene on other individuals who are not capable of making decisions. Therefore, interference in the ‘natural lottery’ of life (i.e. the physical conditions one is born into) through either natural or artificial means is always justified, with a view to improvement: the risk of possible harm is always worth taking, either low or high, reasonable or only likely to happen, individual or social. Above all, it is important to prevent and avoid suffering altogether, while ensuring well-being, whether it is achieved by treating dysfunctions or attained by improving functions. The task of physicians, within the framework of a contractualist approach to medicine, is not solely devoted to treating the sick, but also informing them about existing opportunities to intervene in their bodies and minds, along with fulfilling their requests, based on subjective perception, wishes and willingness. Informed consent ought to be required for intervention, as with any medical practice, expressing the patient’s conscious self-determination, while assuming responsibility for the decision to modify his own body and/or mind, whatever it may be, after being given adequate information. In this perspective, everyone is entitled to the “right to self-­ improvement”, considering benefits in relation to one’s own desires and risks with respect to health. The stance in favor of any request to enhance assumes and implies a materialist-­ mechanist conception of the body. In the context of an evolutionary conception of nature as an ‘imperfect machine’, any manipulation aimed at perfecting it can be justified. Any machine is always perfectible and can be improved through a direct intervention that enables the replacement of parts, the quantitative amplification of capabilities, the enhancement of qualities deemed desirable. Nature is devoid of ontological significance and reduced to a system of entities, where each functionality or alteration must abide by the rules of the organism, according to the deterministic law in terms of cause-effect. The materialist approach to nature is rooted in  Agar (2004); Bostrom (2006), pp. 40–50; Savulescu et al. (2011); Harris (2007).

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non-cognitivism, which denies the existence and knowability of truth in nature, as well as in subjectivism that asserts the primacy of individual self-determination. On these grounds, the libertarian perspective legitimizes all kinds of requests by the subject to alter his or her own body-object, even if this entails causing psycho-­ physical injury, depending on the individual autonomous choice. Given the technological possibility of living longer, healthier, stronger, of becoming more intelligent, refraining from doing so is not justified, arguing that there is nothing morally wrong, in principle, in all forms of enhancement. The only requirement is informed consent and taking full responsibility, alongside the absence of harm to others. Where ‘harm to others’ is interpreted as an obstacle or hindrance to freedom of subjects capable of exercising it. Improvement is considered part of human development, consciously or unconsciously, with reference to any individual or social opportunity, natural or artificial, protecting against harm and producing a benefit, for ourselves and others. Vaccination enhances the healthy body’s resistance to the action of pathogenic viruses; aspirin may exert an enhancing effect and help reduce the risk of heart attacks. Glasses correct sight defects; telescopes or binoculars boost vision. Physical exercise enhances muscular and athletic performance; education improves intelligence and personality. Writing allows us to remember, retrieve information, develop ideas, expand ways of communicating through space and time; alphabet and numbers enable to perform calculation and reasoning. Mnemonic techniques enhance the storage of texts and sequences; the use of mobile phones and computers extend our minds into artificial computer devices. Any action is, upon closer inspection, a form of enhancement: even drinking coffee to stay awake, sleeping for rest, dressing against cold, using shoes for walking, hunting and cooking to feed ourselves, speaking to interact with others. Thanks to these actions, human relationships developed within society and institutions, schools, universities, markets were established; they paved the way for the birth of literature, art, music. Each of these actions accounts for a form of enhancement, as a mechanism meant to make a better life possible (although obviously not inevitable). In this way, if one is to legitimize resorting to vaccination, the use of glasses or telescopes, education and physical exercise, writing and calculating, the use of mobile phones or computers, one may as well consider licit biomedical, genetic, biological and cognitive enhancement of physical, intellectual and emotional capacities. This refers to the so-called ‘argument from precedent’, whose implicit structure involves the following reasoning: we have always employed A to reach target C; element B enables us to achieve goal C; therefore also element B is morally unproblematic. If anything, the use of enhancement technologies results in a biotech ‘shortcut’ that fosters, accelerates and facilitates the achievement of desired results. According to the utilitarian perspective, we are experiencing a historical juncture in which it is no longer sufficient to improve the world around us, but it is now also necessary to change ourselves and the human species. In particular, we have gone so far as reaching a stage where Darwinian evolution is about to give way to a process in which the human being seizes the reins of his own evolution and transmits

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directly to offspring any modification he deems appropriate. Enhancement is, on this account, a stage of evolution: natural selection should be replaced by “deliberate choice” of the selection process, allowing to achieve the same result with much less effort. Although possible negative outcomes still remain unknown, halting progress in this direction would imply hampering or preventing the possibility of accelerating human evolution. On these grounds, enhancement is considered a “sensible gamble” that is worth pursuing. It is the theory of “self-evolution” and “enhancement evolution” that shortens time required for evolutionary progress over millions of years, allowing human beings and humanity to attain and realize their full potential, in order to balance the effects of the natural lottery, in physical and social terms. This approach justifies a “duty to enhancement” as a “duty of beneficence”, which is not only individual but also collective. In this respect, there is of an evolutionary transition to the “post-human” or “trans-human”, which implies a different conception of the body as subject and, likewise, as object becoming gradually devoid of its phenomenal and identity prerogatives. It deals with a pharmacologically and technologically altered body, modified according to subjective desires, being overwhelmed by technology, modified by implants of artificial organs and microchips, interfaced with electronic devices. The most radical technophilic orientations fall within this framework as well, which view the contemporary man as “outdated” by now and dream of future liberation from all biological constraints, inherent in the human condition, with a view to freeing man from his very nature and evolving towards a new being, “no longer” man but “other” than man and “beyond” man. In this perspective, man is both a “subject-­ agent” and “acted upon object”. As regards the perspectives against enhancement, they are inspired by different theories, underlying the dignity of human being, their autonomy and responsibility, together with justice and solidarity.7 The main argument is grounded in the acknowledgement of the possibility to identify objective parameters for determining the concepts of health and disease.8 The “normal functioning” of the organism indicates evidence-based biological referents on the state of health. This is the naturalistic conception, according to which one can provide an objective and universalizable description of disease (and consequently of health), seen as a deviation from rules governing the physiological functions, typically associated with human organisms. This approach emphasizes that the regular functioning of the organism is a natural fact, not a conventional and arbitrary social construction. It clearly recognizes the obstacle or hindrance to the full expression of organic functionalities, in attaining their own purposes, as constituting a pathological state. Deafness and blindness are diseases which need a pharmacological or technological treatment to restore 7  Fukuyama (2002b), Habermas (2003) and Sandel (2007). Cfr. President’s Council on Bioethics (2003). 8  Report of the President’s Council on Bioethics (2003); Kass (2002, 2003), p.  8; Fukuyama (2002a, b, 2006); Habermas (2003); Sandel (2007); Fröding (2013).

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capabilities that the individual “would” naturally be endowed with, in order to overcome what prevents ears from hearing and eyes from seeing. The distinction between health and disease (while acknowledging the existence of nuances in certain experienced circumstances) enables us to draw a distinction between therapy and non-therapy. It should be clarified that prevention (e.g. vaccination) falls into therapy since, despite being a treatment in healthy subjects, its purpose is oriented towards protecting both public health and individual health. Conversely, all biomedical and technological interventions aimed at increasing capabilities “beyond” natural limits and thresholds are extra-therapeutic. On these grounds, proportionality between risks and benefits is weighted against curing the disease. The use of drugs or technologies for improvement purposes can instead cause serious harm, disproportionate compared to the expected benefits, which coincide with the fulfilment of subjective desires. For instance, women who undergo cosmetic surgery to become more beautiful may run deformity risks; a student who uses drugs to improve concentration may get addicted to them; a person who uses psychiatric drugs to control anxiety and sadness may become apathetic; an individual accepting micro-chip implants could seriously and irreparably damage his cognitive ability. This approach claims that the physician cannot become a mere passive and unquestioning executor of desires and will, resulting in a sort of “hetero-­ determination”. In conditions where no state of emergency is occurring, and there is no medical or physical need, but a mere subjective desire, the physician can refuse medical intervention, insofar as the non-congruity between subjective desire and objective condition is highlighted. Excessively risky interventions with regard to achievable benefits (deemed ineffective, costly and burdensome for patients), alongside irreversible and predictably inconclusive interventions, cannot be ethically, deontologically and legally justified, even if requested by patients. On ethical grounds, it cannot be justified given the value of the body, which is not made arbitrarily available for the subject; on deontological grounds, because physicians are called upon to serve the principle of beneficence and non-maleficence, acting for the good of patients and doing no harm to them; on legal grounds, in order to protect the right to physical integrity, as an individual and social good. From the perspective of protection of human dignity, emphasis is placed on the risk that a subjectivist interpretation of health/disease may lead to excessive medicalization and pathologization. Physicians should help healthy subjects who seek medical advice understand the reasons for deeming their requests either acceptable or unacceptable, and in any case refuse to perform an intervention on the body going against excessive desires and expectations, taking on a therapeutic responsibility towards subjects. Part of the physician’s task is to understand whether the enhancement request does not spring from self-dissatisfaction and discomfort in relating to others, a sense of insecurity and as a result of  an external social pressure: in which case, even improvement interventions would fail to achieve the desired goals, making the subject all the more frustrated and insecure, insofar as the merely external intervention is not accompanied by inner growth and development. It is the duty of the physician

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to help the patient understand that improved aesthetic appearance, physical strength or emotional and mental fitness do not necessarily make people inwardly “better” or more happy. The main argument against enhancement, which is meant as an arbitrary alteration “beyond” therapy, refers to the ontological conception of nature and moral reference to the inherent dignity of human beings. In this respect, enhancement should be understood as an increase of accidental qualities (beauty, stature, strength, intelligence) and not a substantial transformation of human beings. A human being without genetic diseases, living longer, with a good quality of life, having an attractive appearance and an enhanced memory, actually gains an advantage. However, in this perspective, the enhancement of qualities, namely the highest possible expression of these characteristics does not, in principle, make human beings “more human” or “more worthy”. A human being is not reducible to the sum of functions; his dignity is independent of considering the presence/absence of qualities and their degree of manifestation. Indeed, enhancing capacities may lead to discrimination, feelings of superiority or subordination, as well as challenging the very human unity and identity. In this context, the logic of enhancement threatens dignity as it is an attempt to overcome the limits of nature, while endeavouring to redesign it according to desires, as well as arbitrary and subjective choices, selecting physical, mental and emotional traits deemed to be better (but how much better?; on what criteria are they based?; who evaluates what is better or worse?). The pursuit of efficiency and perfection may no longer have boundaries. Enhancement is likely to become the expression of the non-acceptance of nature that has been “given” to us, the abuse of objective nature by subjective will. The pharmacological or technological intervention enhancing the body or mind is considered, in this perspective, a mere external facilitation, a ‘biotech shortcut’ that may allow us to achieve even excellent and better results, faster and more efficiently, nonetheless misleading oneself, a ‘fraudulent misrepresentation’ to the detriment of others. Enhancement interventions act directly on the body and mind to produce an effect. The subject remains passive and does not assume any role (if ever, he plays a minimal role) in change. The subject feels the effects reached externally, however, he does not understand their meaning in human terms. As a result, enhancing technologies ‘replace’ personal effort. In opposition to enhancement, “achievement” encompasses the dimension of acquirement, accomplishment, attainment, in the sense of development and realization of potential naturally belonging to “becoming what we are” through an active effort and personal commitment that enable modification of one’s own natural capacities, whilst improving oneself. This is the sense of an action which allows for an authentic and substantial transformation, not in terms of ‘enhancement’ of specific and isolated functions, but of ‘improvement’ as growth and overall attainment of personal and relational identity. ‘Human flourishing’ is not a collection of technologically obtained results, but the constant daily effort in life for development of oneself (becoming what “we are”), as well as the experience of challenging one’s own capabilities, even in the

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face of adversity. Enhancement technologies blur the boundaries between what we achieve by our own efforts and energies and what is evident from the presence of a certain amount of ingested substances or technologies used. Technological and artificial enhancement implies a break in the relationship between the subject as knower/agent, his intentional activities and outcomes. Conversely, achievement allows us to realize change in ourselves, as subjects, even at the cost of sacrifice. In this sense, enhancement becomes a form of ‘social despotism’ which is expressed in the hidden pressure exerted by society on citizens to adapt to standards of beauty, physical and mental efficiency in studying, working, sports performance, society in general. A sort of extrinsic obligation that influences our behaviour and compels us to make choices we would not spontaneously and authentically select. An obligation arising from a diverse spectrum, which shifts from conformism to homologation, towards standards of excellence dictated externally. High-tech societies select and acknowledge the value of certain capabilities, alongside appreciating specific behaviour patterns at the expense of others, which are unlikely to find much recognition and space for expression. Technological development fosters the attainment of a particular cultural or social status, only for those who are endowed with certain physical and psychological qualities, whereas it entails the exclusion of those who are both physically and socially disadvantaged. This gives rise to an enhancement divide, namely a divide between the enhanced and unenhanced. In this sense, enhancement brings about justice-related problems, at different levels. Above all, at the level of distributive justice. The high costs of access to enhancement technologies (moreover, they are not covered by the national health service, precisely because ‘beyond therapy’) make it available only to those who can afford it. This presents us with problems of equality, inevitably introducing differences which increase disparities and discrimination between rich and poor, whilst widening and transforming the gap between the advantaged, becoming increasingly advantaged (enhanced-rich), and the disadvantaged, becoming increasingly disadvantaged (unenhanced-poor), with a hierarchical division of citizens into upper and lower classes. It should also be considered that investing resources in enhancement means taking away resources from prevention, care and treatment of diseases, in a social context faced with resource constraints, which are already insufficient to cover quantitatively and qualitatively growing health needs. A distribution of resources based on a criterion of reasonableness leads us to consider as a priority treatments for diseases in general, in terms of prevention, treatment and rehabilitation, regardless of their degree of severity, over enhancement of capabilities in healthy individuals. Society has a moral obligation to treat diseases, in order to compensate for objective disadvantages. This condition would also exacerbate the gap between the so called developed countries and developing countries, highlighting ethical concerns within the context of global justice. It is equally important to stress that the possibility to enhance, in the sense of selecting individuals according to their characteristics and altering non-existing abilities in an innovative manner, affects the traditional notion of justice, requiring

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a new elaboration. The concept of justice started from a ‘natural lottery’, intervening a posteriori and trying to compensate for disadvantages, deemed intolerable, through distribution, providing more services for the benefit of less advantaged citizens. Now we are developing a new concept of justice a priori, to the extent that it is possible to intervene in bodies by modifying pre-birth conditions or post-birth conditions. If we envisage the possibility of including the choice factor in selective and alterative terms, we can no longer refer to a natural lottery, or at least the natural lottery is irrelevant to justice. Differences in the distribution of natural goods (which should no longer be defined as such) would depend on the choices we make, in front of the options offered by technology. We cannot even talk about social goods in a general sense, since it is possible to obtain them in different ways, with or without enhancement. Arguments in favor and against enhancement highlight two opposing lines of thought, one maintaining an orientation towards interventionism, exalting technology while despising the body (in a bio-optimistic and technophilic perspective), the other towards abstentionism, exalting the body while despising technology (in a bio-pessimistic technophobic perspective). Beyond agreeing or not agreeing with single arguments, an emerging concern for a blind reliance on amelioration technologies, according to individual self-­ determination and evolutionary-utilitarian social duty, comes to the fore; but also for the risks of exhibiting a radical disinclination towards the advancement of scientific knowledge and technological applications in this field. In other words, we cannot rely passively on nature, never interfering with natural processes. Opening up to the possibility of an indiscriminate progress in such a sensitive area is equally questionable, as it can adversely affect human beings today and humankind in the future. Absolutely and categorically condemning enhancement is useless, unjustified and dangerous. Useless as it does not curb progress, unjustified because some methods may be allowed (given the variety of manifestations of the phenomenon) and dangerous, since it is likely to prevent the advancement of knowledge which can yield health benefits. The dual-use of enhancement drugs and technologies make their ethical justification a particularly sensitive and troublesome task: a total ban on research and use of technology can hinder the development of a number of possible therapies a priori; at the same time, the discovery of certain technologies may encourage human beings to use them for enhancement purposes, entailing problematic consequences, at the individual and social levels. The dual-use argument, which was generally brought up by bioconservatives to emphasize risks, is now being used by bioprogressives to justify some development methods. Among conflicting orientations, today, it is essential to outline an intermediate position which could also, on the one hand, prohibit extreme technologies and, on the other, allow us to engage in moderate interventions. A position enabling us to undertake a critical and balanced reflection, while providing the basis for regulation of novel technologies. Paving the way towards a moral reflection and elaboration of legal standards that justify some general reference categories as the conceptual

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h­ orizon for both assessing and specifically regulating individual technologies, at the application level. Critical reflection should take into account current stances in the debate and offer the tools to weigh the possible risks and benefits of each application, thus also considering the invasiveness or non-invasiveness of interventions, the reversibility or irreversibility of every resulting effect and possible implications for present (individuals and society) and future generations, specifically with respect to the dignity of the person, his safety, authentic freedom and fundamental rights, in order to guarantee conditions of justice. This balanced position should assess the conditions for trials in healthy subjects, informed consent, so as to ensure adherence to safety and efficacy requirements, alongside the autonomy of the subject, within the framework of the protection of individual freedom and social justice. The first objection put forward to the use of enhancement drugs or technologies concerns safety issues, in the face of potential risks to humans, society, but also the future of humanity, as well as the environment. In a society obsessed with health, the pursuit of ‘perfect health’ and ‘perfect life’, it is impossible not to shed light on probable health damages. Paradoxically, individuals and society itself are so attracted to results, which are likely to be obtained from new drugs and new technologies (in terms of increasing capacity) that they tend to ignore risks, also owing to the fact that risks are often not well-known (therefore perceived only as possible), sometimes they are not expected to occur immediately, but in the foreseeable future. Yet, even without scientific evidence, it can easily be understood that what is powerful enough to increase capacities, can be just as powerful to cause damage. In this perspective, experimentation plays a significant role in performing a correct ethical assessment of choices within the area of enhancement drugs and technology applications. Experimentation based on diversification, according to different enhancement technologies, should abide by the general rules for clinical trials, set forth in international instruments a long time ago. Carrying out new research aimed at determining more precisely the effectiveness and side effects of drugs and devices in sick individuals is important, in order to better assess whether their possible use for the purpose of enhancing a particular function does not lead to potential decline, temporary or irreversible impairment of other functions. This data is required even before planning trials in healthy subjects. It is thus essential to foster drug, device and technology experimental studies in healthy subjects, choosing appropriate methodologies (statistical sample size and representativeness, uniform inclusion criteria, homogeneity of measurement and assessment of acquired capabilities), with constant monitoring by experienced researchers. Having ethics committees with experts in the field of the experimented technologies is equally necessary, to be able to evaluate the correctness of protocols, along with bioethicists who are very careful to make sure that consent is given after obtaining adequate information. The justification of risk proportionality is a particularly sensitive issue, since we are dealing with trials in healthy subjects, accompanied by conditions of uncertain knowledge. These interventions are not necessary, but optional, selected by subjects experiencing non-disease conditions. We should determine which risks are

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l­egitimate, in order to achieve improvement ‘beyond’ therapy. Risks should be, at least, proportional to the desired modification. We cannot jeopardize basic health for the sake of feeling ‘better’. It is not acceptable to improve an already good eyesight, while running the risk of vision loss; take steroids to build muscles that are already working properly, with the risk of causing kidney damage or sterility; use drugs to boost memory in healthy and intelligent individuals, entailing risks of addiction or decline in cognitive functions to a stage beyond repair. The fact that risks often do not occur immediately, but in the future, does not excuse both researchers and trial participants from giving them careful consideration. The topic of informed consent and previous counselling shows some peculiarities, when dealing with enhancement drug and technology experimentation, which require adequate attention. The general principle of enabling the person to express an explicit, written and clear consent should be applied, within the context of the duty of the physician-researcher to provide complete and detailed information to the applicant. Information includes an accurate and precise description of intervention methods (degree of invasiveness), possible, predictable or unpredictable consequences arising from interventions with short and long-term effects on physical and mental health. Special consideration should be given to cases where risk predictability refers to serious risks with potentially irreversible consequences. Insofar as the possibility/probability of occurrence of this kind of harm is foreseen, the physician-­researcher has a responsibility, inspired by caution, to dissuade the subject from seeking the intervention, even suggesting psychiatric consultation, in case of persistent request. The only exception that could be envisaged is the case of an experimental study also having possible therapeutic effects; namely, it may bring about health benefits in ill subjects. Otherwise the objection of science, on the side of the physician/researcher, is deontologically justified. The need for legal regulation of new enhancement technologies arises even more clearly, both at international and national levels. There are few supporters, in bioethics and particularly in this field, of a “space free from law”, where individual choices are entrusted to self-determination, self-discipline exerted by researchers and the scientific community or to ‘soft’ regulation like codes of conduct. Bio-optimists advocate a permissive and minimal intervention of law, which leaves abundant scope for a free market to thrive, while envisaging a ‘right to enhancement’. To the extent that there is a well-founded fear of extremely serious risks with irreversible effects, temporary rules are allowed, established from time to time, likely to be reviewed and removed. This approach calls for a ‘soft’ regulation, oriented towards minimizing the role of public law, alongside expanding private freedom to its maximum extent. Conversely, bio-pessimists suggest an absolutely prohibitive law, to avoid potential harm to the individual, as well as to present and future society. This view is defined ‘bio-conservative’ as it recommends a ‘heavy’, rigid, coercive-directive intervention of law, designed to ban any technology which could pose a threat to humanity. The first approach exposes human beings and humanity to unpredictable risks and harm; the second one hinders and prevents the dynamic innovation of progress

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in enhancement techno-sciences, with possible therapeutic value, from pursuing its course. We should think of a bio-regulation being able to critically weigh up the interest of scientific advancement and the defense of human beings. In this perspective, the regulation of enhancement technologies should not be created out of nothing, but rather complement and clarify, in terms of content, the general biolegal principles already set out in international documents: the primacy of humans over scientific and technological progress, respect for physical integrity, the non-marketability and arbitrary manipulability of the human body and its parts, informed and responsible freedom, justice. Regulatory integrations should specifically elaborate the meanings of such principles, with particular regard to enhancement technologies. The protection of human dignity and psycho-physical integrity should clearly refer to the defense of human identity in the body and personality from technological invasiveness. It means that invasive and risky technologies cannot be allowed. The defense of freedom and autonomy should be thematized with reference to the need for adequate information and assessment of authentic choices being made without undue external pressures (particularly of a commercial nature). The protection of justice should encompass the compatibility between the right to access (insofar as there is evidence of safety, efficacy, information) and the right not to access, as a conscious choice. Besides concerns about the protection of integrity, security and efficacy of technologies, there is also the question of access, strictly linked to the distribution of scarce resources. Emerging technologies are challenging and require a re-framing in the elaboration and application of the criterion of distributive justice, as it deals with technologies ‘beyond’ therapy and healthcare, with blurring boundaries between medical/non medical applications, with complex, uncertain and likely to reach an unpredictable benefit/risk balance with regard to individuals and society. There is the possibility that, leaving the regulation of distribution to the free market, only wealthy people could afford access to expensive technologies (that may also have therapeutic aims), further increasing the already existing natural and social inequalities. The technological divide (nano-divide, biotechnological divide, digital divide, cognitive divide) outlines a possible scenario of inequalities. The risk is the one of discrimination, stigmatization and marginalization of those having no access to technologies, that live under disadvantaged conditions and emerging technological vulnerabilities. A delicate problem concerns the distribution and allocation of resources to the field of enhancement (beyond therapy) that may be at the expense of those who need to be cured and cared for. Having ‘in principle’ access to technologies (technologies being actually available to everyone, or at least widely available), there should be a right to know, to be informed/educated or right to technological literacy. This means a right to be motivated to a critical awareness in the use of technologies of the benefits/risks on the individual and social level. In this sense, equity of access to emerging technologies requires a duty of adequate information/education and transparent communication and dissemination of scientific novelties. This means also the right not to use

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t­echnologies, to dissent to the use of technologies, the right to refuse the use of technologies when personal identity and interpersonal relationship, safety and privacy are at stake. The conditions to use emerging technologies in an appropriate way is the right to be correctly informed on risks/benefits: information is necessary in order to protect the right to safety (physical, mental, emotional integrity) and to privacy (and confidentiality). The risk of a gap between technologically educated and uneducated (according to age, ability, technological literacy) needs to be overcome or at least limited. Specific challenges arise with reference to the minors, the elderly, the disabled persons and the incompetent. The ethical challenge to protect vulnerable individuals comes to the fore whenever they might access technologies and are adequately informed, but feel an undue pressure to use them, as a hidden form of exploitation, reducing freedom of choice and autonomy. We need to thematize new human rights. The right not to use technologies with uncertain risks, that may be serious and irreversible; the right to achieve, with personal effort, results; the right to behave according to normal standard of performances; the right to resist pressure to accept enhancing technologies, and to avoid social expectations. Social pressure to the use of these emerging technologies becomes direct or indirect coercion that threatens the right to avoid and abstain. An extrinsic indirect hidden coercion impoverishes the authenticity of the person and reduces freedom annulling it in homologation to exterior standard expectations of excellence. There is the risk that the spread of the use of converging technologies may heighten the tendency to compete rather than to cooperate, to tolerate imperfection, to accept others and nature as ‘given’. It should also be considered that improvement is always possible and intrinsic to all human beings: every function, physical, mental, emotional, can be improved in a more lasting manner through instruction, education and continuous training, a rich social life and interpersonal relationships, ranging from studying, learning, continuous stimulation of interests, to healthy lifestyles (nutrition, physical activity). It is a path that clearly requires a lot of time, but it is respectful of the opportunities for growth and development of personal and relational identity as well as of self-esteem and the feeling of self-fulfillment. A ‘right to achievement’ means a right to realization of individual potentialities through personal and active effort, development or flourishing of natural capacities, accepting human limits. Medicalisation of everyday life is a quicker and ‘easier’ solution (a ‘technological shortcut’) to difficulties, but with possible negative consequences both on health and on psychological and social status. These biolegal principles could constitute the comprehensive horizon of regulation, which should be further specified in relation to individual technologies. Given the dynamic pace of techno-scientific developments, it is essential for law, methodologically, to be drawn up and updated in light of a constant comparison and monitoring of scientific results and research orientations. For this purpose, having scientific advisory Committees engaging in a continuous dialogue with legal experts is of paramount importance. The reflection carried out in national and international

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bioethics Committees is equally crucial in providing critical insights and undertaking mediation endeavours, within the context of ethical pluralism on both general and specific issues. This scientific, ethical and legal discussion should open up to society, through adequate information and, at the same time, consultation and monitoring of expectations and emerging concerns. Against this backdrop, law should weigh up scientific assessment and public consultation. It is necessary to seek balance in the relationship between science and society. A condition of complex techno-scientific knowledge requires an informed, inclusive and active democratic participation. This target is achievable by fostering public debate during the regulatory process. This is the emerging horizon towards which we are moving, based on an innovative ‘governance’ for technologies, under conditions of uncertain and unpredictable progress. An horizon focusing on the science-ethics-society triangulation, with legal standards firmly grounded in updated scientific consultations, balanced ethical assessments and informed collective deliberations. Regulation should build upon a real representation, on the basis of reliable empirical data, and imaginary anticipation of possible and foreseeable scenarios, by weighing pros and cons, alongside evaluating alternative options, at the scientific, ethical and social level, while pondering decisions according to a transparent, wise, prudent approach. Being aware of the fact that the more there is uncertainty in the degree of exposure to serious and irreversible risk/harm to human beings and humanity, the more there should be an individual and social responsibility. Regulation will be called upon to adjust to the specificity of different technologies in considering which instruments are required, in order to protect humans and their health, to ensure personal freedom and justice, in a spectrum that embraces prohibitive, restrictive and permissive regulation. Regulatory problems arise both at national and international levels. They do not deal exclusively with drawing up legislation and making regulations within countries, but also with seeking regulatory harmonization across different countries. Although the issues to be tackled can differ according to diverse social and cultural contexts, every technologically advanced country appears to be looking towards a regulation of new enhancement technologies. This biolegal, transnational and intercultural dialogue has started, while the perception of a need to devise a timely, effective and global response has been gradually gaining momentum, especially with regard to particularly urgent areas in the field of bioethics, where human identity, the human species and life on earth are at stake.

4.3  Moral Enhancement Moral enhancement consists in the use of drugs and technologies on healthy subjects to improve moral dispositions and capacities, such as the sense of justice, sympathy, empathy, altruism, cooperation, attenuating aggressiveness, conflicts and

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hatred. This kind of enhancement could be carried out by means of drugs, neuro-­ technologies and genetic interventions. Pharmacological enhancement concerns the use of drugs to increase ‘moral traits’ or to remove ‘immoral tendencies’: reference is generally made to the use of oxytocin, also called ‘love hormone’ or ‘moral molecule’ (considered responsible for maternal and caring behaviour)9 and molecules that inhibit the absorption of serotonin with the effect of increasing cooperation and the capacity to express a moral judgement in a balanced and fair way. Neurological enhancement refers to the activation of cerebral areas (like the amygdala) by means of deep transcranial stimulation or brain implants correlated to emotive responsiveness, the alteration of moral perception or the control of violent behaviour, a requisite of moral conducts.10 It is also referred to as ‘moral brain’. Genetic moral  enhancement consists in the identification and localisation of ‘genes’ or ‘variants’ or ‘genetic precursors’ correlated to moral traits (e.g. MAO-A is the genetic variant that allows the catalyser of serotonin, correlated to moral behaviours), obtainable by the selection of embryos (with such genetic variants) or genetic modification with gene-editing. Along with these more or less realistic and realisable forms are other fanciful scenarios mapped out at imaginary level, which strives to envisage the existence of a very powerful computer that monitors and modifies the thoughts of every human being without their knowledge or a computer that intervenes every time that the subject in question is about to take an action that would cause grave harm to others or the insertion of a microchip into the brain, programmed ad hoc and implanted at birth into the brain of people for the control of their thoughts and behaviour. As a case of enhancement in general, the debate on moral enhancement takes up a number of general arguments that are common to the discussion on other types of enhancement (in particular cognitive and emotive enhancement), but it presents some specificities. It is generally presented as a type of intervention on which ‘one cannot but be favourable’ (even though having doubts about other forms of enhancement), insofar that we must assume that everybody would like to live in a world in which we and all the other individuals are morally better, acting only for the g­ ood/

9  Following experiments on animals it was seen how oxytocin injections in the brains of female mice induce a maternal behaviour even in non-pregnant animals and the inhibitors bring about the distancing of the mothers from their offspring. Equally in males low levels oxytocin cause social distancing and those without the codifying gene shows aggressiveness, indifference to detachment from the mother and absence of social attachment. It is also demonstrated that an excess of oxytocin can produce serious risks to health and induce abnormal behaviours. 10  A number of neuroscientific and neurotechnological experiments concern the anatomical-functional substratum of empathy (the capacity to understand the emotional state of others, to perceive what others perceive). Recent experiences show that to observe someone’s face that expresses an emotion stimulates in the observer the same centres of the brain which are activated when he himself presents an analogous emotive reaction (mirror neurons). With regard to transcranial stimulation in areas of the brain it is shown, from random tests, that the stimulation of the area near the right ear increases aggressiveness.

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advantage of others and stopping or definitively cancelling evil. It seems ‘immoral’ not to want moral enhancement. This is a recent debate which has arisen in the last decade, triggering a lively still ongoing philosophical discussion, powerfully advanced by the supporters of enhancement. It is important to reflect on the main arguments in favour of moral enhancement (albeit in their considerable theoretical diversifications), and a critical analysis. The drive towards enhancement was born in the context of a ‘perfectionist’ vision that exalts all technological possibilities as legitimate according to a libertarian and utilitarian standpoint. In this context numerous arguments are put forward in favour of human enhancement in general and in particular of moral enhancement,11 invoking the principle of self-determination, social utility and the overall improvement of the present and future society. Moral enhancement is today considered necessary in the face of global catastrophes owing to the rapid development of technology that has the potential to annihilate human life on planet Earth.12 The huge techno-scientific development has considerably increased human’s capacity to harm his own kind, broadening such ‘power’ in space and time, with more serious and complex negative consequences, extendable in the global dimension (to all human beings but also to animals, vegetables and to the environment in general) and which can be handed down to future generations (for example, the construction of weapons of mass destruction, global injustices like world poverty, human atrocities like genocides and slavery, the destruction of unrenewable resources, climate change). A fitting “moral psychology” and “moral sense” has not developed in parallel with such technological development, as it is generally limited to the consideration of present and immediate experience, perceiving the responsibility only of what is accidentally connected to our actions, with a lack of involvement for events and actions far away in space and time. A disproportion has thus come about between the exponential capacity of the potential destruction of humanity and the planet and the reduced moral capacity to manage and resolve such ‘common tragedies’. Moral sentiments are accused of ‘short-sightedness’ and ‘parochialism’, linked only to spatial proximity and temporal vicinity. Moral enhancement is considered a scientific and technological solution so that individuals become aware of and ‘empathise’ with global and future issues, seeking a collective solution to avoid human and environmental catastrophes. The standpoint is different of those who think that moral enhancement is not compulsory and directed at everyone, but must be voluntary and directed at single individuals, so as to ‘engineer virtues’, facilitating citizens’ adjustment to moral codes in a d­ emocratic

 Even within the supporters of general enhancement diverging standpoints emerge with regard to moral enhancement. 12  Persson and Savulescu (2012). 11

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society13 or of emotive and non-cognitive improvement for the development of moral capacities, eliminating unjustified prejudices.14 Given the pharmacological or technological possibility to increase moral feelings, to induce more empathic and less aggressive perceptions and behaviours, the abstention from acting is not justified, considering that in principle there is nothing wrong at moral level in any form of enhancement and hence also in moral enhancement. According to this vision, enhancement and therapy are compatible, contiguous and equivalent. The equivalence between therapy and enhancement derives from the common objective of the two types of intervention, identified in the ‘change for the better’, regardless of the fact that this is achieved with means classified as therapies or enhancement. This vision justifies the intervention on human’s body and mind every time that it is accepted by the subject on whom action is taken and is socially justified.15 Enhancement is considered, in this perspective, a social imperative and moral obligation, an “evolutive duty”.16 We have reached an historic moment in which it is possible and also necessary to change ourselves and the human species itself. In particular we have reached a phase in which Darwinian evolution prepares to give way to a dynamic in which human beings can take the reins of evolution and directly transmit the modifications they retain opportune in a moral sense  to his own descendants. In this sense, enhancement represents a phase of evolutionism (enhancing evolution). Natural selection can, and rather must, be substituted by the “deliberate choice” of the selection process that makes it possible to obtain the same result more rapidly. To block progress now in this direction would mean to hinder or impede the possibility to save humanity from wrong and accelerate the evolution of humanity. “Evolutive enhancement”, also in a moral context, shortens the progress that has gone on for millions of years, allowing humanity to reach and fully express its potential, making it possible to balance the natural lottery at physical and social level. In this sense a “duty of moral enhancement” is justified as a “duty of beneficence” not only individual but also collective. Enhancement makes it possible to increase moral dispositions more effectively enabling, more rapidly and quantitatively greater and qualitatively better, what would not be achievable with the traditional methodologies and instruments (education, socialisation), which in this context turn out to be insufficient. In order to resolve the serious global issues that are potentially destructive for humanity and the environment, a biological, neurological and genetic change of the moral character is considered indispensable in the libertarian-utilitarian view. There is no morally relevant difference between the traditional and pharmaco-biotechnological means to increase moral conduct (according to the parity principle). In this perspective it is considered that any action is a form of enhancement insofar as it makes a  Hughes (2015), pp. 86–95. Daniels (2000), pp. 309–322.  Douglas (2008), pp. 228–245. 15  Harris (2016). 16  Harris (2007). 13 14

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better life possible. In this sense, if education and training are considered licit, for the same reason the biomedical or technological enhancement of human physical, intellective and emotive capacities should be licit. The use of enhancement technologies is a pharmacological and biotechnological “short-cut” that fosters, speeds up and facilitates the reaching of the desired results. In the case of moral enhancement such interventions are justified as being necessary for human beings and future humanity. The unlawfulness and the consequent prohibition of moral enhancement cannot be based on the arguments of the curtailing of freedom and the producing of injustice.17 Moral enhancement carried out biotechnologically does not represent a threat for the freedom of the enhanced person, who can always prevail over the order of causes with their will. Determinism is considered compatible with freedom and the necessary condition for morality. We are free when we do what we want to do and this is true also if our behaviour is determined randomly. Therefore, moral enhancement cannot threaten freedom, as a person is nevertheless free in their choices, regardless of the fact of being enhanced or not. Lastly, the fact that enhanced people will not feel the call for wrongdoing and, consequently, will not have the chance to “fall” does not seem to be a sufficient reason to consider those interventions allowing moral enhancement as being unacceptable. On the contrary, it seems to offer a very good reason to appreciate them morally, in so much that they foster the well-being and happiness of the persons concerned who will in fact have fewer opportunities to do wrong and, above all, to be subjected to wrongdoing by others. Furthermore, if technologies were prohibited every time they were not available for everyone, progress would be blocked and many medical applications and practices would be banned (for example, it would not be possible to carry out transplants, considering the shortage of organs). Justice is not parity of access and injustice disparity of access. If that were so, not only should moral enhancement technologies be banned but also the payment of a private tutor with respect to those children attending state school. The arguments in favour of individual or social, strong or weak moral enhancement, are criticized both on scientific and philosophical level. The theories in favour of moral enhancement are critically debatable in their theoretical assumptions. The first question regards scientific implausibility of moral enhancement, or the scientific non feasibility, or the realistic impossibility of moral enhancement. There are a great number of doubts and concerns emerging also in scientific literature as at present no reliable data or results from trials are available. The debate rests on hypotheses and forecasts based on conditional figments and fantasies on feasibility (with the premise “if it were possible”), without any demonstration of the feasibility. There is no point in discussing the legitimacy or illegitimacy of interventions based on unrealistic and non-plausible hypotheses without having reliable empirical 17

 Persson and Savulescu (2016), pp. 263–268.

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data. The only limited scientific data concerns the occasional collection of correlations between some biological-hormonal, neurological and genetic dimensions and of a certain type of perceptions and moral conduct. This data comes from non-­ systematic analyses, not subject to strict scientific investigation methodology, which should be based on statistically significant samples, repeated and repeatable analyses, necessary to validate the results and establish general guidelines. Moreover, these studies are limited to envisaging correlations on empirical bases, where the correlation points to a possibility or more or less high statistical probability of relation among the elements, not a causal determination between the introduction of a substance or the stimulation of a cerebral area or the presence of certain genes and specific perception or moral conduct. Before speaking about moral enhancement, the existence of drugs or safe and effective technologies for this purpose should be verified by means of a trial that would demonstrate their safety (prevalence of benefits over harm, or at least a proportion between benefits and risks) and efficacy (actual feasibility with effective outcomes). So far, no safe and effective drugs or technologies for moral enhancement exist. It has not been demonstrated that the injection of oxytocin or the taking of serotonin or transcranial stimulation in certain areas or the presence/absence of certain genes make human beings sociable and non- aggressive and not more sociable and less aggressive. Not only have no trials been carried out on this, but it would also be extremely problematic from an ethical point of view to experiment such interventions on healthy subjects, given the absolute uncertainty and the possible high risks in the face of non-therapeutic and moreover implausible objectives. The experimentation of moral enhancement is susceptible to a series of scientific and ethical questions: given the constitutive uncertainty of the risks (even serious and irreversible), is it ethically licit to proceed with such experimentation which has as objective not the recovery of the subject (therapeutic objective, justified in the absence of alternatives), but the induction of moral behaviours of which it would be necessary to demonstrate the possibility, and which would on principle have indirect benefits for the individual and direct ones presumably only for the community? Pharmacological experimentation could have no plausibility at preclinical level. It is not possible to evaluate moral enhancement on animals, as their empathy is very different among species, given the cognitive, rational and relational dimension that is specifically human. Parameters exist whereby to evaluate cognitive improvement also on animals (memory of negative experiences, behavioural learning, etc.) and moral improvement (caregiving or rejection), but the qualitative animal-human difference would jeopardise the results. In the context of neuroscientific experimentation on human beings a number of particularly problematic elements emerge: the subjects involved in a study often do not act spontaneously, the tests are carried out in a laboratory (in an artificial environment far from reality) or with preselected subjects often instructed on the aims of the study with the possibility of this influencing the experiment and jeopardising the outcome; the studies concern few subjects while the conclusions present

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g­ eneralisations which are frequently imprecise and incapable of accounting for individual variability. Genetic experimentation is all the more problematic insofar as it would entail genetic alteration (gene-editing), considering the uncertainty of the technique which, given the genomic complexity, could bring about unforeseeable implications in the molecular scissors intervention, with the possibility of inducing pathologies which are irreversible and transmittable to successive generations. The obtaining of informed consent also represents a particularly delicate part of this and is an indispensable requirement to legitimate all research. How can the actual understanding of a scientific, somewhat implausible and at the same time highly risky hypothesis be assessed? In cases of unforeseeable, potentially serious and irreversible risk, the investigator’s responsibility instilled with a sense of precaution and prudence should dissuade the subject from this. It should moreover be stressed that it is improbable that the planning of trials by the pharmaceutical companies in such a context, involving a costly and lengthy process with high risks (as is generally the case in pharmacological experimentation in psychiatry), would be hard put to gain the approval of an ethics committee. Excessively risky interventions with respect to the benefits to be obtained (considered ineffective, burdensome and serious for the patient) and irreversible and foreseeably inconclusive interventions, even if requested by the patient, are not justifiable at ethical, deontological and juridical level: at ethical level with reference to the value of the body, not arbitrarily object available by the subject; at deontological level with reference to the principle of beneficence and non-maleficence of the doctor, called upon to act for the patient’s good and to not cause them any harm; at juridical level for the human right to the protection of physical integrity, as an individual and social good. Furthermore, the viewpoint assumed by the supporters of moral enhancement refers to a mechanistic, deterministic-reductionist concept, which reduces thought and moral conduct univocally and simplistically to biology, neurology and genetics in the context of a social Neo-Darwinism. Feeling, thought, moral decisions and behaviours however are not the direct outcome of biological manipulations, chemical modifications, neurological or genetic changes. There are no “kindness” pills or injections and technologies which directly produce in us motivations or moral judgments which result automatically in good behaviours and the control of evil ones. Hormones, neurons and genes do not ‘make’ us think and/or act morally or desist from immoral thoughts and actions. The hormonal, neurological and genetic modification in humans cannot be the univocal and direct cause that determines thought and/or sentiment, which in turn determine action. At scientific level such a reductionist interpretation does not sufficiently take into account the complexity of the neurobiological and genetic phenomenon. It is now scientifically demonstrated how the brain and the genome are not rigid structures but plastic ones which, by means of internal factors (interactions between genes and neurons) and external socio-cultural and environmental factors, change and take on a shape, playing an important role in the genesis of states, mental dispositions and behaviours.

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In the light of the above considerations, it appears that at present there is no scientific basis on which to carry out moral enhancement, understood as the accretion of empathic dispositions, limiting and erasing aggressive behaviours by means of pharmacological or technological interventions on human beings. Besides the scientific non-plausibility there is also the philosophical non-­ plausibility of moral enhancement. Given the lack of scientific plausibility, the interest in the subject for philosophy runs out in a speculative exercise of imagining possible future scenarios (a method which is by no means new for philosophy, in particular for analytical philosophy, with the use of ‘mental experiments’). The speculative question is asked: If a ‘pill or technology of morality’ existed, should we use it? Would to become more empathetic and less aggressive mean to be more moral? Would the increase of individual morality produce an increase of collective morality? In order to answer these questions it is necessary to reflect on a number of elements of moral philosophy18 and philosophy of law. Morality cannot be atomised, manipulated or engineered but is a complex anthropological dimension that refers to an interaction between the ‘internal’ physical-­ psychic dimension (in which the physical, hormonal, neurological and genetic aspects intersect with the mental aspect, divided into perception, feeling, thought, intuition, reflection, decision and behaviour) and the ‘external’ environmental socio-cultural dimension. Moral complexity derives from the interaction between different levels: the physical level with the mental one, and both with the environmental level. The human physical condition can influence human thoughts, feelings and behaviours but only in terms of possibility and probability, not as causal determination. First and foremost because the mind cannot be reduced to brain, feelings are not attributable only to hormones, nor are behaviours derivable from the presence/ absence of genes. Moreover, there is always (whether we are conscious of it or not) an interaction in space and time of the physical-psychic dimensions with a specific socio-cultural environment (education, condition of existence). It is possible to see a correlation between some physical-psychic conditions and the propensity for sociable or anti-social behaviour. But there are also people with the same hormonal, neurological and genetic conditions who are both sociable and violent, insofar as other factors can supervene that influence the expression of feelings, thoughts and actions. Furthermore, morality cannot be attributed simplistically to an isolatable feeling like empathy, altruism, solidarity or cooperation. These are undoubtedly dimensions of morality but they do not complete it. Morality has an emotive component that concerns the perception of the moral problem; a cognitive component that intervenes in the understanding of the question, in the reflection on the issues at stake, in the interpretation and explicit elaboration of the evaluation and moral judgments; a wilful dimension that concerns the interest for the moral problem, the personal involvement and the motivation to face it and look for a solution. Feeling, ­knowledge 18

 Paulo and Bublitz (2017), pp. 1–15.

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and motivation/disposition of will for moral action are closely connected and single dimensions identifiable, as being decisive, cannot be isolated. Empathy, to which moral enhancement usually refers, is a complex human dimension. It is not attributable to the presence of a certain quantifiable level of a substance in a constant manner, it cannot be isolated from the set of components characterising anthropological moral experience. Empathy is not only a feeling; it also refers to reflection. Empathy is not automatically translated into a moral conduct: there are empathetic people who do not act morally. Empathy can be expressed as a static and passive, non-dynamic and active sentiment. Being empathetic does not mean only being good and not bad. Some empathetic people can behave immorally and unempathetic people morally. The will to cooperate is not moral in itself. It may instead serve to strengthen a group or community in its discriminatory and aggressive policies towards other populations. One can feel a sense of cooperation within a group, bringing about a shutting off, non-cooperation and aggressiveness towards other groups (for example, racism). The enhancement of empathy can strengthen moral sentiment in a partial way towards one’s next of kin/friends/group and indifference towards persons that do not belong to the group; or it can strengthen partnership towards people that behave immorally (a subject can be empathetic towards a criminal). At the same time there can be unempathetic people who, through emotive detachment from certain situations, behave morally (for example, surgeons who necessarily need to detach themselves from the circumstances in order to guarantee precision and efficiency). It is not possible to program people’s moral character and, consequently, make them virtuous with drugs or genetic engineering: virtue is a personal dimension that cannot be planned extrinsically, but realised only internally. The pharmacological or technological enhancement intervention on the body or mind is in this perspective considered an exterior facilitation, a ‘biotechnological shortcut’. Even if it were possible, results could be achieved in a shorter time and more efficiently, but in non-­ authentic form, misleading for oneself and for others. The subject feels the effects that they achieve externally but does not understand their meaning in human terms. In this sense the enhancing technologies ‘substitute’ personal effort. In contraposition to enhancement, achievement indicates the dimension of the acquisition and completion, as the development and enactment of the potential naturally inscribed in ‘becoming what one is’ through an active effort and personal commitment, by the so-called ‘traditional means’ (education, training, socialisation), which enable one to change one’s natural abilities by improving oneself. This is the meaning of the action that makes a substantial authentic transformation possible, not in the sense of ‘enhancement’ of certain isolated functions, but of ‘improvement’ as growth and an overall significant conquest of the personal and relational identity. Human flourishing is not the accumulation of results obtained pharmacologically or technologically, but it lies in the constant daily exertion in life for the realisation of oneself and the experience of proving one’s capacities also in the face of adversities. With enhancement technologies the boundary is blurred between what we

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achieve through our own efforts and energy and what comes from the presence of a certain quantity of substances taken or technologies used. Artificial enhancement interrupts the relationship between the knowing/acting subject, their intentional activities and the results. On the other hand, achievement makes it possible to produce change in oneself as subjects, even at the cost of sacrifices. This is a fundamental element for growth in the moral experience. Biotechnology will never be able to make people virtuous. There is a distinction between the capacities understood as complex human activities aimed at the realisation of oneself with others and the capacities as mere functions. Only human capacities are linked to the good life, a condition of the possibility to attain a happy life. ‘Capacitation’ means being able to choose the modalities whereby to carry out one’s skills as a condition of personal and relational identity, as an expression of true freedom. In terms of happiness, the results do not therefore depend on the taking of drugs or the use of enhancement technologies to which one ends up ‘delegating oneself’, but on free personal and interpersonal action. Morality presupposes our capacity to respond reflexively to events that take place and to ask ourselves how to act and live. Through not only experience but also education and the reactions of others, we learn that there are other people in the world whose interests we must bear in mind and we progressively rectify our behaviour on the basis of this awareness. Of course, morally speaking, particular attitudes or sentiments are extremely important, above all if they predispose us to have more attention towards others. Nevertheless, to be moral it is not sufficient to be ready to sacrifice one’s interest, to be less aggressive and violent or have the will to cooperate with others. And it is not even sufficient to have the capacity to control our immediate impulses or feel some kind of empathic reaction towards other persons. Instead, we should learn to reflexively approve or disapprove of our reactions and to evaluate what kind of behaviour other people could also accept, case by case. We should first and foremost learn to know what is good, to act ethically and to want goodness and to want to achieve it in our life and for others. Those who maintain that drugs and biotechnologies are sufficient to educate to virtue, besides creating unjustified expectations for scientific development, foster the conviction that a moral character can be developed simply by resorting to medicine and following the prescriptions that the medical profession gives out. In this way the distinction between morally responsible persons and those who instead are not responsible is reduced to a medical element. The vicious person is in some way presented as a ‘sick’ person (moral sickness) that society has the task of bringing back to normality with the help of medicine. In this sense moral enhancement would increase the medicalisation process that reduces morality to the taking of a drug (pharmaco-centrism) or to the use of a technology (techno-centrism) to treat mental/psychic ‘moral defects’. When some behaviours are medicalised and treated with drugs, it happens more easily that people feel the need for pharmacological aid for any state that is perceived as psychological, emotional or moral distress. Focusing on the biological or neurological aspect of the distress, medicalisation tends to underestimate, if not disregard, the social and family/relational causes that might be at the origin of the malaise,

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r­esorting directly to drugs or technology for a solution. Medicalisation is also a market drive, well expressed by the phenomenon of the market’s ‘production of pathologies’ (the so called ‘disease mongering’). Moral enhancement, whether it be pharmacological or technological, is not necessary today in the face of the issues emerging from techno-science on a global scale. The need for the expansion of spatial-temporal morality has already been the subject of reflection of moral philosophy: for some time now (since the origins of bioethics in the 1970s) there has been a growing awareness that the acceleration of techno-scientific progress has called for the foundation of a macro-ethics of responsibility (Hans Jonas), synchronically enlarged to non-human beings and diachronically extended to near and distant future generations. The need for an awareness of the new dimension of moral issues demands a fitting rational reflection that allows the reworking of treatment in the twofold sense of concern and regard for others (human and non-human, existing in the present and the near or distant future). However, the ‘qualitative’ spatial and temporal extension of the reference of responsibility does not require a ‘quantitative’ increase of moral sentiment of each single individual (given that this is possible, safe and effective). Moreover, it is not the spatial or temporal closeness and distance that changes perception and moral understanding. As a rational and emotive feeling, morality allows us to gain awareness of emerging issues, on an individual and global scale, near and far. The increase of conscience or moral emotions is not an indispensable requirement to extend or project the moral horizon. The tragedies of the distant past also allow us to reflect morally today (for example, the Holocaust). Many ethical reflections have justified the recognition of the subjectivity of future generations (for example, the consumption of scarce resources), animals and the environment (it suffices to think of animalisms and bio/eco-centric theories). Spatial proximity and temporal immediacy can affect the morality of daily life, the attention to each single case, to situations. But the element of interdependence and vulnerability that unites us insofar as belonging to humanity, the implications for everyone, today and tomorrow, force us inevitably to look beyond the present and the near future, regardless of the possibility of enhancement. Global problems cannot be resolved without investigating the general causes and treating individual defects. The supporters of moral enhancement do not seek the cause and genesis of the problem (which is moreover extremely complex), but limit themselves to referring to the means whereby to resolve problems. But it is not possible to resolve moral problems without knowing the complexity of the causes. The solution of the global issue of climate change involves complex and structural institutional and non-institutional politico-social solutions, national and international, cultural and economic, which cross-refer to complex present and future inter-individual interactions, which cannot be reduced to the modification of individual moral defects either pharmacologically or technologically. This proposal to the problem (by the supporters of moral enhancement) presupposes the reducibility of events in the historical, social, cultural and economic dimension to individual behaviours. It assumes that all social processes can be exhaustively explained and resolved individually. While it is true that society would not exist without i­ ndividuals,

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this does not imply that we can explain and remedy complex social disfunctions with individual modifications. It is possible that the world could be better with more empathic and less selfish people, but to think that the modification of single individuals in some moral characteristics (given that it is possible) will automatically produce the solution to present and future global issues is utopian. Moral enhancement would not be a choice of freedom, and hence would be immoral. Given that it were possible as well as being safe and efficient, a massive dose of goodness pills or technologies may not result in a global moral improvement and would restrict human freedom at the same time. Human beings would end up being forced to be moral. They would be manipulated so as never to be able to make the wrong choice, having no alternatives. If the direct pharmacological and technological manipulation of emotions/thoughts/moral behaviours were possible, this would interfere with human freedom. If human beings were biologically wired to do good, the freedom to choose and act would have no reason to exist, which is the prerequisite of morality. Morality exists only and because there is the possibility of choice and thus also the possibility of doing wrong. In this sense moral enhancement would not be an expression of freedom but on the contrary a form of ‘social despotism’19 or hidden or explicit pressure of society towards citizens to conform to predefined standards. A sort of extrinsic obligation that forces and conditions human beings to make choices that would not be made spontaneously and authentically, with inevitable consequences on personal and relational identity. Moral competence does not mean “being better in being good”, but rather means “being better in knowing good and understanding what is likely to lead to good”. The space between knowing goodness and doing goodness is a region governed by freedom. The knowledge of good is a necessary premise but the freedom to make mistakes exists. Without the freedom to make mistakes, good cannot be a choice; without freedom, moral sense and virtue disappear. There is no virtue in doing what one must necessarily do or in a determined manner. In this sense enhancement restricts freedom, annulling the ‘right to non-­ enhancement’ or ‘right to de-enhancement’. The choice not to be enhanced becomes an option that is no longer possible in a cultural and social model based on moral enhancement. This is a model that risks being uncritically assumed, without an adequate critical awareness of the important anthropological dimensions that are sacrificed, that is, identity, authenticity and freedom. Both the hypothesis of compulsory moral enhancement for everyone and individual voluntary enhancement raise several critical points. Compulsory enhancement for everyone would be coercive for the population in general: besides annulling individual freedom, it would raise several questions. Who would have the power to decide what modifications must be introduced? How would it be possible to find the resources for enhancement for everyone, considering that it would necessarily be repeated as it would not be definitive?

19

 Pessina (2017), pp. 1–7; Reichlin (2017), pp. 1–10.

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Moreover, today’s liberal democracies could come across some difficulties in implementing these moral enhancement programs, since liberal ideology maintains that the State must have a position of evaluative neutrality. Which morality should be enhanced? The choice of one single moral model would risk an arbitrary imposition of a standardised moral standpoint and an impoverishment of the pluralist debate for society. This would result in the production of a homogenous and undifferentiated society, in which the dispositions of the citizens would conform to the model of good and selected virtue. Nevertheless, in perspective the absence of different concepts of morality could be a serious impoverishment for society which would no longer have the possibility to learn how much other global visions can teach one on life and conduct. The people who will be responsible for the enhancement program could be incapable of implementing the most appropriate social agendas, taking advantage of their position of power to adopt different policies from those aimed at improvement (like for example making the population much more docile and obedient instrumentally for that very power) or convincingly deciding on, but getting wrong, a program that they propose as the best one (but is in reality the worst one). Furthermore, there would be no guarantee that those making the decisions about moral enhancement have no interests in carrying out a ‘moral de-enhancement’, intentionally wanting wrongdoing instead of good, with a consequent moral decline instead of moral advancement of humanity. Individual voluntary enhancement would create injustice, insofar as it would make moral only those with the resources to purchase drugs and undergo technologies which (perhaps) can make them more inclined to be good. It must also be considered that investing resources in enhancement in general and in moral enhancement in particular, means taking away resources for the prevention, treatment and assistance for illnesses in a social context in which the resources are already insufficient to cover all the healthcare needs that tend to be ever increasing in quantity and quality. A criterion of reasonableness in the distribution of the resources leads one to consider as having priority those treatments for illnesses in general, at the level of prevention, treatment and rehabilitation, regardless of the level of seriousness, with respect to the mere enhancement of the capacity of those who are healthy. Society has a moral obligation to treat illness in order to compensate objective situations of disadvantage. The proposed solution to ‘democratise’ and universalise access to enhancement, or to guarantee access to everyone on the basis of the respect of the principle of equality, is problematic also owing to the huge healthcare costs that would make it impracticable, jeopardising treatment for people with illnesses and other social needs in the context of healthcare policies for the macro-allocation of resources. The analysis of philosophical theories in support of moral enhancement highlights a number of contradictions: the measure of harm that techno-science can cause and will cause is in contradiction with the techno-scientist assumption of libertarianism and utilitarianism, which exalt progress; the identification of a common objective moral sense to be identified in empathy as concern for others is in

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contradiction with the non-cognitivist standpoint of libertarianism that presupposes the unknowability of an objective truth and the exaltation of the importance of moral pluralism; the concept of biological, neurological and genetic determination and the consideration of the need (for some) to impose moral enhancement on everyone, is in contrast with the centrality of freedom in the libertarian and liberal theorisations. In the context of the theorisation of the legality/dutifulness of moral enhancement a clear distinction is missing between drugs and technologies that increase moral sense and therapeutic treatments on individuals with mental disorders aimed at the control of antisocial and criminal minds or at mental and public health. Even though it is not easy to clearly distinguish between enhancement and therapy, as ‘grey areas’ exist that cannot be distinguished between health and illness (owing to the added subjective dimension of health and illness), there is a basic difference: each intervention to restore the regular functioning of the organism in achieving its own aims is therapeutic; enhancement is ‘beyond’ therapy. Such distinction is indispensable at bioethical level since it highlights the legitimacy of even experimental therapeutic interventions, on the basis of the proportionality between risks and benefits. The risks are balanced according to the benefits expected, which concern recovery. For example, the giving of serotonin to a depressed patient, using transcranial stimulations for psychiatric pathologies and genetic therapies for serious illnesses. Instead, the use of drugs or technologies with a view to improvement can cause serious harm that is disproportionate with respect to the benefits to be obtained, which correspond to objectives which are furthermore uncertain and little plausible. For example, excesses of oxytocin or the use of transcranial stimulations on patients can lead to imbalances and diminish functions, identity and personality, even in a serious and potentially irreversible way. Moreover, there is no ‘moral illness’, or hormonal, neurological or genetic condition that can be identified as the pathological cause of certain perceptions, thoughts or behaviours. Even the psychiatric pathologies of antisocial thoughts and behaviours must be interpreted in the context of a bio-psycho-social paradigm which cannot be reduced to a single element. The reduction of a social behaviour to one single physical, hormonal, neurological and/or genetic element, risks not properly taking into account the psychological and environmental component. This could on the one hand lead to consider individuals as being ill or preventively incriminate those with certain hormonal, neurological or genetic features and on the other to consider pharmacological and technological interventions as sufficient for their recovery to sociality, neglecting other environmental dimensions that require suitable social policies able to overcome inequalities. Given their invasiveness and riskiness, pharmacological and technological treatments could be used in a ‘therapeutic’ way in exceptional cases, to be discussed case by case by specialised ethics committees for psychopathic personalities, dysfunctional mental disorders, situations that can harm society, only on condition that no other reasonable possibilities exist to do this in other ways, with the consent of

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the subject. Nevertheless, given the weakening of the human moral capacity and the possible alteration of identity, they should be considered as a last resort. It is important that public opinion is suitably informed on this and that there is an increased awareness with regard to the expectations that the recourse to moral enhancements can realistically meet and, even more so, concerning the possible risks and harm for both mental and physical health associated with them, by means of reasoned and critical discussions on the issue. Enhancement would be limited to interventions on moral conduct and emotionality in order to induce appropriate behaviours and eradicate inappropriate ones, but it would not improve moral capacity, understood as the capacity for understanding and reflection, while moral education develops a personal capacity of discernment through support to the establishment of moral personality, stimulating motivation and encouraging reflection in many ways (lessons, reading, media, testimonies, examples).

4.4  Roboethics and Artificial Intelligence: Beyond Humans The expansion of human capabilities through emerging technologies resulting from converging developments in robotics, information technology, and the cognitive sciences is transforming contemporary and future medicine. Within the healthcare setting, the robotic revolution of surgical robots and robotic caregivers may be considered the main examples.20 Robo-ethics is part of the techno-ethics that regards the ethics of technology in general, with specific reference to the ethics of machines and their social implications.21 It is the branch of applied ethics that studies the positive and negative implications of robots to society, aiming at inspiring the moral design, development and use of robots, especially of intelligent and autonomous robots. There is a bioethical debate over how robotics can develop in a way compatible with humans and with respect for both individual and societal human dignity. The robotic revolution will cause many changes in civil society (affecting our working life, recreation, healthcare and transport, the organisation of our cities, as well as agriculture and energy production, and the protection of the environment) and military defense.

 The terms “robot” and “robotics” emerge in literary contexts. “Robot” is first credited to Karel Čapek’s Czech (1920). Such robots were created with the purpose of functioning as a sort of servant class of workers. The term “robotics” derived from “robot,” is ascribed to Isaac Asimov in several of his 1940s short stories. These short stories also famously established the Three Laws of Robotics that serve as a benchmark for mainstream cultural awareness of robotic ethics. The meaning and use of “robot” and “robotics” are occasionally distinguished, with “robotics” including a somewhat broader range of technologies; however, they are typically used synonymously. 21  Italian Committee for Bioethics, Italian Committee of Biotechnologies and Life Sciences (2017); European Group on Ethics in Science and New Technologies (2018a, b); Comest, UNESCO (2017). 20

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Robotics forms part of the more general ‘converging technologies’, given the merging of different scientific sectors. The construction of a robot with AI requires the convergent collaboration of electronic and mechanical engineers, computer scientists, psychologists, neurologists, cognitive scientists, AI experts, logicians, mathematicians, philosophers, legal experts, economists, designers and artists all to work together.22 Robots are artificial machines which work mechanically and substitute the activity and/or human mind (in Czech ‘robot’ means work). They may or may not look like human beings  (in appearance and actions); have an artificial body (embodiment) or not have an artificial body (computer); be non-intelligent (telerobot, completely commanded by man) or intelligent (with some degree of autonomy). In the context of robotics, the future possibility of building robots with artificial intelligence is debated, such as artificial moral agents or the so called “electronic persons”.23 The future goal is to build autonomous-automatons, artificial with different degrees of intelligence and autonomy in behaviour and decisions (from operative morality to functional morality). Robotics has made extraordinary progress in the different generations: from being mechanical, static, passive, repetitive and executive objects, today robots are becoming autonomous bodies with general and not just specific functions, able to move and interact with the environment, with the capacity to learn and adapt to the environment, with the capacity for perception, analysis, reasoning, decision-making and expression. Robots are generally built in a similar way to humans and are called ‘androids’ or ‘humanoids’ in as much as they imitate the morphology, action and thought of humans.24 The recent rapid progress of robotics calls for a structured ethical reflection with respect to the real issues and the anticipation of probable and possible future scenarios, of a distant or near future between a real and fictitious world. A first ethical aspect of robotics regards the design, programming and production of robots, which should be based on the protection of physical integrity, safety, the principle of beneficence/non-maleficence with reference to the primacy of human dignity over robots. There is ongoing debate on the drawing up of codes of conduct for robot engineers and on the implementation of the ethics of engineering and computer technology. During the design and production phase, the designers themselves should reflect on the safety conditions in the respect of the physical integrity of the human being, with the balancing of risks/benefits, according to the principle of precaution (abstain from actions that will presumably cause more harm than benefits, when the harm is  Tzafestas (2016); Lin et al. (2012), pp. 35–52; Veruggio and Operto (2008), pp. 1499–1524.  See Report with Recommendations to the Commission on Civil Law Rules on Robotics issued by the European Parliament Committee on Legal Affairs, 2016; European Parliament Resolution of 16 February 2017 with Recommendations to the Commission on Civil Law Rules on Robotics (2015/2103(INL)). 24  There is already a considerable spread in the design and use of robots in USA, Japan, China and Europe (in Italy at the Italian Institute of Technologies in Genova). 22 23

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potentially serious, invasive or irreversible), minimisation of foreseeable and preventable harm, limiting every excessively risky application and refusing dangerous projects, following the principle of proportionality (avoid greater or additional harm with respect to the non-use of robots). The possibility is being debated of setting up ethics committees for the reviewing and assessment of robotic research, which would evaluate the ethicality of the project and its applications, which should follow the principle of non-maleficence, or the non-harming of human beings, and beneficence, acting in the interests of human beings. A second ethical problem regards the human/machine interaction. Instead of enhancing human vulnerability the use and application of robotic technology could increase it. In this context the issue of “addiction to technology” can be presented in a new form, understood as “personal addiction” (the habituation to their support and “company” will perhaps create a psychological addiction to robots) and “social addiction” or “robotic addiction” (the increasing dependence on robots, as today we depend on oil and mobile telecommunications). If robots have human forms, the interaction can trigger (in a misleading fashion) emotions, attachment and addiction, in particular for people in conditions of fragility, such as children, the elderly and the people with disabilities. The difficulty in distinguishing between real and imaginary, natural and artificial, typical of the subjects living with the aid of robots and intelligent systems in the fields of education, games and art can increase such addiction. Studies have been carried out to analyse the aesthetic impact of robot design at emotive level, according to age, cultural conditions and people’s character. Insofar as mechanised activities lead to a dehumanisation of interpersonal relations or cause a technological addiction to machines in human beings, robotization represents risks for  them and their  dignity. ‘Opt-out’ mechanisms could be foreseen which block the robot before the process leading to technological addiction is triggered or which limit the humanoid morphology of robots, so as not to increase the affective as well as the functional dimension. Recent developments in robotics have put forward the pressing question on the intelligence of machines. Are robots intelligent and/or can they become intelligent? To what extent can human beings design an autonomous robot? Is intelligence programmable? Does an artificial intelligence exist? Does only a human dimension of intelligence exist? Can a thinking machine be constructed, with robotic conscience and robotic soul?25 At present one can speak of artificial intelligence and autonomy in a limited way. From an engineering point of view, intelligence is the capacity for a machine to process information coming from sensorial perception, interpret it in order to elaborate a model of the environment, plan and carry out a mission obtaining a useful outcome. The designing of the intelligent capacity to autonomously resolve problems and act in the environment depends on algorithms of epistemic deontic logic (calculated in a finite and deterministic way for specific actions). The autonomy cannot but be limited, distinct from personal freedom, intentionality and individual creativity. 25

 Russel and Norvig (2003) and Husbands (2014).

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Computational knowledge can be constructed, on the basis of a collection of data that is reproducible with algorithms without being able to build conscience, understanding, recognition, abstraction, memory, imagination and motivation. In this sense machines can be superior to humans in the gathering of data and calculation: electronic machines rapidly process a huge amount of data and can also simulate human reasoning. Nevertheless, they are not able to think like the human mind. Robots could even be created that are capable of thinking like humans but a very ‘high power’ would be needed, while for human beings only ‘low power’ is sufficient. This is a goal that is most likely only technically realisable in a limited way and is, in any case, not economically viable. The possibility is also being debated of drawing up ethical norms for robots (the so-called ‘machine ethics’ or ‘moral machine’) to prevent harmful behaviours (with possible negative implications both for humans and environment), putting ethical principles into the machines or procedures to resolve ethical dilemmas, in order to introduce the capacity to take ethical decisions.26 The drawing up of ‘machine medical ethics’ is an example of this, which includes ethical deontological rules for the action of a ‘medical robot’. But is ethics programmable? Some authors maintain that robots are more moral agents than humans, thanks to their mechanical speed and the lack of ‘human imperfection’, able to decide rationally without egoism, emotions, weakness of willpower. There are many criticisms of this standpoint maintaining that the human moral evaluation is mechanically irreplaceable, insofar as it involves many human parts besides rationality, also emotion and empathy; moreover, ethical pluralism prevents the elaboration of a univocal ethical code to be put into machines. The programming of “appropriate” ethical principles and rules into the robots is necessary but not so easy to realize. Even Asimov’s three laws pose difficult programming issues (translation into algorithm, capable of interpreting the different possible situations, in order to implement ethical decision making by robots). The artificial intelligence or control software are not sufficiently advanced to permit the effective application of the ethical theories (top-down rules combined with bottom­up machine learning offers the best theoretical approach). There is a discussion on the possibility to apply a combination between a deontological approach (a priori duty) and a teleological approach (evaluation of the choice on the basis of the consequences of the action). In this sense a distinction needs to be made between the “weak artificial intelligence”, which aims at designing and building machines that act “as if” they were intelligent, without being a complete reproduction of human natural intelligence, and the “strong artificial intelligence”, which sets itself the aim of conceiving machines similar to human beings, to the point of even developing self-­consciousness, rationality and self-determination, reproducing the details of the brain and the human performances. The main anthropological and ethical concern on the reproducibility of human intelligence in the strong sense underlines the lack of the possibility to reproduce the emotional, the semantic, and the motivational dimension. 26

 Anderson and Anderson (2011). See Floridi (2011), pp. 184–212.

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The human rational decision cannot be reduced to a mere logical process, which maximizes utility and minimizes risks, but it needs to be integrated with emotions, the comprehension of meaning, the capacity of self-assigning tasks, goals and aspirations. These dimensions remain exclusively human and cannot be artificially reproduced. The problem will also arise of the responsibility of the actions carried out by robots, in the hypothesis of the creation of intelligent artificial agents. Unlike other sectors in which technological development produces “objects” used by human beings, in this case “subjects” will be created for the most part autonomous with respect to humans, having responsibility too. Jurisprudence will have to produce legislation that tackles the problem of the responsibility of actions carried out by robots. Insofar as robots are considered autonomous agents (in decisions and actions), they must be imputable for moral and/or juridical accountability or liability for actions or omissions. Currently, given that robots cannot be considered autonomous agents, the responsibility lies with the constructor: but it may be also of the designer or programmer or developer or producer or the team, and of the seller, the owner or the user. One can speak of ‘shared’ or ‘distributed’ responsibility, which should be balanced according to the circumstance in the identification of the modality of the compensation for damage. It is necessary to guarantee traceability mechanisms for the reconstruction of the decision-making processes and responsibility with reference to robots.27 From the social point of view, the problem will arise of managing the progressive substitution of man with intelligent machines which will work more efficiently (fast, precise and cheap) with respect to human beings. The introduction of robots into society that substitute humans in traditionally and exclusively human activities can cause social unrest (for example, the loss of jobs) which will have to be dealt with. On the one hand the introduction of robots could take away the more menial, tiring or dangerous tasks thus on the other hand permitting social progress, on condition that the possibility lies with human beings to develop more noble activities at the same time that require greater creativity and which are thus able to give greater satisfaction. An economic social evaluation is ethically important before any authorisation to the introduction of robotic products and systems onto the market in order to avoid the so-called ‘robot divide’, a source of inequality in the access to technologies (owing to costs, availability of technologies, competence and motivation to use them).28 The main responsibility for the development of an ethics for robotics lies first of all with the scientists and the technologists whose role will be to work to increase transparency of research and public awareness concerning the issues of robotics, so that society can take an active part in the process of the creation of a collective conscience able to identify and prevent the misuse of modern technology. This outcome 27 28

 Holder et al. (2016), pp. 383–402.  Peláez (2014).

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is particularly important to prevent irrational fears that can divert the attention from real problems, and in final analysis, produce attitudes of a generalised and acritical refusal of a technology that can be an instrument of economic development and social progress insofar as assisting and not substituting humans. However, it is not just a question of educating citizens but the scientists and technologists themselves to the ethical problems by introducing courses on ethics in the scientific faculties of engineering, setting up ethics committees also in ICT companies as well as in hospitals and healthcare facilities, so as to create an interdisciplinary debate that might have a bearing not only on the application phase of the research results but also on the design phase. It is a question of thinking and foreseeing the ethical implications at individual and social level, allowing a sort of ‘anticipation’ of the ethical debate and possibly also a respectful technological design of certain moral values and limitations from the very start. Citizens and users should be suitably informed about the opportunities and limitations of technologies, also in view of their inclusion and participation in the delineation of public and normative policies. It is necessary to encourage and foster a critical awareness of the issues and a public debate and education, abreast with the rapid change of technologies. The appropriate training of the users should also be set up, especially if doctors or healthcare operators (for example, in robotic surgery or robotic assistance).29

4.5  Beyond Humans: Transhumanism and Posthumanism Philosophical reflection is needed to elaborate the conceptual framework within which to interpret the ethical problems of converging technologies. The anthropological issue underlying the developments of such technologies represents a particular subject for reflection in relation to the limitations of manipulation/alteration of human beings before the possible interventions of the progressive artificialisation of humanity or the anthropomorphising of technology. Scenarios which start from the technologisation of the body and the informatisation and artificialisation of the mind, point to future developments in which the artificial becomes increasingly similar to the natural and tends to fuse and ‘be confused’ with it, in such a way that the difference between human beings and machine is annulled, in a symbiosis between humanity and technology, organic and inorganic life, animate and inanimate life. The first philosophical element which emerges is that of the reduction of the body and mind to object and the consequent tendency towards a devaluation of the body. The use of such technologies presupposes a reductionist and mechanistic vision of the body, which becomes an object and a product of technology, reduced to replaceable parts both by other parts of other bodies and by technological parts, to the point that it is difficult to distinguish between the enhanced functions of the body or the enhanced functions of those very technologies. 29

 Rathenau Instituut (2017).

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The body is distinguished dualistically by the mind, which is also reduced to modified and computationally replaceable neural components. The technologisation of the body and the digitalisation of the mind are both subject to the control of techno-science in every aspect: dynamic, sensorial, cognitive and emotive. This control is expressed in the recognition and registration of the existing functions and in the induction of automated artificial functions. This control hinders all autonomy and privacy to the point of annulling it. The connection of the mind to machines and other brains (brain-to-brain interface) allows no intimacy either of the body or of its thoughts. Every movement and thought is or can be located, recorded, transmitted, manipulated, modified, ending up even by erasing the uniqueness and singularity of the individual in one collective whole. The possibility of instantaneously exchanging actions and thoughts in a global network risks wiping out the boundary between individual and community. This is the human condition, according to ‘post-humanism’ and ‘trans-­ humanism’. The condition of human being that has come about as a consequence of the techno-science scenarios.30 Starting from a materialistic concept of being and the ontological negation of nature and disregarding of the peculiarity of what is biological, the idea of ethically fostering the transition ‘beyond humans’ means progressively abandoning the humanity of beings and the species itself. The abandoning of the biological for the virtual/artificial/digital has the aim of broadening human capacities, to have better lives and better minds. The motive for trans-humanism31 is the superhuman and hyper-human desirability for improvement, expressed moderately in the quest to increase beauty, physical stamina and life expectancy; radically with the cancellation of the human condition itself, perceived and experienced as a limitation. The objective is expressed in the Transhumanism Declaration (MCT): “it is ethical and desirable to use technoscientific means to overcome the human condition (data)”. In this perspective, the enhancement of human being is attained in the techno-human condition that denies stasis and is reached with technological evolution.32 Human enhancement takes on a new and radical meaning: from the enhancement of human functions to the enhancement of human being understood as ‘enhanced human’.33 This is the perspective of a post-human and trans-human future that will tend to empty human bodies ‘in flesh and blood’, reducing them to mere receptacles of biotechnological, mechanical and electronic components, flows of changing information able to assist to the point of substituting the vital processes of the organism with the promise of unlimited perfection. Technological enhancement by the amplification of the body or expansion of its functions becomes cyborgisation or the artificial substitution of the body itself.  For an introduction to posthumanism and posthuman see Hayles (1999) and Pepperell (2003).  World Transhumanist Association, Transhumanism Declaration, http://humanityplus.org/learn/ philosophy/transhumanist-declaration. 32  Bostrom (2006), pp. 40–50. 33  Savulescu and Maslen (2015), pp. 79–96. 30 31

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What counts is that the function ‘functions’ as perfectly as possible, the body is not necessary, except as a casing of the function. A perfection that fulfils the dream of ‘technological immortality’.34 In the convergence of technologies, it is man himself that becomes technology in a sort of ‘pan-technologism’. In contraposition to the post-humanist and trans-humanist theories emerges a critical reflection starting from the consideration of the human body as a complex organism non-reducible to a machine, just as the human brain is not reducible to a computer. Starting from the neurosciences, it is highlighted that the human brain cannot be reduced to the sum of neurons and synaptic interactions, but is a complex organ of extreme plasticity and dynamicity that is shaped by and interacts with the surrounding environment (persons, things). The recent developments in neurological knowledge show the overcoming of the mind/brain dualism: the mind emerges from the brain, incarnated in an organism, with which it maintains a continuous exchange of information during its existence. The human conscience is not reducible to the sum of information or a calculating computational machine: it is subjective, intentional, emotive, intuitive, creative and is made up of an uninterrupted development through interpersonal and environmental relations. The recognition of the close connection between cognitive and emotive dimensions, in the individual and inter-individual context, has highlighted the so-­ called ‘Cartesian error’,35 pointing out the complexity of subjectivity which cannot be reduced to objectivity. In this sense an aspect is grasped of the inappropriateness of the prophesies of the advent of ‘disincarnated minds’. The presupposition from which the converging pieces of research departs is the possibility of simulating and experimenting the functioning of the mind on a computer, in a functionalist perspective, ignoring the complexity of the human mind and the brain/mind relationship. J. Habermas36 stresses that the substitution of the carbon body (subject to entropy) with a non-anthropic body (made of silicon) and the dematerialisation of existence would entail the sacrifice of individual subjectivity and would bring about “a self-­ understanding of an ethically new gender” which he maintains is incompatible with the normative self-understanding of persons that live autonomously and act responsibly. The virtualisation, informatisation and artificialisation of bodies would make it possible to transcend the physical world and its limitations, opening up the possibility of an instantaneous access in a global network (a sort of angelic and divine access) to the world. Technology would make it possible to overcome the limitations of the body (illness and death too), to achieve the ‘most perfect’ enhancement. Such a dream, however, would pay the high price of the negation of human identity and specific identity, which man cannot renounce if not renouncing his very self. In this context enhancement would become a real substitution of human being: a sort of substitutive artificial enhancement of the traditionally human functions,  Moravec (1990).  Damasio (2005). 36  Habermas (2003). 34 35

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which ends up annulling the human role and identity itself.37 The risk is de-­ humanisation and dis-humanisation, as pointed out by F. Fukuyama38 in the production of a human ‘biotechnological monster’ which is no longer human and which will find itself on the edge of humanity like a chimera.

4.6  Emerging Technologies and the Future of Work One of the main emerging ethical question in the framework of converging technologies and robotics concerns work. Faced with the transformations of work in the era of emerging technologies (neurosciences, genomics, biometrics,  robotization, digitalization, artificial intelligence, enhancement), considering the potential (predictable and unpredictable) effects on job of technological transformation—given the uncertainty and margin of unknown effects and the difficulty to have a definitive overview—it is possible to identify some positive effects (opportunities) and some negative effects (challenges) of technological transformation on human beings (and the environment) in an ethical perspective.39 We should avoid possible unfounded fears, unjustifiable hypes and exaggerations of the technological future of work. It is relevant to outline a balanced realistic view even if only probabilistic (not enthusiastically optimistic-technophilic nor pessimistic-­technophobic40), in order to elaborate an ethical reflection. The aim is to minimize bad effects and maximize good opportunities in a ‘sustainable transition’ of work in the era of emerging technologies respectful of ethical principles. It can be useful to distinguish between those future scenarios that are still being debated from those where some consensus has been reached among experts. For example, there are still widely divergent opinions regarding the impact of robots on the number and kinds of jobs needed in the future (job replacement and robotic automation of repetitive and routine tasks; job creation given the limits of automation). Likewise, experts do not seem to question the fact that the type of employment/jobs will certainly change due to increasing and unavoidable digitization of ­ orkers; our everyday life.41 Biometrics raises concerns related to the surveillance of w genomics to genetic profiling; enhancement to their performances, both physical and mental, in the competitive market.  Wilson (2007), pp. 419–425.  Cf. Fukuyama (2002a). 39  McKinsey Global Institute (2017) and European Parliament (2017). On the topics see: Floridi (2017), pp. 1–4; Floridi (2014a), pp. 143–150; Floridi (2014b); Ford (2015); Frey and Osborne (2013); Good work: The Taylor Review of Modern Working Practices, July 2017; Kremer et al. (2017); Osborne and Benedict Frey (2013); Rifkin (2014); Sachs and Kotlikoff (2015). 40  On technological unemployment: Luddites in 1811, Maynard Keynes in 1930. 41  Even if robotization and digitalization for certain respects overlap, they may be distinguished because robots are intelligent machines with mechanical bodies, whereas digitalization refers only to artificial intelligence (robots without a mechanical body). 37 38

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Technological progress brings up some specific ethical issues related to the future of work, in the context of a number of sociologically described general trends pertaining to this field: flexibilization (the possibility to change careers/works/tasks several times during life time; temporary and non-permanent jobs; self-­employment, self-organization, job-sharing); hybridation (combination of different jobs; combination of general skills and specific technological skills, double-deep skills); decentralization, displacement (work on online platforms at any time and from anywhere; remote/mobile work; globalized work, across borders and time zones). We do not need to prohibit technological progress unconditionally, nor to permit it without any discrimination. The question is not whether technology should be allowed to progress (and to be implemented), but what kind of technology we want to rely on and for what purpose, in relation to the future of work. Ethical values and principles may trace the framework of reference, in order to govern, control and guide technological transformation, whenever possible, in a way compatible and aligned with human development and flourishing. Technologization of work is not an unavoidable destiny or a fate. It cannot (scientifically) and must not ethically be stopped, but it should be ‘accompanied’ by ethical values and principles. To reach this aim we need an anticipation of possibly new technological scenarios and re-semantization of the ethical ‘traditional’ principles, in light of new requirements and challenges posed by work technologies (i.e. analysis of disappearing jobs, transforming jobs, emerging of new jobs). In the era of technologization, we should not neglect the moral meaning of work in the context of human dignity. Work is necessary for human beings to flourish and express what is important to them and what they believe in (ethics of virtue, of achievement), as well as to strengthen communities (common good). Work is one of the conditions (not the only one, but one of the essential) for a person to fulfil oneself in relation to others in society. Work is a fundamental need of each person: through work anyone can contribute to transform reality and to transform oneself. Work allows people to succeed, expressing their potentialities, not only skills, but capacities and capabilities in the broad sense. It is one of the ways through which the person expresses his character. It is not only a way to produce goods and services. It should not be reduced to a means for productivity and profit. In this sense, work is not axiologically neutral, as it has an anthropological relevance. Work should also be considered as a way to generate personal good and social good. A way to conduct a good life, developing the fulfilment of the person, and the flourishing of each human being, thanks to personal and social recognition and to valorisation of personal capacities (whatever capacities, to whatever extent possible). The ethical reflection on work underlines the nature of work, not only its function. It cannot be reduced to an instrument for the achievement of an external goal (profit, productivity), but it has an intrinsic value or non-instrumental value, an anthropological value. We should be aware that human beings are more than their work. In this sense joblessness is one of the conditions of loss of self- esteem, loss

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of social reputation, of personal unhappiness. Work and quality of work is a condition of human dignity. In this sense work, as a value, should be guaranteed to all, regardless of skills, levels of performances reachable or technological capacities to interact with machines. The ethical aim should be the access to work for everyone (on a quantitative level) and the betterment of work for everyone (on a qualitative level). New emerging technologies, such as robotization, digitalization, biometrics, enhancement, challenge, in many respects, the intrinsic value of work both on a personal and social level, as it will be further explained. On the one hand, emerging technologies open new possible opportunities, such as: increase in the efficiency of work; emergence of new categories of work; improvement of production; betterment of the quality of work; liberation from routine tasks; humanization of work. Technologies may open the possibility of flexible and remote working, that may be useful in some specific circumstances, in order to combine work, education, leisure, personal and family care; the increase and acceleration of global contacts in time-less settings. On the other hand, technologies may raise some challenges: risks for dignity, personal identity, safety, security, autonomy, privacy, justice. Above all there is an emergence of new vulnerabilities in relation to the “gender gap” (low rate of scientific expertise in women, which represents a high percentage of the future of work), “age gap” (difficulties and barriers for old people or inactive people, in the context of the rapidly ageing population), and “ability gap” (possible marginalization of people without technological skills, and of cognitively disabled people). There is a risk of possible dehumanization, or reduction of humanization of work. Remote work brings to a decrease of interpersonal face-to-face relationships; robotics brings to a delegation of human activities to machines. Potential inequalities may emerge and there is an increasing threat of global competition. The best way to respect the dignity of human beings is to guarantee work for everyone, helping to express virtuously the human’s own identity and capacities in a relational way, helpful for society as a whole (common good), in a virtuous circle. This ideal aim is the moral horizon of shared values, which inspires the analysis and interpretation of the values at stake. In the three technological revolutions (steam engine, electricity, ICT), there has always been reference to the ‘end of work’, but the forecast was wrong. The incorrect forecast stemmed from a defect of perspective that transferred the destruction of the workplace to the sector of technological advancement without considering economy as a whole. In fact, in each of the technological revolutions, some economic sectors had been destroyed but not the economic system that could count on a transversal production factor, which increased productivity and work. The 4th technological revolution (the so-called “second age machine”) has new characteristics. The reduction of labour with automation/digitalization of work is often seen as one of the main challenges faced by our societies. And it surely is in certain respects. It is important to keep in mind, however, that the main cause of inequality and ­poverty is not only the advent of machines and digital technologies, but also the fact

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that income does not correspond with people’s contribution to society, in the context of economic growth and social sustainability. On the basis of the Charter of Fundamental Rights of the European Union,42 human rights’ perspective as a legal and an ethical point of reference is needed in order to protect all humans, alongside the protection of their human dignity, autonomy and justice. This is the ethical framework for an analysis of the ethical challenges of the future of work.43 It is a matter of fact, already happening, the so-called phenomenon of “robotization of work”.44 The progressive substitution, in some areas, of human beings with smart machines and robots (intelligent machines with mechanical bodies), as they are/will be more efficient, precise, rapid and less costly than humans. By introducing robots, many of the traditionally exclusively human activities may be or will be performed by them. Human unemployment in certain specific areas will become inevitable. As far as the substitution regards dangerous, humiliating or tiresome works, it will be an opportunity for the protection of human dignity, individual wellbeing and social progress. This kind of human-machine substitution of work is ethically valuable and desirable. Human beings will have time and the possibility to develop activities more ‘noble’ (or at least less dangerous, humiliating and tiresome), giving more space and time to opportunities for self-realization (practicing another job, increasing leisure time and fostering social relationships). The introduction of smart machines and learning machines (capable of learning, in relation to the environment) represents an innovation in automated work. Not only routine work, but also specialized and innovative (knowledge generative) work may be performed by machines. The expansion of human mechanical replacement is increasing and is still meant to grow, due to the pace of progress in this sector in big expansion (in technologically advanced countries), but, at the moment, the ‘threat’ is over-estimated. For example, domestic robots clean but do not replace human work of house-­ care; automation is restricted to specific activities. Surgical robots increase in ­surgical activities but require human presence, check and intervention; humans con Charter of Fundamental Rights of the European Union, 2000/C 364/01.  The articles of the Charter of Fundamental Rights of the European Union related to the topics are: 1 (human dignity), 3 (right to the integrity of the person), 6 (right to liberty and security), 7 (respect for private and family life), 8 (protection of personal data), 11 (freedom of expression and information), 12 (freedom of assembly and of association), 14 (right to education), 15 (freedom to choose an occupation and right to engage in work), 16 (freedom to conduct a business), 17 (right to property), 21 (non-discrimination), 23 (equality between women and men), 26 (integration of persons with disabilities), 27 (workers’ right to information and consultation within the undertaking), 28 (right of collective bargaining and action), 29 (right of access to placement services), 30 (protection in the event of unjustified dismissal), 31 (fair and just working conditions), 32 (prohibition of child labour and protection of young people at work), 33 (family and professional life), 34 (social security and social assistance), 37 (environmental protection). 44  Robot from robota = forced work, Karl Capek, 1920. L. Floridi quotes Keynes as the first referring to the “technological unemployment” in 1930. 42 43

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tinue to be essential in order to control and guide robotic action in surgical areas. Assistive robots and carebots can substitute caregivers in routine and tiring labours; they represent a mechanical help for human care, which is unreplaceable; a total robotization of care (for the elderly, disabled people, autistic children, etc.) could bring to human isolation and to dehumanization of care, and would not allow carers to express human virtues in empathy and interpersonal relationship with vulnerable individuals. Learning machines applied to economics that search data and learn from experience require the programming and supervision of experts. In these examples it emerges that human skills may be integrated, complemented, but not substituted, in the context of “person centered work”. However, while there are some tasks that machine learning systems can carry out more accurately or effectively than humans, there are many others where human competencies remain higher, and which could never be adequately replicated by machines. In this regards, there is an emerging ethical need to keep and to defend the area of “human work or activities non-replaceable by machines”, as creativity, innovation, capacity of problem-solving in unstructured context, complex cognitive tasks (interpretation, judgment), interpersonal relationship, emotional involvement, empathy, artistic performances, sensing, special kinds of handicraft.45 The defense of the human being and his dignity is a value worthy of recognition in an age of technologisation of work. The aim is not to reach the best goals with the most efficient means, but to develop, thanks to new technologies, the intrinsic capacities of the human being. Technology may become, in certain respects, an ‘enemy’ for human beings (replacing jobs), but also a ‘companion’ in the promotion of a more ‘dignified job’ (technically and humanly higher). In some industrial sectors, the adoption of advanced technologies requires highly skilled workers. In many areas (above all cognitive and handicraft), there is a collaboration between robots and humans, a close direct interaction (the so-called ‘co-robot’). It is important to investigate how we are going to socialize such system of intelligence and how we should best adopt it and adapt to it from an ethical perspective, because many solutions are not inevitable, and some may be preferable to others and should be privileged. Machines and humans will work together not against one another but as ‘partners’ in order to beat disease, ignorance, poverty. We need to ensure that individual and social benefits are maximised, to determine which forms of artificial agency and interactions we like to see flourishing. We need realistic solutions, in order to avoid human replacement or technologisation as depersonalisation or mechanization of work, depriving work of personal significance and fulfilment, always bearing in mind that the quality of work cannot be measured only on productivity/efficiency, but also on personal fulfilment and inter-relational social cohesion.  In this sense, we may say that what is affected by automation is thus mostly labour, not work. Automation tends to reduce the amount of time that people spend labouring, not working, considering labour as a low cognitive, routine repetitive activity.

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In the context of an increasing digitalization in the workplace, a number of consequences may arise for personal identity and human dignity. The implementation of ICT in work may introduce many benefits: enhancing and speeding up of interpersonal communication in real time and in a global context; facilitating individual and environmental data collection. The expansion of ICT enables and will enable worldwide communication and allows citizens to obtain broad information in a simple manner, in a fast time, in their own language and in indefinite quantities. This opens many opportunities for economic and social development in workplace. ICT may, at the same time, raise some risks. It may limit interpersonal relationships, the need to meet people and work together. There is an underlying risk of digital isolation from face-to-face relationship, which may bring to forms of digital individualism and reduce solidarity between workers. The use of ICT may also induce “technology addiction”, the workers being pressed to be permanently online. There is a risk of reification. The worker is likely to become a passive executor of external digitalized and automated order (through a tablet which details performances, activities of every working moment and place). This may lead to a perception to be externally controlled, to be digitally mechanized; a risk of dehumanization, objectification, subordination, with limited possibilities to express personal capacities and personal identity within a technological ‘digital reductionism’ in the workplace. The use of digital technologies in order to ‘quantify’ work productivity may lead to a ‘quantified self’ (what is non-measurable is not considered as ‘worthwhile’), with possible negative consequences, as loss of personal motivation of work in its qualitative meaning, inducement to perceive work only as efficient productivity (measurable) performances in a competitive logic, possible reduction of personal innovation and creativity. In this context it is important to balance benefits/risks of ICT, guaranteeing a proportionality in the workplace. The respect for physical and psychological integrity (safety, wellbeing) of the person is one of the main conditions for the respect of human dignity. Integrity/ safety may be achieved in the context of work in the era of emerging technologies, relying on the ethical principles of beneficence and non-maleficence, maximizing objective benefits and minimizing potential physical, psychological and social harm. In this context it should be applied the principle of precaution (in case of serious risks, potentially invasive, irreversible and intergenerational) and the principle of appropriateness/proportionality (the risks should not be disproportionate to the potential benefits), from the perspective of a ‘comparative risk/benefit assessment’ for the protection of the worker’s wellbeing and physical, social and mental integrity. This value requires a specific interpretation in the context of the future of work in the era of emerging technologies. The introduction of robots in the workplace, with the aim of realizing a productive and efficient collaboration with humans, needs to be experimented, in order to guarantee safety and integrity. The ethical requirements of research need to be interpreted and applied also to the use of robotic technology in the workplace. Concerns

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arise, above all, with regard to robot-humans collaboration. In this context, machines and humans are not separated, but they work side-by-side. Reference to ethical codes of engineering in constructing robots applicable to the workplace (safety-by-design), should take into account the principle of proportionality and benefits/risks analysis. In this context, an ethics committee of experts (roboticists, engineers, ethicists) should review the experimentation and results and verify the liability, accountability, responsibility. Who is responsible for mistakes or errors of robots? Debate on the category of ‘shared responsibility’, traceability is ethically and legally needed. There should be quality standard and ethics committees in robotic companies in the workplace. Liberty and autonomy are strongly related to human dignity. The protection of freedom, in the sense of liberty and autonomy, refers to the possibility to make choices having the capacity to decide for oneself and pursue a course of action in one’s life. Autonomy means also self-determination, self-sufficiency and a lack of dependency on others (in an individualistic sense); but autonomy refers also in a relational sense to the human capacity that includes responsibility, especially with regard to those who are facing cognitive inability or particularly vulnerable conditions (children, mentally incompetent individuals, the elderly, cognitive disabled persons). Ambient intelligence and persuasive technology in workplace have an ambivalent relationship with human freedom. Whereas in many cases they have been designed to create freedom, as they quietly can relieve of some tasks, they also form a threat to this freedom, because of their possible influence and control. Robotization may challenge autonomy, bringing on one hand a (possible) technological substitution of a human’s decision and, on the other, introducing a new kind of technological dependence, the so-called ‘robotic dependence’. An increase in the use of robots in the workplace may be one of the causes, in the near future, of dependence on robots in everyday life, in the workplace and beyond. The use of robots could enhance our capacities (both at cognitive and physical levels), but also increase our vulnerabilities, decreasing our autonomy and liberty. The so-called ‘robotic deception’ consists in the difficulty in distinguishing natural/artificial performance; android robots with excessive humanistic resemblance, whose interaction in the workplace may cause emotions, attachments. Dependence may affect personal abilities of action, thought, resulting in delegating to machines and de-humanizing work. Another manifestation, in this context, of reduction of autonomy is the phenomenon of “technological paternalism”, the tendency to delegate decisions to technologies. Delegating complex tasks to intelligent system may lead to loss of workers’ control over machines, loss of some human and professional skills, loss of autonomy and dilution of responsibility. In addition, digital technologies in the workplace may reduce personal liberty and autonomy if used with the intention to control, monitor, track the worker, during his working time and in his personal life out of work. Digital technologies (i.e. wearable sensors, electronic bracelets, electronic registers, smart phones, computers, online platforms) may be used to constantly register workers’ activity, localization, habits during work-time or out of work; to monitor

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productivity and discipline of workers (remotely, simultaneously, with no space or time limits). Also everyday life out of work may be tracked, monitored, controlled. Such data may be elaborated by algorithms, or a mathematical and statistical evaluation of productivity, with immediate algorithmic feed-back to workers in order to immediately correct wrong activities. The worker may be not fully informed about how the data (captured and tracked during work-time) will be used, stored and for how long, who will use it and for what purpose, via which paths, who is responsible and to what extent in the workplace. It should be explicitly declared by companies/firms the exclusive use of data for working purpose, and the exclusion of any use of data for surveillance of personal life. The limits of work surveillance should be defined. The digital surveillance in the workplace brings to a possible scenario of pervasiveness and invasiveness/intrusiveness in worker’s life (inside or outside work), reducing control (legitimate within certain proportional limits) to an impersonal constant check. This equally leads to a change in the perception of work, becoming codified, proceduralized, externalized with a pressure on maximization of profit and productivity (risking to lose the real sense of work, non- reducible to production and quantification of production). Algorithmic reductionism may be used both for checking activity and for prediction/selection of workers, profiling data and information. The use of data from external sources of the working environment (i.e. social networks), in order to select workers or to fire workers, should be regulated. The likelihood of implicit and undue surveillance, and possible forms of stigmatization or discrimination in workplace (the registering of certain ideologies, habits, practices, preferences may be used to select workers, reducing autonomy and liberty), comes to the fore. Companies may encourage the sharing of data, adjusting salary/premiums on the basis of sharing and lifestyle habits. Therefore, there is an emerging possibility of using ICT in forms of control in the workplace, which limit individual freedom on the basis of a predefined “standardisation” of behaviour considered to be “best” in a specific context (but who should define the standard?; should this not be assessed on a case by case basis?; by whom?). This problem arises in the context of employment between digital workers or potential workers and employers. There is an ethical need to discuss possible new rights in the context of the ethical value of autonomy/liberty. The right of the worker to be offline, the right not to be controlled (or at least under specific conditions), the right to save interpersonal relations, the right not to be profiled, stigmatized, discriminated. There is a delay in the psycho-social analysis of the impact of digital technologies in the workplace. The speed of application of digital technologies and the delay of social perception of the ethical problems is arising, especially referring to the dignity, liberty and autonomy of the worker. Given the impact of technologies on working condition, it is essential that workers are aware of the use of such system, and participate in the reflection process surrounding its design. An ‘intelligent workplace’ should use technologies to protect workers (health, safety, autonomy: i.e. prevention of accidents related to worker

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inattention; collection and processing of physiological data in order to check workers’ health, reducing risks and safeguarding health), not to carry out surveillance. Strictly connected to autonomy, privacy needs to be protected in workplace. Privacy includes security, confidentiality, appropriate use and protection of personal information. In the era of emerging technologies it is one of the values at stake. Robots may also record, process and analyse information. Robots are not only collaborating in the workplace, but also entering our homes, registering our movements, habits and preferences. Privacy protection is required. Privacy may be protected from the very beginning by constructing robots respectful of privacy (privacy-by-design). The need for the protection of confidentiality of certain information and the means to defend one’s own digital privacy in the workplace should be highlighted. Workers risk losing much of the control they have on their private information in this digital space through the expansion of data. The possibility of anonymisation techniques to preserve privacy is diminished in the age of big data. The challenge presented to digital workers lies in their gaining critical awareness of the problem, determining which devices and instruments they are able and willing to use, in order to avoid, as far as possible, losing control over their privacy in the context of blurring boundaries between professional and private life work, home and leisure. The use of data may refer to socio-demographic information (gender, age, civil status, education); personal information (religion, political and ideological affiliation; emotional states, attitudes, aptitudes, preferences, behaviours, thoughts, feelings, personal communications, groups belonging etc.); and also health information (biological or genetic data, health condition). There is a need for people to have sufficient control of their data when using the Internet in general, and also in the workplace, especially the so-called sensitive data, including health data. There is a need of transparent procedure in the information process: the reason for the collection of data, who will use it, which data, how the data is collected, where it will be stored, for how long and for what reason and purpose, should be clearly specified. The reason and purpose should be only explicitly related to work. Any other use should be clarified and justified by companies and firms and freely accepted by workers, without undue inducement. It must also be taken into account that, currently, online platforms (in particular private companies) can forward or sell the data as “macro-aggregates” to other companies (if not legally prohibited) without asking for specific and precise consent. Promotion of data sharing in the workplace should be ethically reviewed (by ethics experts, possibly in ethics committees in the workplace), and at least openly transparent. The workers should be free to send or not send information about their habits, lifestyles, preferences (sometimes the standard of curriculum requires also the explicit mention to personal skills). There should be an ethical requirement of confidentiality. The use of data from social networks for the evaluation of the worker or the use of information coming from different digital sources as criteria of selection in the

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workplace raises an ethical problem.46 It is known to computer scientists that the so-called “delete” key does not guarantee the loss of files, e-mails and messages, which can be recovered very easily (data persistence). This digital knowledge of any citizen, carrying out public or professional activities, can and may bring about significant consequences in the workplace (i.e. the loss of work itself). The digital information from different sources can be used to influence decision in the workplace. Through seemingly innocuous online activity, people can therefore reveal more personal information, which might be used in workplace. And citizens should be aware of it, above all young generations. The selection in the use of data and information, the creation of (non-causal) relationships between information and predictions (i.e. the anticipation of likely future scenarios, behaviours, etc.) are built from algorithms, developed by mathematicians and computer scientists. Algorithms calculate on the basis of variables, seeking correlations, outlining predictions. It may be applied in the workplace, in order to select possible workers. However, selected behaviour through algorithms corresponds to frequent behaviour; frequency is the key element of statistical analysis (infrequent behaviour risks to be marginalized). The pressure of homologation, conformity of behaviour (as well as the pressure to share) highlights the reduction of the space for freedom in the era of big data. Profiling technologies are often used in the workplace to identify the major and minor probability or propensity to act in certain ways, of certain stratified groups of individuals (the so called “group identity”). But “probability” does not coincide with reality. The ethical importance of accountability and transparency in relying on algorithms used by providers relates to the release and processing of personal data. Opacity should be avoided. Another ethical principle to be applied in workplace, besides dignity, autonomy and privacy, is justice. Justice means equality (equal treatment for all) and non-­ discrimination. It is strongly connected to human dignity. In the context of the future of work in the era of emerging technologies justice means equity in the access to work and inclusiveness in the workplace, without any form of exclusion (stigmatization, marginalization, discrimination). The machine substitution of work is causing/may cause social tensions. We need more interdisciplinary studies (on an ethical, economic, sociologic, psychological level) on its impact, in order to implement strategies. Strategies that should guarantee a balance between benefits (efficiency, cost reduction, technological competitiveness in the international market) and risks/damages (work reduction for human beings, social assistance and insurances, social and economic inequalities). It is necessary to perform an economic and social evaluation before their introduction in the marketing order to avoid the ‘robot divide’, a root for inequalities as regards access to technologies, but also availability and education/motivation to use them. Technologisation and digitalization have decreased the demand for low-skilled information workers, but have increased it for highly skilled ones (above all, having knowledge of informatics, engineering). Digital progress may leave some people, or 46

 Ajunwa et al. (2017), p. 735.

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a lot of people, “behind”. Given the fast rate of technological progress, computer and learning machines are acquiring basic skills at an extraordinary pace and they are threatening the future of digital work for vulnerable human beings. Digital literacy is becoming a necessary requirement in the workplace; digital skills or data skills are required for nearly every kind of job. It has become the condition to work, and to participate in society. There is, today, a “digital divide” because of age, socio-economic status, and geographical area; the elderly, the less educated, the inhabitants of developing countries, cognitive disabled persons are the most vulnerable in the digital age. There is an ethical requirement to overcome, or at least to narrow, the digital gap between the skills available and the skills needed, in order to ensure the value of justice.47 Digital literacy and big data literacy cannot be reduced to digital skills (both generic and specialistic) in the context of ‘skill polarization’, but should include also digital competence in a more broad sense (knowledge of the nature and role of ICT), and critical awareness (knowledge of the ethical problems emerging from the use of ICT and social networks, both in the workplace and outside; and connected legal regulation).48 Equal access to digital literacy should in principle be guaranteed, allowing everyone to acquire the tools, knowledge, skills and motivation to use new information technologies, in order to have work chances within the global society and not be marginalized. At the same time, there must be guarantees—at least temporarily—of alternative access to jobs without digital skills (that may be acquired through internal training) so as to ensure equal opportunities and non-discrimination. Unemployed people are at risk as their possibility of work depends on their capacity to learn digital skills. The ethical need to guarantee justice and fairness is emerging49; the  need to invest not only in education as up-skilling for intelligent, high-level people or re-­ skilling to update not ‘native digitals’, but above all to include, sustain and not abandon, in a solidaristic way, those who are unable to acquire digital skills, who do not have the capacity to develop skills (because of mental disability or age) or who do not want to acquire digital skills. Disabilities (both physical and/or mental) can become a barrier to work; it is difficult for people with disabilities to be incorporated in the workforce. Effective ­integration of disabled people is a challenge, and technologies may be helpful in this regard, in order to overcome and help to overcome barriers to mobility, language expression, interpersonal relationship. It is essential to provide new technological  There are a lot of initiatives of the European Commission in this field: New Skills for New Jobs, 2008; Digital Agenda, 2010, Digital Competence Framework for the Citizen Evaluation of Digital Skills; Digital Economy and Social Index, Overview of the Evolution of Digital Skills in Europe; Grand Coalition for Digital Jobs, 2013; New Skills Agenda, 2016. 48  Recommendation of the European Parliament and the Council of 18 December 2006 on key competences for lifelong learning, 2006/962/EC. 49  ILO-EC Conference on: Inequalities and the World of Work: what Role for Industrial Relations and Social Dialogue?, Brussels, 23–24 February 2017. 47

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tools to overcome these barriers and to facilitate integration of persons with disabilities.50 One of the needs, in order to improve the accessibility of jobs and policies in favour of job improvement, is the implementation of information. It seems a paradox. In the age of ‘big data’ we lack objective information on the future of technology and work (‘data gaps’). This is the warning of T. Mitchell and E. Brynjolfsson.51 The Report US National Academies of Sciences, Engineering, and Medicine details the impacts of information technology on the workforce (2017) affirming that in the next 10–20 years technology will replace or at least affect every occupation (self-­ driving vehicles will replace taxis or trucks; online education will replace schools/ universities, etc.). We have an intuition of this trend, in the light of the rapid development of technologies, we may imagine and anticipate scenarios but we have no empirical data of the “4th industrial revolution”. We lack data on the scope and rate of change (especially artificial intelligence), which technologies and which jobs will be affected (eliminated, increased, transformed), which opportunities will emerge. The authors affirm: “policy makers are flying blind into what has been called the fourth industrial revolution or the second machine age”.52 The “paucity of information will lead to missed opportunities” (both in the public and private sector). In the era of digital knowledge we have a generation, proliferation and expansion of data available (in some areas precise, detailed). What we lack is precise data and analysis. We should acknowledge that this problem inevitably exists with all policy making challenges. We cannot model the future because we do not know what factors to model into the system (as new factors will emerge, and different ones will matter compared to today). This is, of course, because the world is not a laboratory. The authors underline: “The irony of our information age is that despite the flood of online data, decision-makers all too often lack timely relevant information”. Given also the difficulties in the dynamically evolving context (according to Moore’s law applied to artificial intelligence, performances double every 2 years), it is difficult to observe and track changes, to map progress and elaborate anticipations; it would be essential for policy-makers to build strategies. The collection and use of data on the reality of work should not be used only for commercial purposes in the big market, but should be used also for political improvements of society. It is a fact the unwillingness of companies to divulgate data due to competition; privacy and obstacles to sharing are other factors. We lack data on job-seekers and skills required. We do not have enough systematic data on things that actually matter, such as what skills are needed for types of  The new divide is also between active and passive users: active users have a lot of bandwidth, and the skills/money to upload data and generate content, passive users do not. This last distinction is independent from the time spent online: people with low education levels and socioeconomic status tend to be in the passive group, increasing the digital gap also in the context of motivation. 51  Mitchell and Brynjolfsson (2017). 52  Ibidem, p. 290. 50

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work and labour that are important for our societies. Merely asking what employers want is not a sufficient way of establishing what skills are needed on courses available to learn skills required for the new jobs; we lack data on the kind of employment (kind of work, kind of sectors, etc.). Open access to massive real-time data (dynamically updated and shared) could be essential, in order to have a rapid overview of the present situation and anticipate, predict scenarios. We need objective data on present transformation in the technology in workplace and anticipation for the near and remote future (by experts, on an interdisciplinary setting), in order to elaborate realistic policies for workers (elimination of jobs, transformation of jobs, creation of new jobs). Given that the future is structurally unpredictable, we need empirical data to observe, understand and analyse the present in real-time and try to anticipate future scenarios, in order to orient, guide, adapt, plan or at least to be prepared in the future on an ‘evidence-based’ or at least ‘probability-­based’ framework, remaining not only passive observers of what is happening. We need a data-driven approach to education and decision making; experimentation, trial and test of these approaches in an age of unpredictable changes and unknown impact and consequences is needed in order to accommodate rapidly education and policies. With the awareness that adaptation should be quick in the rapidly changing technological environment. Digital data does not cover the exhaustive information on the present phenomena (there is a problem of the ‘quality of data’, that needs to be validated), not all organizations and companies are digitalized with online platforms; not all the sectors are digitally represented, giving also the fact that the use of smart phones, apps and social networks vary according to the socio-demographic context. We lack data and a systematic analysis, that may be done only by national governments. We need “truly representative data”, in order to have an objective framework of the present condition of work, on which to (possibly) predict the future of work. We need automated tools; information to citizens on the value for society of sharing true information on work (‘public good’ for present and future generations). We need job placement websites statistics; openness of data sharing. This infrastructure may be realized by governments: collection of true data and statistics from private and public sources; protection of open access to all, protection of privacy and anonymity; ‘normalizing’ data overcoming possible biases and integrating data in the context of the evaluation (employment, unemployment; transformation of kinds) of the economic framework (standard key indicators of economy, productivity, etc.). In light of the information on the present and future condition of work in the era of emerging technologies, the relevant ethical requirement for policy-making is the elaboration of a plan for an adequate education. The technological change of the work environment gives rise to the need for more qualified formation and training. The present “work-ethos” based on a paid job and on full-occupation requires adaptation according to the consequences of the robotic and digital transformation. Moreover, specific research, education, and in-service training in ethics need to be addressed. As new types of professional and personal skills are required for

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t­echnological progress, active education policies are urgently needed to cater for this changing reality in the world of work. Within this framework, it is necessary to tailor education to technological change (education is going slower than the acceleration of technology); identification of new expectations regarding the skills required for the jobs of the future, and how the education system and labour market respond to those requirements (what is lacking, what needs to be improved). Emphasis is underlined in ‘skilling’ and ‘re-skilling’ of citizens. There is a reference to ‘new education’ and training policies to ensure that the workforce has adequate skills to thrive in the robotic and digital age and make sure they are not being left behind (i.e. cross disciplinary, multi-tasking, digital, etc.). But an adequate educational project should aim not only to improve skills, but also to accompany people in the technological work transition, adaptation process of personal capacities, realizing how to manage changes and cope with the emerging of new occupations/ modification of tasks. The educational problem, on an ethical point of view, is not only how fast and efficiently people may acquire digital or technologically interactive skills, the new skills identified that will be on demand in the new digitalized and automation age (boundaries between machine abilities and human capacities are dynamically blurring), but also the education to the best way to create the condition in the emerging technological context to develop personal capacities, above all capacities complementary to technologies (creativity, interpersonal relationship, social engagement). Education should refer to the future generation on the new ways of working, but also to people already in the labour force, strengthening workforce training and lifelong learning, continuing training in the dynamic working environment and looking for new forms of alliance between technologies and work, in order to realize more dignified work. It is equally important to educate to avoid over-reliance on technology that could bring to ‘de-skilling’. Education should primarily aim to ‘critical thinking’ (beyond digital skills) in the interaction with technologies; to ‘digital participation’, motivation and engagement. The question “How can society and its citizens, in particular vulnerable groups, such as the disabled or the long-term unemployed, get onto the digital train and stay abreast of new technologies and methods?” is an important ethics issue. One condition may be to use (or implement the use) of emerging technologies to facilitate learning (and motivation to learning) for disabled people, old people or cognitively impaired people, improving innovative and personalized teaching, flexible and adaptable to the person’s need. There is an emphasis on acquiring skills for new jobs, but less attention on the ethical protection of vulnerable persons, who are not in the condition to acquire skills, or who have skills but are not employed. There is an emerging ethical need for social protection (economic protection) of particularly vulnerable people, in order to compensate inequalities between countries and within countries in the framework of social inclusiveness.

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The digital transformation is predicted to lead to a substantial loss of existing paid jobs, because self-learning systems will be less expensive than human ­employees. This development is of ethical concern, since the reduction of the paid labor-­market provokes a lack of sources of income, of financial means for social welfare, of structuring daily life, of the purpose of human life, and of the selfunderstanding of humans. Beyond that, it contributes to the widening of the gap between the rich and the poor because less people are directly involved economically and socially in a more efficient and more effective value-creation-process. The reduction of the welfare state and of the systems of protection from which labour has benefited until now is a great concern that needs to be addressed. It is also foreseeable to reduce daily working hours, as it may occur to be more productive in less time. At the same the time, the retirement age will increase as a way to obtain a higher return from workers whose education and training will be more costly and whose performance can be maintained for a longer time, and in that way to pay their contributions to the corresponding insurance program and pension funds. Given that the future of work will undoubtedly involve higher rates of change between sectors and locations in which we work and that, in turn, means a change in skill requirements, we need to think carefully about the supports and safety nets we can provide to people in making those transitions. Of course, there is also the questions of long-term supports such as pensions, the traditional model of which is challenged in the aforementioned context. Fiscal policies should ensure that redistribution bridges potential inequality gaps that may result from labour market polarisation (high, medium, low skilled). Particularly, self-employment and flexibility often result in fewer opportunities and weakened job security for the low skilled. As the world of work becomes more flexible, employees are expected to shoulder growing responsibility for skills development, social security, and health insurance. The high-skilled minority (with creativity, analytical and problem solving capabilities, trans-disciplinary and communication skills) will have strong bargaining power in the labour market (also in the context of social security), whilst the low-­ skilled will bear the weakness of flexibility and cost reduction, resulting in growing inequality. For highly skilled individuals, a progressive work environment allows for greater autonomy and a better balancing of work and family life. While the low-­ skilled worker sees jobs disappearing and security decreasing. Social security protection should be object of a critical rethinking and reflection. Social security systems should adapt to new, constantly changing requirements, unresolved ethical and practical problems relating to the changing labour market. There is a big discussion on the so called ‘universal basic income’ given to all citizens on the basis of social justice and moral solidarity, including unemployed or people who cannot have access to the new changing jobs. Social security should cover the risk of illness and the incapacity of work, unfit for work/or temporary work, unemployment, pension. Social security systems should change in the framework of intergenerational solidarity and personalization of social assistance or support the weakest.

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Social security becomes a fundamental ethical question in a conception of economy that cannot be reduced to market, but it is also a ‘civic economy’ and ‘social economy’, which produces relational goods and services (care; commons; quality of human relations and cooperations; associationism; ethical finance).53 Social security should also adapt to the new scenarios, of increased diversity in the workforce, both culturally and generationally, by supporting a greater range of working organizations and arrangements, adapting to the new situations and creating, where possible, conditions of a decent and meaningful work. Intergenerational differences require careful management in the workplace, since many young people are trapped in low-level entry positions, as older people stay in employment longer. Fostering intergenerational solidarity in the workplace is extremely important to the future of work. There is an ethical need to reflect on ‘additional protections’ for vulnerable group of workers and stronger incentives for firms and companies to treat them fairly. Keeping in mind that having a job is in itself vital to people’s health and well-being; the decency and quality of people’s work is also a major factor in helping people to achieve personal fulfilment and social recognition, something which benefits them and serves the wider public interest. It is important to reiterate that simply using more casual forms of labour does not necessarily reduce the obligations on an employer in terms of employment protections. Employment rights therefore need to strike the right balance between security, flexibility and innovation. Above all, people need transparency, information and advice about what their rights and legal position may be in any particular context and relationship. It is relevant to develop legislation to make it easier for all working people to receive basic details about their employment relationship up front as well as updating the rules on continuous employment to make it easier to accrue service. Clarifying the legal framework and addressing unfair risk transfer to vulnerable workers are all important steps to ensuring fair and decent work. We need to go back to some of the fundamental principles and processes for the distribution of resources in our societies, and the problem of justice and equity, (also) in the context of the plan regarding technological advancement. Including rethinking the relationship between labour and income to ensure that also those who are not within paid labour relationships can lead healthy and dignified lives; tackling the global problem of tax evasion and tax avoidance. If this is done, then funds to secure the fundamental needs (housing, healthcare, education) and daily practices (transportation, digital connectivity) for everybody will be much easier to achieve. Therefore, the central ethical concerns related to the future of work are those dealing with the issues of human dignity and social justice addressed in The

 Rifkin’s proposal of ‘sharing economy’ describes a shift from capitalism/market/profit/competition/propriety to commons/collaboration/sharing/social trust, which also means absence of profit and propriety, reduction of work (in the quantitative aspects) and human liberation from work. Rifkin (2014).

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European Pillar of Social Rights planned by the European Commission The Future of Work in the EU: “The European Pillar of Social Rights planned by the European Commission will cover equal opportunities and access to the labour market, including skills development in three main areas: and life-long learning and active support for employment, to increase employment opportunities, facilitate transitions between different statuses and fair working conditions, to set an adequate and reliable balance of rights and improve the employability of individuals; obligations between workers and employers, as well as between flexibility and security elements, to facilitate job creation, job take-up and the adaptability of adequate and sustainable social protection, as well as access to high quality firms, while promoting social dialogue; essential services, including childcare, healthcare and long-­ term care, to ensure dignified living and protection against risks, and to enable individuals to participate fully in employment and more generally in society. Within these policy areas, 20 principles have been identified. One is the need for flexible labour contracts that can facilitate the entry to the labour market and promote career transitions for employees, while also maintaining employers’ ability to respond swiftly to shifts in demand. Also important from the point of view of ‘flexicurity’ are secure professional transitions, including the preservation and portability of social and training entitlements and access to individualised job-search assistance”. Previous major waves of technological change (the industrial revolution, the use of electricity, and the development of electronics), have also been characterised by productivity increases. In each case, the benefits of these productivity increases have been spread across society raising living standards and wellbeing. There have also been changes in the work environment with some jobs or sectors being lost, or substantially changed, and others being created. The 4th revolution (Ind. 4.0) may have a different impact. The nature and modality of this change/‘disruption’ in the workplace, due to many factors (economic growth, technological advancement), will depend on the social, political, ethical, and legal environments in which these technologies evolve. Understanding who will be most affected, how the benefits are to be distributed, and where the opportunities for growth lie is key to designing the most effective interventions to ensure that the benefits of this technology are broadly shared. To avoid creating a group of people who are ‘left behind’ by the advance of this technology, action is needed with the purpose of developing governance and policy responses in the framework of ethical principles and shared values. At this early stage, it may be possible for society to shape the change, ethically inspiring policy responses to ensure there are not groups of people marginalized as a result of social changes to which this technology contributes. The potential benefits accruing from technologies and their possibly significant consequences for employment need active intervention (both political and legal), ethically framed. Without such ethical reference, there is a risk that the potential benefits of emerging technologies in the workplace may accrue to a small number of people, with others left behind, or otherwise disadvantaged by changes to society.

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While it is not yet clear how potential changes to the world of work might look, ethical reflection is required now about how society can ensure that the increased use of technologies in the workplace is not accompanied by increased inequality amongst certain vulnerable groups. Reflection on how the benefits of technologies can be shared by all (as regards quantity and quality of work) is a key ethical and legal challenge for the future of society as a whole.54

References Acatech Position Paper. (2015–2016). Skills for industry 4.0. training requirements and solutions. Washington, DC: National Academy of Science and Engineering. Agar, N. (2004). Liberal Eugenics: In defence of human enhancement. London: Blackwell. Ajunwa, I., Crawford, K., & Schultz, J. (2017). Limitless worker surveillance. California Law Review, 105, 735. Anderson, M., & Anderson, S.  L. (Eds.). (2011). Machine ethics. Cambridge: Cambridge University Press. Antón, P. S., Silberglitt, R., & Schneider, J. (2001). The global technology revolution. Bio/Nano/ Materials trends and their synergies with information technology by 2015. Santa Monica: National Defence Research Institute RAND. Berloznik, R., Casert, R., Deboelpaep, R., van Est, R., Enzing, C., van Lieshout, M., et al. (Eds.). (2006). Technology assessment on converging technologies. Brussels: European Parliament. Bostrom, N. (2006). Welcome to a World of exponential change. In P. Miller & J. Wilsdon (Eds.), Better Humans? The politics of human enhancement and life extension (pp. 40–50). London: Demos. Brynkolfsson, E., & McAfee, A. (2014). The second machine age: Work, progress, and prosperity in a time of brilliant technologies. New York: W.W. Norton & Company. Citi GPS Global Perspectives and Solutions. (2015). Technology at work, February 2015. Citi GPS Global Perspectives and Solutions. (2016). Technology at work v2.0. The future is not what it used to be, January 2016. Damasio, A. R. (2005). Descartes error: Emotion, reason, and the human brain. New York: Avon Books. Daniels, N. (2000). Normal functioning and enhancement-treatments distinction. Cambridge Quarterly of Health Care Ethics, 9, 309–322. Douglas, T. (2008). Moral enhancement. Journal of Applied Philosophy, 25(3), 228–245. European Group on Ethics in Science and New Technologies. (2018a). Statement on artificial intelligence, robotics and ‘Autonomous’ systems. European Group on Ethics in Science and New Technologies. (2018b). Future of work. Future of society. European Parliament. (2017). Digital skills in the EU labour market, European Parliament Research Service, January 2017. Floridi, L. (2011). On the morality of artificial agents. In M. Anderson & S. L. Anderson (Eds.), Machine ethics (pp. 184–212). Cambridge: Cambridge University Press. 54  Acatech Position Paper (2015–2016), Brynkolfsson and McAfee (2014), Citi GPS (2015, 2016), Science and Technology Committee, House of Commons (2015), Stiglitz (2014), The National Academies of Sciences Engineering Medicine (2017), The Oxford Martin Programme on Technology and Employment (2015), The Royal Society of Edinburgh, the Committee on Digital Skills (2014), The Royal Society (2017), Went et al. (2015), UK Commission for Employment and Skills (2014) and European Group on Ethics in Science and New Technologies (2018b).

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Osborne, M. A., & Benedict Frey, C. (2013). The future of employment. Oxford: Oxford Martin School. Paulo, N., & Bublitz, J. C. (2017). How (not) to argue for moral enhancement: Reflections on a decade of debate. Topoi, 38, 1–15. Peláez, L. (2014). The robotics divide. A new frontier in the 21st century? London: Springer. Pepperell, R. (2003). The posthuman condition consciousness. Beyond the brain. Bristol: Intellect. Persson, I., & Savulescu, J. (2012). Unfit for the future: The need for moral enhancement. Oxford: Oxford University Press. Persson, I., & Savulescu, J. (2016). Moral bioenhancement, freedom and reason. Neuroethics, 9(3), 263–268. Pessina, A. (2017). A clay person. The promises of moral bioenhancement. Topoi, 38, 1–7. President’s Council on Bioethics. (2003). Beyond therapy. Biotechnology and the pursuit of happiness, Washington D.C. Rathenau Instituut. (2017). Human rights in the robot age: Challenges arising from the use of robotics, artificial intelligence, and virtual and augmented reality. The Hague: Rathenau Instituut. Reichlin, M. (2017). The moral agency argument against moral bioenhancement. Topoi, 1–10. Rifkin, J. (2014). The zero margin cost society. New York: Palgrave. Roco, M. C., Bainbridge, W. S., & National Science Foundation. (2002). Converging technologies for improving human performance. Nanotechnology, biotechnology, information technology and cognitive science, NSF/DOC-sponsored report, June 2002. Russel, S., & Norvig, S. (2003). Artificial intelligence: A modern approach. New York: Pearson. Sachs, J., & Kotlikoff, L. (2015). Robots are us: Some economics of human replacement. In “The National Bureau of Economic Research”, February 2015. Sandel, M. J. (2007). The case against perfection. Cambridge: Harvard University Press. Savulescu, J., & Maslen, H. (2015). Moral enhancement and artificial intelligence: Moral AI? In J. Romportl, E. Zackova, & J. Kelemen (Eds.), Beyond artificial intelligence: The disappearing human-machine divide (pp. 79–96). Cham: Springer International Publishing. Savulescu, J., Meulen, T., & Kahane, G. (2011). Enhancing human capacities. London: Wiley-Blackwell. Science and Technology Committee, House of Commons. (2015, December). Inquiry: Digital skills gap, London. Stiglitz, J. (2014). Unemployment and innovation, “The National Bureau of Economic Research”, November 2014. Strand, R., & Kaiser, M. (2015). Report on ethical issues raised by emerging sciences and technologies. Strasbourg: Council of Europe, Committee on Bioethics. The National Academies of Sciences Engineering Medicine. (2017). Information technology and the U.S. workforce. Where are we and where do we go from here? Washington DC: The National Academy Press. The Oxford Martin Programme on Technology and Employment. (2015). The changing nature of innovation and work. Addressing inequality brought on by technological change. New York: Citigroup. The Royal Society. (2017). Machine learning: The power and promise of computers that learn by example, April 2017. The Royal Society of Edinburgh, the Committee on Digital Skills. (2014). Inquiry: Digital skills in UK, September 2014. Tzafestas, S. G. (2016). Roboethics. A navigating overview. Dordrecht: Springer. UK Commission for Employment and Skills. (2014). The Future of Work: Jobs and Skills in 2030, Evidence Report 84, February 2014. UNESCO, World Commission on the Ethics of Scientific Knowledge and Technologies (COMEST). (2017). Robotics ethics. van Est, R. (2014). Intimate technology. The battle for our body and behaviour. The Hague: Rathenau Instituut.

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Chapter 5

Innovation in Techno-Science and Governance

5.1  T  echno-Scientific Progress, Ethical Pluralism and Governance Problematic techno-scientific development on the one hand and, at the same time, ethical and cultural pluralism on the other, gives rise to new issues concerning regulation and policies, on a national, regional and international level. Bioethics cannot avoid referring to biolaw and biopolitics.1 This is mainly due to the increasing need in present day society all over the world for a certain kind of ‘governance’, through legal regulations and policies, related to scientific and technological progress. It aims to regulate new and emerging rights.2 The different theoretical models of biolaw leads to different types of regulation. The debate on biolaw revealed several lines of thought and different models regarding the understanding of the relationship between ethical pluralism and biolaw. We are, currently, in front of several possible models of biopolitics. The abstensionist model is the deliberate non-intervention of politics in bioethics and biolaw. This choice can be made for several reasons: indifference toward bioethical issues; fear that bioethical problems may prove divisive in society and jeopardize its cohesion; awareness of a lack of shared values combined with the risk of a possible regulation enforcing a one-sided ethical perspective. In statute law countries, such a decision taken by politics not to legislate inevitably leads to judicial interventions compensating for political stalemate, whenever disputes arise in practice. In this way, case-law replaces the role of legislation, carrying the risk of discretion and creativity (the court may  decide on ideological grounds), along with heterogeneity. Since there is no rule of binding precedent, any 1  Ethics and law interact in various ways: they may significantly overlap with one another, but they remain two different normative systems. Ethics reflects on what is good or bad, and aims at promoting the fulfilment of our tendencies towards the good, law ensures human relationships and guarantees the common interests of society of peaceful coexistence. 2  See Palazzani (2018).

© Springer Nature Switzerland AG and G. Giappichelli Editore 2019 L. Palazzani, Innovation in Scientific Research and Emerging Technologies, https://doi.org/10.1007/978-3-030-16733-2_5

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judge can issue different judgments while ruling on similar cases which, occasionally, result in incoherent interpretations with reference to the legal system as well as conflicting interpretations with reference to existing laws. Moreover, unlike the latter, common law countries, where case-law traces a generally homogeneous ­regulatory path, the political need for a general rule enacted by the Parliament, however, comes to the fore in particular fields of bioethics, with the aim of clarifying and defining some general aspects. Non-intervention in bioethical issues by politics can often become dangerous, due to the intrusiveness of both technocracy and the market, alongside a ‘technological far-west’. These questions turn out to be all the more sensitive and challenging whenever life and health of individuals are at stake, as well as the survival of the environment and of humanity itself. Sometimes political non-intervention in bioethics means an implicit liberal-­ libertarian protection of the freedom of individuals (when actions are not explicitly prohibited, they are considered allowed). Sometimes it means a conservative defense of existing law, considering that even if they do not deal explicitly with bioethical issues, their extensive interpretation may result as in a form of legally binding protection of legal goods (for example, life or human dignity). Other possible biopolitical models are the ‘soft’ or ‘hard’ intervention decisions in politics (interventionist models). ‘Soft’ political instruments refer both to case-law intervention or to ‘light’, flexible, procedural laws, which are designed to define a minimum content, while leaving more or less broad scope for the courts’ discretion when interpreting and implementing rules, and for citizens to make choices between different courses of action. A soft law initiative can prove effective, on the one hand, in ensuring flexibility within a context of ethical pluralism and rapid transformation of society; on the other hand, it can be risky, since it is likely to shape scenarios leading to uncertain and unpredictable outcomes. The political decision to intervene with specific and detailed ‘hard’ legislation, governing precise questions and laying down core values pertaining to a particular ethical perspective, is generally designated as the substantial interventionist paradigm. This is the case of legislative measures, when existing law is deemed silent, outdated, ambiguous and the risk of violation of human dignity arises. This model aims to establish both specific and detailed content for each subject, identifying principles and rules for the regulation of specific cases. The purpose of bio-­ legislation is, at least, to clarify general principles, in order to set interpretive limits for judges, while avoiding discretion and creativity of legal decisions, alongside ensuring legal certainty among both professionals in the field and citizens. This orientation may be criticized, as the overlap or close connection between law and morality is blamed for ‘imposing’ one moral perspective, while delegitimizing others. It may be accused of illiberality, not taking in due consideration the demands for autonomy, and charged with obscurantism, as it may block or tend to hinder scientific progress through prohibitions. Rules based on a unique ethics can

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cause social fractures and need to be progressively reviewed, edited, revised, as well as becoming quickly obsolete compared to the pace of scientific advancement. Another possible biopolitical approach may be entrusting bio-political decision-­ making to the majority rule, without taking a stance in relation to the different types of intervention. This policy can resolve conflict effectively by looking for a practical, although not theoretical, way out, in an effort to mediate a resolution. The majority rule, in bioethics, may be considered as a pragmatic solution. It lacks dialectic confrontation towards minimum shared by all values. It does not bring appreciable effects in contributing to regulatory certainty and effectiveness applied to the objects being governed. The law requires a broad political and social consensus, in order to ensure that regulatory decisions are accepted, stable and efficient. In this regard, given the pros and cons of each possible intervention or non-­ intervention by biopolitics, there is a need to explore single contexts and problems drawing on a rationale for normative differentiation (prohibition vs. permission; soft vs. hard law; case-law vs. legislation). However, what is really essential is identifying a ‘place’ devoted to scientific updating activity, ethical pluralistic discussion and insight exchange, an in-depth examination of legal aspects in the normative framework with a view to devising a minimal set of shared standards that should be enshrined in biolaw and biopolitics. And these ‘places’ are, in fact, Bioethics Committees established at the national and international levels.

5.2  T  he Role of Bioethics Committees: Seeking Shared Basic Principles/Values Notwithstanding existing differences in establishment, nature and structural configuration, ethics and bioethics Committees play a key role, both at national and international levels, providing scientific updates, engaging in interdisciplinary discussion, and ethical-legal analysis. On a theoretical level, there is an increasing need for an ‘ethical balance’ or ‘ethical mediation’, which should not be reduced to a mere compromise or pragmatic agreement. Conversely, a minimum level of shared ethical standards requires weighing principles and values at stake, in the face of real complexity, through balanced critical reflection and dialectic argumentation. In terms of methodology, an ethical balance is achieved, at national and international levels, through a constant exchange of insights with regard to the theories and arguments held by others. This interdisciplinary and pluralistic approach succeeds insofar as every ethical concept has been adequately and consistently articulated and justified. It should be aware of existing restraints and problems, in the willingness to consider the arguments of others through dialectic and dialogic dimensions. It is appropriate to assess to what extent the position involved is shared by others, even checking it against different and opposite stances, while striving for balance in

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defining a set of shared or likely to be shared minimum ethical standards. It may also entail partially giving up the ‘maximum’ expression of one’s own theory to find common ground, avoiding irreconcilable conflicts as far as possible. The aim of the Committee’s discussions is to elaborate opinions and documents with final recommendations that can contribute towards giving the conceptual instruments to governments, in order to understand the often complex, dynamic, changeable issues and their importance and urgency, outlining the possible scenarios or lines of action in social policies to be undertaken at public level. These lines of action should seek a balance between the needs of science and technology to progress and the protection of human beings. The elaboration of minimum ethical elements for regulating techno-science draws inspiration from the horizon of fundamental human rights as a conceptual framework, which form a crucial part of national Constitutions and international documents. These documents have undergone, in recent decades, a process of explicit specification and interpretation, in light of emerging issues stemming from scientific and technological development, through declarations issued by international organizations (UNESCO, WHO), conventions, resolutions, recommendations, directives, regional regulations (i.e. the Union of several African countries (COPAB); the Asian Bioethics Association; Regional Organizations of American States; in Europe, the European Group on Ethics in Science and New Technologies at the European Commission, the Committee on Bioethics DH-BIO of the Council of Europe). The reference to human rights is guaranteed in legislation, at national level, by Constitutions3; both in national legislation and case-law, by international documents (declarations, conventions), European norms and judgments of the European Court of Human Rights and the Court of Justice of the European Union. In this context, individuals, national legislation and European norms are called upon to refer to basic fundamental human rights, placed at a higher level. The human rights framework refers to different norms. At the level of United Nations: Universal Declaration of Human Rights (1048); Declaration on the Use of Scientific and Technological Progress in the Interest of Peace and for the Benefit of Mankind (1975); Resolution 38/111 on Implication of Scientific and Technological Developments for Human Rights (1983); Resolution 38/112 on Human Rights and Scientific and Technological Development (1983); Resolution 1986/9 of the Commission on Human Rights on the Use of the Scientific and Technological Developments for the Promotion and the Realization of Human Rights and Fundamental Freedoms (1983); Resolution 1999/63 of the General Assembly on Human Rights and Bioethics (1999); Cartagena Protocol on Biosafety (2000); Declaration on Human Cloning (2005); Convention on the Rights of Persons with Disabilities (2006); New and Emerging Issues Relating to the Conservation and Sustainable Use of Biodiversity (2012).

3  Andorno (2009), pp. 223–240; Andorno (2013); Barilan (2012); van Beers et al. (2014); Beyleveld and Brownsword (2002).

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At the level of UNESCO, the declarations written by the International Bioethics Committee (IBC) and approved by the General Assembly: Universal Declaration on the Human Genome and Human Rights (1997); International Declaration on Human Genetic Data (2003); Universal Declaration of Bioethics and Human Rights (2005). At the level of the Council of Europe: Convention of the Protection on Human Rights and Fundamental Freedoms (1950); European Social Charter (1996); Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data (1981); Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (1999); especially Additional Protocol on the Prohibition of Cloning Human Beings (1998); Additional Protocol concerning Biomedical Research (2005); Additional Protocol concerning Genetic Testing for Health Purposes (2008). At the level of the Parliamentary Assembly of the Council of Europe: Recommendation 934 on Genetic Engineering (1982); on the Preparation of a Convention on Bioethics (1991); on Biotechnology and Intellectual Property (1999); on Biotechnology (2000); on the Protection of the Human Genome (2001), on Nanotechnology: Balancing Benefits and Risks to Public Health and the Environment (2013). At the level of the Committee of Ministers of the Council of Europe: Recommendation on Regulations for Automated Medical Data Banks (1981); on Medical Research on Human Being (1990); on Prenatal Genetic Screening, Prenatal Genetic Diagnosis and Associated Genetic Counselling (1990); on Research on Biological Materials of Human Origin (2006). At the level of the European Union: Charter of Fundamental Rights of the European Union (2000). The work of discussion and production carried out by Committees of bioethics, along with the elaboration, interpretation and clarification of fundamental human rights, within the various international and national institutional settings, has contributed to entrenching some shared principles, such as: –– the primacy of the human being and his dignity over the sole interest of science or society; the respect for physical and psychological integrity (safety, wellbeing); the ban on exploitation and commercialization of the human body, manipulation or arbitrary use of the body and its parts (cells, tissues); the ban on physical and psychological invasiveness (i.e. using devices, experimental treatments), arbitrary and non-therapeutic eugenic selection; –– beneficence and non-maleficence: maximizing objective benefits and minimizing potential physical, psychological and social harm, applying the principle of appropriateness/proportionality (the risks should not be disproportionate to the potential benefits), from the perspective of a comparative risk/benefit assessment for the protection of the subject’s wellbeing and physical, social and mental health; –– the protection of freedom, in both the sense of autonomy and responsibility (counselling and informed consent to medical treatment), especially with regard to those who are facing inability or particularly vulnerable conditions (children,

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mentally incompetent individuals, the elderly, pregnant women or of childbearing age, prisoners, military, poor); –– justice or guaranteeing equal treatment for all, equity of access to healthcare, equality, non-discrimination and solidarity; –– precaution, caution and prudence, in the face of uncertain or risky technologies, which are likely to cause serious and irreversible damage to human beings, humanity, the environment, and future generations. These shared values and principles do not give a clarified solution of each ethical problem. Some ambiguities and conflicts persist, particularly in the context of sensitive and controversial issues. We need to clarify, theoretically and practically, whether dignity should be viewed as absolute (always and unconditionally) or relative (varying according to circumstances); if the proportionality/disproportionality of interventions should be defined on the basis of objective and/or subjective standards; if autonomy should be interpreted either in the sense of self-determination and self-reference or in relation to responsibility towards oneself and/or others; if justice is to be understood in liberal-individualistic or constitutively social-­ solidaristic terms. The Committees also display openness to society, by means of an adequate dissemination of information, while, at the same time, undertaking consultation and monitoring expectations, as well as emerging concerns. Today, the role of ‘active citizenship’ is growing in importance, along with the need to build (institutional and diverse) platforms for dialogue and an interdisciplinary approach to pluralist discussion, which enable dynamic updating and active interaction between experts of new technologies and citizens. Interaction aims to adequately inform and educate the citizens (the so called ‘technological and scientific literacy’), alongside trying, on one hand, to prevent an irrational fear of novelty in science and, on the other hand, a blind trust as both attitudes are emotional, uncritical, non-reflective and inadequately justified. The goal focuses on raising social awareness, while enabling citizens to develop a critical awareness, in order to ensure their participation and active involvement in ethical reflections on tecno-scientific development, drawing up biolaws and policy-­ making decisions. Briefly: The aim of the Committee’s discussions is to contribute towards giving the conceptual instruments to those in governments and to society, in a broad sense, so as to understand the often complex, dynamic, changeable issues and their importance and urgency, envisaging the possible scenarios and lines of action in social policies to be undertaken at public level. These lines of action should attempt, through the search for an ethical balance, to reconcile the needs of science and technology to progress with the protection of human beings, health, environment, avoiding the shifts to a radical techno-scientism or just as radical obscurantism (anti-technoscientism).

5.3  A New Regulatory Approach Facing Emerging Technologies

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5.3  A  New Regulatory Approach Facing Emerging Technologies In these last years, the need to accelerate the regulatory process has led to formal legislation increasingly pushing towards new models of biolaw and biopolitcs. European institutions started to introduce new forms of normativity, a new model of ‘soft law’ or ‘non-legally binding’ instruments. On the one hand, reference on existing legislation ensures continuity and guarantees the control of techno-­scientific developments; on the other, experimentation with new normative tools implements previous norms and allows to keep up with, and possibly to anticipate, the pace of innovation in techno-science. Soft laws represent a way to produce normativity quickly without going through the length of the traditional legislative process.4 The regulation of the new emerging technologies, characterized by speed of development, uncertainties and unpredictability, is based on some criteria: anticipation, proactive imagination and identification of the potential scenario, possible or probable negative features and outcomes of new technologies (through the interdisciplinary and pluralistic discussion of Committees of experts); analogical reasoning, namely ruling the new on the basis of its similarities to the past; flexible and easily modifiable normativity, as codes of conducts, or elaboration of integrations and provisional updating of existing regulation. The process begins with the effort of building and envisaging scenarios to anticipate hypothetical unknown future outcomes, while assuming that existing legislation in “similar” fields can be extensively or analogically applied to new technologies, ensuring a process of flexible modification. This new kind of governance is oriented towards soft instruments, more easily allowing changes, adaptations and reviewing, and does not require setting up a formally complete and timely regulatory framework, which may or may not eventually take place. The inefficiencies of the law, constantly chronologically “lagging behind” (the so called ‘law lag’) techno-scientific innovation and giving space to diversification due to pluralistic ethical approach, is changed by the methodology of anticipation that requires not only accelerating the pace of normativity but even being ahead of its objects. The biopolitical choice to soften the regulation, instead of regulating (interventionist model) and non-regulating or deregulating (abstentionist model), allows maintaining and conveying a sense of legitimacy and control through normativity without actually formally exercising it. Within this context of soft normative guidance as a constituent of the new European regulatory process facing new emerging technologies, ethics as a ‘soft normativity’ plays the role of ‘co-productionist understanding’ of social and technological change. The rise of ethics as a tool for governance acquires a special meaning. Ethics has progressively become an ‘institutional practice’ within the field of health but also ‘beyond’ health in the techno-scientific domain. The main  Ruggiu (2018) and Casonato (2017).

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expression of ‘institutionalized moral reasoning’ consists in ethics Committees, established to produce policy opinions on the ethical aspects of new technologies (often meant also to include legal and social implications). The European Group on Ethics in Science and New Technologies may be one example of expert committee, whose role is strictly connected with the EU deliberative process. Whenever directives touch upon values, the opinion of the EGE has to be taken into account and mentioned. As EU law making process is complicated and slow, this approach brings dynamism, envisaged as a way to respond to the ­accelerating pace of development in the relationship between science, technology and the key values of society. Opinions of expert Bodies (as national and international Committees) outlines the “timely manner” in which ethics advice should respond to more rapid, complex and unpredictable science and technology developments. In this sense, also ethics opinions are imitating legislative documents.5

References Andorno, R. (2009). Human dignity and human rights as a common ground for a global bioethics. Journal of Medicine and Philosophy, 34, 223–240. Andorno, R. (2013). Principles of international biolaw: Seeking common ground at the intersection of bioethics and human rights. Geneva: Bruylant. Barilan, Y.  M. (2012). Human dignity, human rights, and responsibility: The new language of global bioethics and biolaw. New York: The MIT Press. Beyleveld, D., & Brownsword, R. (2002). Human dignity in bioethics and biolaw. Oxford: Oxford University Press. Casonato, C. (2017). 21st Century biolaw: A proposal. Biolaw Journal, 1, 81–95. Palazzani, L. (2018). Bioethics and biolaw: From theory to practice. Torino: Giappichelli. Ruggiu, D. (2018). Human rights and emerging technologies. Analysis and perspective in Europe. Singapore: Pan Stanford Publishing. van Beers, B., Corrias, L., & Werner, W. G. (Eds.). (2014). Humanity across international law and biolaw. Cambridge: Cambridge University Press.

 See the often long “descriptive” preambles of “Having regard to” and “Whereas”.

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