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Doctors Playing Gods? The Legal Challenges in Regulating the Experimental Stage of Cybernetic Human Enhancement

Published online by Cambridge University Press:  20 April 2021

Thibault Moulin
Thibault Moulin*
Affiliation:
Dr Thibault Moulin is a Lecturer at the Catholic University of Lyon, France; tmoulin@univ-catholyon.fr.
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Abstract

The emergence of new technologies might challenge our assumptions about biomedical research: medical progress may not only cure but enhance human capacities. In particular, the emergence of brain-machine interfaces will admittedly allow disabled people to move or communicate again, but also has various military applications, such as remote control of drones and avatars. Although there is no express legal framework pertaining to the experimental phase of human enhancement techniques, they are actually constrained by international law. According to international humanitarian law, civilians and prisoners of war may be subjected to experiments only when required by their state of health or for medical treatment. According to international human rights law, experimentations are permissible when they meet two conditions: (i) free consent, and (ii) proportionality (that is, the adequacy of risk and benefit). In light of these conditions, this article assesses the situations in which experimentation involving brain-computer interfaces would be lawful. It also gives specific attention to those experimentations carried out on members of the armed forces. In fact, owing to the military hierarchy and the unique nature of its mission (to protect national security at the risk of their own lives), it is necessary to determine how the military may comply with this legal framework.

Keywords

human enhancementhuman experimentationbrain-computer interfacesinternational human rights lawinternational humanitarian law

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Articles
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Israel Law Review , Volume 54 , Issue 2 , July 2021 , pp. 236 - 262
Copyright
Copyright © The Author(s), 2021. Published by Cambridge University Press in association with the Faculty of Law, the Hebrew University of Jerusalem

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Footnotes

This article was written in the framework of a research fellowship at the Federmann Cyber Security Center of the Hebrew University of Jerusalem. The author would like to thank Professor Noam Lubell (University of Essex), Professor Yuval Shany (Hebrew University of Jerusalem), and Professor Yaël Ronen (Academic Center for Science and Law at Hod Hasharon), as well as the anonymous reviewers and the editorial staff, for their assistance and comments. Responsibility for any mistakes is that of the author.

†

The online version of this article has been updated since original publication. A notice detailing the changes has also been published.

References

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2 ibid.

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4 Jacques J Vidal, ‘Toward Direct Brain-Computer Communication’ (1973) 2 Annual Review of Biophysics 157, 157. See also Hakim Si-Mohammed and others, ‘Defining Brain-Computer Interfaces: A Human-Computer Interaction Perspective’, HAL, September 2019, 1, https://hal.inria.fr/hal-02163771/document.

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8 Comité d’Éthique pour la Défense (France), ‘Avis portant sur le soldat augmenté’, 18 September 2020, 3, https://www.defense.gouv.fr/content/download/601120/10129553/20200918_Comité%20d%27éthique%20de%20la%20défense_Avis%20portant%20sur%20le%20soldat%20augmenté.pdf. See also Ministry of Defence (MoD) (UK), ‘Human Factors Integration for Defence Systems’, October 2015, JSP 912, Pt 2, para 80, https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/483177/20151030-JSP_912_Part_2_DRU_version_Final-U.pdf; State Council (China), ‘State Council Notice on the Issuance of the Next Generation Artificial Intelligence Development Plan’, 8 July 2017, https://chinacopyrightandmedia.wordpress.com/2017/07/20/a-next-generation-artificial-intelligence-development-plan (translation by Graham Webster and others); Kania, Elsa B, ‘Minds at War: China's Pursuit of Military Advantage through Cognitive Science and Biotechnology’ (2020) 8(3) Prism 83Google Scholar.

9 ‘Telepresence’ consists of ‘allowing a human operator to have an at-a-distance presence in a remote environment via a brain-actuated robot’: Gareth Evans, ‘Brain Computer Interfacing: A Big Step towards Military Mind-Control’, Army Technology, 16 July 2013, https://www.army-technology.com/features/featurebrain-computer-interfacing-military-mind-control.

10 Department of Defense (US), ‘Fiscal Year (FY) 2013 President's Budget Submission’, 2012, Vol 1–123, https://www.darpa.mil/attachments/(2G4)%20Global%20Nav%20-%20About%20Us%20-%20Budget%20-%20Budget%20Entries%20-%20FY2013%20(Approved).pdf.

11 DARPA, ‘Six Paths to the Nonsurgical Future of Brain-Machine Interfaces’, 20 May 2019, https://www.darpa.mil/news-events/2019-05-20.

12 For instance, the CT2WS system is currently developed by DARPA, and the basic idea was that ‘[e]ven though a person may not be consciously aware of movement or of unexpected appearance, the brain detects it and triggers the P-300 brainwave, a brain signal that is thought to be involved in stimulus evaluation or categorization’; see Katie Drummond, ‘Military's “Luke Skywalker” Binoculars Use Brain Waves to Spot Threats’, Forbes, 18 September 2012, https://www.forbes.com/sites/katiedrummond/2012/09/18/darpa-threat-recognition/#7a1dbd921272.

13 Juengst, Eric, ‘What Does Enhancement Mean?’ in Parens, Erik (ed), Enhancing Human Traits: Ethics and Social Implications (Georgetown University Press 2000) 29, 29Google Scholar. See also Clarke, Steve, ‘Cognitive Bias and Collective Enhancement’ in Savulescu, Julian, ter Meulen, Ruud and Kahane, Guy (eds), Enhancing Human Capacities (Wiley-Blackwell 2011) 127, 128Google Scholar. This aspect is sometimes subject to criticism: experts underline that notions such as ‘disease’, ‘treatment’ and ‘medicine’ are difficult to define; see, inter alia, Peter J Whitehouse and others, ‘Enhancing Cognition in the Intellectually Intact’ (1997) 27 The Hastings Center Report 14, 17; Gert, Bernard, Culver, Charles M and Clouser, K Danner, Bioethics: A Systematic Approach (Oxford University Press 2006) 161–63CrossRefGoogle Scholar; Peterson, Daniel R, ‘Policing Future Nontherapeutic Application of Genetic Enhancement through International Agreement’ (2008) 30 Houston Journal of International Law 743, 752Google Scholar. The specific challenges raised by cosmetic surgery, vaccination and mood enhancers are often highlighted in this connection; see McKeown, Alex, ‘Enhancement and Therapy: Is It Possible to Draw a Line?’ in ter Meulen, Ruud, Mohamed, Ahmed D and Hall, Wayne (eds), Rethinking Cognitive Enhancement (Oxford University Press 2017) 193, 197–99Google Scholar. In the views of the French ethical committee for defence, reparations with a medical purpose are not considered as enhancement: Comité d’Éthique pour la Défense (France) (n 8) 4.

14 Daniels, Norman, ‘The Genome Project, Individual Differences, and Just Health Care’ in Murphy, Timothy F and Lappé, Marc A (eds), Justice and the Human Genome Project (University of California Press 1994) 110, 122Google Scholar. Yet, experts have noted the difficulties in defining what is normal for a species and how persons with specific gifts should be treated: Eric Juengst and Daniel Moseley, ‘Human Enhancement’, Stanford Encyclopedia of Philosophy, 15 May 2019, https://plato.stanford.edu/entries/enhancement.

15 Charles Fried, ‘Introduction: The Need for a Philosophical Anthropology’ (1973) 48 Indiana Law Journal 527, 530.

16 The President's Council on Bioethics (US), ‘Beyond Therapy: Biotechnology and the Pursuit of Happiness’, October 2003, https://biotech.law.lsu.edu/research/pbc/reports/beyondtherapy/beyond_therapy_final_report_pcbe.pdf; Arnold Sauter and Katrin Gerlinger, ‘Pharmakologische Interventionen zur Leistungssteigerung als gesellschaftliche Herausforderung’, April 2011, https://www.tab-beim-bundestag.de/de/pdf/publikationen/berichte/TAB-Arbeitsbericht-ab143.pdf; Académies suisses des sciences (Switzerland), Une médecine pour les personnes en bonne santé? Analyses et recommandations concernant le human enhancement (2012), http://www.samw.ch/dam/jcr:ef05a27c-d47e-4890-8394-ed6774fa1912/rapport_assm_human_enhancement_2012.pdf.

17 European Parliament, ‘Human Enhancement’, 15 May 2009, IP/A/STOA/FWC/2005-28/SC35, https://www.europarl.europa.eu/RegData/etudes/etudes/join/2009/417483/IPOL-JOIN_ET(2009)417483_EN.pdf; European Parliament Resolution of 24 April 2009 on Regulatory Aspects of Nanomaterials (2008/2208(INI)), https://www.europarl.europa.eu/sides/getDoc.do?type=TA&reference=P6-TA-2009-0328&language=EN.

18 Dinniss, Heather A Harrison and Kleffner, Jann K, ‘Soldier 2.0: Military Human Enhancement and International Law’ (2016) 92 International Law Studies 432Google Scholar; Liivoja, Rain and Chircop, Luke, ‘Are Enhanced Warfighters Weapons, Means, or Methods of Warfare?’ (2018) 94 International Law Studies 161Google Scholar; Noll, Gregor, ‘Weaponising Neurotechnology: International Humanitarian Law and the Loss of Language’ (2014) 2 London Review of International Law 201CrossRefGoogle Scholar.

19 It is arguable, then, that performing refractive surgery on someone who has perfect eyesight would be tantamount to enhancement.

20 Psychostimulants, such as Ritalin, have long been used to promote wakefulness among the armed forces; see, for instance, Annas, Catherine L and Annas, George J, ‘Enhancing the Fighting Force: Medical Research on American Soldiers’ (2009) 25 Journal of Contemporary Health and Policy 283Google ScholarPubMed; Imogen Goold, ‘The Legal Aspects of Cognitive Enhancement’ in Ter Meulen, Mohamed and Hall (n 13) 250.

21 Hildt, Elisabeth, ‘Brain-Computer Interaction and Medical Access to the Brain: Individual, Social and Ethical Implications’ (2010) 4 Studies in Ethics, Law, and Technology 1, 6Google Scholar.

22 Abhang, Priyanka A, Gawali, Bharti W and Mehrotra, Suresh C, Introduction to EEG- and Speech-Based Emotion Recognition (Elsevier 2016) 169Google Scholar.

23 Hildt (n 21) 2.

24 Abhang, Gawali and Mehrotra (n 22) 167.

25 ibid 168.

26 Trials of War Criminals before the Nuremberg Military Tribunals, Vol II, United States of America v Brandt and Others, Judgment, 20 August 1947, 175–78.

27 Ministry of Health (Argentina), ‘Guia para Investigaciones en Salud Humana’, 2011, 14, https://salud.misiones.gob.ar/wp-content/uploads/2017/07/Guia-inv-Salud-Humana.pdf; National Health and Medical Research Council (Australia), ‘National Statement on Ethical Conduct in Human Research’, 2018, 10, https://nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018; Loi relative aux expérimentations sur la personne humaine (Belgium), art 5(1); Code de la Santé Publique (France), arts L1121-2, L1121-3; Federal Ministry of Health (Nigeria), National Code of Health Research Ethics, August 2007, s F(a), http://www.nhrec.net/nhrec/NCHRE_Aug%2007.pdf; Law 14/2007, of 3 July, on Biomedical Research, 2007 (Spain), art 10(2); Loi fédérale relative à la recherche sur l’être humain, 2011 (Switzerland), art 10; National Health Research Act 2013 (Zambia), ss 45(3)(a)–(b).

28 Argentina (n 27) 14; Belgium (n 27) art 5(3); Act on Scientific Research in the Health Sector, 2014 (Iceland), art 15; Spain (n 27) art 14(1); Switzerland (n 27) art 11.

29 Belgium (n 27) art 5(5); Medical Research Act, 2004 (Finland), s 4; France (n 27) art L1121-2; Iceland (n 28) art 4; Spain (n 27) art 2(b); Ethical Review Act, 2003 (Sweden), para 8; Switzerland (n 27) art 4.

30 Argentina (n 27) 14; Belgium (n 27) art 2(17); Finland (n 29) s 2(4); France (n 27) art L1121-3; Sweden (n 29) para 11; Switzerland (n 27) art 10(1)(d).

31 ‘Permissible Medical Experiments’ in Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol 2 (US Government Printing Office 1949) 181–82 (Nuremberg Code) principles 2, 4, 8.

32 Argentina (n 27) 16; Belgium (n 27) art 10; Ley Sobre la Investigacion Cientifica en el Ser Humano, Su Genoma, y Prohibe la Clonacion Humana, 2006 (Chile), art 10; Canadian Institutes of Health Research, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (2014) (TCPS2) (Canada), art 2.1, https://www.cmcc.ca/Tri-Council%20Policy%20Statement.pdf; Ley Reguladora de Investigación Biomédica, 2014 (Costa Rica), art 55; France (n 27) art L1121-4; Iceland (n 28) art 12; Nigeria (n 27) s (E)(d)(1); Human Biomedical Research Act, 2015 (Singapore), Pt 4, s 17(1)(a); Spain (n 27) art 2(e); Sweden (n 29) para 6; Switzerland (n 27) art 45(1)(a); Zambia (n 27) s 17; Finland (n 29) s 3; German Medical Assembly, (Model) Professional Code for Physicians in Germany, 1997, revised 2011 (Germany), art 15(1), English translation at: https://www.bundesaerztekammer.de/fileadmin/user_upload/downloads/MBOen2012.pdf. It may also be limited to research involving more than low risk or vulnerable persons: Australia (n 27) 84; 45 CFR 46.103.

33 World Medical Association (WMA), Declaration of Helsinki (DoH), adopted in 1964, revised version of 1975, para 2, https://www.wma.net/wp-content/uploads/2018/07/DoH-Oct1975.pdf. This requirement is still valid in the current version of the DoH: WMA, ‘Declaration of Helsinki’, adopted in 1964, revised version of 2013, para 23, https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects. The DoH was developed by the WMA. It contains several ethical principles for medical research and has been described as ‘the cornerstone of research ethics’: Bošnjak, Snežana, ‘The Declaration of Helsinki – The Cornerstone of Research Ethics’ (2001) 9 Archive of Oncology 179Google Scholar. It must be noted that during the drafting process of the ICCPR (n 53 below) ‘[a] Yugoslav motion that would have required the approval of a higher medical institution was not accepted’: Schabas, William A, Nowak's CCPR Commentary: U.N. International Covenant on Civil and Political Rights (3rd edn, NP Engel 2019) 214Google Scholar.

34 The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (US), ‘The Belmont Report – Ethical Principles and Guidelines for the Protection of Human Subjects of Research’, 18 April 1979, https://www.hhs.gov/ohrp/sites/default/files/the-belmont-report-508c_FINAL.pdf.

35 Nuremberg Code (n 31) principle 1.

36 ibid principle 6.

37 Canada (n 32) 3; Australia (n 27) 6; 45 CFR 46.101 (US); 10 USCS § 980 (US).

38 NHA, 2004 (South Africa), para 72.

39 It is quite clear, however, that neither the Biological Weapons Convention (BWC) nor the Chemical Weapons Convention (CWC) have anything to say about BCIs. According to art 1 BWC, ‘[e]ach State Party to this Convention undertakes never in any circumstances to develop, produce, stockpile or otherwise acquire or retain: (1) microbial or other biological agents, or toxins whatever their origin or method of production, of types and in quantities that have no justification for prophylactic, protective or other peaceful purposes; (2) weapons, equipment or means of delivery designed to use such agents or toxins for hostile purposes or in armed conflict’. According to art I CWC, ‘[e]ach State Party to this Convention undertakes never under any circumstances: (a) To develop, produce, otherwise acquire, stockpile or retain chemical weapons, or transfer, directly or indirectly, chemical weapons to anyone; (b) To use chemical weapons; (c) To engage in any military preparations to use chemical weapons; (d) To assist, encourage or induce, in any way, anyone to engage in any activity prohibited to a State Party under this Convention’. According to art II CWC, ‘Chemical Weapons means the following, together or separately: (a) Toxic chemicals and their precursors, except where intended for purposes not prohibited under this Convention, as long as the types and quantities are consistent with such purposes; (b) Munitions and devices, specifically designed to cause death or other harm through the toxic properties of those toxic chemicals specified in subparagraph (a), which would be released as a result of the employment of such munitions and devices; (c) Any equipment specifically designed for use directly in connection with the employment of munitions and devices specified in subparagraph (b)’. It is thus obvious that BCIs cannot be viewed as bacteriological or chemical weapons, and thus remain out of the scope of the BWC and the CWC. See also Pinson, Robert D, ‘Is Nanotechnology Prohibited by the Biological and Chemical Weapons Conventions?’ (2004) 22 Berkeley Journal of International Law 279, 299Google Scholar; Wynn, Lara, ‘The Non-Fiction of Captain America: A Legal Analysis of the Potential and Perils of Genetic Engineering in Modern Warfare’ (2014) 5 Journal of Biosecurity, Biosafety and Biodefense Law 109, 122CrossRefGoogle Scholar; Patrick Lin, Maxwell J Mehlman and Keith Abney, ‘Enhanced Warfighters: Risk, Ethics, and Policy’, 1 January 2013, 31–2, http://ethics.calpoly.edu/Greenwall_report.pdf. As to the contribution of art 36 of the First Additional Protocol to the Geneva Conventions of 1949 (AP I) (n 45 below), I had the opportunity to study its contribution elsewhere: Moulin, Thibault, ‘No More Humans? Cybernetically-Enhanced Soldiers under the Legal Review of Article 36’ (2021) 8(2) Journal of Law and Cyber Warfare (forthcoming)Google Scholar.

40 Geneva Convention (III) relative to the Treatment of Prisoners of War (entered into force 21 October 1950) 75 UNTS 135 (GC III), art 13.

41 ibid.

42 ‘Protected persons’ are those who ‘find themselves, in case of a conflict or occupation, in the hands of a Party to the conflict or Occupying Power of which they are not nationals’: Geneva Convention (IV) relative to the Protection of Civilian Persons in Time of War (entered into force 21 October 1950) 75 UNTS 287 (GC IV), art 4.

43 ibid art 32.

44 GC III (n 40) arts 129–130; GC IV (n 42) arts 146–147.

45 Protocol Additional to the Geneva Conventions of 12 August 1949, and relating to the Protection of Victims of International Armed Conflicts (entered into force 7 December 1978) 1125 UNTS 3 (AP I), art 11(1).

46 ibid.

47 ibid. This article also mentions that experimentations must comply ‘with generally accepted medical standards which would be applied under similar medical circumstances to persons who are nationals of the Party conducting the procedure and who are in no way deprived of liberty’.

48 ibid art 11(2)(a)–(c).

49 Protocol Additional to the Geneva Conventions of 12 August 1949, and relating to the Protection of Victims of Non-International Armed Conflicts (entered into force 7 December 1978) 1125 UNTS 609 (AP II), art 5(2)(e).

50 MoD (UK), ‘The Joint Service Manual of the Law of Armed Conflict’, 2004, JSP 383, para 7.5.1, https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/27874/JSP3832004Edition.pdf.

51 Office of General Counsel, Department of Defense, Law of War Manual, 2016, para 7.5, https://dod.defense.gov/Portals/1/Documents/pubs/DoD%20Law%20of%20War%20Manual%20-%20June%202015%20Updated%20Dec%202016.pdf?ver=2016-12-13-172036-190. In fact, most war manuals and national acts of application are of little help, as they merely repeat the provisions of Geneva law, without adding much substance: Australian Defence Forces, ‘Law of Armed Conflict’, 2006, ADDP 06.4, paras 9.58, 9.95, 10.20, 12.37, 13.25; Office of the Judge Advocate General (Canada), ‘Law of Armed Conflict’ 2001, B-GJ-005-104/FP-021, paras 907, 909, 1121, 1607, 1608; MoD (France), ‘Manuel du droit des conflits armés’, 2012, 37, 73; MoD (Germany), ‘Law of Armed Conflict – Manual’, 2013, ZDv 15/2, paras 596, 606, 804, 1516; MoD (Mexico), ‘Manual de Derecho International Humanitario para el Ejercirto y F.A.M.’, 2009, 52; Dahir portant approbation du règlement de discipline générale des Forces armées royales, 1974 (Morocco), art 25; Prevention and Prohibition of Torture Act, 2012 (Uganda), s II(5).

52 The International Committee of the Red Cross (ICRC) highlighted in 1987 that they had ‘not been assembled in a universally adopted international instrument’. It nevertheless found it possible ‘to mention certain instruments which give some indications of this matter’, and referred to instruments ‘adopted by the World Medical Association’: the Declaration of Geneva, the International Code of Medical Ethics, the Rules of Medical Ethics in Time of War, the Rules to ensure Aid and Care for the Wounded and Sick, particularly in Time of Armed Conflict; see ICRC, Commentary of the Additional Protocols of 8 June 1977 to the Geneva Conventions of 12 August 1949 (Martinus Nijhoff 1987) 155.

53 International Covenant on Civil and Political Rights (entered into force 23 March 1976) 999 UNTS 171 (ICCPR), art 7.

54 Schabas (n 33) 216.

55 UN HRC, General Comment No 20: Article 7 (Prohibition of Torture, or Other Cruel, Inhuman or Degrading Treatment or Punishment (10 March 1992), para 7.

56 UN HRC, Concluding Observations on the United States (18 December 2006), UN Doc CCPR/C/USA/CO/3/Rev.1, para 31.

57 European Commission of Human Rights, X v Denmark, App no 9974/82, 2 March 1983, 4. For other cases related to hazardous experiments see ECtHR, LCB v UK, App no 23413/94, 9 June 1998; ECtHR, Roche v UK, App no 32555/96, 19 October 2005.

58 European Convention for the Protection of Human Rights and Fundamental Freedoms (entered into force 3 September 1953) 213 UNTS 221 (ECHR).

59 ECtHR, Herczegfalvy v Austria, App no 10533/83, 24 September 1992, para 82.

60 ECtHR, Bataliny v Russia, App no 10060/07, 23 July 2015, para 87.

61 ECtHR, VC v Slovakia, App no 18968/07, 8 November 2011, paras 107–19. The ECtHR also had the opportunity to determine how persons who lack capacity to give free consent should be treated. For instance, breaches of art 8 ECHR were found when medical procedures were carried out on children in spite of their parents’ objections: ECtHR, Glass v UK, App no 61827/00, 9 March 2004, paras 61–83; ECtHR, MAK and RK v UK, App nos 45901/05 and 40146/06, 23 March 2010. A breach of art 2 ECHR was found when a patient whose ‘mental soundness had been called into question’ refused to undergo medical treatment as, according to the Court, the patient's ‘decision-making capacity’ and ‘capacity to understand’ should have been assessed by the doctors: ECtHR, Arskaya v Ukraine, App no 45076/05, 5 December 2013, paras 69–70. A violation of art 3 ECHR was found when an underage woman underwent a sterilisation which ‘was not a life-saving intervention’, as ‘neither the applicant's nor her legal guardians’ informed consent had been obtained prior to it’. The Court ruled that ‘[t]he procedure was therefore incompatible with the requirement of respect for her human freedom and dignity’: ECtHR, Case of IG and Others v Slovakia, App no 15966/04, 13 November 2012, para 122.

62 Council of Europe, 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 (entered into force 1 December 1999) CETS 164 (Oviedo Convention), art 5.

63 Council of Europe, ‘Accession by States which are not Member States of the Council of Europe and which Have Not Participated in the Elaboration of the Convention’, November 2018, https://rm.coe.int/16808ff399.

64 Argentina (n 27) 18; Australia (n 27) 16–17; Belgium (n 27) art 6(1); Canada (n 32) art 3.1; Costa Rica (n 32) art 9; Finland (n 29) s 6; France (n 27) art L1122-1-1; Iceland (n 28) art 18; Nigeria (n 27) s F(g); Singapore (n 32) s 6; South Africa (n 38) s 71(1)(b); Spain (n 27) arts 3(f), 4, 13; Sweden (n 29) para 17; Switzerland (n 27) arts 7(1), 16; US, 45 CFR 46.116–17; Zambia (n 27) s 45(1)(b). It may be noted that consent in writing was always required by the DoH.

65 White v Paulsen, 997 F. Supp. 1380, 1998 US Dist.

66 In re Cincinnati Radiation Litigation, 874 F. Supp 796, 1995 US Dist.

67 Abdullahi v Pfizer, Inc., 562 F.3d 163 2009 US App.

68 Nuremberg Code (n 31) principle 9.

69 Oviedo Convention (n 62) art 5.

70 Australia (n 27) 17; Belgium (n 27) art 6(3); Canada) (n 32) art 3.1(b); Chile (n 32) art 11; Finland (n 29) s 6; France (n 27) art L1122-1; Iceland (n 28) arts 18, 21; Nigeria (n 27) s F(g); Singapore (n 32) s 14(1); Spain (n 27) art 4(3); Switzerland (n 27) art 7(2); US, 45 CFR 46.116 a(8).

71 It may be noted that the DoH includes a risk/benefit balance, and considers that the ‘primary purpose’ of human experimentation is to study ‘diseases’, and to ‘improve preventive, diagnostic and therapeutic interventions’: DoH (n 33) paras 6, 16–18.

72 UN General Assembly, Report of the Third Committee (9 December 1958), UN Doc A/4045, 5–6.

73 Dinstein, Yoram, ‘The Right to Life, Physical Integrity, and Liberty’ in Henkin, Louis (ed), The International Bill of Rights: The Covenant on Civil and Political Rights (Columbia University Press 1981) 114, 125Google Scholar.

74 Manfred Nowak, UN Covenant on Civil and Political Rights: CCPR Commentary (2nd edn, NP Engel 2005) 191. See also Schabas (n 33) 215.

75 UN HRC, Third Periodic Report, The Netherlands (25 August 2000), UN Doc CCPR/C/NET/99/3, Annex.

76 UN HRC, Concluding Observations of the Human Rights Committee: Netherlands (27 August 2001), UN Doc CCPR/CO/72/NET, para 7.

77 ibid.

78 ibid.

79 Spain (n 27) art 14(3); Switzerland (n 27) art 12(1).

80 Nigeria (n 27) s F(d)(5).

81 UN HRC, Fourth Periodic Report, The Netherlands (2007), UN Doc CCPR/C/NLD/4, para 73.

82 ibid. The English version of the fourth periodic report was not available when this article was drafted. The French version reads as follows: ‘il existe des situations où d’éventuels dommages durables, causés par la recherche médicale, par exemple sur des malades atteints d'une maladie mortelle, peuvent être justifiés.

83 UN HRC, Concluding Observations of the Human Rights Committee: Netherlands (25 August 2009), UN Doc CCPR/C/NLD/CO/4.

84 UN HRC, Third Periodic Report, The Netherlands (n 75) 60. The Netherlands explained in the third periodic report that the authorisation of ‘non-therapeutic medical research which is of great importance to the advance of medical care for minors and incapacitated adults’ complied with the objects and purpose of the ICCPR: ibid 11.

85 ibid 60.

86 UN HRC, Concluding Observations: Netherlands (2001) (n 76) para 7.

87 UN HRC, Concluding Observations: Netherlands (2009) (n 83) para 8.

88 UN HRC, Fifth Periodic Report submitted by The Netherlands (8 November 2018), UN Doc CCPR/C/NLD/5, 34. Similar requirements were adopted by Argentina: Argentina (n 27) 17. The legislation of many states authorises research on minors and incapacitated persons in two scenarios: (i) when a direct benefit for the subject is expected; (ii) when the research may benefit persons in the same category as the participant and involves only minimal risk for the participant: see Canada (n 32) art 4.6; Finland (n 29) ss 7–8; France (n 27) arts L1121-7, L1121-8; Iceland (n 28) art 23; Spain (n 27) art 20; Switzerland (n 27) arts 22–24. In some states, however, experimentation on these subjects is permissible when their participation is indispensable, and when the purpose of such research is to improve the health or welfare of the group to which the participant belongs: Australia (n 27) 66; Belgium (n 27) arts 7–8 (the risk must still be proportional to the expected benefit for the subject); South Africa (n 38) ss 71(2)–(3); Zambia (n 27) ss 45(4)–(5) (provided that the experimentation does not ‘pose a significant risk to the health of the minor’ and the ‘potential benefit of the health research or experimentation does not significantly outweigh’ the potential risk). In Singapore, experimentation on these subjects is lawful when ‘there are reasonable grounds for believing that biomedical research of comparable effectiveness cannot be carried out without the participation of [this] class’: Singapore (n 32) ss 7–8. In the US, research on children that involves greater than minimal risk and without any expected direct benefit may be lawful if the Institutional Review Board finds that ‘the risk represents a minor increase over minimal risk’, ‘the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations’, ‘the intervention or procedure is likely to yield generalizable knowledge about the subjects’ disorder or condition which is of vital importance for the understanding or amelioration of the subjects’ disorder or condition’: US, 45 CFR 46.406. It must be mentioned that most of these criteria appeared in the DoH, as provisions pertaining to ‘a potential research subject who is incapable of giving informed consent’ were included in 2000. According to the DoH, ‘[t]hese individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the group represented by the potential subject’, if ‘the research cannot instead be performed with persons capable of providing informed consent’, and if ‘the research entails only minimal risk and minimal burden’: DoH (n 33) para 28. A reference to the existence of vulnerable populations appeared in the DoH in 2000: DOH, ibid (revised in 2000), para 8.

89 As underlined by the periodic report itself, the WMO is guided by 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, [2014] OJ L 158/1: UN HRC, Fifth Periodic Report, The Netherlands (n 88) paras 9–12.

90 Medical Scientific Research with Humans Act (WMO), art 3(1)(d).

91 UN HRC, Concluding Observations on the Fifth Periodic Report of the Netherlands (22 August 2019), UN Doc CCPR/C/NLD/CO/5.

92 Specific forms of protection are in place for further categories of persons in several states. For pregnant women (with sometimes nursing mothers, embryos and foetuses) see Australia (n 27) 61–64; Costa Rica (n 32) art 68; France (n 27) art L1121-5; Finland (n 29) s 9; Department of Health (South Africa), ‘Ethics in Health Research: Principles, Processes and Structures’, 1 March 2015, 35, https://www.sun.ac.za/english/research-innovation/Research-Development/Documents/Integrity%20and%20Ethics/DoH%202015%20Ethics%20in%20Health%20Research%20-%20Principles,%20Processes%20and%20Structures%202nd%20Ed.pdf; Spain (n 27) art 19; Switzerland) (n 27) art 26 (for pregnant women, embryos and foetuses in vivo); US, 45 CFR 46.204 (for pregnant women and foetuses) and 45 CFR 46.205(b)(1)(i) (for ‘neonates of uncertain viability’); Zambia (n 27) s 45(7). For prisoners or persons placed in a mental health institution see Australia (n 27) 68; Costa Rica (n 32) arts 65(c), 67; Finland (n 29) s 10; France (n 27) art L1121-6; Department of Health (South Africa) (n 92) 39; US, 45 CFR 46.306; Zambia (n 27) s 45(7). For persons who, in a situation of emergency, are unable to give consent see Costa Rica (n 32) art 65(d); Iceland (n 28) art 24; Spain (n 27) art 21; Switzerland (n 27) art 30. For persons depending on medical care see Australia (n 27) 70–72; Costa Rica (n 32) art 65(a), (e); Department of Health (South Africa) (n 92) 38. For persons in dependent relationships see Australia (n 27) 68–69; Department of Health (South Africa) (n 92) 38. For students see Australia (n 27) 68; Costa Rica (n 32) art 67; Department of Health (South Africa) (n 92) 38. For minorities or communities see Argentina (n 27) 14, 26; Australia (n 27) 77–79; Costa Rica (n 32) art 66. For persons involved in illegal activities see Australia (n 27) 75–76. For persons deprived of legal capacity see Iceland (n 28) art 23(d). For persons lacking resources and education see Argentina (n 27) 25. For severely ill persons see Costa Rica (n 32) art 65(f). Some states consider that hierarchy may also justify specific protection, in the case of workers in a hierarchical system, healthcare workers, or members of the armed forces: Zambia (n 27) s 45(7); Department of Health (South Africa) (n 92) 38; Australia (n 27) 68.

93 Abhang, Gawali and Mehrotra (n 22) 169.

94 Hildt (n 21) 2.

95 ‘BCI Post-Stroke Neurorehabilitation (BCI-Stroke)’, US National Library of Medicine, 2015, https://clinicaltrials.gov/ct2/show/NCT02404857; ‘Neurofeedback Rehabilitation Based on Motor Imaging in Patients in the Immobilization Phase (REMINARY)’, US National Library of Medicine, 2018, https://clinicaltrials.gov/ct2/show/NCT03545451; ‘Evaluation of Evoked Potentials Recording Modalities in Healthy Volunteer Population (3Electrods)’, US National Library of Medicine, 2012, https://clinicaltrials.gov/ct2/show/NCT01518426; ‘Tapfinger Psychomotor Target (TAPFINGER)’, US National Library of Medicine, 2015, https://clinicaltrials.gov/ct2/show/NCT02574026.

96 ‘The Effect of Neurofeedback on Eating Behaviour’, US National Library of Medicine, 2014, https://clinicaltrials.gov/ct2/show/NCT02148770.

97 ‘Brain-Computer Interface System for Training Memory and Attention in Elderly’, US National Library of Medicine, 2014, https://clinicaltrials.gov/ct2/show/NCT02228187; ‘Effectiveness of a Brain-Computer Interface Based System for Cognitive Enhancement in the Normal Elderly (3ECog)’, US National Library of Medicine, 2012, https://clinicaltrials.gov/ct2/show/NCT01661894.

98 ‘Stable and Independent Communication Brain-Computer Interfaces’, US National Library of Medicine, 2017, https://clinicaltrials.gov/ct2/show/NCT03213561.

99 ‘Sensorimotor Rhythm Brain-Computer Interface Switch to Operate Assistive Technology’, US National Library of Medicine, 2010, https://clinicaltrials.gov/ct2/show/NCT01117727; ‘Brain Computer Interfaces (Mu Rhythm Learning)’, US National Library of Medicine, 2013, https://clinicaltrials.gov/ct2/show/NCT02011399; ‘Sensorimotor Based Brain Computer Interface’, US National Library of Medicine, 2014, https://clinicaltrials.gov/ct2/show/NCT02169375; ‘P300 Brain Computer Interface Keyboard to Operate Assistive Technology’, US National Library of Medicine, 2009, https://clinicaltrials.gov/ct2/show/NCT00860951; ‘A P300 Brain Computer Interface to Operate Power Wheelchair Tilt’, US National Library of Medicine, 2010, https://clinicaltrials.gov/ct2/show/NCT01123148; ‘Non-Invasive Brain-Computer Interface for Virtual Object Control’, US National Library of Medicine, 2014, https://clinicaltrials.gov/ct2/show/NCT02071485; ‘EEG-Based Brain-Computer Interface Project for Individuals with Amyotrophic Lateral Sclerosis (ALS) (BCI)’, US National Library of Medicine, 2008, https://clinicaltrials.gov/ct2/show/NCT00718458; ‘Moving a Paralyzed Hand Through Use of a Brain-Computer Interface’, US National Library of Medicine, 2005, https://clinicaltrials.gov/ct2/show/NCT00242242; ‘Non-Invasive Brain Signal Training to Induce Motor Control Recovery after Stroke’, US National Library of Medicine, 2008, https://clinicaltrials.gov/ct2/show/NCT00746525; ‘Treatment of Chronic Stroke with IpsiHand’, US National Library of Medicine, 2015, https://clinicaltrials.gov/ct2/show/NCT02552368.

100 ‘Brain Machine Interface Control of an Robotic Exoskeleton in Training Upper Extremity Functions in Stroke’, US National Library of Medicine, 2013, https://clinicaltrials.gov/ct2/show/NCT01948739; ‘Feasibility of mindBEAGLE in Disorders of Consciousness or Locked-In Syndrome’, US National Library of Medicine, 2016, https://clinicaltrials.gov/ct2/show/NCT02772302; ‘Sensorimotor Rhythm Brain-Computer Interface Switch to Operate Assistive Technology’ (n 99); ‘Non-Invasive Brain Signal Training to Induce Motor Control Recovery after Stroke’ (n 99).

101 For instance, underage subjects were only solicited when the device was intended to treat or alleviate the consequences of attention deficit hyperactivity disorder (ADHD), autism spectrum disorder (ASD), locked-in state, spinal injuries, strokes or tetraplegia: ‘Brain-Computer Interface (BCI) Based Intervention for Attention Deficit Hyperactivity Disorder (ADHD)’, US National Library of Medicine, 2011, https://clinicaltrials.gov/ct2/show/NCT01344044; ‘Neurofeedback on Event-related Potential (ERP) (MyB)’, US National Library of Medicine, 2017, https://clinicaltrials.gov/ct2/show/NCT03289793; ‘Effectiveness of a Electroencephalogram (EEG) Biofeedback for the Treatment of ADHD (EEG)’, US National Library of Medicine, 2008, https://clinicaltrials.gov/ct2/show/NCT00802490; ‘BCI (Brain Computer Interface) Intervention in Autism’ (BCIAUT), US National Library of Medicine, 2015, https://clinicaltrials.gov/ct2/show/NCT02445625; ‘Rt-fMRI NF Intervention Study in ASD’ (NF-ASD), US National Library of Medicine, 2015, https://clinicaltrials.gov/ct2/show/NCT02440451; ‘Brain Computer Interface Complete Locked-in State Communication’, US National Library of Medicine, 2016, https://clinicaltrials.gov/ct2/show/NCT02980380; ‘Brainwave Control of a Wearable Robotic Arm for Rehabilitation and Neurophysiological Study in Cervical Spine Injury (CSI: Brainwave)’, US National Library of Medicine, 2015, https://clinicaltrials.gov/ct2/show/NCT02443558; ‘Neurofeedback Training of Alpha-band Coherence After Stroke’, US National Library of Medicine, 2014, https://clinicaltrials.gov/ct2/show/NCT02223910; ‘Restoring High Dimensional Hand Function to Persons with Chronic High Tetraplegia’, US National Library of Medicine, 2018, https://clinicaltrials.gov/ct2/show/NCT03482310.

102 ‘Mirror Neuron Network Based Motor Imagery Training to Improve Brain Computer Interface Performance in Spinal Cord Injury Patients (BCI)’, US National Library of Medicine, 2017, https://clinicaltrials.gov/ct2/show/NCT03098927; ‘Combined Transcranial Direct Current Stimulation and Motor Imagery-based Robotic Arm Training for Stroke Rehabilitation’, US National Library of Medicine, 2013, https://clinicaltrials.gov/ct2/show/NCT01897025; ‘Stable and Independent Communication Brain-Computer Interfaces’ (n 98); ‘Identification of Time-invariant EEG Signals for Brain-Computer Interface’, US National Library of Medicine, 2016, https://clinicaltrials.gov/ct2/show/NCT02787200; ‘Brain-Computer Interface (BCI)-Based Feedback for Chronic Pain Management’, US National Library of Medicine, 2017, https://clinicaltrials.gov/ct2/show/NCT03032497; ‘Affect Regulation Based on Brain-Computer Interface towards Treatment for Depression’, US National Library of Medicine, 2018, https://clinicaltrials.gov/ct2/show/NCT03696667; ‘Effectiveness of a Brain-Computer Interface Based System for Cognitive Enhancement in the Normal Elderly (3ECog)’ (n 97); ‘A P300 Brain Computer Interface Keyboard to Control Assistive Technology for Use by People with Amyotrophic Lateral Sclerosis’, US National Library of Medicine, 2010, https://clinicaltrials.gov/ct2/show/NCT01119001; ‘Sensorimotor Rhythm Brain-Computer Interface Switch to Operate Assistive Technology’ (n 99); ‘Brain Computer Interfaces (Mu Rhythm Learning)’ (n 99); ‘Sensorimotor Based Brain Computer Interface’ (n 99); ‘Assistive Soft Robotic Glove Intervention Using Brain-Computer Interface for Elderly Stroke Patients’, US National Library of Medicine, 2017, https://clinicaltrials.gov/ct2/show/NCT03277508; ‘Moving a Paralyzed Hand Through Use of a Brain-Computer Interface’ (n 99); ‘First Study with a Brain Implant to Help Locked-in Patients Communicate at Home (UNP)’, US National Library of Medicine, 2014, https://clinicaltrials.gov/ct2/show/NCT02224469; ‘Investigation on the Cortical Communication (CortiCom) System (CortiCom)’, US National Library of Medicine, 2018, https://clinicaltrials.gov/ct2/show/NCT03567213; ‘Brain-Computer Interface (BCI) Based Intervention for Attention Deficit Hyperactivity Disorder (ADHD)’ (n 101); Brain-Computer Interface-based Programme for the Treatment of ASD/ADHD’ (‘ASDBCI’), US National Library of Medicine, 2015, https://clinicaltrials.gov/ct2/show/NCT02618135; ‘BCIAUT’ (n 101); ‘NF-ASD’ (n 101).

103 Konrad, Peter and Shanks, Todd, ‘Implantable Brain Computer Interface: Challenges to Neurotechnology Translation’ (2010) 38 Neurology of Disease 369, 374Google ScholarPubMed.

104 ‘Brain Computer Interface: Neuroprosthetic Control of a Motorized Exoskeleton (BCI)’, US National Library of Medicine, 2015, https://clinicaltrials.gov/ct2/show/NCT02550522; ‘A P300 Brain Computer Interface Keyboard to Control Assistive Technology for Use by People with Amyotrophic Lateral Sclerosis’ (n 102); ‘Chronic Stroke Rehabilitation with Contralesional Brain-Computer Interface’, US National Library of Medicine, 2018, https://clinicaltrials.gov/ct2/show/NCT03611855; ‘Wireless Brain-Computer-Interface-Controlled Neurorehabilitation System for Patients with Stroke’, US National Library of Medicine, 2013, https://clinicaltrials.gov/ct2/show/NCT01880268; ‘Brain Computer Interface (BCI) Technology for Stroke Hand Rehabilitation (ARTS-BCI)’, US National Library of Medicine, 2011, https://clinicaltrials.gov/ct2/show/NCT01287975; ‘Brain Computer Interface (BCI) Based Robotic Rehabilitation for Stroke’, US National Library of Medicine, 2009, https://clinicaltrials.gov/ct2/show/NCT00955838; ‘Assistive Soft Robotic Glove Intervention Using Brain-Computer Interface for Elderly Stroke Patients’ (n 102); ‘BCI and FES for Hand Therapy in Spinal Cord Injury’, US National Library of Medicine, 2013, https://clinicaltrials.gov/ct2/show/NCT01852279; ‘CSI: Brainwave’ (n 101); ‘A Brain Centered Neuroengineering Approach for Motor Recovery After Stroke: Combined rTMS and BCI Training’, US National Library of Medicine, 2014, https://clinicaltrials.gov/ct2/show/NCT02132520; ‘Patient Self-managed BCI-FES’, US National Library of Medicine, 2017, https://clinicaltrials.gov/ct2/show/NCT03257982; ‘Efficacy of Hand Exoskeleton Controlled by BCI in Post Stroke Patients (iMove)’, US National Library of Medicine, 2014, https://clinicaltrials.gov/ct2/show/NCT02325947; ‘Brain Training System Using Electroencephalography (EEG) for Neurorehabilitation of Hand Function After Stroke’, US National Library of Medicine, 2014, https://clinicaltrials.gov/ct2/show/NCT02323074; ‘Neurofeedback Training of Alpha-band Coherence After Stroke’ (n 101); ‘Microelectrode Brain-Machine Interface for Individuals with Tetraplegia’, US National Library of Medicine, 2011, https://clinicaltrials.gov/ct2/show/NCT01364480; ‘Microgrid II – Electrocorticography Signals for Human Hand Prosthetics’, US National Library of Medicine, 2017, https://clinicaltrials.gov/ct2/show/NCT03289572; ‘Restoring High Dimensional Hand Function to Persons with Chronic High Tetraplegia’ (n 101); ‘A Study of Neurostyle Brain Exercise Therapy Towards Enhanced Recovery (nBETTER) for Stroke (nBETTER)’, US National Library of Medicine, 2016, https://clinicaltrials.gov/ct2/show/NCT02765334; ‘Therapy to Improve Reaching Movement in Upper Limb’, US National Library of Medicine, 2018, https://clinicaltrials.gov/ct2/show/NCT03508037; ‘The Role of MNS in Improving Motor Performance’, US National Library of Medicine, 2016, https://clinicaltrials.gov/ct2/show/NCT02971371; ‘Cortical Recording and Stimulating Array Brain-Machine Interface (CRS-BMI)’, US National Library of Medicine, 2013, https://clinicaltrials.gov/ct2/show/NCT01894802; ‘BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons with Tetraplegia’ (‘BrainGate2’), US National Library of Medicine, 2009, https://clinicaltrials.gov/ct2/show/NCT00912041; ‘Providing Closed Loop Cortical Control of Extracorporeal Devices to Patients with Quadriplegia’, US National Library of Medicine, 2013, https://clinicaltrials.gov/ct2/show/NCT01964261; ‘Providing Brain Control of Extracorporeal Devices to Patients with Quadriplegia’, US National Library of Medicine, 2013, https://clinicaltrials.gov/ct2/show/NCT01849822; ‘Sensorimotor Rhythm Brain-Computer Interface Switch to Operate Assistive Technology’ (n 99); ‘Brain Computer Interface (BCI) System for Stroke Rehabilitation’, US National Library of Medicine, 2014, https://clinicaltrials.gov/ct2/show/NCT02323061; ‘A P300 Brain Computer Interface to Operate Power Wheelchair Tilt’ (n 99); ‘Moving a Paralyzed Hand Through Use of a Brain-Computer Interface’ (n 99); ‘ECoG Direct Brain Interface for Individuals with Upper Limb Paralysis’, US National Library of Medicine, 2011, https://clinicaltrials.gov/ct2/show/NCT01393444; ‘Non-Invasive Brain Signal Training to Induce Motor Control Recovery After Stroke’ (n 99); ‘BCI-stroke’ (n 95); ‘REMINARY’ (n 95).

105 ‘Brain Computer Interface Complete Locked-in State Communication’ (n 101); Robust Intelligent Keyboard for Quadraplegic Patients (PVCRoBIK)’, US National Library of Medicine, 2012, https://clinicaltrials.gov/ct2/show/NCT01707498; ‘Clinical Validation Protocol for BCI for the Communication of Patients Suffering from Neuromuscular Disorders (PVCAFM)’, US National Library of Medicine, 2014, https://clinicaltrials.gov/ct2/show/NCT02284022; ‘Brain Computer Interface for Communication in ICU: A Feasibility Study (RoBIK-1)’, US National Library of Medicine, 2009, https://clinicaltrials.gov/ct2/show/NCT01005524; ‘UNP’ (n 102); ‘Communication by Brain-Computer Interface in Amyotrophic Lateral Sclerosis: Feasibility Study’, US National Library of Medicine, 2013, https://clinicaltrials.gov/ct2/show/NCT01897818; ‘3Electrods’ (n 95); ‘Brain Implant for Neural Control of a Computer’, US National Library of Medicine, 2013, https://clinicaltrials.gov/ct2/show/NCT01958086. The projects that focus on both senses (communication and movements) are: ‘An In-home Study of Brain Computer Interfaces’, US National Library of Medicine, 2010, https://clinicaltrials.gov/ct2/show/NCT01123200; ‘CortiCom’ (n 102); ‘ECoG BMI for Motor and Speech Control (BRAVO)’, US National Library of Medicine, 2018, https://clinicaltrials.gov/ct2/show/NCT03698149; ‘Cortex Changes in Real/Imagined Movements in Amyotrophic Lateral Sclerosis (ALS)’, US National Library of Medicine, 2008, https://clinicaltrials.gov/ct2/show/NCT00809224.

106 ‘ECoG Direct Brain Interface for Individuals with Upper Limb Paralysis’ (n 104).

107 ‘Investigation on the Bidirectional Cortical Neuroprosthetic System (BiCNS)’, US National Library of Medicine, 2017, https://clinicaltrials.gov/ct2/show/NCT03161067.

108 ‘3ECog’ (n 97).

109 ‘Assessment of Visual Function with a Portable Brain-Computer Interface’, US National Library of Medicine, 2018, https://clinicaltrials.gov/ct2/show/NCT03760055.

110 ‘BCIAUT’ (n 101); ‘NF-ASD’ (n 101).

111 ‘Affect Regulation based on Brain-Computer Interface towards Treatment for Depression’ (n 102).

112 ‘Brain-Computer Interface (BCI)-based Feedback for Chronic Pain Management’ (n 102); ‘Neurofeedback for Fibromyalgia’, US National Library of Medicine, 2014, https://clinicaltrials.gov/ct2/show/NCT02146495; ‘Electroencephalography Based Neurofeedback in Chronic Neuropathic Pain’, US National Library of Medicine, 2012, https://clinicaltrials.gov/ct2/show/NCT01560039.

113 As once underlined by South Africa, ‘most research involves a mix of “therapeutic” and “non-therapeutic” interventions or components and reviewers usually assess the proposal as a whole’: Department of Health (South Africa) (n 92) 30.

114 Department of Defense (US), ‘Fiscal Year (FY) 2007 Budget Estimates’, February 2006, 11.

115 Abby Phillip, ‘A Paralyzed Woman Flew an F-35 Fighter Jet in a Simulator – Using only her Mind’, The Washington Post, 3 March 2015, https://www.washingtonpost.com/news/speaking-of-science/wp/2015/03/03/a-paralyzed-woman-flew-a-f-35-fighter-jet-in-a-simulator-using-only-her-mind/?noredirect=on.

116 ibid.

117 Juengst and Moseley (n 14).

118 Council of Europe, ‘Recommendation No R(90)3 of the Committee of Ministers to Member States concerning Medical Research on Human Beings’, 6 February 1990, principle 2(2).

119 Council of Europe, ‘Explanatory Report to the 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’, 4 April 1997, para 97, https://rm.coe.int/CoERMPublicCommonSearchServices/DisplayDCTMContent?documentId=09000016800ccde5.

120 Oviedo Convention (n 62) art 16(ii).

121 Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedicine Research (entered into force 1 September 2007) CETS 195, art 6(2)

122 Bosnia and Herzegovina, Bulgaria, the Czech Republic, Georgia, Hungary, Montenegro, Norway, Portugal, Moldova, Slovakia, Slovenia, Turkey.

123 AP to Oviedo Convention (n 121) art 6.

124 The Oviedo Convention expressly refers to ‘person[s]’, ‘minor[s]’ and ‘adult[s]’ who do ‘not have the capacity to consent’: Oviedo Convention (n 62) art 6(1)–(3). The Additional Protocol also refers to research ‘during pregnancy or breastfeeding’, on persons ‘in emergency clinical situations’, or ‘deprived of liberty’: Oviedo Convention (n 62) art 17(1)(ii)–(iii); AP to Oviedo Convention (n 121) arts 15, 18, 19, 20.

125 Oviedo Convention (n 62) art 17(1)(ii); AP to Oviedo Convention (n 121) art 15(1)(i).

126 Oviedo Convention (n 62) art 17(2)(i); AP to Oviedo Convention (n 121) art 15(2)(i)

127 Oviedo Convention (n 62) art 17(2)(ii); AP to Oviedo Convention (n 121) art 15(2)(ii).

128 Patrick Cockburn, ‘US Navy Tested Mustard Gas on its Own Sailors’, Independent, 4 October 2015, https://www.independent.co.uk/news/world/us-navy-tested-mustard-gas-on-its-own-sailors-in-1943-the-americans-used-humans-in-secret-1497508.html; ECtHR, Roche v UK (n 57).

129 Brigid Glanville, ‘Ex-US Pilot Anthrax Vaccine Court Martial’, ABC, 12 February 2003, https://www.abc.net.au/worldtoday/stories/s782721.htm; Parliament (Australia), ‘Appendix 3 – Anthrax Vaccinations’ (2004), https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Foreign_Affairs_Defence_and_Trade/Completed_inquiries/2002-04/defhealth/report/d03; Alexandra Kirk, ‘Anthrax Vaccine Causes Headache for Defence’, ABC, 12 February 2003, https://www.abc.net.au/worldtoday/stories/s782718.htm; ‘Israel to Pay $6 Million Compensation to Anthrax Vaccine Trial Subjects’, RT, 13 January 2014, https://www.rt.com/news/anthrax-israel-idf-vaccine-compensation-536; Jim Hill, ‘Marine Gets 30 Days in Jail, Bad Conduct Discharge for Refusing Anthrax Vaccine’, CNN, 17 June 1999, http://edition.cnn.com/US/9906/17/marine.anthrax.

130 Mehlman, Maxwell J and others, ‘Ethical and Legal Issues in Enhancement Research on Human Subjects’ (2011) 20 Cambridge Quarterly of Healthcare Ethics 30, 41CrossRefGoogle ScholarPubMed.

131 For a contrary view see Savulescu, Julian, ‘Science Wars – How Much Risk Should Soldiers Be Exposed to in Military Experimentation?’ (2015) 2 Journal of Law and the Biosciences 99, 100CrossRefGoogle ScholarPubMed. He argues: ‘Premise 1. Soldiers legitimately consent to lethal risk as a part of combat and occupation. Premise 2. War involves both physical violence and biological threat to national security. Conclusion. Soldiers can legitimately consent to lethal risk research into biological threat to national security’.

132 UN HRC, General Comment No 20 (n 55) para 7.

133 Australia (n 27) 68.

134 Department of Health (South Africa) (n 92) 38.

135 According to Efthimios Parasidis – and considering military hierarchy and the legal requirements of the Uniform Code of Military Justice (10 USC 47) – members of the US armed forces should be considered as a ‘class of individuals that is vulnerable to coercion and undue influence’. This vulnerability is caused by military command structure, mandatory use of investigational medical products, informed consent waivers, and the problem of mixed agency, when a military physician has an obligation to someone other than the patient, such as a commanding officer: Efthimios Parasidis, ‘Classifying Military Personnel as a Vulnerable Population’ in Glenn Cohen and Holly Fernandez Lynch (eds), Human Subjects Research Regulation: Perspectives on the Future (The MIT Press 2014) 65, 65. In the US, the regulations in force underline that ‘[v]oluntary consent of the human subject is essential’, and that ‘[m]ilitary personnel are not subject to punishment … for choosing not to take part as human subjects’: US Army, ‘Clinical Investigation Program’, 1 September 1989, AR 40–38, s 3–3(e). Some additional protections were set to prevent the risk of coercion: for research involving more than low risk, officers shall not be present when the consent is obtained, and an ombudsman may be commissioned: United States Army Medical Research and Materiel Command, ‘HQ USAMRMC Institutional Review Board Policies and Procedures’, 2010, s 8–7(c).

136 In fact, the HRC only described ‘children, prisoners, pregnant women, mentally disabled persons, or economically disadvantaged persons’ as ‘persons vulnerable to coercion or undue influence’: UN HRC, Concluding Observations on the US (n 56) para 31.

137 US, 21 CFR 50.23.

138 UN HRC, Concluding Observations, US (n 56) para 31.

139 ibid.

140 ibid.

141 See also US, 10 USCS §980 (n 37).

142 UN HRC, Concluding Observations on the Fourth Periodic Report of the United States of America (23 April 2014), UN Doc CCPR/C/USA/CO/4.

143 ECtHR, Engel and Others v The Netherlands, App nos 5100/71, 5101/71, 5102/71, 5354/72, 5370/72, 8 June 1976, para 54. See also European Commission of Human Rights, Vereinigung Demokratischer Soldaten Österreichs and Berthold Gubi v Austria, App no 15153/89, 30 June 1993, para 47.

144 ECtHR, Grigoriades v Greece, App no 121/1996/740/939, 25 November 1997, para 45.

145 ECtHR, Engel and Others v The Netherlands (n 143) para 54.

146 ECtHR, Grigoriades v Greece (n 144) para 45.

147 ECtHR, Smith and Grady v UK, App nos 33985/96 and 33986/96, 27 September 1999, para 89.

148 ibid.

149 ECtHR, Mosendz v Ukraine, App no 52013/08, 17 January 2013, para 91.

150 Council of Europe, Committee of Ministers, Recommendation CM/Rec(2010)4 of the Committee of Ministers to Member States on Human Rights of Members of the Armed Forces, 24 February 2010, para 6, https://www.refworld.org/docid/506979172.html.

151 In France, for instance, the Service de Santé des Armés systematically requires the free consent of participants before experimentation, while military doctors are legally required to comply with the law and recommendations of the ethics committee: Instruction N° 549/DEF/DCSSA/EPG/ECX relative aux expérimentations realisées par les professionnels de santé du service de santé des armées (France), s 2.3; Décret n° 2008-967 du 16 septembre 2008 fixant les règles de déontologie propres aux praticiens des armées (France), art 9. The French Minister for the Armed Forces recently recommended that consent must be obtained, except in limited circumstances: Ministère des Armées (France), ‘Discours de Florence Parly, ministre des Armées, introduisant la table-ronde “Éthique et soldat augmenté” au Digital Forum innovation défense’, 2020, https://www.defense.gouv.fr/salle-de-presse/discours/discours-de-florence-parly-ministre-des-armees-introduisant-la-table-ronde-ethique-et-soldat-augmente-au-digital-forum-innovation-defense. However, in a recent opinion the French ethical committee for defence underlined that the right to consent might be limited for members of the armed forces in some situations, and that the military command may impose enhancement without prior consent. Those situations remain to be defined, and members must be informed of the risk: Comité d’Éthique pour la Défense (France) (n 8) 26–27.

152 In the views of the French ethical committee for defence, a benefit/risk assessment must be undertaken for each enhancement: Comité d’Éthique pour la Défense (France) (n 8) 21.

153 Mehlman and others (n 130) 42.

154 This system also has the potential for preventing friendly fire: see Drummond (n 12).

155 Department of Defense (US), ‘Fiscal Year (FY) 2010 Budget Estimates’, May 2009, 12.

156 Savulescu (n 131) 103. He considers that it is never in the interests of soldiers to be exposed to biomedical risks – at least, no more than to active combat – but it is in the interests of the state that they be (ibid 101). He also contends that in the framework of military experimentation, the mission of institutional review boards must be ‘to ensure that the risk is minimized and proportionate to the threat’ (ibid).

157 Mehlman, Maxwell J and Li, Tracy Yeheng, ‘Ethical, Legal, Social, and Policy Issues in the Use of Genomic Technology by the U.S. Military’ (2015) 47 Case Western Reserve Journal of International Law 115, 125Google Scholar.

158 ibid 126.

159 ibid.

160 ibid 134.

161 ibid.

162 Kaur, Tejinder and Singh, Birinder, ‘Brain Computer Interface: A Review’ (2017) 4 International Research Journal of Engineering and Technology 3593, 3595Google Scholar.

163 Shivam Kolhe and others, ‘Automation of Appliances Using Electroencephalography’ in Dac-Nhuong Le and others, Emerging Technologies for Health and Medicine: Virtual Reality, Augmented Reality, Artificial Intelligence, Internet of Things, Robotics, Industry 4.0 (John Wiley & Sons 2018) 225, 242.

164 DARPA (US), ‘Broad Agency Announcement Next-Generation Non-Surgical Neurotechnology (N3)’, 23 March 2018, 4–5, https://www.grants.gov/web/grants/view-opportunity.html?oppId=302121.

165 Oviedo Convention (n 62) art 16(ii).

166 AP to Oviedo Convention (n 121) art 6(2).

167 UN HRC, Concluding Observations on the US (n 56) para 31.

168 Patrick Tucker, ‘Defense Intel Chief Worried about Chinese “Integration of Human and Machines”’, Defense One, 10 October 2018, https://www.defenseone.com/technology/2018/10/defense-intel-chief-worried-about-chinese-integration-human-and-machines/151904.

169 Ren, Yuanpeng and others, ‘Legal Protection of the Rights of Clinical Trial Subjects in China’ (2018) 32 Journal of Biomedical Research 77Google ScholarPubMed.

170 SGDSN (France), ‘Chocs futurs’, 2017, 171, http://www.sgdsn.gouv.fr/uploads/2017/04/sgdsn-document-prospectives-v5-bd.pdf (author's translation).