¹ Caplan AL. Is there a duty to serve as a subject in biomedical research? IRB: Ethics and Human Research 1984;6:1–5; Harris J. Scientific research is a moral duty. Journal of Medical Ethics 2005;31:242–8; Brassington I. Defending the duty to research? Bioethics 2011;25:21–6.

² Chan S, Zee Y-K, Jackson G, Harris J. “Risky” research and participants’ interests: The ethics of phase 2C clinical trials. Clinical Ethics 2011;6:91–6, at 91–2.

³ See note 2, Chan et al. 2011, at 91–2.

⁴ Nuffield Council on Bioethics. Animal-to-Human Transplants—The Ethics of Xenotransplantation. London: Nuffield Council on Bioethics; 1996, at para. 7.7. See also para. 7.4.

⁵ See, e.g., Re T (Adult: Refusal of Treatment)[1992] 4 All ER 649, CA.

⁶ Kong WM. Legitimate requests and indecent proposals: Matters of justice in the ethical assessment of phase I trials involving competent patients. Journal of Medical Ethics 2005;31:205–8.

⁷ Mason JK, Laurie GT. Mason and McCall Smith’s Law and Medical Ethics. Oxford: Oxford University Press; 2011, at 612–3; Plomer A. The Law and Ethics of Medical Research: International Bioethics and Human Rights. London: Cavendish; 2005, at 47–8.

⁸ Royal College of Physicians (RCP). Guidelines on the Practice of Ethics Committees in Medical Research Involving Human Subjects. 4th ed. London: Royal College of Physicians; 2007, at para. 3.4–3.7 respectively.

⁹ Regulation 2(1), The Medicines for Human Use (Clinical Trials) Regulations 2004, SI 2004 No. 1031 as amended.

¹⁰ Section 30 Mental Capacity Act 2005.

¹¹ See note 8, RCP 2007, at para. 3.1–3.2 and 3.4; Department of Health (DH). Research Governance Framework for Health and Social Care. 2nd ed. London: DH; 2005 Annex 2008, at para. 1.10; General Medical Council (GMC). Good Practice in Research. London: GMC; 2010, at para. 1, respectively.

¹² HSC 2003/011. The Interventional Procedures Programme—Working with the National Institute for Clinical Excellence to Promote Safe Clinical Innovation, at para. 16, emphasis in original.

¹³ Ministry of Health (MH). Operational Standard for Ethics Committees. Wellington: MH; 2006, at para. 116.

¹⁴ See note 13, MH 2006, at para. 118 and 121 respectively

¹⁵ See note 13, MH 2006, at para. 120 and 125 respectively.

¹⁶ See note 13, MH 2006, at para. 125–126.

¹⁷ See note 2, Chan et al. 2011, at 92.

¹⁸ See note 9, The Medicine for Human Use (Clinical Trials) Regulations 2004.

¹⁹ See note 8, RCP 2007; see note 11, GMC 2010.

²⁰ For a helpful overview, see Stauch M, Wheat K, with Tingle J. Text, Cases and Materials on Medical Law and Ethics. 4th ed. London: Routledge; 2011, at 487–98.

²¹ National Institute for Health and Clinical Excellence (NICE). The Legal Implications of NICE Guidance; 2004; available at http://www.nice.org.uk/media/8BD/2B/Legal_context_nice_guidance.pdf (last accessed 23 Nov 2012).

²² See note 8, RCP 2007, at para. 3.5, emphasis supplied.

²³ Nicholson RH, ed. Medical Research with Children: Ethics, Law, and Practice—The Report of an Institute of Medical Ethics Working Group on the Ethics of Clinical Research Investigations on Children. Oxford: Oxford University Press; 1986, at 36.

²⁴ McLean S. Gene therapy—Cure or challenge? In Freeman M, Lewis A, eds. Law and Medicine Current Legal Issues. Vol. 3. Oxford: Oxford University Press; 2000, at 205–22.

²⁵ These questions include issues regarding competence to consent and who makes selection decisions, as is discussed in Fovargue S. Xenotransplantation and Risk: Developing a Developing Biotechnology. Cambridge: Cambridge University Press; 2012, at chap. 3 and 5.

²⁶ See note 6, Kong 2005, at 207.

²⁷ Fox RC, Swazey JP. The Courage to Fail—A Social View of Organ Transplants and Dialysis. Edison, New Jersey: Transaction; 2002, at 105.

²⁸ Christopherson LK, Lunde DT. The selection of cardiac transplant recipients and their subsequent psychological adjustment. Seminars in Psychiatry 1971;3:36–45, at 40.

²⁹ Boseley S. Human guinea pigs lend their courage to a golden era of cancer research. The Guardian 2011 Aug 22.

³⁰ Hughes V. When patients march in. Nature Biotechnology 2010;28:1145–8. See also, e.g., the lobbying that occurred around the use of Herceptin, as evidenced in articles in The Guardian during 2005–2006.

³¹ Fox M. Research bodies: Feminist perspectives on clinical research. In Sheldon S, Thomson M, eds. Feminist Perspectives in Health Care Law. London: Cavendish; 1998:115–34, at 123.

³² Orme NM, Fletcher JG, Siddiki HA, Harmsen WS, O’Byrne MM, Port JD, et al. Incidental findings in imaging research: Evaluating incidence, benefit, and burden. Archives of Internal Medicine 2010;170:1525–32.

³³ Chahal M. Off-trial access to experimental cancer agents for the terminally ill: Balancing the needs of individuals and society. Journal of Medical Ethics 2010;36:367–70.

³⁴ McLean SAM, Williamson L. Xenotransplantation: Law and Ethics. Aldershot: Ashgate; 2005, at 29–30; Hardy JD, Chavez CM. The first heart transplant in man—Developmental animal investigations with analysis of the 1964 case in the light of current clinical experience. American Journal of Cardiology 1968;22:772–81; Reemtsma K, McCracken BH, Schlegel JU, Pearl MA, Pearce CW, DeWitt CW, et al. Renal heterotransplantation in man. Annals of Surgery 1964;160:384–408; Starzl TE, Marchioro TL, Peters GN, Kirkpatrick CH, Wilson WEC, Porter KA, et al. Renal heterotransplantation from baboon to man: Experiences with 6 cases. Transplantation 1964;2:752–76.

³⁵ See note 33, Chahal 2010, at 367; Gray L. Dying can aid stem cell research. The Scotsman 2005 Dec 27.

³⁶ Welin S. Starting clinical trials of xenotransplantation—Reflections on the ethics of the early phase. Journal of Medical Ethics 2000;26:231.

³⁷ B NHS Trust v. J[2006] EWHC 3152.

³⁸ World Medical Association (WMA). Declaration of Helsinki, Ethical Principles for Medical Research Involving Human Subjects, adopted by the 18th WMA, Helsinki, Finland, June 1964, as amended in 2008.

³⁹ Council for International Organizations of Medical Sciences (CIOMS) and World Health Organization (WHO). International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva: CIOMS; 2002.

⁴⁰ See note 38, WMA 2008, at B12, B14–15, B18, B21; note 39, CIOMS and WHO 2002, at Guidelines 1–2, 8, and Appendix 1.

⁴¹ See note 38, WMA 2008, at B22, B24, B26–29; note 39, CIOMS and WHO 2002, at Guidelines 4–6.

⁴² See note 39, CIOMS and WHO 2002, at General Ethical Principles.

⁴³ See note 38, WMA 2008, at A6, A9, B11, B21, B24.

⁴⁴ See note 38, WMA 2008, at C35, emphasis supplied.

⁴⁵ See note 38, WMA 2008, at A1.

⁴⁶ See note 39, CIOMS and WHO 2002, at Guideline 13.

⁴⁷ See note 39, CIOMS and WHO 2002, at Commentary on Guideline 13, emphasis supplied.

⁴⁸ See note 39, CIOMS and WHO 2002, at Guideline 12.

⁴⁹ See note 39, CIOMS and WHO 2002, at Commentary on Guideline 12, emphasis supplied.

⁵⁰ See note 39, CIOMS and WHO 2002, at Guideline 4.

⁵¹ GMC. Good Medical Practice. London: GMC; 2006, at 5.

⁵² See note 11, GMC 2010, at para. 4.

⁵³ GMC. Consent: Patients and Doctors Making Decisions Together. London: GMC; 2008; GMC. Confidentiality. London: GMC; 2009.

⁵⁴ See note 53, GMC 2008, at para. 9(f).

⁵⁵ See note 8, RCP 2007, at para. 3.5.

⁵⁶ See note 13, MH 2006, at para. 1.

⁵⁷ See note 13, MH 2006, at para. 123, 132, and 134.

⁵⁸ See note 13, MH 2006, at para. 134.

⁵⁹ See note 13, MH 2006, at para. 135.

⁶⁰ See note 12, HSC 2003/011, at para. 1, 4, and 7.

⁶¹ See note 12, HSC 2003/011, at para. 4.

⁶² See note 12, HSC 2003/011, at para. 8.

⁶³ See note 12, HSC 2003/011, at para. 10, emphasis supplied.

⁶⁴ See http://www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Healthservicecirculars/DH_4064922 (last accessed 23 Nov 2012).

⁶⁵ See note 12, HSC 2003/011, at para. 2.

⁶⁶ See note 12, HSC 2003/011, at para. 10.

⁶⁷ DH. Health Service Circulars; http://webarchive.nationalarchives.gov.uk/20120405095111/http://www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Healthservicecirculars/index.htm (last accessed 23 Nov 2012), emphasis supplied.

⁶⁸ See note 21, NICE 2004, at 3.

⁶⁹ See note 21, NICE 2004, at 3.

⁷⁰ “A doctor is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art”: Bolam v. Friern Hospital Management Committee [1957] 2 All ER 118, 121 per McNair J.

⁷¹ Jones M. Medical Negligence. 4th ed. London: Sweet & Maxwell; 2008, at para. 3-057.

⁷² See text for note 62. Competence is determined by the provisions of the Mental Capacity Act 2005.

⁷³ Chatterton v. Gerson [1981] 1 All ER 257, 265 per Bristow J.

⁷⁴ R v. Brown [1994] 1 AC 212, 258–259 per Lord Mustill, HL.

⁷⁵ Simms v. Simms and another; PA v. JA and another[2002] EWHC 2734.

⁷⁶ See note 75, Simms, at para. 57, emphasis supplied.

⁷⁷ See note 75, Simms, at para. 57, emphasis supplied.

⁷⁸ See note 75, Simms, at para. 48.

⁷⁹ See note 75, Simms, at para. 48.

⁸⁰ See note 75, Simms, at para. 48, emphasis supplied.

⁸¹ See note 75, Simms, at para. 49, emphasis supplied.

⁸² See note 75, Simms, at para. 51, emphasis supplied.

⁸³ See note 75, Simms, at para. 57.

⁸⁴ See note 75, Simms, at para. 58, emphasis supplied.

⁸⁵ See note 7, Mason, Laurie 2011, at 628.

⁸⁶ DH. Xenotransplantation Guidance. London: DH; 2006, at 3.

⁸⁷ See note 25, Fovargue 2012, at chap. 2.