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The (Ab)use of Those with No Other Hope?

Ethical and Legal Safeguards for Recipients of Experimental Procedures

Published online by Cambridge University Press:  14 March 2013

SARA FOVARGUE
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Type
Special Section: Open Forum
Information
Cambridge Quarterly of Healthcare Ethics , Volume 22 , Issue 2 , April 2013 , pp. 181 - 191
Copyright
Copyright © Cambridge University Press 2013

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References

Notes

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.