Regulating research and experimentation: A view from the UK

Journal of Law, Medicine and Ethics

Volumn 32, Issue 4, 2004, Pages 604-612

  McLean, Sheila A M ^a  

^a UNIVERSITY OF GLASGOW   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CONFERENCE PAPER; CORRELATION ANALYSIS; DECISION MAKING; EUROPE; EXPERIMENTAL TEST; FEASIBILITY STUDY; FOLLOW UP; GOVERNMENT REGULATION; HEALTH CARE QUALITY; HOSPITAL; HUMAN; HUMAN RIGHTS; INFORMATION PROCESSING; INFORMED CONSENT; MEDICAL ETHICS; MEDICAL LITERATURE; MEDICAL RESEARCH; MEDICAL SOCIETY; NONHUMAN; PUBLIC HEALTH; RISK ASSESSMENT; STANDARDIZATION; UNITED KINGDOM;

EID: 13844275522     PISSN: 10731105     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2004.tb01966.x     Document Type: Conference Paper

References (73)

1. B.M. Dickens, "Human Rights in Medical Experimentation," Israeli Yearbook on Human Rights 9 (1979): 23.
2. C. Foster, The Ethics of Medical Research on Humans (Cambridge: Cambridge University Press, 2001): at 1.
3. D. Giesen, "Civil Liability of Physicians for New Methods of Treatment and Experimentation: A Comparative Examination," Medical Law Review 3 (1995): 22-52, at 22.
4. J.K. Mason, R.A. McCall Smith, and G.T. Laurie, Law and Medical Ethics, 6th ed (London: Butterworths, 2002):at 573
5. R. Nicholson, Medical Research with Children: Ethics, Law, and Practice (Oxford: Oxford University Press, 1986): at 25.
6. 1955 Sess. Cas. 200.
7. See, e.g., Maynard v West Midlands Regional Health Authority, 1 All E.R. 635 (1985).
8. Hunter v Hanley, 1955 Sess. Cas. at 206.
9. Lloyd's Rep Med 236 (2004).
10. Id. at 245.
11. Ibid. Id
12. Ibid. Id
13. Id. at 246.
14. Lloyd's Rep Med 207 (2004).
15. Lloyd's Rep Med 211 (2004).
16. Id. at 209.
17. Id. at 245.
18. Ibid. Id.
19. These committees were first recommended by the Royal College of Physicians of London in 1967, Royal College of Physicians (RCP) 1967. See also the DHSS advisory circular, Supervision of the Ethics of Clinical Research Investigations and Fetal Research (1975) HSC (IS) 153. Modern alterations to this position will be considered infra.
20. See GMC, Research: The Role and Responsibilities of Doctors (2002), available at 〈http://www.gmc-uk.org/standards/research.htm〉 (last visited October 11, 2004).
21. See, e.g., Research Governance Framework for Health and Social Care (London: Department of Health, 2004); Governance Arrangements for NHS Research Ethics Committees in Scotland, Edinburgh (2001), available at 〈http://www.show.scot.nhs.uk/cso/aboutcso/RECgov.doc〉 (last visited October 11, 2004).
22. See, e.g., Research Governance Framework for Health and Social Care (London: Department of Health, 2004); Governance Arrangements for NHS Research Ethics Committees in Scotland, Edinburgh (2001), available at 〈http://www.show.scot.nhs.uk/cso/aboutcso/RECgov.doc〉 (last visited October 11, 2004).
23. I. Chalmers, and R.I. Lindley, "Double Standards on Informed Consent to Treatment," in L. Doyal and J.S. Tobias, eds., Informed Consent in Medical Research (London: BMJ Books, 2001): 266-275, at 269.
24. R.J. Levine, "Uncertainty in Clinical Research," Law, Medicine Health Care 16 (1998):174-182, at 174.
25. I. Kennedy and A. Grubb, eds., Principles of Medical Law (Oxford: Oxford University Press, 1998): at 1011-1012.
26. J. Katz, "The Consent Principle of the Nuremberg Code: its Significance Then and Now," in G. J. Annas and M.A. Grodin (eds), The Nazi Doctors and the Nuremberg Code (New York: Oxford, 1992): 227-239, at 227.
27. Its most recent version was agreed at Edinburgh in 2000.
28. J.F. Childress, "Nuremberg's Legacy: Some Ethical Reflections," Perspectives in Biology and Medicine 43, no. 3 (2000): 347-61 at 351.
29. Article 5.
30. Article 8.
31. Article 25.
32. D. Evans and M.A. Evans, Decent Proposal: Ethical Review of Clinical Research (Chichester: John Wiley & Sons, 1996): at 17.
33. R.B. Redmon, "How Children can be Respected as "Ends" Yet Still be Used as Subjects in Non-therapeutic Research," Journal of Medical Ethics 12 (1986): 77-91, at 79.
34. Although this is not always the case. In the case of R. v. Brown, 1 All E.R. 545 (1996), consensual sado-masochistic practices undertaken in private by adult homosexuals were nonetheless held to be criminal. This was upheld by the European Court of Human Rights in the case of Laskey, Jaggard and Brown v. United Kingdom 24 E.H.R.R. 39 (1997).
35. Laskey, Jaggard and Brown v United Kingdom 24 E.H.R.R. at 66.
36. R. v Brown, 1 All E.R. at 574.
37. Giesen, supra note 3, at 22-52.
38. Id. at 38.
39. M. Baum, "The Ethics of Clinical Research," in P. Byrne, ed., Ethics and Law in Health Care and Research (Chichester: John Wiley & Sons, 1990): 1-8, at 3.
40. J.K. Mason, R.A. McCall Smith and G.T. Laurie, op cit, pp 585-586.
41. S.A.M. McLean and J.K. Mason, Legal and Ethical Aspects of Healthcare (London: GMM, 2003): at 97.
42. Id. at 238.
43. The entirety of this debate forms part of an excellent analysis of medical research in L. Doyal and S. Tobias, eds., Informed Consent in Medical Research (London: BMJ Books, 2001):at 63 et seq.
44. M. Dennis, et al., "Evaluation of a Stroke Family Care Worker: Results of a Randomised Controlled Trial," British Medical Journal 314 (1997):1071-76.
45. R. Smith, "Should the BMJ reject all studies that do not include informed consent?" British Medical Journal 314 (1997): 1059-60, at 1059.
46. S.A.M. McLean, "Commentary: Not Seeking Consent Means Not Treating the Patient with Respect," British Medical Journal 314 (1997):1076.
47. Bolitho v. City and Hackney Health Authority, 39 BMLR 1 (1997); Pearce v. United Bristol Healthcare NHS Trust, 48 BMLR 118 (1999).
48. 2 All E.R. 118 (1957).
49. Gold v. Haringey Health Authority, 2 All E.R. 888 (1987).
50. 1 All E.R. 643 (1985).
51. A.R. Maclean, "Beyond Bolam and Bolitho," Medical Law International 5, no 3 (2002): 205-30.
52. Simms v Simms, supra cit, at p. 244
53. McHardy v. Dundee, SLT (Notes) 19 (1960).
54. 53 DLR 2d. 436 (1965).
55. Kennedy and Grubb, supra note 24, at 735.
56. McLean, supra note 45.
57. This situation was changed in 2001 by the Department of Health's Governance Arrangements for NHS Research Ethics Committees, available at 〈http://www.doh.gov.uk/research/documents/gafrec.pdf〉, and in Scotland by the document Governance Arrangements for NHS Research Ethics Committees in Scotland (2001), available at 〈http://www.show.scot.nhs.uk/cso/aboutcso/ RECgov.doc)〉.
58. This situation was changed in 2001 by the Department of Health's Governance Arrangements for NHS Research Ethics Committees, available at 〈http://www.doh.gov.uk/research/documents/gafrec.pdf〉, and in Scotland by the document Governance Arrangements for NHS Research Ethics Committees in Scotland (2001), available at 〈http://www.show.scot.nhs.uk/cso/aboutcso/ RECgov.doc)〉.
59. Directive 2001/20/EC (April 4, 2001) of the European Parliament and of the Council.
60. Section 5 of The Medicines for Human Use (Clinical Trials) Regulations 2004.
61. For one kind of objection, see, for example, J. Norman, "New System for Ethics Approval is Unacceptable," British Medical Journal 328 (2004):1018.
62. H.K. Beecher, "Ethics and Clinical Research," N. Engl J. Med. 274 (1966): 1354-60, at 1354.
63. M. Pappworth, Human Guinea Pigs: Experimentation on Man (London: Routledge & Keegan Paul, 1967).
64. A.M. Capron "Is National, Independent Oversight Needed for the Protection of Human Subjects?" Accountability in Research 7 (1999): 283-309.
65. Id. at 283.
66. The events, and the subsequent judicial inquiry into them, are discussed in A.V. Campbell, "An 'Unfortunate Experiment'" Bioethics 3 (1989): 59. For further analysis, see C. Paul, "The New Zealand Cancer Study: Could it Happen Again?" British Medical Journal 297 (1988): 533; G. Gillett, "NZ Medicine after Cartwright," British Medical Journal 300 (1990): 893.
67. The events, and the subsequent judicial inquiry into them, are discussed in A.V. Campbell, "An 'Unfortunate Experiment'" Bioethics 3 (1989): 59. For further analysis, see C. Paul, "The New Zealand Cancer Study: Could it Happen Again?" British Medical Journal 297 (1988): 533; G. Gillett, "NZ Medicine after Cartwright," British Medical Journal 300 (1990): 893.
68. The events, and the subsequent judicial inquiry into them, are discussed in A.V. Campbell, "An 'Unfortunate Experiment'" Bioethics 3 (1989): 59. For further analysis, see C. Paul, "The New Zealand Cancer Study: Could it Happen Again?" British Medical Journal 297 (1988): 533; G. Gillett, "NZ Medicine after Cartwright," British Medical Journal 300 (1990): 893.
69. Katz (1992), supra note 25, at 229.
70. British Medical Association, The Medical Profession & Human Rights: Handbook for a Changing Agenda (London: Zed Books/ BMA Books, 2001): at 204.
71. J. F. Childress, "Nuremberg's Legacy: Some Ethical Reflections," Perspectives in Biology and Medicine 43, no. 3 (2000): 347-61, at 352.
72. J. Katz, "Human Experimentation and Human Rights," Saint Louis University Law Journal 38 (1993): 7-54, at 9.
73. C. Levine, "Has AIDS changed the Ethics of Human Subjects Research?" Law, Medicine and Health Care 12 (1988):167-73, at 167.