Protection of human participants from risks in biomedical research: An analysis of the law of South Africa and international ethical guidelines

Medicine and Law

Volumn 22, Issue 1, 2003, Pages 73-94

  Monnye, Segoane L ^a  

^a NONE

Author keywords

Beneficence; Clinical equipoise; Conflict of interest; Participants' welfare; Placebos; Randomized controlled trials; Risk benefit analysis; Social and economic harm

Indexed keywords

BIOMEDICINE; DEATH; ECONOMIC ASPECT; HEALTH; HUMAN; LAW; MEDICAL ETHICS; MEDICAL RESEARCH; PHYSICAL DISEASE; PRACTICE GUIDELINE; PROPHYLAXIS; QUALITY OF LIFE; REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; RISK MANAGEMENT; SOCIAL ASPECT; SOUTH AFRICA; WELFARE;

EID: 0038750606     PISSN: 07231393     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (56)

1. South African Medical Research Council report (executive summary), The Impact of HIV/AIDS on Adult Mortality in South Africa 6 (Sept 2001).
2. See Charlene Smith and Aaron Nicodemus, More human guinea pigs for virodene at http://www.sn.apc.org/wmail/issues/990319/NEWS1.htm
3. Lurie Peter and Wolfe Sidney M, Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries, 337 New Engl J Med 853-56 (1997).
4. See Michael D. Lemonick and Andrew Goldstein, At your own risk, Time: New York 46 (April 22,2002).
5. A. S. Hornby, Oxford Advanced Learner's Dictionary of Current English 1025 (6th impression 2000).
6. Robert J. Levine, Ethics and Regulation of Clinical Research 26 (1st ed 1981).
7. Eileen Welsome, The plutonium experiment, Albuquerque Trib., (1993).
8. George J. Annas, Questing for grails: Duplicity, betrayal, and self-deception in postmodern medical research, 12 J Contemp H L & Pol'y 297, 305 (1996).
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12. Charles Weijer, The ethical analysis of risk, 28 J. L. Med. & Ethics 344 at 348 (2000).
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17. Mark Rothstein, Genetic Secrets: Protecting Privacy and Confidentiality in the Genetic Era 281 at 282 (1997).
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19. Jillian Green Aids worker killing fiasco under review, The Mercury (August 31 1999).
20. (1) SA 1 CC (2000).
21. Guideline 1.2(D) provides: "A risk-benefit analysis of the study should precede the conduct of research. Risk-benefit analysis should take cognisance of benefits and harms beyond the life of the study itself, particularly in the case of chronic life threatening conditions. Alternate ways of providing benefits to the patients might be available without research; thus the distinction between the probability of harm and the possible benefits of the effects must be made. The principal investigator has the ethical duty of excluding participants who are at undue risk."
22. See The nuremberg code (1947) In A Mitscherlich and F Mielke, Doctors of Infamy: The Story of the Nazi Medical Crimes xxiii-xxv (1949).
23. The treatment of research subjects as objects of study continues to prevail despite the criticism it generates. In 2000, shortly after the U.S. drug trial was criticized for not providing HIV positive pregnant women with drugs to prevent transmission of this disease to the child during birth, scientists from the U.N. AIDS Program launched similar studies in South Africa, Uganda and Tanzania to see whether babies whose mothers are HIV positive could be protected from HIV infection with low-cost drug therapy See Lurie Peter and Wolfe Sidney M note 4 and Michael D Lemonick, Good news at a price, New York Times 64 (Feb 15 1999).
24. Baruch A Brody, The Ethics of Biomedical Research: An International Perspective 31 (1998).
25. George J Annas, supra note 8 at 303.
26. The Declaration of Helsinki was adopted by the 18th World Medical Association General Assembly in 1964 at Helsinki, Finland. The aim of the Declaration was to develop a statement of ethical principles to provide guidance to physicians in medical research involving human beings. The Declaration has been amended five times, the last time being in 2000 at the World Medical Association General Assembly held at Edinburgh, Scotland.
27. CIOMS is an international, non governmental organization established by WHO and UNESCO in 1949 to represent international organization in the field of biomedical science. Among its main objectives, it is intended to facilitate and promote international activities in the field of biomedical sciences, especially when the participation of several international associations and national institutions is deemed necessary and to serve the scientific interests of the international biomedical community in general. Since its inception, it has issued Proposed Ethical Guidelines (1982) which was superseded by International Ethical Guidelines for Biomedical Research Involving Human Subjects (1993). As the 1993 version is currently being updated, discussion will be given to the Revised Draft even though itis not yet finally approved. Of importance between CIOMS guidelines and the Declaration of Helsinki is that the former attempts to
28. Kevin M King, A proposal for the effective international regulation of biomedical research involving human subjects, 34 Stan. J. Int'l L. 163 at 185 (1998).
29. Principle five of the Declaration of Helsinki.
30. Guidelines four of CIOMS.
31. See Department of Health (US), Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, 4 (April 18 1979) under the principle of beneficience.
32. Claude Barnard, An Introduction for the Study of Experimental Medicine 99 (1957).
33. Edmund D Pellegrino and David C Thomasma, For the Patient's Good: The Restoration of Beneficence in Health Care 26 (1988).
34. Peter A Clark, Placebo surgery for Parkinson's diseases: Do the benefits outweight the risk?, 30 J.L. Med. & Ethics 58 at 63 (2002).
35. George P Smith, Biomedicine and bioethics: De Lege Latta, De Lege
36. Ferenda "The law today, as laid down; and what tomorrow may bring", J Contemp HL & Pol'y 233 at 244 (1993).
37. See Principle 16 of Declaration of Helsinki.
38. Sharon Hoffmann, The use of placebo in clinical trials: Responsible research or unethical practice, 33 Conn. L. Rev. 449, 478 (2001).
39. Dale L. Moore, An IRB member's perspective on access to innovative therapy, 57 Alb. L. Rev. 559, 572 (1994) who argus that it would be unjust to exclude a vulnerable population from research that can be carried out only on vulnerable persons because it is directed at the condition from which suffer.
40. Samuel Hellman, The patient and the public good, 1 Nature Medicine 400 at 402 (1997).
41. Parkinson disease is defined as a disordered of motor function characterized by tremor, rigidity, bradykinesia, gait disturbances and postural instability - see T. Freedman et al, Use of placebo surgery in controlled trials of a cellular-based therapy for Parkinson's disease, 341 N Engl J. Med. 988 (1999).
42. C W Olanow, A 61-year old man with Parkinson's disease, 275 JAMA 716 at 722 (1996).
43. B. Freedman, Equipoise and the ethics of clinical research, 317 N. Engl. J Med 141 (1987).
44. F. Gifford, Uncertainty about clinical equipoise, 322 BMJ 795 (2001);
45. V M Gordon, et al., Toward a more comprehensive approach to protecting human subjects: The interface of data safety monitoring boards and institutional review boards in randomized clinical trials, 20 IRB 1 (1998).
46. See C. Weijer, et al., Clinical equipoise and not the uncertainity principle is the moral underpinning of the randomized controlled trial, 321 BMJ 756-758 (2000).
47. R J Levine, Clinical trials and physicians as double agents, 65 Yale Journal of Biology and Medicine 66 (1992).
48. Pilar N Ossorio, Pills, bills and shills: Physician-researcher's conflict of interest, VIII Widener Law Symposium Journal 75-103 (2001).
49. This is an acknowledgement of the reality of statement made by J C Smuts, Africa and Some World Problems 53 (1930), when he said the devil of Africa is ... disease, with which only medical science can cope properly.
50. Supra note 36 at 106.
51. See Richard Horton, The new public health of risk and radical engagement, 352 The Lancet 251-252 (1998). "There are other issues in public health where the precautionary principle does not operate but could- e.g. food safety, pharmaceutical regulation, cigarette advertising and regulations about alcohol intake among car drivers,"
52. See Dr. Hans JoachimsPriess and Dr. Christian Pitschas, Protection of public health and the role of the precautionary principle under WTO Law: A trojan horse before Geneva's walls?, 24 Fordham Int'l L. J. 519-520 (2000). For example the European Community (EC) has relied on this principle in EC Measure Concerning Meat and Meat Products (Hormones).
53. Francois Ewald, The return of the crafty genius: An outline of a philosophy of precaution, 6 Conn. Ins. L.J. 47 (1999/2000).
54. See Principle 17.
55. Charmian Barton, The Status of the precautionary principle in Australia: Its emergence in legislation and as a common law doctrone, 22 Harv. Envtl. L. Rev 510 (1998).
56. Robert Steinbrook, Protecting research subjects - The crisis at Johns Hopkins, 343 New Engl. J Med. 716 at 718 (2002).