Research on human subjects, exploitation, and global principles of ethics

Interdisciplinary Science Reviews

Volumn 25, Issue 4, 2000, Pages 298-306

  Harris, John ^a  

^a UNIVERSITY OF MANCHESTER   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 0042724884     PISSN: 03080188     EISSN: None     Source Type: Journal    
DOI: 10.1179/030801800679323     Document Type: Article

References (46)

1. M. ANGELL: 'The ethics of clinical research in the third world', New England J. Med., 1997, 337, 18 September. See also the symposium on HIV/AIDS vaccines in Bioethics, 1998, 12, (4).
2. M. ANGELL: 'The ethics of clinical research in the third world', New England J. Med., 1997, 337, 18 September. See also the symposium on HIV/AIDS vaccines in Bioethics, 1998, 12, (4).
3. 'Twenty years after: the legacy of the Tuskegee syphilis study', Hastings Centre Rep., 1992, 22, (6), 339-342.
4. B. R. BLOOM: 'The highest attainable standard: vexed ethical issues in AIDS vaccines', Science, 1998, 279, 9 January, 186-188.
5. S. HOLM and J. HARRIS: 'Is the precautionary principle valid?', correspondence in Nature, in press.
6. For other examples of this phenomenon and its problematic consequences see J. HARRIS: 'Goodbye Dolly: the ethics of human cloning', J. Med. Ethics, 1997, 23, 353-360; 'Cloning and human dignity', Cambridge Q. Healthcare Ethics, 1998, 7, 163-168; and 'Genes, clones and human rights', in 'The genetic revolution and human rights: the Amnesty Lectures 1998', (ed. Justine C. Burley); 1999, Oxford, Oxford University Press.
7. For other examples of this phenomenon and its problematic consequences see J. HARRIS: 'Goodbye Dolly: the ethics of human cloning', J. Med. Ethics, 1997, 23, 353-360; 'Cloning and human dignity', Cambridge Q. Healthcare Ethics, 1998, 7, 163-168; and 'Genes, clones and human rights', in 'The genetic revolution and human rights: the Amnesty Lectures 1998', (ed. Justine C. Burley); 1999, Oxford, Oxford University Press.
8. For other examples of this phenomenon and its problematic consequences see J. HARRIS: 'Goodbye Dolly: the ethics of human cloning', J. Med. Ethics, 1997, 23, 353-360; 'Cloning and human dignity', Cambridge Q. Healthcare Ethics, 1998, 7, 163-168; and 'Genes, clones and human rights', in 'The genetic revolution and human rights: the Amnesty Lectures 1998', (ed. Justine C. Burley); 1999, Oxford, Oxford University Press.
9. A third contentious type of clinical research on HIV concerns 'the ethics of ongoing trials in the Third World of regimens to prevent the vertical transmission of... HIV infection. All except one of the trials employ placebo-treated control groups, despite the fact that Zidovudine has already been clearly shown to cut the rate of vertical transmission greatly...' (M. ANGELL: 'The ethics of clinical research in the third world', New England J. Med., 1997, 337, 18 September). The ethics of this sort of trial raise different issues with which we will not here be directly concerned.
10. This treatment is by no means indicated in all cases of HIV infection. In the UK, for example, in cases in which CD4 count remains high and viral load is low, ARV combination therapy is not routinely offered.
11. Oral evidence given at a meeting of the working party for the joint WHO/UN programme on HIV/AIDS (UNAIDS), Geneva, 25-26 June 1998.
12. For example, different clades (varieties) of the virus may be dominant in different regions of the world and it might not be possible to guarantee that the infrastructure which could deliver complicated and expensive therapy during a trial would be maintained (or be maintainable) thereafter. See H. VARMUS and D. SATCHER: 'Ethical complexities of conducting research in developing countries', New England J. Med., 1997, 337, 2 October.
13. Article 1.5 and article II.3 of the World Medical Association Declaration of Helsinki as amended by the 48th General Assembly, Somerset West, Republic of South Africa, October 1996.
14. C. GILKS, B. BIRYAWAHO, J. DARBYSHIRE, N. FRENCH, E. KATABIRA, P. KALEEBU, J. WEBER, and J. WHITWORTH: draft proposal, May 1998. I have drawn on this proposal at a number of points in this paper.
15. 'Twenty years after: the legacy of the Tuskegee syphilis study', Hastings Centre Rep., 1992, 22, (6), 29-40.
16. Here, as elsewhere, I am grateful for the expert advice of Søren Holm.
17. It makes similarly little sense to question the ethics of a railway system characterised by the punctuality of its trains on the basis that the Nazis (allegedly) made the trains run on time (which is sometimes cited in mitigation of fascism). The invocation of such principles was definitively lampooned by F. M. Cornford in 1908: 'The principle is that a few bad reasons for doing something neutralise all the good reasons for doing it.' (F. M. CORNFORD: 'Microcosmographia academica', chapter VIII; 1908, Cambridge, Bowes and Bowes).
18. 1993, Geneva, Council for International Organizations of Medical Sciences (CIOMS).
19. See M. ANGELL: 'The ethics of clinical research in the third world' (Note 1).
20. Here the argument echoes my 'Ethical genetic research on human subjects', Jurimetrics, 1999, 40, (1).
21. See for example J. HARRIS: 'The ethics of clinical research with cognitively impaired subjects', Italian J. Neurol. Sci., 1997, 18, 9-15.
22. And may also have specific contractual duties to them.
23. I wish to acknowledge explicitly that this paper does not examine certain pertinent questions of detail concerning the kind of information that ought to be given to any subject participating in the research. See also my article in Jurimetrics cited in Note 17.
24. For example in cases of research on young children, mental patients, and others whom it is reasonable to assume may not be adequately competent.
25. This is generally acknowledged as one of the major principles of bioethics if not of ethics more generally. See J. HARRIS: 'Violence and responsibility'; 1980, London, Routledge, Kegan Paul, and T. L. BEAUCHAMP and J. F. CHILDRESS: 'Principles of biomedical ethics', 4th edn; 1994, New York, NY, Oxford University Press.
26. This is generally acknowledged as one of the major principles of bioethics if not of ethics more generally. See J. HARRIS: 'Violence and responsibility'; 1980, London, Routledge, Kegan Paul, and T. L. BEAUCHAMP and J. F. CHILDRESS: 'Principles of biomedical ethics', 4th edn; 1994, New York, NY, Oxford University Press.
27. B. R. BLOOM: 'The highest attainable standard: vexed ethical issues in AIDS vaccines' (Note 3).
28. Here I assume that this symmetry is self-evident. I have argued this point in 'The Marxist conception of violence', Philosophy & Public Affairs, 1974, 3, (2) and in 'Violence and responsibility'; 1980, London, Routledge/Kegan Paul.
29. Here I assume that this symmetry is self-evident. I have argued this point in 'The Marxist conception of violence', Philosophy & Public Affairs, 1974, 3, (2) and in 'Violence and responsibility'; 1980, London, Routledge/Kegan Paul.
30. See 'Violence and responsibility' (Note 24).
31. I have omitted discussion of whether or not issuing free condoms to participants should be part of the obligation to protect subjects.
32. See J. HARRIS: 'Ethical issues in geriatric medicine', in 'Textbook of geriatric medicine and gerontology', (ed. R. C. Tallis, J. C. Brockelhurst, and Howard Fillett), 5th edn; 1998, London, Churchill Livingstone.
33. I use this term in a non-technical sense.
34. Those over 65 may be excused if they wish.
35. I talk here of minimal risk in the sloppy fashion usual in such contexts. However, 'risk' is ambiguous between 'degree of danger' and 'probability of occurrence of danger'. In the case of MMR probability of occurrence is low but danger is high. This of course is not the case in HIV vaccine trials or dose sparing ARV therapy where danger is low and probability of occurrence is low. When set against the facts of living with HIV infection or the high risk of it the research specifically addressed in this paper is less problematic than population 'protection' campaigns with MMR.
36. If these suggestions are broadly acceptable and an obligation to participate in research is established, this may well become one of the ways in which research comes to be funded in the future.
37. If any are.
38. Of course the historical explanation of the Declaration of Helsinki and its concerns lies in the Nuremberg trials and the legacy of Nazi atrocities. However we are, I believe, in real danger of allowing fear of repeating one set of atrocities to lead us into committing other new atrocities.
39. These residual dangers include the difficulties of constructing suitable consent protocols and supervising their administration in rural and isolated communities and in populations which may have low levels of formal education.
40. For a version of this principle applied in the context of genetics see my 'Ethical genetic research on human subjects' (Note 17).
41. As Marcia Angell rightly points out in her New England Journal of Medicine editorial (see Note 1).
42. See R. DWORKIN: 'Taking rights seriously'; 1977, London, Duckworth.
43. The CIOMS gloss on their own guideline creates a kind of catch 22 which is surely unreasonable and unwarranted. Wherever the best proven diagnostic and therapeutic methods are guaranteed by a study in a context or for a population who would not normally expect to receive them, this guideline would be broken. CIOMS guideline 4 therefore surely contradicts and violates not only the Declaration of Helsinki but also its own later guideline 14.
44. See M. WILKINSON and A. MOORE: 'Inducement in research' and P. MCNEILL: 'Paying people to participate in research: why not?', Bioethics, 1997, 11, (5); and also the discussion of commercial exploitation in J. HARRIS: 'Wonderwoman and Superman: the ethics of human biotechnology', chapter 6; 1992, Oxford, Oxford University Press.
45. See M. WILKINSON and A. MOORE: 'Inducement in research' and P. MCNEILL: 'Paying people to participate in research: why not?', Bioethics, 1997, 11, (5); and also the discussion of commercial exploitation in J. HARRIS: 'Wonderwoman and Superman: the ethics of human biotechnology', chapter 6; 1992, Oxford, Oxford University Press.
46. See M. WILKINSON and A. MOORE: 'Inducement in research' and P. MCNEILL: 'Paying people to participate in research: why not?', Bioethics, 1997, 11, (5); and also the discussion of commercial exploitation in J. HARRIS: 'Wonderwoman and Superman: the ethics of human biotechnology', chapter 6; 1992, Oxford, Oxford University Press.