Going from principles to rules in research ethics

Bioethics

Volumn 25, Issue 1, 2011, Pages 9-20

  Sachs, Benjamin ^a  

^a NEW YORK UNIVERSITY   (United States)

Author keywords

Belmont report; Beneficence; Declaration of Helsinki; Justice; Nuremberg code; Research ethics; Respect for persons

Indexed keywords

ARTICLE; BENEFICENCE; DEVELOPING COUNTRY; ETHICS; HUMAN; HUMAN EXPERIMENT; INTERNATIONAL COOPERATION; MEDICAL ETHICS; METHODOLOGY; PATIENT RIGHT; PERSONHOOD; PERSUASIVE COMMUNICATION; RESEARCH ETHICS; SOCIAL JUSTICE;

BENEFICENCE; CODES OF ETHICS; COERCION; DEVELOPING COUNTRIES; ETHICS, RESEARCH; HUMAN EXPERIMENTATION; HUMANS; INTERNATIONAL COOPERATION; PATIENT RIGHTS; PERSONHOOD; RESEARCH DESIGN; SOCIAL JUSTICE;

EID: 78650257733     PISSN: 02699702     EISSN: 14678519     Source Type: Journal    
DOI: 10.1111/j.1467-8519.2009.01744.x     Document Type: Article

References (40)

1. I would like to thank Margaret Little, Alan Wertheimer, Frank Miller and Dave Wendler for reading previous drafts of this paper and providing excellent comments.
2. Policy of the World Medical Association. [Accessed 3 Dec 2008].
3. Policy of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. [Accessed 10 Jan 2008].
4. Bethesda, Maryland: 2001. [Accessed 10 Jan 2008].
5. Food and Drug Administration, 'Guidance for Institutional Review Boards and Clinical Investigators,' 1998 Update. [Accessed 10 Jan 2008].
6. Office of Human Subjects Research, National Institutes of Health. Information Sheet 20 - Guidelines for Remuneration of Research Subjects in the Intramural Research Program and Registration in the Clinical Research Volunteer Databases. [Accessed 8 April 2008].
7. E. Emanuel, D. Wendler & C. Grady. What Makes Clinical Research Ethical? JAMA 2000; 283(20): 2701-2711 at 2705.
8. R. Macklin. The Paradoxical Case of Payment as Benefit to Research Subjects. IRB 1989; 11(60): 1-3.
9. A.R. Feinstein & J.L. Lichtenstein. 1978. Medical Ethics and the Architecture of Clinical Research. Appendix to Belmont Report, Vol. I. Washington. DC: US Government Printing Office. DHEW Publication No. (OS) 78-0013 Part 9: 33-34.
10. R.J. Levine. 1986. Ethics and Regulation of Clinical Research. 2nd edn. New Haven, Conn: Yale University Press: 20.
11. I do not mean to suggest that there can never be a reasonable expectation in the absence of a behavior or practice that prompts it. I do think, however, that any expectation as specific as the one under consideration here - the expectation that some doctor be engaged in scientific research - is unreasonable in such an absence. It seems to me only that the most basic expectations, expectations of decent and moral conduct, are reasonable no matter what has actually occurred.
12. CIOMS. op. cit. note 5, Guideline 1.
13. Diamonds have more useful purposes too, but all I need for my point to go through is that some diamonds are mined just for jewelry.
14. CIOMS, op. cit. note 5; Nuremberg Code op. cit. note 2, Directive 3; Emanuel et al., op. cit. note 9, p. 2704; D.D. Rutstein. 1969. The Ethical Valid Design of Human Experiments. In Experimentation with Human Subjects. Paul Freund, ed. New York: Braziller Daedalus Library: 383-401; Levine, op. cit. note 12.
15. CIOMS. op. cit. note 5, General Ethical Principles.
16. At least Belmont doesn't endorse maximization in its 'Applications' section alongside its endorsement of Risk Minimization. It does mention maximization in its 'Basic Ethical Principles' section without criticizing or rejecting it.
17. While it may appear at first that Post-Trial Access does not qualify as a rule that applies to investigators vis-à-vis their treatment of subjects, I want to insist that it does. Granted, the obligation to fund post-trial access will usually fall to the study sponsor, as NBAC points out, since the investigator herself will generally lack the funds to pay for the post-trial interventions. However, the rule itself is supposed to be enforced by IRBs - bodies that control the behavior of investigators, not sponsors. The idea behind the rule, therefore, must be that investigators have an obligation to their subjects to ensure that the sponsor provides them (the subjects) with post-trial access to control or experimental interventions. If investigators had no obligations to subjects related to post-trial access, it would be wrong to constrain their behavior in the way the Declaration of Helsinki encourages IRBs to do.
18. I will ignore the corollary of Post-Trial Access that is found in the Declaration of Helsinki, CIOMS and NBAC: the requirement to make any benefits of the study reasonably available to members of the community from which subjects were drawn. I ignore his rule because it is not concerned with the investigator vis-à-vis her treatment of her subjects.
19. NBAC, op. cit. note 6, pp. 58-59.
20. For the reciprocity-based argument, see NBAC, op. cit. note 6, pp. 59-61. For the non-Exploitation-based argument, see L.H. Glantz et al. Research in Developing Countries: Taking 'Benefit' Seriously. Hastings Cent Rep 1998; 28(6): 38-42, reprinted in Ethical Issues in Modern Medicine. 6th edn. 2003. B. Steinbock et al., eds. New York: McGraw-Hill: 781-786
21. G.J. Annas & M.A. Grodin. Human Rights and Maternal-Fetal HIV Transmission Prevention Trials in Africa. Am J Public Health 1988; 88: 560-563.
22. One might use the principle of beneficence in a very straightforward argument for the claim that investigators ought to guarantee post-trial access to subjects. (There is a hint of such an argument in NBAC, p. 60.) However, that argument, too, would fall prey to this objection.
23. A. Wertheimer. 1996. Exploitation. Princeton, N.J.: Princeton University Press.
24. CIOMS, op. cit. note 5, General Ethical Principles - Justice; R. Macklin. 2004. Double Standards in Medical Research in Developing Countries. Cambridge: Cambridge University Press: ch. 4.
25. Several commentators are indeed worried that the offer of post-trial access might constitute undue inducement. See: Nuffield Council. 2002. The Ethics of Research Related to Healthcare in Developing Countries. London: Nuffield Council; Pharmaceutical Research and Manufacturers of America. 2001. PhRMA Discussion Paper on the Declaration of Helsinki as Revised in October 2000. Relatedly, Emily Bass of the International AIDS Vaccine Initiative quotes Charles Weijer as saying that a promise of ancillary care can constitute an undue inducement. [Accessed 12 Mar 2008]. For a contrasting viewpoint, see NBAC, op. cit. note 6, pp. 46-48, and Macklin, op. cit. note 24, pp. 122-127.
26. NBAC, op. cit. note 6, p. 60. NBAC does not defend its claim.
27. E. Emanuel. Undue Inducement: Nonsense on Stilts?. Am J Bioeth 2005; 5(5): 9-13.
28. The distinction between the two kinds of incommensurability is nicely explained in Ruth Chang. 1997. Introduction. In Incommensurability, Incomparability, and Practical Reason. Ruth Chang, ed. Cambridge, Mass.: Harvard University Press: 1-34.
29. Risk Payment is not explicitly endorsed in any of the canonical ethical pronouncements (I count the FDA's information sheets as policy pronouncements), yet in my view it still qualifies as a canonical rule. As indicate in Table 1 and in footnote 33, the rule is endorsed by several commentators. Furthermore, there is not a single published criticism of it. Finally, the Belmont Report and CIOMS can, I believe, be read as implicitly endorsing Risk Payment.
30. CIOMS, op. cit. note 5, Guideline 8; Declaration of Helsinki, op. cit. note 3, Principle 16; The Belmont Report, op. cit. note 4, Part C2; Nuremberg Code, op. cit. note 2, Directive 6: 45 Code of Federal Regulations 46:111a(2).
31. CIOMS, op. cit. note 5, General Ethical Principles - Respect for Persons; Belmont Report, op. cit. note 4, Part B1.
32. G. McGee. A Piece of My Mind: Subject to Payment. JAMA 1997; 278(3): 199-200. For a similar argument, see T.F. Ackerman. An Ethical Framework for the Practice of Paying Research Subjects. IRB 1989; 11(4): 1-4.
33. Emanuel, op. cit. note 27.
34. Thanks to Alan Wertheimer and an anonymous reviewer for pressing me to address this argument.
35. This phrase is taken from Derek Parfit, 1987. Reasons and Persons. Oxford: Oxford University Press: 159.
36. E. Chwang. Against the Inalienable Right to Withdraw from Research. Bioethics 2008; 22(7): 370-378.
37. I thank an anonymous reviewer for pressing me to address this argument, specifically, and more generally the issue of prima facie rules.
38. The distinction between hard and soft paternalism was originally elucidated by Joel Feinberg. 1986. Harm to Self. New York: Oxford University Press: 12-16.
39. The rule requiring that risks to subjects be offset by potential benefits to them and to society. See footnote 31.
40. B. Sachs. The Exceptional Ethics of the Investigator-Subject Relationship. Journal of Medicine & Philosophy, forthcoming.