The ethics of altruism in clinical research

Hastings Center Report

Volumn 39, Issue 4, 2009, Pages 26-36

  Jansen, Lynn A ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ALTRUISM; MEDICAL CARE; MEDICAL DECISION MAKING; MEDICAL EDUCATION; MEDICAL ETHICS; MEDICAL RESEARCH; PATERNALISM; REVIEW; ARTICLE; CLINICAL TRIAL; ETHICS; HIGH RISK BEHAVIOR; HUMAN; PSYCHOLOGICAL ASPECT; RESEARCH SUBJECT;

ALTRUISM; CLINICAL TRIALS AS TOPIC; HUMANS; PATERNALISM; RESEARCH SUBJECTS; RISK-TAKING;

EID: 70349579722     PISSN: 00930334     EISSN: 1552146X     Source Type: Journal    
DOI: 10.1353/hcr.0.0164     Document Type: Review

References (44)

1. See J. Harris, "Scientific Research Is a Moral Duty, "Journal of Medical Ethics 31(2005):242-48.
2. For a discussion of the history, see A. L. Caplan, "Is There a Duty to Serve as a Subject in Biomedical Research? "IRB: A Review of Human Subjects Research 6, no. 5(1984):1-5.
3. P. S. Appelbaum et al., "False Hopes and Best Data: Consent to Research and the Therapeutic Misconception, "Hastings Center Report 12, no. 2(1987):20-24.
4. See also S. Horng and C. Grady, "Misunderstanding in Clinical Research: Distinguishing Therapeutic Misconception, Therapeutic Misestimation, and Therapeutic Optimism, "" IRB: Ethics & Human Research 25, no. 2(2003):11-16.
5. See C. Swanton, Virtue Ethics: A Pluralistic View (Oxford, U. K.: Oxford University Press, 2003), 128-60.
6. That altruistic behavior requires the presence of this kind of motive is consistent with how the term is used in ordinary English. It also fits well with how the term is used by moral philosophers. There are other characterizations of altruism, however. In the biological literature, altruism is sometimes construed in terms of "fitness-sacrificing" behavior-that is, acting in a manner that sets back one's own reproductive fitness for the sake of advancing the reproductive fitness of another. Altruism is also sometimes identified simply with helpful self-sacrificing behavior. For a critical discussion of these alternative characterizations of altruism, see R. Joyce, The Evolution of Morality (Cambridge, Mass.: MIT Press, 2007), 13-19.
7. S. Joffe et al., "Altruism among Participants in Cancer Clinical Trials, "Proceedings of the American Society of Clinical Oncology 22(2003):523, abstract 2103.
8. See A. Mele, Motivation and Agency (Oxford, U. K.: Oxford University Press, 2003), 22-23.
9. See S. Joffe and F. G. Miller, "Rethinking Risk-Benefit Assessment for Phase I Cancer Trials, "Journal of Clinical Oncology 24, no. 19(2006):2987-90;
10. see also R. J. Levine, Ethics and Regulation of Clinical Research, second ed. (New Haven, Conn.: Yale University Press, 1988), 8-10.
11. Determining whether a clinical trial offers participants a reasonable expectation of direct therapeutic benefit is far from an easy or straightforward matter. For an excellent discussion of some of the difficulties and uncertainties involved in making these assessments, see N. M. P. King, "Defining and Describing Benefit Appropriately in Clinical Trials, "Journal of Law, Medicine and Ethics 28 (2000), 332-43.
12. F. G. Miller, "Ethical Issues in Research with Healthy Volunteers: Risk-Benefit Assessment, "Clinical Pharmacology and Therapeutics 74, no. 6(2003):513-15.
13. While it is widely thought that participation in early-phase oncology trials offers participants no reasonable expectation of direct therapeutic benefit, there is some recent debate on the matter. Compare M. Agrawal and E. Emanuel, "Ethics of Phase I Oncology Studies: Reexamining the Arguments and Data, "Journal of the American Medical Association 290(2003):1075-82;
14. Joffe and Miller, "Rethinking Risk-Benefit Assessment for Phase I Cancer Trials, "and King, "Defining and Describing Benefit Appropriately in Clinical Trials." "
15. E. Emanuel, D. Wendler, and C. Grady, "What Makes Clinical Research Ethical? "Journal of the American Medical Association 283(2000):2701-2711.
16. 45 CFR 46. 111a (2).
17. We should allow for the unlikely possibility that a person might give valid, rational consent to participate in a clinical trial that offers no reasonable expectation of direct therapeutic benefit, even if she has no altruistic motive for doing so. For all we know, she might have idiosyncratic preferences. (On this matter, see J. Feinberg, Harm to Self [New York: Oxford University Press, 1986], 106-113, on the distinction between a rational and a "reasonable" decision.) Be this as it may, I shall not discuss this kind of case further.
18. F. G. Miller and H. Brody, "A Critique of Clinical Equipoise: Therapeutic Misconception in the Ethics of Clinical Trials, "Hastings Center Report 33, no. 3(2003):19-28.
19. See J. Feinberg, Harmless Wrongdoing (New York: Oxford University Press, 1988), 177: "exploitation of a person is normally a way of using someone for one's own ends, which is somehow wrongful or blameworthy, whether it wrongs the other person or not."
20. See also A. Wertheimer, Exploitation (Princeton, N. J.: Princeton University Press, 1996), 207: "An exploitative transaction is one in which A takes unfair advantage of B. "
21. A known level of risk would include both an understanding of the likelihood (probability) that a harm will result and an understanding of its magnitude. See Levine, Ethics and the Regulation of Clinical Research, 37.
22. For the purpose of the thought experiment, we can assume that the trial would be scientifically valid whether it was conducted at one or both sites-even though there would be advantages to conducting the trial at both sites.
23. F. G. Miller and A. Wertheimer, "Facing Up to Paternalism in Research Ethics, "Hastings Center Report 37, no. 3(2007):24-34, at 32.
24. For examples of researchers experimenting on themselves, see C. Fried, Medical Experimentation: Personal Integrity and Social Policy (Amsterdam, the Netherlands: North-Holland Publishing Company, 1974), 167-68.
25. D. Parfit, Reasons and Persons (Oxford, U. K.: Clarendon Press, 1984).
26. See also J. Griffin, Well-Being: Its Meaning, Measurement, and Moral Importance (Oxford, U. K.: Clarendon Press, 1986)
27. and T. M. Scanlon, What We Owe to Each Other (Cambridge, Mass.: Harvard, 1998).
28. J. Rachels, The Elements of Moral Philosophy, third ed. (Boston, Mass.: McGraw- Hill College, 1999).
29. Scanlon, What We Owe to Each Other, 133.
30. Parfit, Reasons and Persons, 495.
31. Parfit uses the example to cast doubt on the desire-fulfillment approach to wellbeing.
32. Charles Fried pressed this point in his early book on research ethics. The researcher-participant relationship becomes less ethically problematic if it is"a joint venture" rather than a transaction in which one party uses the other to advance his or her purposes. See Medical Experimentation: Personal Integrity and Social Policy, 166-72.
33. Wertheimer makes a similar point in discussing exploitation and surrogacy contracts. He notes that commercial surrogacy gives rise to concerns about exploitation since it is a transaction between the involved parties. However, if a woman altruistically gives her child to another party, then it is not a transaction. Norms of fair benefit do not apply, and so altruistic, noncommercial surrogacy does not invite the charge of exploitation. See Wertheimer, Exploitation, 250, note 8.
34. Wertheimer, Exploitation, 209.
35. See R. M. Sorrentino, "Evidence for Altruism: The Lady Is Still Waiting, "Psychological Inquiry 2, no. 2(1991):147-50.
36. L. Wallach and M. A. Wallach, "Why Altruism, Even Though it Exists, Cannot Be Demonstrated by Social Psychological Experiments, "Psychological Inquiry 2, no. 2(1991):153-55.
37. See J. Berg et al., Informed Consent: Legal Theory and Clinical Practice, second ed. (Oxford, U. K.: Oxford University Press, 2001), 297-98. It is also possible that, at least with respect to some possible trials- such as those that study social psychological phenomena-limiting recruitment to altruistic patients would inject bias into the study sample.
38. Feinberg, Harmless Wrongdoing, 176.
39. See also Wertheimer, Exploitation, 247-53.
40. See Miller and Brody, "A Critique of Clinical Equipoise, "and L. A. Jansen," A Closer Look at the Bad Deal Trial: Beyond Clinical Equipoise, "" Hastings Center Report 35, no. 5(2005):29-36.
41. Miller and Wertheimer appreciate the force of this question. They suggest that high-risk research might be ruled out in order to safeguard public confidence and public support for clinical research. This is a sensible concern, but as Miller and Wertheimer acknowledge, it rests on a calculation of benefits and costs. And it is not obvious how this calculation would come out. See "Facing Up to Paternalism in Research Ethics, "32-33.
42. For a range of examples that involve self-abnegation or "loss of self, "see J. Hampton, "Selflessness and Loss of Self, "Social Philosophy and Policy 10, no. 1(1993):135-65.
43. See Feinberg, Harmless Wrongdoing, 207.
44. S. V. Shiffrin makes a similar point in her discussion of the "unconscionability doctrine" in the law. Shiffrin argues that if a judge refuses to enforce an unconscionable contract that was entered into voluntarily by all the parties, then it does not follow that the judge behaves paternalistically. Rather, the judge's concern may be "to avoid complicity with exploitation. "See S. V. Shiffrin, "Paternalism, Unconscionability Doctrine, and Accommodation, "Philosophy and Public Affairs 29, no. 3(2000):230.