A normative justification for distinguishing the ethics of clinical research from the ethics of medical care

Journal of Law, Medicine and Ethics

Volumn 33, Issue 3, 2005, Pages 566-574

  Litton, Paul ^a   Miller, Franklin G ^a  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 27544482107     PISSN: 10731105     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2005.tb00519.x     Document Type: Review

References (41)

1. See e.g., J. Sugarman, "Using Empirical Data to Inform the Ethical Evaluation of Placebo Controlled Trials," Science and Engineering Ethics 10 (2004): 29-35;
2. F. G. Miller and H. Brody, "What Makes Placebo-Controlled Trials Unethical?" American Journal of Bioethics 2, no. 2 (2002): 3-9;
3. R. M. Veatch, "Subject Indifference and the Justification of Placebo-Controlled Trials," American Journal of Bioethics 2, no. 2 (2002): 12-13;
4. T. Lemmens and P. B. Miller, "Avoiding a Jekyll-And-Hyde Approach to the Ethics of Clinical Research and Practice," American Journal of Bioethics 2, no. 2 (2002): 14-17;
5. E. J. Emanuel and F. G. Miller, "The Ethics of Placebo-Controlled Trials - A Middle Ground," N. Engl. J. Med. 345 (2001): 915-19;
6. B. Freedman, K. C. Glass, C. Weijer, "Placebo Orthodoxy in Clinical Research II: Ethical, Legal, and Regulatory Myths," Journal of Law, Medicine & Ethics 24 (1996): 252-59.
7. See e.g., 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;
8. C. Weijer and P. B. Miller, "Therapeutic Obligation in Clinical Research," Hastings Center Report 33, no. 3 (2003): 3.
9. P. Clark, "Placebo Surgery For Parkinsons Disease: Do the Benefits Outweigh the Risks?" Journal of Law, Medicine & Ethics 30 (2002): 58-68, at 62.
10. World Medical Association, "Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects," adopted in 1964 and amended in 1975, 1983, 1989, 1996, and 2000, reprinted in JAMA 284 (2000): 3043-45.
11. T. Lemmens and P.B. Miller, supra note 1.
12. Id. at 14, 15. David Steinberg similarly questions the ethical relevance of the divergent goals of research and care: "The dominant goals of clinical research and clinical care may differ; however, the existence of a goal does not suffice as its moral justification." D. Steinberg, "Clinical Research should not be Permitted to Escape the Ethical Orbit of Clinical Care," American Journal of Bioethics 2, no. 2 (2002): 27-28, at 27.
13. P. B. Miller and C. Weijer, "Rehabilitating Equipoise," Kennedy Institute of Ethics Journal 13 (2003): 93-118, at 110-11.
14. T. M. Scanlon, What We Owe To Each Other (Cambridge, MA: Harvard University Press, 1998).
15. Id. at 4.
16. Id. at 106.
17. R. Kumar, "Reasonable Reasons in Contractualist Moral Argument," Ethics 114, no. 1 (2003): 6-37, at 14.
18. Id. at 14.
19. Id. at 14; Scanlon, supra note 8, at 204, 251.
20. E. J. Emanuel et al., "Scandals and Tragedies of Research with Human Participants (Introduction to Part I)," in E. J. Emanuel et. al., eds., Ethical and Regulatory Aspects of Clinical Research (Baltimore: The Johns Hopkins University Press, 2003): 1-5, at 1.
21. E. J. Emanuel et al., "Preface," in E. J. Emanuel et. al. eds., Ethical and Regulatory Aspects of Clinical Research (Baltimore: The Johns Hopkins University Press, 2003): xv-xviii, at xv.
22. For a discussion of the different legal duties that should guide clinical research and practice, respectively, based on the different ethical duties supported by the distinctive goals of those enterprises, see E. H. Morreim, "Litigation in Clinical Research: Malpractice Doctrines Versus Research Realities," Journal of Law, Medicine & Ethics 32 (2004): 474-484.
23. E. J. Emanuel, D. Wendler, and C. Grady, "What Makes Clinical Research Ethical?" JAMA 283 (2000): 2701-2711.
24. Id. at 2701- 2702. These documents include the Nuremberg Code, the Declaration of Helsinki, the Belmont Report, International Guidelines for Biomedical Research Involving Human Subjects, as well as others.
25. Id. at 2701, citing R. J. Levine, Ethics and Regulation in Clinical Research, 2nd ed. (New Haven: Yale University Press, 1988).
26. F. G. Miller and H. Brody, supra note 1.
27. E. J. Emanuel, D. Wendler, and C. Grady, supra note 17, at 2708.
28. Ibid.
29. K. C. Glass, Letter to the Editor, "Clinical Equipoise and the Therapeutic Misconception," Hastings Center Report 33, no. 5 (2003): 5-6, at 5.
30. B. Freedman, K. C. Glass, C. Weijer, supra note 2, at 253.
31. Steinberg, supra note 6, at 27.
32. Scanlon, supra note 8, at 248-56.
33. Id. at 252.
34. Id. at 253.
35. So, for example, Rousseau argues that a choice to become a slave should not be respected precisely because it is irrational or unacceptably foolish: Now, since, in the relations between men, the worst that can happen to someone is for him to see himself at the discretion of someone else, would it not have been contrary to good sense to begin by surrendering into the hands of a leader the only things for whose preservation they needed his help? What equivalent could he have offered them for the concession of so fine a right? J. J. Rousseau, "Discourse on the Origin of Inequality," in D. A. Cress, trans., Basic Political Writings (Indianapolis: Hackett Publishing, 1987): at 72. Steinberg, in fact, makes this argument, stating that "no rational person would sign" a consent form that informed a potential subject that the ethics governing the protocol deviated from the ethics of medical care. Steinberg, supra note 6, at 27.
36. P. S. Appelbaum, T. Grisso, E Frank, et al., "Competence of Depressed Patients for Consent to Research," American Journal of Psychiatry 156 (1999): 1380-84.
37. E. J. Emanuel and F. G. Miller, supra note 2; B. Freedman, K. C. Glass, C. Weijer, supra note 2.
38. P. S. Appelbaum C. W. Lidz, T. Grisso, "Therapeutic Misconception in Clinical Research: Frequency and Risk Factors," IRB 26, no. 2 (2004): 1-8.
39. F. G. Miller and D. L. Rosenstein, "The Therapeutic Orientation to Clinical Trials," N. Engl. J. Med. 348 (2003): 1383-86.
40. World Medical Association, supra note 4.
41. P. S. Appelbaum, "A Theory of Ethics for Forensic Psychiatry," The Journal of the American Academy of Psychiatry and the Law 25 (1997): 233-247, at 239.