A Non-Paternalistic Model of Research Ethics and Oversight: Assessing the Benefits of Prospective Review

Journal of Law, Medicine and Ethics

Volumn 40, Issue 4, 2012, Pages 930-944

  London, Alex John ^a  

^a CARNEGIE MELLON UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CONFLICT; ETHICS; HUMAN; HUMAN EXPERIMENT; MEDICAL RESEARCH; NONBIOLOGICAL MODEL; ORGANIZATION; ORGANIZATION AND MANAGEMENT; PATERNALISM; PROFESSIONAL STANDARD; SOCIAL BEHAVIOR; SOCIAL JUSTICE; TRUST; UNITED STATES;

BIOMEDICAL RESEARCH; DISSENT AND DISPUTES; ETHICS COMMITTEES, RESEARCH; HUMAN EXPERIMENTATION; HUMANS; MODELS, ORGANIZATIONAL; ORGANIZATIONAL CULTURE; PATERNALISM; SOCIAL JUSTICE; SOCIAL RESPONSIBILITY; TRUST; UNITED STATES;

EID: 84872129305     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2012.00722.x     Document Type: Article

References (40)

1. J. H. Mueller, "Ignorance Is Neither Bliss Nor Ethical, "Northwestern University Law Review 101, no. 2 (2007): 809-836 for the clearest "capture-theoretic" account of research ethics regulation. Mueller argues that the one clear benefit of increased regulation has been "jobs, jobs, jobs" for the research ethics "industry, " going so far as to wonder "if there may not be nearly as many ethics reviewers, regulators, and staff as there are researchers, " and referring to the research ethics enterprise as a "pyramid scheme" (at 820-821).
2. "Trying to unravel the mystery of the social sciences' survival in the face of IRB encroachment is a challenge replete with paradoxes and illusions. The exercise demands that we probe the convergent logics of two mutually exclusive things that must somehow co-exist: creativity and regulation." Later, these authors assert that the survival of any creative research at all must itself be attributed to complicity of researchers with these organs of censorship: "That any creative research at all has survived under the IRB system, distorted as we believe it has become, must be attributed to the dynamics of consensual censorship between investigators and IRBs." C. H. Bledsoe, B. S. Herin, and A. G. Galinsky et al., "Regulating Creativity: Research and Survival in the IRB Iron Cage, "Northwestern University Law Review 101, no. 2 (2007): 593-641, at 597 and 628.
3. Columbia Law School press release dated November 24, 2009 quoting Philip Hamburger.
4. C. Schneider, "Session 2: National Ethics Committees: Mission, Functions, Philosophies, and Modus Operandi, " discussion on March 12, 2009, transcript available at (last visited December 4, 2012).
5. R. E. Malone, V. B. Yerger, C. McGruder, and E. Floelicher, "'It's Like Tuskegee in Reverse': A Case Study of Ethical Tensions in Institutional Review Board Review of Community-Based Participatory Research, " American Journal of Public Health 96, no. 11 (2006): 1914-1919.
6. S. N. Whitney and C. E. Schneider, "Viewpoint: A Method to Estimate the Cost in Lives of Ethics Board Review of Biomedical Research, " Journal of Internal Medicine 269, no. 4 (2011): 392-406.
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10. I am not denying that there are vulnerable individuals or groups in the U.S. who may require special protection in the research context. Rather, the point is that the framework that I propose can ground central aspects of the current system of research oversight without recourse to such claims. It is a separate question whether there is a legitimate role for hard or soft paternalism in research ethics, and an answer in the affirmative would provide reasons to bolster or strengthen some of these mechanisms. Because critics often deny a legitimate role for paternalism, it is important to demonstrate whether, how, and which aspects of research oversight can be justified without recourse to such claims.
11. G. Hardin, "The Tragedy of the Commons, " Science 162, no. 3859 (1968): 1243-1248.
12. Contrast the high-status of research and researchers, and the way that this reflects on institutions that support them, with the low-status of used car salesmen as discussed below.
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23. For recent revelations of the lengths that researchers from the U.S. Public Health Services were willing to go to in order to infect research subjects with Syphilis in the 1940s, see S. M. Reverby, "'Normal Exposure' and Inoculation Syphilis: A PHS 'Tuskegee' Doctor in Guatemala, 1946-48, "Journal of Policy History 23, no. 1 (2011): 6-28.
24. The delay, inconvenience, and possible anxiety caused in research subjects by informed consent is a recurring theme in research scandals of the post-World-War II era. For an excellent case study see J. D. Arras, "The Jewish Chronic Disease Hospital Case, " in E. J. Emanuel, C. Grady, and R. Crouch et al., eds., The Oxford Textbook of Clinical Research Ethics (New York: Oxford University Press, 2008): at 73-79.
25. Indeed, one of the factors that enabled the Tuskegee syphilis study to persist over a 40 year period was the commitment of public health researchers to the idea that understanding the natural history of the disease was of fundamental importance. This professional curiosity persisted even after this information lost any clinical value it may once have had. Moreover, those involved in the study maintained its importance even once it was clear that the study itself had little or no social value. See J. H. Jones, Bad Blood, rev. ed. (New York: Free Press
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31. G. A. Akerlof, "The Market for 'Lemons': Quality Uncertainty and the Market Mechanism, " Quarterly Journal of Economics 84, no. 3 (1970): 488-500.
32. For a discussion of recent cases in which trial data were not published, or were published only years after studies were completed, see J. Fauber, "BMJ: Discipline Researchers Who Withhold Research Results, "MedPage Today, January 3, 2012, available at (last visited December 4, 2012).
33. A. J. London, J. Kimmelman, and M. E. Emborg, "Beyond Access vs. Protection in Trials of Innovative Therapies, " Science 328, no. 5980 (2010): 829-830.
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35. Advisory Committee on Human Radiation Experiments. Final Report of the Advisory Committee on Human Radiation Experiments (New York: Oxford University Press, 1996): at 273.
36. Compare to Philip Pettit's articulation of the civic republican conception of freedom and equal standing: "Being unfree consists in being subject to arbitrary sway: being subject to the potentially capricious will or the potentially idiosyncratic judgment of another. Freedom involves emancipation from any such subordination, liberation from any such dependency. It requires the capacity to stand eye to eye with your fellow citizens, in a shared awareness that none of you has the power of arbitrary interference over another." P. Pettit, Republicanism: A Theory of Freedom and Government (Oxford: Oxford University Press, 1997): at 5.
37. R. Dresser, "Wanted: Single, White Male for Medical Research, " Hastings Center Report 22, no. 1 (1992): 24-29, at 26-27
38. C. Weijer and R. A. Crouch, "Why Should We Include Women and Minorities in Randomized Controlled Trials?"Journal of Clinical Ethics 100, no. 2 (1999): 79-87.
39. 45 C.F.R. § 46.111(a)2 (2009).
40. A. J. London, J. Kimmelman, and B. Carlisle, "Rethinking Research Ethics: The Case of Postmarketing Trials, " Science 336, no. 6081 (2012): 544-545.