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

See Mueller J. H. , “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).

“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.” Bledsoe C. H. Herin B. S. , and Galinsky A. G. , “Regulating Creativity: Research and Survival in the IRB Iron Cage,” Northwestern University Law Review 101, no. 2 (2007): 593–641, at 597 and 628.

Columbia Law School press release dated November 24, 2009 quoting Philip Hamburger.

Schneider C. , “Session 2: National Ethics Committees: Mission, Functions, Philosophies, and Modus Operandi,” discussion on March 12, 2009, transcript available at <http://bioethics.georgetown.edu/pcbe/transcripts/march09/session2.html> (last visited December 4, 2012).

See Bledsoe , supra note 1, at 608 and 610.

Malone R. E. Yerger V. B. McGruder C. , and Floelicher E. , ‘“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.

Whitney S. N. and Schneider C. E. , “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.

See Mueller , supra note 1, at 810.

Hyman D. A. , “Institutional Review Boards: Is This the Least Worst We Can Do?” Northwestern University Law Review 101, no. 2 (2007): 749–774, at 756.

See Mueller , supra note 1, at 832.

Miller F. and Wertheimer A. , “Facing Up to Paternalism,” Hastings Center Report 37, no. 3 (May-June 2007): 24–34; Jansen L. A. and Wall S. , “Paternalism and Fairness in Clinical Research,” Bioethics 23, no. 3 (2009): 172–182.

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.

Hardin G. , “The Tragedy of the Commons,” Science 162, no. 3859 (1968): 1243–1248.

Contrast the high-status of research and researchers, and the way that this refects on institutions that support them, with the low-status of used car salesmen as discussed below.

London A. J. , “Clinical Research in a Public Health Crisis: The Integrative Approach Managing Uncertainty and Mitigating Confict,” Seton Hall Law Review 39, no. 4 (2009): 1173–1202; London A. J. , “Threats to the Common Good: Biochemical Weapons and Human Subjects Research,” Hastings Center Report 33, no. 5 (2003): 17–25; Jonas H. , “Philosophical Reflections on Experimenting with Human Subjects,” Daedalus 98, no. 2 (1968): 219–247.

Goodman S. N. , “Stopping at Nothing? Some Dilemmas of Data Monitoring in Clinical Trials,” Annals of Internal Medicine 146, no. 12 (2007): 882–887.

Temple R. and Ellenberg S. , “Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments: Part 1: Ethical and Scientific Issues,” Annals of Internal Medicine 133 no. 6 (2000): 455–463.

Senn S. , “The Misunderstood Placebo,” Applied Clinical Trials 10, no. 5 (2001): 40–45.

Potts M. , “Thinking About Vaginal Microbicide Testing,” American Journal of Public Health 90, no. 2 (2000): 188–190; Leon A. C. , “Can Placebo Controls Reduce the Number of Non-Responders in Clinical Trials? A Power–Analytic Perspective,” Clinical Therapeutics 23, no. 4 (2001): 596–607; Freedman B. Weijer C. , and Glass K. C. , “Placebo Orthodoxy in Clinical Research I: Empirical and Methodological Myths,” Journal of Law, Medicine, & Ethics 24, no. 3 (1996): 243–251.

Miller F. G. and Grady C. , “The Ethical Challenge of Infection-Inducing Challenge Experiments,” Clinical Infectious Diseases 33, no. 7 (2001): 1028–1033.

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 Reverby S. M. , “‘Normal Exposure’ and Inoculation Syphilis: A PHS ‘Tuskegee’ Doctor in Guatemala, 1946–48,” Journal of Policy History 23, no. 1 (2011): 6–28.

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 Arras J. D. , “The Jewish Chronic Disease Hospital Case,” in Emanuel E. J. Grady C. , and Crouch R. , eds., The Oxford Textbook of Clinical Research Ethics (New York: Oxford University Press, 2008): At 73–79.

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 Jones J. H. , Bad Blood, rev. ed. (New York: Free Press, 1993); Jones J. H. , “The Tuskegee Syphilis Experiment,” in Emanuel E. J. Grady C. , and Crouch R. , eds., The Oxford Textbook of Clinical Research Ethics (New York: Oxford University Press, 2008): At 86–96.

Beecher H. E. , “Ethics and Clinical Research,” New England Journal of Medicine 274, no. 24 (1966): 1354–1360, at 1354.

25. Id., at 1354–1355.

26. Id., at 1354.

27. Id., at 1355.

28. Id., at 1360.

For related arguments, see Moss J. , “If Institutional Review Boards Were Declared Unconstitutional, They Would Have to Be Reinvented,” Northwestern University Law Review 101, no. 2 (2007): 801–807.

Suntharalingam G. Perry M. R. , and Ward S. , “Cytokine Storm in a Phase 1 Trial of the Anti-CD28 Monoclonal Antibody TGN1412,” New England Journal of Medicine 355, no. 10 (2006): 1–11.

Dingwall R. , “The Ethical Case Against Ethical Regulation in Humanities and Social Science Research,” 21st Century Society 3, no. 1 (2008): 1–12, at 3.

Akerlof G. A. , “The Market for ‘Lemons’: Quality Uncertainty and the Market Mechanism,” Quarterly Journal of Economics 84, no. 3 (1970): 488–500.

For a discussion of recent cases in which trial data were not published, or were published only years after studies were completed, see Fauber J. , “BMJ: Discipline Researchers Who Withhold Research Results,” MedPage Today, January 3, 2012, available at <http://www.medpagetoday.com/PublicHealthPolicy/ClinicalTrials/30482> (last visited December 4, 2012).

London A. J. Kimmelman J. , and Emborg M. E. , “Beyond Access vs. Protection in Trials of Innovative Therapies,” Science 328, no. 5980 (2010): 829–830.

Carpenter D. , “Confdence Games: How Does Regulation Constitute Markets?” in Balleisen E. and Moss D. , eds., Government and Markets: Toward a New Theory of Regulation (New York: Cambridge University Press, 2009): At 164–190.

See London , supra note 34.

Advisory Committee on Human Radiation Experiments. Final Report of the Advisory Committee on Human Radiation Experiments (New York: Oxford University Press, 1996): at 273.

On the link between regulation relating to the FDA and civic republican values, see Carpenter , supra note 35.

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.” Pettit P. , Republicanism: A Theory of Freedom and Government (Oxford: Oxford University Press, 1997): at 5.

The term “soldiers of science” is used by Jones James H. to describe the reasoning of the U.S. Public Health Service when it prevented the men who were the unknowing participants in a scientific study from attempting to join the U.S. Military to fight during World War II. Rather than being soldiers in the military, if these men were to be put in harm's way, it would be as soldiers of science. See Jones (2008), supra note 23.

Dresser R. , “Wanted: Single, White Male for Medical Research,” Hastings Center Report 22, no. 1 (1992): 24–29, at 26–27; Weijer C. and Crouch R. A. , “Why Should We Include Women and Minorities in Randomized Controlled Trials?” Journal of Clinical Ethics 100, no. 2 (1999): 79–87.

45 C.F.R. § 46.111(a)2 (2009).

London A. J. Kimmelman J. , and Carlisle B. , “Rethinking Research Ethics: The Case of Postmarketing Trials,” Science 336, no. 6081 (2012): 544–545.

See London , supra note 34.