Heterogeneity in IRB Policies with Regard to Disclosures about Payment for Participation in Recruitment Materials

45 C.F.R. § 46 (2009).

National Science Foundation (NSF), “Frequently Asked Questions and Vignettes: Problems and Advice on Dealing with Them: What Issues Arise Concerning Compensation,” available at <http://www.nsf.gov/bfa/dias/policy/hsfaqs.jsp#s>(last visited July 25, 2014);.

Largent E. A. Grady C. Miller F. G. Wertheimer A. , “Money, Coercion, and Undue Influence: Attitudes about Payments to Research Participants,” IRB: Ethics & Human Research 34, no. 1 (2012): 1–8, at 1;.

Largent E. Grady C. Miller F. G. Wertheimer A. , “Misconceptions about Coercion and Undue Influence: Reflections on the Views of IRB Members,” Bioethics 27, no. 9 (2013): 500–507, at 500.

See NSF, supra note 2.

U.S. Food and Drug Administration (FDA), U.S. Department of Health and Human Services, “Recruiting Study Subjects – Information Sheet,” available at <http://www.fda.gov/RegulatoryInformation/Guidances/ucm126428.htm>(last visited July 25, 2014).

See Largent (2013), supra note 2, at 500–501, and 507.

The current Common Rule and subsequent guidance from federal agencies following the Common Rule has a “protectionist ethos” meant to protect human subjects from potential risks of research and also from researchers who may unintentionally exploit their subjects.

See Henry L. M. , “Moral Gridlock: Conceptual Barriers to No-Fault Compensation for Injured Research Subjects,” Journal of Law, Medicine & Ethics 41, no. 2 (2013): 411–423;.

O'Connor D. , “The Apomediated World: Regulating Research When Social Media Has Changed Research,” Journal of Law, Medicine & Ethics 41, no. 2 (2013): 470–483, at 476–477. However, scholars have reported research subjects' concerns about the IRB. As Rothman notes, “[P]atients…want to make their own calculations of risks and benefits and to decide for themselves, without the veto power of an IRB, whether a protocol is worth entering.” D. J. Rothman, Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making (New York: Aldine de Gruyter, 2003): At 252.

Such restrictions on providing information may also infringe on the investigator's speech, not unlike the regulations on advertising the prices of alcohol, which the Supreme Court struck down as violating the First Amendment. See 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 503 (1996) (Stevens plurality)

Also analogously, in a pharmaceutical case, the Supreme Court emphasized that they have long “rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information.” Thompson v. W. States Med. Ctr., 535 U.S. 357, 374 (2002).

See Rothman , supra note 6, at 251;.

Maloney D. M. , Protection of Human Research Subjects: A Practical Guide to Federal Laws and Regulations (New York: Plenum Press, 1984): At 222–224. For examples of variation in how IRBs classify risks for multi-center studies, see Green L. A. Lowery J. C. Kowalski C. P. Wyszewianski L. , “Impact of Institutional Review Board Practice Variation on Observational Health Services Research,” Health Research and Educational Trust 41, no. 1 (2005): 214–230;.

McWilliams R. Hoover-Fong J. Hamosh A. Beck S. Beaty T. Cutting G. , “Problematic Variation in Local Institutional Review of a Multicenter Genetic Epidemiology Study,” JAMA 290, no. 3 (2003): 360–366;.

Mansbach J. Acholonu U. Clark S. Camargo C. A. Jr. , “Variation in Institutional Review Board Responses to a Standard, Observational, Pediatric Research Protocol,” Academic Emergency Medicine 14, no. 4 (2007): 377–380;.

Revina B. Deuel L. Siderowf A. Dorsey E. R. , “Local Institutional Review Board (IRB) Review of a Multicenter Trial: Local Costs without Local Context,” Annals of Neurology 67, no. 2 (2010): 258–260;.

Silverman H. Hull S. C. Sugarman J. , “Variability among Institutional Review Boards' Decisions within the Context of a Multicenter Trial,” Critical Care Medicine 29, no. 2 (2001): 235–241;.

Vick C. C. Finan K. R. Kiefe C. Neumayer L. Hawn M. T. , “Variation in Institutional Review Processes for a Multisite Observational Study,” American Journal of Surgery 190, no. 5 (2005): 805–809.

Meyer M. , “Regulating the Production of Knowledge: Research Risk-Benefit Analysis and the Heterogeneity Problem,” Administrative Law Review 65, no. 2 (2013): 237–298.

Grant R. W. Sugarman J. , “Ethics in Human Subjects Research: Do Incentives Matter?” Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine 29, no. 6 (2010): 717–738, at 732–733.

Ackerman T. , “An Ethical Framework for the Practice of Paying Research Subjects,” IRB: Ethics and Human Research 11, no. 4 (1989): 1–4;.

Lynch H. F. , “Human Research Subjects as Human Research Workers,” available at <http://ssrn.com/abstract=2296100>(last visited September 7, 2013).

See, for example, Phillips T. B. , “Money, Advertising and Seduction in Human Subjects Research,” American Journal of Bioethics 7, no. 2 (2007): 88–90.

See Largent (2012), supra note 2.

Id.

Id.

See Largent (2013), supra note 2, at 501.

Id., at 501. For a similar argument, see Wertheimer A. Miller F. G. , “Payment for Research Participation: A Coercive Offer?” Journal of Medical Ethics 34, no. 5 (2008): 389–392.

Bentley J. P. Thacker P. G. , “The Influence of Risk and Monetary Payment on the Research Participation Decision Making Process,” Journal of Medical Ethics 30, no. 3 (2004): 293–298.

See, for example, Halpern S. D. , “Towards Evidence Based Bioethics,” BMJ 331, no. 7521 (2005): 901–903.

See Bentley Thacker , supra note 18.

Grady C. Dickert N. Jawetz T. Gensler G. Emanuel E. , “An Analysis of U.S. Practices of Paying Research Participants,” Contemporary Clinical Trials 26, no. 3 (2005): 365–375.

Ripley E. Macrina F. Markowitz M. Gennings C. , “Why Do We Pay? A National Survey of Investigators and IRB Chairpersons,” Journal of Empirical Research on Human Research Ethics 5, no. 3 (2010): 43–56.

Tishler C. L. Bartholomae S. , “The Recruitment of Normal Healthy Volunteers: A Review of the Literature on the Use of Financial Incentives,” Journal of Clinical Pharmacology 42, no. 4 (2002): 365–375;.

see Phillips , supra note 12.

Bramstedt K. A. , “Recruiting Healthy Volunteers for Research Participation via Internet Advertising,” Clinical Medicine & Research 5, no. 2 (2007): 91–97, at 96.

Id., at 93.

Id., at 95–96.

Dickert N. Emanuel E. Grady C. , “Paying Research Subjects: An Analysis of Current Policies,” Annals of Internal Medicine 136, no. 5 (2002): 368–373.

Id.

Grady C. , “Payment of Clinical Research Subjects,” Journal of Clinical Investigation 115, no. 7 (2005): 1181–1187, at 1686.

See Phillips , supra note 12, at 90.

Viera A. J. Garrett J. M. , “Understanding Interobserver Agreement: The Kappa Statistic,” Family Medicine 37, no. 5 (2005): 360–363.

See Rothman , supra note 6, at 90.

See, for example, Stark L. , “Victims in Our Own Minds? IRBs in Myth and Practice,” Law & Society Review 41, no. 4 (2007): 777–786.

Some paternalism might border on what Largent and colleagues call “pseudo-paternalism.” This occurs when IRBs “[prohibit] people from doing what is actually in their interests by their own reasonable lights.” See Largent (2013), supra note 2, at 505.

Yanow D. Schwartz-Shea P. , “Reforming Institutional Review Board Policy: Issues in Implementation and Field Research,” PS: Political Science and Politics i (2008): 483–494, at 491.

Department of Health and Human Services, “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Researchers,” Federal Register 76, no. 143 (2011): 44512–44531.

See Stark , supra note 33, at 783.

45 C.F.R. § 46.116 (2009).

See FDA, supra note 4.

A survey conducted in the 1970s revealed that “a substantial minority of researchers felt that the review is an unwarranted intrusion on a researcher's autonomy, that IRBs get involved in inappropriate areas, that IRBs make judgments they are not qualified to make, and that IRBs impede research.” See Maloney, supra note 8, at 224.

For a discussion of how it was once presumed that methodological training would reduce unethical research, see Haggerty K. , “Ethics Creep: Governing Social Science Research in the Name of Ethics,” Qualitative Sociology 27, no. 4 (2004): 391–414, at 393.

45 C.F.R. § 46.107(c) (2009). See also Rothman, supra note 6, at 90.

See Maloney , supra note 8, at 222.