The “Common Rule,” found at 45 C.F.R. 46, Subpart A, is a set of federal regulations for protecting human subjects in research that were codified by 15 agencies and departments in 1991.Google Scholar

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Here I am using the term “sponsors” as a general term to refer to institutions that fund and support research. The ethical obligations of sponsors (separate from those of investigators) are discussed infra.Google Scholar

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Id., at 10, 73. The Commission explicitly noted that including language about investigator obligations would help harmonize the Common Rule with the FDA's guidelines (21 CFR Section 312.60), but it would also help harmonize the regulations with research regulations from other countries. See, e.g., SA Health Info, “Ethics in Health Research,” available at <http://www.sahealthinfo.org/ethics/ethicsassesment.htm> (last visited April 24, 2013). (last visited April 24, 2013).' href=https://scholar.google.com/scholar?q=Id.,+at+10,+73.+The+Commission+explicitly+noted+that+including+language+about+investigator+obligations+would+help+harmonize+the+Common+Rule+with+the+FDA's+guidelines+(21+CFR+Section+312.60),+but+it+would+also+help+harmonize+the+regulations+with+research+regulations+from+other+countries.+See,+e.g.,+SA+Health+Info,+“Ethics+in+Health+Research,”+available+at++(last+visited+April+24,+2013).>Google Scholar

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45 C.F.R. 46, Subpart A (2009). The Common Rule only mentions investigators in the description of what research is exempt, the definitions of “human subject” and “intervention,” the sections on obtaining and documenting informed consent, and the descriptions of who should receive notice from the IRB about its decision. Although Subpart C, which provides additional protections for prisoners involved in research, does discuss investigators' responsibilities with regard to fair subject selection, this Subpart is not part of the Common Rule. The Common Rule has more to say about sponsors, and recognizes that “[e]ach institution engaged in research which is covered by this policy and which is conducted or supported by a federal department or agency shall provide written assurance satisfactory to the department or agency head that it will comply with the requirements set forth in this policy.” It goes beyond compliance to some degree, however, by indicating that all institutions have to prepare “[a] statement of principles governing the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution.” Finally, the Common Rule indicates that both sponsors and investigators cannot use exculpatory language in informed consent documents that would constitute a waiver of the rights of individual subjects.Google Scholar

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45 C.F.R. 46.111(a)(1) (2009). Similarly, the regulations note that “[i]n evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research).” See 45 C.F.R. 46.111(a)(2) (2009).Google Scholar

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See Azar, , supra note 17, at 38 (quoting a researcher who “viewed the IRB more as a hurdle to get over rather than a way of helping me improve my research.”).Google Scholar

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See 45 C.F.R. 46.109(e) (“An IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research.”).Google Scholar

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Given the state of flux and considerable ethical debate around some ethical obligations, it can be difficult to determine how best to codify them into regulations. The NIH policy on post-trial access to antiretroviral therapy demonstrates one way of incorporating duties that are still somewhat unclear. It requires that investigators plan in advance how they will address post-trial access, and that these plans will be evaluated by an independent body, but it does not rule out research that does not provide access to treatment post-trial. See National Institutes of Health, “Guidance for Addressing the Provision of Antiretroviral Treatment for Trial Participants Following Their Completion of NIH-Funded HIV Antiretroviral Treatment Trials in Developing Countries,” 2005, available at <http://grants.nih.gov/grants/policy/antiretroviral/guidance.doc> (last visited April 25, 2013).+(last+visited+April+25,+2013).>Google Scholar

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For example, various obligations to share benefits with communities in multinational research are very controversial. See, e.g., Shah, S. K. Wolitz, R. Emanuel, E. J., “Refocusing the Responsiveness Requirement,” Bioethics 27, no. 3 (2013): 151–159. London, A. J. Kimmelman, J., “Justice in Translation: From Bench to Bedside in the Developing World,” The Lancet 372, no. 9632 (2008): 82–85. Wolitz, R. Emanuel, E. J. Shah, S. K., “Rethinking the Responsiveness Requirement for International Research,” The Lancet 374, no. 9692 (2009): 847–849. World Medical Association, Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects (2008). Grady, C., “Ethics of International Research: What Does Responsiveness Mean?” Virtual Mentor, Ethics Journal of the American Medical Association 8, no. 4 (2006): 235–240. Macklin, R., Double Standards in Medical Research in Developing Countries (Cambridge, UK: Cambridge University Press, 2004): At 3. Participants in the 2001 Conference on Ethical Aspects of Research in Developing Countries, “Moral Standards for Research in Developing Countries: From ‘Reasonable Availability’ to ‘Fair Benefits,’” Hastings Center Report 34, no. 3 (2004): 17–27. Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Biomedical Research Involving Human Subjects (Geneva, World Health Organization, 2002).CrossRefGoogle Scholar

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Here I am considering penalties that would apply directly to researchers through the Common Rule and that are not mediated through the IRB. IRBs do have authority to disapprove research in advance or terminate ongoing research, but again, these types of penalties rely on compliance with the IRB, and not a recognition of the obligations sponsors and investigators retain independently of the IRB. See 45 C.F.R. §§46.109, 46.113.Google Scholar

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The FDA requires that investigators sign a form in which they make several commitments, such as agreeing to conduct a study according to the protocol and notifying the sponsor of any deviations from the protocol, inform patients about the investigational nature of the drugs used, keep accurate records, and obtain review from a qualified IRB. See <http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074728.pdf> (last visited April 25, 2013). Notably, these commitments generally relate to ensuring the correct process is followed and do not emphasize the importance of ethical behavior on the part of the investigator. Nevertheless, the general approach used by the FDA could be adapted for investigators presenting their studies for review to IRBs.+(last+visited+April+25,+2013).+Notably,+these+commitments+generally+relate+to+ensuring+the+correct+process+is+followed+and+do+not+emphasize+the+importance+of+ethical+behavior+on+the+part+of+the+investigator.+Nevertheless,+the+general+approach+used+by+the+FDA+could+be+adapted+for+investigators+presenting+their+studies+for+review+to+IRBs.>Google Scholar

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