Revising the Common Rule: Prospects and Challenges

56 Fed. Reg. 28,003–28,023 (June 18, 1991). The HHS regulations implementing the Common Rule are codified at 45 C.F.R. part 46, subpart A.

“Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,” 76 Fed. Reg. 44,512–44,531 (July 26, 2011) [hereinafter ANPRM].

Presidential Commission for the Study of Bioethical Issues, Moral Science: Protecting Participants in Human Subjects Research (December 2011).

Institute of Medicine, Responsible Research: A Systems Approach to Protecting Research Participants (2002).

National Bioethics Advisory Commission, Ethical and Policy Issues in Research Involving Human Participants, Vol. 1 (August 2001).

Government Accountability Office, Human Subjects Research: HHS Takes Steps to Strengthen Protections, But Concerns Remain, GAO-01-775T (2001).

Kim S. Ubel P. De Vries R. , “Pruning the Regulatory Tree,” Nature 457, no. 7229 (2009): 534–535.

Emanuel E. J. , “Oversight of Human Participants Research: Identifying Problems to Evaluate Reform Proposals,” Annals of Internal Medicine 141, no. 4 (2004): 282–291.

Emanuel E. J. Menikoff J. , “Reforming the Regulations Governing Research with Human Subjects,” New England Journal of Medicine 365, no. 12 (2011): 1145–1150, at 1145.

Puglisi T. , “Reform within the Common Rule?” Hastings Center Report Special Report 43, no. 1 (2013): S40–S42, at S40.

Exec. Order No. 13,563, “Improving Regulation and Regulatory Review,” 76 Fed. Reg. 3821–3823, at 3822 (January 18, 2011).

See ANPRM, supra note 2.

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Basken P. , “Federal Overhaul of Rules for Human Research Hits Impasse,” Chronicle of Higher Education (March 7, 2013), available at <http://chronicle.com/article/overhaul-of-rules-for-human/137811/> (last visited April 29, 2013).

See Puglisi , supra note 5, at S40.

See Basken , supra note 9 (quoting E. Greg Koski).

Eysenbach G. , “Medicine 2.0: Social Networking, Collaboration, Participation, Apomediation, and Openness,” Journal of Medical Internet Research 10, no. 3 (2008): e22, available at <http://www.jmir.org/2008/3/e22/> (last visited May 16, 2013).