Hostname: page-component-848d4c4894-nmvwc Total loading time: 0 Render date: 2024-06-26T10:56:42.121Z Has data issue: false hasContentIssue false
  • English
  • Français

Revising the Common Rule: Prospects and Challenges

Published online by Cambridge University Press:  01 January 2021

Leslie Meltzer Henry
Get access Rights & Permissions [Opens in a new window]

Abstract

An abstract is not available for this content so a preview has been provided. Please use the Get access link above for information on how to access this content.
Image of the first page of this content. For PDF version, please use the ‘Save PDF’ preceeding this image.'
Type
Introduction
Information
Journal of Law, Medicine & Ethics , Volume 41 , Issue 2 , Summer 2013 , pp. 386 - 389
Copyright
Copyright © American Society of Law, Medicine and Ethics 2013

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

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.Google Scholar
“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].Google Scholar
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. et al., “Oversight of Human Participants Research: Identifying Problems to Evaluate Reform Proposals,” Annals of Internal Medicine 141, no. 4 (2004): 282–291.CrossRefGoogle Scholar
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.CrossRefGoogle Scholar
Puglisi, T., “Reform within the Common Rule?” Hastings Center Report Special Report 43, no. 1 (2013): S40–S42, at S40.CrossRefGoogle Scholar
Exec. Order No. 13,563, “Improving Regulation and Regulatory Review,” 76 Fed. Reg. 3821–3823, at 3822 (January 18, 2011).CrossRefGoogle Scholar
See ANPRM, supra note 2.Google Scholar
Id.Google Scholar
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).+(last+visited+April+29,+2013).>Google Scholar
See Puglisi, , supra note 5, at S40.Google Scholar
See Basken, , supra note 9 (quoting E. Greg Koski).Google Scholar
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).CrossRefGoogle Scholar