Hostname: page-component-745bb68f8f-d8cs5 Total loading time: 0 Render date: 2025-01-11T22:49:32.989Z Has data issue: false hasContentIssue false
  • English
  • Français

What the ANPRM Missed: Additional Needs for IRB Reform

Published online by Cambridge University Press:  01 January 2021

Charles W. Lidz  and
Suzanne Garverich
Get access Rights & Permissions [Opens in a new window]

Extract

The federal Common Rule, which governs the conduct of research with human subjects, specifies the criteria and procedures by which Institutional Review Boards (IRBs) should review such research. Although there is wide agreement that IRBs, or Research Ethics Committees as they are called in most of the world, are essential to assuring that human subjects research meets common standards of ethics, IRBs have always come under considerable criticism. Some have critiqued IRBs for using important resources inefficiently, including the large amount of time researchers put into submitting applications, modifications, and reports and delaying the start of data collection within the limited time that grants and contracts provide. Others have critiqued the inconsistency of review of multi-site projects.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 41 , Issue 2 , Summer 2013 , pp. 390 - 396
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

U.S. Department of Health and Human Services, Editor, Basic HHS Policy for Protection of Human Research Subjects (“The Common Rule”), in 45CFR46.Google Scholar
National Commission for the Protection of Human Subjects, Report and Recommendations for Institutional Review Boards (Washington, D.C.: US Government Printing Office, 1978).Google Scholar
Koski, G., An Open Letter to the Human Research Community, 2002, available at <http://archive.hhs.gov/ohrp/references/oltr.pdf> (last visited April 23, 2013). Gordon, E., “Trials and Tribulations of Navigating IRBs: Anthropological and Biomedical Perspectives of ‘Risk’ in Conducting Human Subjects Research,” Anthropological Quarterly 76, no. 2 (2003): 299–320.Google Scholar
Eaton, W., “The Reliability of Ethical Reviews: Some Initial Findings,” Canadian Psychologist 24, no. 1 (1983): 14–18. Cartwright, A., “Research Ethics Committees,” BMJ 300, no. 6724 (1990): 607. Grodin, M. Zaharoff, B. Kaminow, P., “A 12-Year Audit of IRB Decisions,” Quality Review Bulletins 12 (1986): 82–86. Giammona, M. Glantz, S., “Poor Statistical Design in Research on Humans: The Role of Committees on Human Research,” Clinical Research 31 (1983): 572–578. Ceci, S. J. Peters, D. Plotkin, J., “Human Subjects Review, Personal Values, and the Regulation of Social Science Research,” American Psychologist 40, no. 9 (1985): 994–1002. Ashford, J. J., “Recent Experience of Ethics Committee Review of a Multicenter Research Project,” Journal of Clinical Pharmacology 23 (1987): 373–374. Stair, T. et al., “Variation in Institutional Review Board Responses to a Standard Protocol for a Multicenter Clinical Trial,” Academic Emergency Medicine 8, no. 6 (2001): 636–641. Bell, J. Whiton, J. Connelly, S., Evaluation of NIH Implementation of Section 491 of the Public Health Service Act, Mandating a Program of Protection for Research Subjects (1998).CrossRefGoogle Scholar
Lidz, C. W. et al., “IRBs: How Closely Do They Follow the Common Rule?” Academic Medicine Academic Medicine 87, no. 7 (2012): 1–6.Google Scholar
Candilis, P. Lidz, C. et al., “The Silent Majority: Who Speaks at IRB Meetings,” IRB: Ethics and Human Research 34, no. 4 (2012): 1–12. see Lidz, , supra note 6. Lidz, C. W. Simon, L. et al., “The Participation of Community Members on Institutional Review Boards,” Journal of Empirical Research in Human Research Ethics 7, no. 1 (2012): 1–8. Lidz, C. W. Simon, L. et al., “The Participation of Community Members on Institutional Review Boards,” Journal of Empirical Research in Human Research Ethics 7, no. 1 (2012): 1–8.Google Scholar
DHHS Office of the Secretary, “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators - Advance Notice of Proposed Rulemaking,” Federal Register 76, no. 170 (2011): 44,512–44,531.Google Scholar
Id.Google Scholar
Id.Google Scholar
See Stair, et al., supra note 5. Hammerschmidt, D. E. Keane, M. A., “Institutional Review Board Review Lacks Impact on the Readability of Consent Forms for Research,” American Journal of the Medical Sciences 304, no. 6 (1992): 348–351.Google Scholar
Ben-Shahar, O. Schneider, C. E., “The Failure of Mandated Disclosure,” University of Chicago Law & Economics, Olin Working Paper No. 516, available at <http://ssrn.com/abstract=1567284> (last visited April 8, 2013).+(last+visited+April+8,+2013).>Google Scholar
MacKintosh, D. R. Molloy, V. J., “Opportunities to Improve Informed Consent,” Applied Clinical Trials (May 2003): 46–48 National Cancer Institute”, NCI Recommendations for the Development of Informed Consent Documents for Cancer Clinical Trials (1998).Hochhauser, M., “The Informed Consent Form: Document Development and Evaluation,” Drug Information Journal 34, no. 14 (2000): 1309–1317.Google Scholar
See supra note 10.Google Scholar
Ziewacz, J. et al., “Crisis Checklists for the Operating Room: Development and Pilot Testing,” Journal of the American College of Surgery 213 (2011): 212–217.CrossRefGoogle Scholar
Waggoner, W. Mayo, D., “Who Understands? A Survey of 25 Words or Phrases Commonly Used in Proposed Clinical Research Consent Forms,” IRB 17, no. 1 (1995): 6–9. Tarnowski, K. et al., “Readability of Pediatric Biomedical Research Informed Consent Forms,” Pediatrics 85 (1980): 58–62. Hammerschmidt, D. Keane, M., “Institutional Review Board Review Lacks Impact on the Readability of Consent Forms for Research,” American Journal of the Medical Sciences 304, no. 6 (1992): 348–351.CrossRefGoogle Scholar