Hostname: page-component-78c5997874-s2hrs Total loading time: 0 Render date: 2024-11-19T13:11:55.316Z Has data issue: false hasContentIssue false
  • English
  • Français

Can Central IRBs Replace Local Review?

Published online by Cambridge University Press:  01 January 2021

Margaret R. Moon
Get access Rights & Permissions [Opens in a new window]

Abstract

The NIH has initiated a plan to mandate use of central IRBs for all multi-site research. This manuscript argues against the mandate, proposing that there is inadequate evidence to support the purported gains in efficiency and that the ethical integrity of research may suffer with any exclusion of the local review voice.

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 45 , Issue 3: Symposium - Controversies in Clinical Research Ethics , Fall 2017 , pp. 348 - 351
Copyright
Copyright © American Society of Law, Medicine and Ethics 2017

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

National Institutes of Health, NOT-OD-15-026 Request for Comments on the Draft NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research (December 14, 2014).Google Scholar
Menikoff, J., “The Paradoxical Problem with Multiple-IRB Review,” New England Journal of Medicine 363, no. 17 (2010): 1591-1593.CrossRefGoogle Scholar
McWiliams, R. et al., “Problematic Variation in Local Institutional Review of a Multicenter Genetic Epidemiology Study,” JAMA 290, no. 3 (2003): 360-366; Green, L. et al., “Impact of Institutional Review Board Practice Variation on Observational Health Services Research,” Health Services Research Journal 41, no. 1 (2006): 214–230.CrossRefGoogle Scholar
See Menikoff, supra note 2.Google Scholar
The Belmont Report, Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Bethesda, Md.: The Commission, 1978).Google Scholar
See Greene, et al., supra note 3.Google Scholar
Secretary's Advisory Council on Human Research Protections, Attachment F: Recommendations Regarding the Draft NIH Policy on the Use of a Single IRB for Multi-Site Research (April 24, 2015).Google Scholar
Id.Google Scholar
Clinical Trials Transformation Initiative, Use of Central IRBs for Multicenter Clinical Trials, Final Report; Check, D. K. et al., “Use of Central Institutional Review Boards for Multi-center Clinical Trials in the United States: A Review of the Literature,” Clinical Trials 10, no. 4 (2013): 560-567; Silberman, G. and Kahn, K. L., “Burdens on Research Imposed by Institutional Review Boards: The State of the Evidence and Its Implications for Regulatory Reform,” Milbank Quarterly 89, no. 4 (2011): 599–627.Google Scholar
Dilts, D. M. and Sandler, A., “Invisible Barriers to Clinical Trials: The Impact of Structural, Infrastructural, and Procedural Barriers to Opening Oncology Clinical Trials,” Journal of Clinical Oncology 24, no. 28 (2006): 4545-4552.CrossRefGoogle Scholar
See Greene, et al., supra note 3.Google Scholar
Mascette, A. M. et al., “Are Central Institutional Review Boards the Solution? The National Heart, Lung, and Blood Institute Working Group's Report on Optimizing the IRB Process,” Academic Medicine 87, no. 12 (2012): 1710-1714.CrossRefGoogle Scholar
Ervin, M. A. et al., “Evidence Gaps and Ethical Review of Multicenter Studies,” Science 350, no. 6261 (2015): 362-363; Grady, C., “Do IRBs Protect Human Research Participants?” JAMA 304 (2010): 1122-1123.Google Scholar
U.S. Department of Health and Human Services, Protection of Human Subjects, 45 CFR§ 46.101(f).Google Scholar
Gearhart, J., “21st Century Cures Act: Proposals for All Aspects of Research,” July 20, 2015, available at <http://www.quorumreview.com/21st-century-cures-act-proposes-widespread-research/> (last visited August 2, 2017).+(last+visited+August+2,+2017).>Google Scholar
Secretary's Advisory Council on Human Research Protections, “Attachment A: Recommendations on Consideration of Local Context with Respect to Increasing Use of Single IRB Review,” January 10, 2013, available at <http://www.hhs.gov/ohrp/sachrp-committee/recommendations/2013-january-10-letter-attachment-a/> (last visited August 2, 2017). (last visited August 2, 2017).' href=https://scholar.google.com/scholar?q=Secretary's+Advisory+Council+on+Human+Research+Protections,+“Attachment+A:+Recommendations+on+Consideration+of+Local+Context+with+Respect+to+Increasing+Use+of+Single+IRB+Review,”+January+10,+2013,+available+at++(last+visited+August+2,+2017).>Google Scholar
O'Rourke, P. et al., “Harmonization and Streamlining of Research Oversight for Pragmatic Clinical Trials,” Clinical Trials 12, no. 5 (2015): 449-456.Google Scholar