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. 2019 Jan;41(1):15-21.
doi: 10.1002/eahr.500002.

Public Comments on the Proposed Common Rule Mandate for Single-IRB Review of Multisite Research

Holly A Taylor  1 , Stephan Ehrhardt  2 , Ann-Margret Ervin  3
Affiliations

Public Comments on the Proposed Common Rule Mandate for Single-IRB Review of Multisite Research

Holly A Taylor et al. Ethics Hum Res. 2019 Jan.

Abstract

We reviewed the public comments submitted in response to the Department of Health and Human Services' (DHHS's) original and revised proposal for mandated single-IRB review of federally funded multisite research to see who responded to the proposed mandate and to determine what they said and how the agency addressed the public comments in its revised proposal. Our analysis indicates that support for the single-IRB mandate was limited. The most common argument against the proposed mandate came from those concerned with the loss of site-specific institutional review board (IRB) review of the protocol for a multisite study to address issues relevant to local context. Concerns were also raised that the single-IRB approach would replace one inefficient system (that entails, for example, multiple reviews of a single study) with another potentially inefficient system (involving the negotiation and management of multiple interinstitutional agreements). Empirical research about the implementation of DHHS's final rule-and the separate rule of the National Institutes of Health-mandating single-IRB review is needed to determine whether the single-IRB model achieves the stated goals.

Keywords: Common Rule; human subjects research; local IRBs; multisite studies; research ethics; single IRBs.

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References

    1. Abbott L, and Grady C, “A Systematic Review of the Empirical Literature Evaluating IRBs: What We Know and What We Still Need to Learn,” Journal of Empirical Research on Human Research Ethics 6, no. 1 (2011): 3–19. - PMC - PubMed
    1. Emanuel EJ, “Reform of Clinical Research Regulations, Finally,” New England Journal of Medicine 373, no 24 (2015): 2296–99. - PubMed
    1. Koski G, et al. , “Cooperative Research Ethics Review Boards: A Win-Win Solution?,” IRB: Ethics & Human Research 27, no. 3 (2005): 1–7; - PubMed
    2. Check DK, et al. , “Use of Central Institutional Review Boards for Multicenter Clinical Trials in the United States: A Review of the Literature,” Clinical Trials 10, no. 4 (2013): 560–67; - PubMed
    3. Hudson KL, and Collins FS, “Bringing the Common Rule into the 21st Century,” New England Journal of Medicine 373, no. 24 (2015): 2293–96. - PMC - PubMed
    1. Greene SM, et al. , “The Process Is the Product: A New Model for Multisite IRB Review of Data-Only Studies,” IRB: Ethics & Human Research 32, no. 3 (2010): 1–6; - PubMed
    2. Cola PA, Reider C, and Strasser JE, “Ohio CTSAs Implement a Reliant IRB Model for Investigator-Initiated Multicenter Clinical Trials,” Clinical and Translational Science 6, no. 3 (2013): 176–8; - PMC - PubMed
    3. Kaufmann P, and O’Rourke PP, “Central Institutional Review Board Review for an Academic Trial Network,” Academic Medicine 90, no. 3 (2015): 321–3; - PMC - PubMed
    4. Winkler SJ, Witte E, and Bierer BE, “The Harvard Catalyst Common Reciprocal IRB Reliance Agreement: An Innovative Approach to Multisite IRB Review and Oversight,” Clinical and Translational Science 8, no. 1 (2015): 57–66; - PMC - PubMed
    5. Stoffel B, Sorkness C, and Pech C, “Use of a Single, Independent IRB: Case Study of an NIH Funded Consortium,” Contemporary Clinical Trials Communications 8 (2017): 114–21. - PMC - PubMed
    1. Final NIH Policy on the Use of a Single Institutional Review Board for Multi-site Research, National Institutes of Health, June 21, 2016, https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html.

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