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

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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.

Original languageEnglish (US)
Pages (from-to)15-21
Number of pages7
JournalEthics & human research
Volume41
Issue number1
DOIs
StatePublished - Jan 1 2019

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Research Ethics Committees
Research
United States Dept. of Health and Human Services
Empirical Research
Negotiating
National Institutes of Health (U.S.)

Keywords

  • Common Rule
  • human subjects research
  • local IRBs
  • multisite studies
  • research ethics
  • single IRBs

ASJC Scopus subject areas

  • Medicine(all)

Cite this

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title = "Public Comments on the Proposed Common Rule Mandate for Single-IRB Review of Multisite Research",
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.",
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author = "Taylor, {Holly A.} and Stephan Ehrhardt and Ervin, {Ann Margret}",
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