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Public Comments on the Proposed Common Rule Mandate for Single‐IRB Review of Multisite Research
Author(s) -
Taylor Holly A.,
Ehrhardt Stephan,
Ervin AnnMargret
Publication year - 2019
Publication title -
ethics and human research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.353
H-Index - 32
eISSN - 2578-2363
pISSN - 2578-2355
DOI - 10.1002/eahr.500002
Subject(s) - mandate , common rule , institutional review board , human services , context (archaeology) , agency (philosophy) , political science , negotiation , argument (complex analysis) , medicine , law , sociology , informed consent , alternative medicine , paleontology , social science , surgery , pathology , biology
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.