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. 2015 Feb;8(1):57-66.
doi: 10.1111/cts.12202. Epub 2014 Sep 8.

The Harvard Catalyst Common Reciprocal IRB Reliance Agreement: an innovative approach to multisite IRB review and oversight

Sabune J Winkler  1 , Elizabeth Witte, Barbara E Bierer
Affiliations

The Harvard Catalyst Common Reciprocal IRB Reliance Agreement: an innovative approach to multisite IRB review and oversight

Sabune J Winkler et al. Clin Transl Sci. 2015 Feb.

Abstract

Reduction of duplicative Institutional Review Board (IRB) review for multiinstitutional studies is a desirable goal to improve IRB efficiency while enhancing human subject protections. Here we describe the Harvard Catalyst Master Reciprocal Common IRB Reliance Agreement (MRA), a system that provides a legal framework for IRB reliance, with the potential to streamline IRB review processes and reduce administrative burden and barriers to collaborative, multiinstitutional research. The MRA respects the legal autonomy of the signatory institutions while offering a pathway to eliminate duplicative IRB review when appropriate. The Harvard Catalyst MRA provides a robust and flexible model for reciprocal reliance that is both adaptable and scalable.

Keywords: IRB authorization agreement; bioethics; cede review; cooperative agreement; institutional review boards; master IRB agreements; multicenter clinical trials; reliance agreement; reliance agreement models; research ethics.

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Figures

Figure 1
Figure 1
Harvard Catalyst reliance model.
Figure 2
Figure 2
Harmonizing regulatory interpretation: policy and procedural alignment to “uncheck the box.”
Figure 3
Figure 3
Harmonizing regulatory interpretation: adoption of common subject injury language.
Figure 4
Figure 4
Harmonize regulatory processes: Human Subjects Training.
Figure 5
Figure 5
A central from and process facilitate request of ceded IRB review.
See this image and copyright information in PMC

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