Can Central IRBs Replace Local Review?

Author:

Moon Margaret R.

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.

Publisher

Cambridge University Press (CUP)

Subject

Health Policy,General Medicine,Issues, ethics and legal aspects

Reference17 articles.

1. 1. 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).

2. 15. Gearhart, J. , “21st Century Cures Act: Proposals for All Aspects of Research,” July 20, 2015, available at (last visited August 2, 2017).

3. Problematic Variation in Local Institutional Review of a Multicenter Genetic Epidemiology Study

4. Are Central Institutional Review Boards the Solution? The National Heart, Lung, and Blood Institute Working Group’s Report on Optimizing the IRB Process

5. “Harmonization and Streamlining of Research Oversight for Pragmatic Clinical Trials,”;O'Rourke;Clinical Trials,2015

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