Science
6 November 2015 vol 350, issue 6261, pages 597-712
http://www.sciencemag.org/current.dtl

Policy Forum
Research Ethics
Evidence gaps and ethical review of multicenter studies
Ann-Margret Ervin1,*, Holly A. Taylor1,2, Curtis L. Meinert1, Stephan Ehrhardt1
Author Affiliations
1Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
2Johns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA.

Large, multicenter clinical studies are the backbone of evidence-based prevention and health care. Ethical review of multicenter research is usually conducted by the institutional review board (IRB) of each participating institution. However, variation in interpretation of regulations by IRBs is common and can have ethical and scientific implications (1, 2). Recent mandates in the United States aim to reduce the administrative burden and to expedite multicenter research by conducting ethical review with a single, central IRB of record (CIRB). Yet the quality of ethical review must not suffer. We characterize current models of ethical review in the United States and identify research gaps that must be addressed before such policies are instituted.