NIH Policy on Single-IRB Review - A New Era in Multicenter Studies

Affiliations

¹ From the Department of Epidemiology (A.-M.E., S.E.) and the Department of Health Policy and Management (H.A.T.), Johns Hopkins Bloomberg School of Public Health, and the Johns Hopkins Berman Institute of Bioethics (H.A.T.) - both in Baltimore.

Ann-Margret Ervin et al. N Engl J Med. 2016.

. 2016 Dec 15;375(24):2315-2317.

doi: 10.1056/NEJMp1608766.

¹ From the Department of Epidemiology (A.-M.E., S.E.) and the Department of Health Policy and Management (H.A.T.), Johns Hopkins Bloomberg School of Public Health, and the Johns Hopkins Berman Institute of Bioethics (H.A.T.) - both in Baltimore.

No abstract available

References

1. Abbott L, Grady C. A systematic review of the empirical literature evaluating IRBs: what we know and what we still need to learn. J Empir Res Hum Res Ethics. 2011;6:3–19. - PMC - PubMed
1. Ervin AM, Taylor HA, Meinert CL, Ehrhardt S. Evidence gaps and ethical review of multicenter studies. Science. 2015;350:632–3. - PMC - PubMed
1. Final NIH policy on the use of a single institutional review board for multi-site research. National Institutes of Health; Bethesda, MD: Jun 21, 2016. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html.
1. Scenarios to illustrate the use of direct and indirect costs for single IRB review under the NIH policy on the use of a single IRB for multi-site research. National Institutes of Health; Bethesda, MD: Jun 21, 2016. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-109.html.
1. Kaufmann P, O'Rourke PP. Central institutional review board review for an academic trial network. Acad Med. 2015;90:321–3. - PMC - PubMed