“You Really Do Have to Know the Local Context”: IRB Administrators and Researchers on the Implications of the NIH Single IRB Mandate for Multisite Genomic Studies
Year: 2019
Type: article
Abstract: In 2016, the U.S. National Institutes of Health (NIH) announced a new policy requiring single institutional review board (sIRB) review for multisite studies. However, adherence to the new policy requires the separation of regulatory institutional review board (IRB) work per Federal guidance from site-specific local compliance concerns. In particular, genomic research is subject to a wide range of state laws, institutional requirements, and local population preferences. In this qualitative study, we explored the anticipated needs of genomics researchers and IRB administrators around implementing the policy. We observed multiple uncertainties, particularly about intersite communication processes, sIRB selection processes, and roles of the reviewing IRB and local sites regarding local context information relevant to genomics. Optimal implementation of the NIH policy may require additional guidance for researchers and IRB administrators.
Authors: Nora B. Henrikson, Paula R. Blasi, Jeremy J. Corsmo, Emily Sheffer Serdoz, Aaron Scrol, Sarah M. Greene, Tanya L. Matthews, James D. Ralston
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: green
Awards: G2388603646, G2551136184
OpenAlex ID: W2945695065