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J Empir Res Hum Res Ethics. 2019 Jul;14(3):286-295. doi: 10.1177/1556264619850440. Epub 2019 May 22.

"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.

Author information

1
1 Kaiser Permanente Washington Health Research Institute, Seattle, USA.
2
2 Cincinnati Children's Hospital Medical Center, OH, USA.
3
3 University of Cincinnati, OH, USA.
4
4 Vanderbilt University Medical Center, Nashville, TN, USA.
5
5 Health Care Systems Research Network, Seattle, WA, USA.

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.

KEYWORDS:

genomics; local context; multisite; research; single IRB

PMID:
31113270
PMCID:
PMC6565467
[Available on 2020-07-01]
DOI:
10.1177/1556264619850440

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