A Guide to Compliance with the Single IRB Mandate: Making the Best Choices for Your Institution
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Date
2021-05
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Abstract
The National Institute of Health (NIH) rolled out the new single IRB (sIRB) on January 25, 2018. The single IRB allows institutions that participate in multi-site studies to be the overseers of the institutional review board of human subject participants. Prior to this rollout, most sites with multiple studies had their own IRB office conduct an independent review of studies that involved human subject research. The NIH realized that most sites submitted an application to the review board for the same study, which prompted their introduction of the single IRB. In this Capstone Project, the author developed a training guide to address researchers' questions regarding multi-site studies and the submission of human subject protocols. The revised human subject regulations determined that only specific studies that include non- exempt human subject research using funds from the NIH will be reviewed and considered for a single IRB protocol. The author of this Capstone Project developed several flow charts and scope of project guidelines that will provide researchers with the necessary information to successfully submit their multi-site applications to the NIH Institutional Review Board in a manner that will suit their project’s and institution’s best interests.
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guide, compliance, protocol, research