Do the FDA regulations permit non-local IRB review?


Under certain circumstances, local review by an Institutional Review Board (IRB) may not be available, such as with research conducted by investigators unaffiliated with an institution with an IRB. Although conceptually modeled for local IRB review, FDA regulations do not prohibit review of research by IRBs in locations other than where the research is to be performed (e.g. independent or non-institutional IRB). Therefore, an IRB may review studies that are not performed on-site as long as 21 CFR parts 50 and 56 requirements are met.

About the Author
Proxima CRO Team
Stephanie Mull
Director of Project Management

Stephanie has over 20 years of clinical research experience working from the site, CRO and sponsor perspectives. She graduated Summa Cum Laude from Concordia University in St. Paul, MN, with a degree in Natural Science - biology and math.

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