Guidelines for Ceding IRB Review to an External IRB
The HS IRBs strongly support the use of single IRB review models to streamline the IRB review and approval process for multisite and collaborative research. This includes ceding IRB review to an external IRB for eligible studies, as described below. All decisions regarding whether IRB oversight can be ceded to an external IRB are made on a case-by-case basis. Study teams are encouraged to consult with the HS IRBs Reliance Team about whether ceding IRB review is appropriate for their study. NOTE: The HS-IRBs have the contracted with independent or commercial IRBs to serve as the IRB of record for most industry-sponsored trials and the eligibility criteria for those IRBs are slightly different.
Version: January 2017
What research is eligible for review by an external IRB?
- Studies for which use of an external IRB is a requirement of the sponsor or funding agency for participation in the study
- Multisite or collaborative research studies that qualify for expedited or convened IRB review and are not otherwise ineligible as described below. (IRB review for studies that qualify for exempt review is generally not ceded to an external IRB since it is often faster for the HS IRBs to review the project and some reliance agreements do not allow for ceding of exempt studies.)