As of January 20, 2020, studies subject to the Revised Common Rule Cooperative Research Provision (45 CFR 46.114(b)) must use a single IRB as required by the terms and conditions of award. This includes studies that are not subject to the NIH sIRB policy – such as domestic, multisite career development (K) and fellowship (F) awards.
The HHS Office of Human Research Protections (OHRP) has issued limited exceptions to the requirement for a single IRB under the Revised Common Rule. Consequently, the following NIH-funded multi-site domestic studies may continue to use multiple IRBs only for the duration of the exception granted by NIH.
- Studies for which NIH approved an exception from its single IRB policy before January 20, 2020 and the study was initially approval by an IRB before January 20, 2020
- Studies for which the NIH single IRB policy does not apply and the research was initially approved by an IRB before January 20, 2020
- Studies conducted under ongoing, non-competing awards with receipt dates prior to January 25, 2018 if an IRB initially approved the research prior to January 20, 2020
Note: studies that received an exception from NIH must transition to a single IRB prior to the next competing award.
See the Guide Notice for complete details and corresponding updates to application instructions.