1 Comments
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.
While we know about this rule, there are clearly turf wars ongoing. In a closed group I heard from a PI of a multi-site study that one site simply decided not to join the project if they had to refer to the parent IRB. So NIH may make the rule, but they can’t force a site to join. It isn’t clear to me how often that happens.