What is Single IRB review and how can I use it? –
The single IRB (sIRB) mandate is mix of federal policies and regulations that require certain types of federally-funded studies that involve multiple institutions to use a single IRB to accomplish IRB review and approval for all of the institutions.
2 implementation dates
1. The revised Common Rule single IRB provisions, effective January 19, 2020
- Federally funded cooperative research – that is, studies that involve more than one institution.
- Protocols may be the same or different at each institution.
- Exceptions:VA sites; international sites; site involving tribal nations.
- Guidance for implementation of this provision has not yet been published.
2. The NIH policy is effective as of January 25, 2018
NIH Policy Click here for an overview of the changes in NIH policies on Human Subjects Research
- NIH funded studies in which the sites are all using the same protocol. These will typically be clinical trials, but can include observational studies.
- Exceptions: VA sites; international sites; site involving tribal nations.
- sIRB must be designated at the time of proposal submission.
- GS will not serve as the sIRB for a multi-site study except in rare cases with prior approval.
- GS reserves the right to elect not to serve as the IRB of record on any study for which the administrative staff cannot document appropriate board expertise.
- GS will only act as the primary IRB with prior approval.
- Standing Conditions:
- non-medical clinical trial or research
- all sites conduct the same protocol
- Each institution maintains a reliance agreement with GS and provides local oversight
- Check your FOA – NIH may mandate the IRB.
- External IRB (WIRB)
- Required for non-observational clinical trials or industry sponsored clinical research.
- Reliance agreement with an accredited institutions primary IRB
- Each IRB that serves as a primary IRB will require an agreement with each of the relying IRBs.
Last updated: 12/17/2018