Single IRB Review and How to 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.
Two Implementation Dates
Applies to:
- 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.
- NIH Policy
- Click here for an overview of the changes in NIH policies on Human Subjects Research
- NIH FAQ
Applies to:
- 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
- Standing Conditions:
Options
- Check your FOA – NIH may mandate the IRB.
- External IRB
- 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.