Single IRB and External IRB
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.
There are 2 implementation dates
1. The revised Common Rule (federal human subjects regulations), effective January 19, 2020
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.
2. The NIH policy is effective as of January 25, 2018 — Policy Link
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.
o 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.
o 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
Options:
- Check your FOA – NIH may mandate the IRB.
- External IRB (WIRB)
- Required for non-observational clinical trials or industry sponsored 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: 9/18/2020
Contact Information
Research Integrity
P.O. Box 8005
Suite 3000, Veazey Hall
Statesboro, GA 30460
E-mail: irb@georgiasouthern.edu
General Inquiries: 912-478-5465
Related Links
Research Integrity • PO Box 8005, Statesboro, GA 30460 • General Inquiries: 912-478-5465 • irb@georgiasouthern.edu