Single IRB and External IRB

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.