Submitting an Applicable NIH Grant Requiring sIRB

Quick guide: Submitting an Applicable NIH Grant Requiring sIRB

The Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research is effective for grants submitted after January 25, 2018. The policy applies to NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subject research and requires that a single IRB (sIRB) provide IRB approval for all participating sites.

  • The policy applies to domestic awardees and participating domestic sites only; foreign sites participating in NIH-funded, multi-site studies will not be expected to follow this policy.
  • Exceptions to the policy can be requested, based on law or regulation, or due to some other compelling reason.

sIRB is not a new concept; many IU investigators already utilize sIRB processes via the KC IRB Reliance Request. The NIH policy has important implications for investigators submitting applicable NIH grants and even for investigators who are simply participating sites in grants submitted by external investigators.

Words to know

AwardeesAwardees are responsible for ensuring that authorization agreements are in place; copies of authorization agreements and other necessary documentation should be maintained in order to document compliance with this policy, as needed. As appropriate, awardees are responsible for ensuring that a mechanism for communication between the sIRB and participating sites is established. Awardees may delegate the tasks associated with these responsibilities.

Reviewing IRB – The IRB that will be reviewing research from all participating sites

Communication plan – A written plan that details the flow of documents and communication between the lead study team and participating sites

Multi-site study – Research that uses the same protocol to conduct non-exempt human subject research at more than one site

Participating site – In a multi-site study, a domestic entity that will rely on the sIRB to carry out the site's IRB review of human subjects research for the multi-site study

sIRB – The selected Reviewing IRB that conducts the ethical review for participating sites of the multi-site study

How it works

The NIH sIRB policy requires that multi-site studies are reviewed by a single IRB to promote efficient and expeditious research.

If you are submitting a grant application for a multi-site that will use the same protocol to conduct non-exempt human subjects research at more than one institution, you are expected to include a plan for the use of the sIRB in the application/proposal submitted to NIH. The NIH’s acceptance of the plan will be incorporated as a term and condition in the Notice of Award or in the Contract Award.