Participating as a site in a study requiring sIRB

Quick guide: Participating as a site in a study 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 are not expected to follow this policy.
  • Exceptions to the policy can be requested, based on law or regulation, or due to some other compelling reason.

If you are participating as a site on an applicable sIRB grant application, but are not the primary grant applicant, you still have responsibilities.

Words to know

  • Awardees - Awardees 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 local sites
  • Multi-site study – Sites that use the same protocol to conduct non-exempt human subject research at more than one site
  • Participating site – A multi-site study is 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 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 in order to promote efficient and expeditious research. Sites that cede review to a reviewing IRB are considered participating IRBs.