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 responsible for review and oversight of a research project. Also known as the IRB of record or the single IRB (sIRB).
  • Multi-site study – Research which uses 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

How it works

The NIH sIRB policy requires that multi-site studies are reviewed by a single IRB, called the Reviewing IRB, in order to promote efficient and expeditious research. Sites that rely on a Reviewing IRB are considered participating IRBs.

When the participating site submits a grant proposal as a subcontractor to the awardee/primary grant holder, the HSO office is notified via an automatic email. After review, HSO can provide a letter of support agreeing to rely on the Reviewing IRB or suggest that the lead site request an exception to the policy for IU's participation.

sIRB review is not appropriate for all research. As such, the NIH policy allows grant applicants to request an exception to the policy under one of the following allowable exception categories. The lead applicant is responsible for making exception requests. HSO will review the proposal to determine whether an exception should be requested and work with the lead applicant to submit the required information.

  • Regulatory or policy exception: Local IRB review is required by an existing federal, state, or local/institutional regulation or policy. Applicant must indicate which site(s) require local review and include a specific citation to the relevant law, regulation, or policy.
  • Compelling justification: Applicant should provide the rationale for why the single IRB of record cannot serve as the reviewing IRB for the site(s), and why the local IRB is uniquely qualified to be the reviewing IRB for the specific site(s).
  • Post-award exceptions requests: For any post-award changes that necessitate an exception request, such as the addition of a new domestic site that may be unable to use the sIRB, awardees must contact their PO or CO. For policy-based exceptions, the awardee will need to provide the appropriate citation to verify the requirement for local IRB review for the newly added site(s) to the PO or CO. For other exceptions, the awardee must provide compelling justification to the PO or CO to be reviewed by the NIH ERC.