NIH Policy on Single IRB

The Final NIH Policy on Use of a Single IRB for Multi-Site Research establishes the expectation that all domestic sites participating in multi-site studies involving non-exempt human subjects research funded by NIH will use a single Institutional Review Board (sIRB).

Effective Date

This policy applies to all competing grant applications (new, renewal, revision, or resubmission) with receipt dates on or after January 25, 2018.  Ongoing, non-competing awards will not be expected to comply with this policy until the grantee submits a competing renewal application.  For contracts, the policy applies to all solicitations issued on or after January 25, 2018. 


  • NIH-funded
  • Non-exempt human subject research
  • Multi-site where each site will conduct the same protocol
  • Domestic sites
  • Supported through grants, cooperative agreements, contracts, or NIH intramural Research Program
  • Does not apply to career development, research training, or fellowship awards

Expectations for Applications / Proposals

Applicant / Offerors will be expected to include a plan for use of a sIRB in the applications / proposals they submit to NIH. NIH’s acceptance of submitted plan will be incorporated as a term and condition in Notice of Award or in Contract Award.

sIRB Plan

The PHS Human Subjects and Clinical Trials Information Form Application Guide provides instructions on what needs to be included in the sIRB plan.

Selection of the sIRB

Contact the MSU IRB Reliance Coordinator, Kim Hess, to discuss the selection of the sIRB.


MSU as the IRB of Record: Do not include a direct cost to support administrative tasks of supporting a single IRB.

Independent (commercial) IRB as IRB of Record: Independent IRBs, which are not affiliated with a research institution, are neither included under another institution’s F&A rate agreement nor do they have Federally-negotiated indirect cost rate agreements of their own. Therefore, the fees charged by independent IRBs may be charged as a direct cost when they are serving as the single IRB. Please refer to for further guidance on single IRB cost allocation.

Delayed Onset

If your human subjects study meets the NIH definition of "Delayed Onset," include information regarding how the study will comply with the NIH single Institutional Review Board (sIRB) policy prior to initiating any multi-site study in the delayed onset study justification.


The NIH will determine whether to grant an exception following an assessment of the need. Exceptions to the NIH policy will be made where review by the proposed sIRB would be prohibited by a federal, tribal, or state law, regulation, or policy.  Requests for exceptions that are not based on a legal, regulatory, or policy requirement will be considered if there is a compelling justification for the exception. 


Please visit the NIH website, Single IRB Policy for Multi-Site Research, for additional resources.