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OHSRP Guidance: NIH Single IRB (sIRB) Policy in the Context of the Intramural Research Program


This guidance is essential reading for all Intramural Research Program (IRP) investigators contemplating involvement in multi-site protocols. It will address the following topics:

  • The application of the NIH Single IRB (sIRB) Policy to IRP Research
  • When IRP investigators should seek guidance from OHSRP/IRBO if initiating or participating in multisite research
  • The process for seeking an Exception from the NIH sIRB Policy

Application of the NIH sIRB Policy to IRP Research

The NIH sIRB Policy requires that all domestic sites in multi-site studies use an sIRB to review non-exempt human subjects research when the study receives any NIH funding.

All IRP research is NIH-funded and IRP involvement in a multi-site protocol is interpreted by the Policy’s authors as NIH funds supporting multi-site research, even if all the other participating sites are receiving no NIH funds. This is true whether the NIH is the lead site or is a participating site in research initiated by another institution. Therefore, the mere involvement of the IRP in multi-site research can trigger the sIRB Policy and subject all involved domestic sites to the sIRB requirement.

In the context of the IRP, the NIH sIRB Policy:

  • Applies to all multi-site protocols submitted for INITIAL REVIEW on or after January 25th, 2018;
  • Applies to all extramurally funded studies with a grant/ contract- application, or grant/contract renewal submitted on or after January 25, 2018; and
  • It is also triggered EVERY TIME the NIH IRP seeks to become involved in:
    • A new multi-site study; or
    • An existingmulti-site study, if that study received initial IRB approval on or after January 25th, 2018.

This includes:

  • Multi-site studies sponsored and funded by a pharmaceutical company or a non-profit organization
  • IRP-initiated multi-site research where only the NIH site is funded, and all other participating sites are self-funded

The Policy does allow for exceptions in the following circumstances:

  • Where review by the proposed sIRB would be prohibited by federal, state, or tribal laws, regulations or policies.
  • Where a compelling justification can be made for a site not to be subject to the sIRB Policy. An exception request on this basis must be reviewed and approved by the NIH sIRB Exceptions Review Committee (ERC). See below for more information about the exceptions application process.

When Investigators Should Seek Guidance from OHSRP/IRBO to Facilitate Involvement in a Multi-site Protocol

NIH investigators considering initiating or participating in multi-site research should seek guidance from OHSRP as early as possible and certainly when:

  • Initiating new multi-site research
  • Invited to join:
    • New multi-site research initiated by another institution
    • Existing multi-site research initiated by another institution that was approved on or after January 25, 2018
    • An extramurally funded study that applied for a grant/contract or grant/ contract renewal on or after January 25, 2018
  • Adding site(s) to an existing NIH IRP single-site study initially approved on or after January 25, 2018
  • Joining an extramurally funded multi-site study as a participating site where the extramural sites are:
    • Seeking NIH grant funding and the NIH site has been asked to:
      • Serve as the sIRB, or
      • Rely on an external sIRB
  • Involved in an existing extramurally funded multi-site study that is seeking the renewal of an NIH grant/ contract applied for prior to January 25, 2018 and the NIH site has been asked to:
      • Serve as the sIRB, or
      • Rely on an external sIRB
  • Applying for a U01 Grant and needing to identify which entity will serve as the sIRB.

The Process for Seeking an Exception from the NIH sIRB Policy

As stated above, certain exceptions are permitted under the sIRB Policy. There is an automatic exception for studies where review by the proposed sIRB would be prohibited by federal, state, or tribal laws, regulations or policies require local IRB review. The other available exception requires that a “compelling justification” be made for not being subject to the Policy which is reviewed by the ERC.

The NIH sIRB ERC is convened by the NIH Office of Extramural Research (OER) and meets on an ad hoc basis to review requests for exceptions to the NIH sIRB Policy. There is no appeal process to the determination of the NIH sIRB ERC. For that reason, it is important to prepare a detailed request with a robust justification for an exception.

The presumption of the Exceptions Committee is that all multi-site research should use a single IRB. It is likely therefore that in most circumstances it will not give an exception. For this reason, the requestor must provide a “compelling justification” for not being subject to the sIRB Policy. A “compelling justification” should describe the burden on the NIH site or other participating sites e.g., costs will be incurred, changing existing IRB arrangements will be highly disruptive to the research or otherwise highly burdensome.

OHSRP is the IRP point of contact for all submissions to the ERC. The process for applying for a “compelling justification” exception is as follows:

1. Determine whether your proposed involvement in a multi-site protocol triggers the sIRB Policy (see above).

a. Review OHSRP Guidance distributed in February 2019 and/or arrange a consult with OHSRP.

b. Contact the Reliance and sIRB Team by phone 301-402-3713, or email nih-reliance-sirb@nih.gov. 

2. Request an Exceptions Application Form (EAF) from OHSRP. OHSRP will provide Instructions for Filing a Request for an Exception to the NIH Single IRB (sIRB) Policy for Multi-Site Research with the NIH sIRB Exceptions Review Committee and guidance to help you complete the EAF.

3. Complete the EAF and submit it to OHSRP.

4. OHSRP will review the EAF and work with the study team to ensure that it captures the circumstances accurately, provides a compelling justification, and contains the information required by the NIH sIRB ERC.

5. If applicable, OHSRP will provide a Letter of Support explaining why the NIH cannot serve as the sIRB for your research to accompany your application.

6. Once the ERC has rendered its decision, the ERC will notify the IRP PI by email.

Where can I find out more information about the NIH sIRB Policy?



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