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Single IRB for Multi-Site or Cooperative Research

An NIH funded study being conducted at more than one U.S. site involving non-exempt human subjects research may be subject to the NIH Single IRB policy and/or the revised Common Rule cooperative research provision ( §46.114  Link to Non-U.S. Government Site - Click for Disclaimer ). NIH-supported studies conducting multi-site or cooperative research may need to have a single IRB, if any of the following apply:

  • Submitted for an NIH grant application on or after January 25, 2018
  • Submitted for an NIH Research & Development (R&D) contract solicitation issued on or after January 25, 2018
  • Submitted for an NIH intramural research study with initial review on or after January 25, 2018
  • Received initial IRB approval on or after January 20, 2020*
  • Transitioned the study at one or more sites to the 2018 Requirements  Link to Non-U.S. Government Site - Click for Disclaimer

*As of January 20, 2020, studies subject to the Revised Common Rule Cooperative Research Provision (45 CFR 46.114(b)) must use a single IRB as required by the terms and conditions of award. This includes studies that are not subject to the NIH sIRB policy – such as domestic, multisite career development (K) and fellowship (F) awards.

NIH Single IRB Policy

Certain studies may be subject to the NIH Single IRB policy Link to Non-U.S. Government Site - Click for Disclaimer even if they are not subject to the revised Common Rule cooperative research provision.

Competing grant applications with due dates on January 25, 2018 and beyond, R&D contract solicitations issued on or after January 25, 2018, as well as intramural research studies submitted for initial review after January 25, 2018 are all subject to the NIH Single IRB policy if involving multi-site non-exempt human subjects research using the same research protocol.

NIH applicants using the FORMS-F or later grant application package do not need to submit a plan describing the use of a single IRB at the time of application submission. However, applicants required to use a single IRB must provide the name of the single IRB of record during Just-in-time submission before an award is issued. Providing the name of the sIRB of record satisfies the sIRB policy requirement for an sIRB plan for NIH grant applicants.

Revised Common Rule Cooperative Research sIRB Mandate

The compliance date for the revised Common Rule cooperative research sIRB mandate (§46.114  Link to Non-U.S. Government Site - Click for Disclaimer ) is January 20, 2020 for research initially approved by an IRB on or after this date. Additional information about the revised Common Rule provision and guidance on the Office for Human Research Protections (OHRP) exception determinations is found on the OHRP Single IRB Exception Determinations Link to Non-U.S. Government Site - Click for Disclaimer  website.

Exception Requests

Exceptions to use of a single IRB are rare.

For questions or requests for an exception to the NIH single IRB policy and/or (temporarily) the revised Common Rule cooperative research sIRB mandate, applicants/awardees should consult with their Program Officials (POs), and offerors with their Contracting Officials (COs).

Exception requests to the NIH Single IRB policy must provide sufficient information which demonstrates a compelling justification for an exception to the NIH Single IRB policy.

Temporarily, during the COVID-19 Public Health Emergency, NIH will consider case by case exceptions for use of a sIRB under the revised Common Rule. This is based on Office for Human Research Protections (OHRP) guidance issued in October 2020. 

Exception requests to the revised Common Rule cooperative research provision during the COVID-19 Public Health Emergency must include justification as to why the study meets the exception criteria defined by OHRP. Additional information about the OHRP exception determinations is found on the Link to Non-U.S. Government Site - Click for DisclaimerOHRP Single IRB Exception Determinations website and NIH guide notice on Exceptions to Use of a Single IRB During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - NOT-OD-21-006.

For general sIRB questions, contact the NIH Single IRB policy mailbox at SingleIRBPolicy@mail.nih.gov.

Notices and Statements

  • NOT-OD-21-174 Reminder of Guidance on Requirement for NIH Single Institutional Review Board (IRB) Plan
  • NOT-OD-21-006 Exceptions to Use of a Single IRB During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
  • NOT-OD-20-058 Additional Guidance on the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
  • NOT-OD-18-004 Guidance on Implementation of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
  • NOT-OD-18-003 Guidance on Exceptions to the NIH Single IRB Policy
  • NOT-OD-17-076 Revision: Notice of Extension of Effective Date for Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
  • NOT-OD-16-109 Scenarios to Illustrate the Use of Direct and Indirect Costs for Single IRB Review under the NIH Policy on the Use of a Single IRB for Multi-site Research
  • NOT-OD-16-094 Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
  • Director's Statement  Link to Non-U.S. Government Site - Click for Disclaimer
This page last updated on October 15, 2021
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