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 (rCR) cooperative research provision ( §46.114 ). NIH-funded or -supported studies conducting multi-site or cooperative research may need to have a single IRB (sIRB), 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
*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, multi-site, career development (K), fellowship (F) awards, and Other Transaction (OT) awards.
NIH Single IRB Policy
Certain studies may be subject to the NIH Single IRB policy 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 (sIRB) policy if involving multi-site non-exempt human subjects research conducting 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 sIRB at the time of application submission. However, applicants required to use a sIRB 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 provision (§46.114) 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 can be found on the OHRP Single IRB Exception Determinations website.
Exceptions to use of single IRB are rare.
NIH Single IRB Policy exception requests not based on a federal/state/Tribal law, regulation, or policy require the review and approval of the NIH Office of the Director (OD). NIH will consider exception requests for studies subject to the NIH Single IRB Policy if they are NOT also subject to the revised Common Rule (rCR) cooperative research sIRB provision.
As of the end of the COVID 19 Public Health Emergency, NIH does not have the authority to approve exception requests to the rCR Cooperative Research Provision. Exception requests for studies subject to the rCR cooperative research sIRB provision will not be considered.
For questions or requests for an exception to the NIH Single IRB Policy applicants/recipients 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 to demonstrate a compelling justification for an exception to the NIH Single IRB Policy. Note that NIH does not consider the cost associated with a single IRB as a compelling justification.
Applicants or offerors must include all necessary single IRB costs in the proposed budget in the NIH application or contract proposal and should not assume that an exception will be approved. For both grant applications and contracts, the award budget may need to be adjusted if an exception is approved.
For general sIRB questions, contact the NIH Single IRB policy mailbox at SingleIRBPolicy@mail.nih.gov.
Notices and Statements
- NOT-OD-23-097: NIH Can No Longer Grant Common Rule Exceptions to the Use of a Single IRB for Multi-site Research After the COVID-19 Public Health Emergency Expiration Date of May 11, 2023
- 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 Revie 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