Single IRB Policy for Multi-site Research

Learn about policy expectations for the use of single IRBs for multi-site grant applications with due dates January 25, 2018 and beyond, and for contract solicitations published starting January 25, 2018.  

Purpose

Historically, in many multi-site studies, each site has its own IRB which conducts an independent review of studies involving human research participants. The use of a single IRB of record for multi-site studies that are conducting the same protocol will help streamline the IRB review process by eliminating the unnecessary repetition of those reviews across sites.

The goal of this policy is to enhance and streamline the IRB review process for multi-site research so that research can proceed as quickly as possible without compromising ethical principles and protections for human research participants.

Policy Guidelines & Implementation

For applications with due dates on or after January 25, 2018, and contract solicitations published on or after January 25, 2018, NIH expects that all sites participating in multi-site studies, which involve non-exempt human subjects research funded by the NIH, will use a single Institutional Review Board (sIRB) to conduct the ethical review required for the protection of human subjects.

This policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research. It does not apply to career development, research training or fellowship awards. Implementation of the NIH sIRB policy is expected to reduce unnecessary administrative burdens and systemic inefficiencies while maintaining appropriate human subjects protections.

Applicants are expected to include a plan for the use of a sIRB in the grant applications and contract proposals they submit to the NIH (for due dates on or after January 25, 2018).

Resources

• Single IRB and Exception Process Webinar (October 18, 2017): find materials from the webinar including slides, video recording, and Q&As 
• NIH Office of Science Policy (OSP) Webpage: find policy documents and resources

Notices and Statements

• 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

Other

• CTTI’s Evaluation Framework for the NIH Single IRB Policy Report - September 13, 2019 (PDF, 369 KB)