Department of Health
and Human Services (HHS)
and Human Services (HHS)
August 23, 2021
NOT-OD-16-094 – Final 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
Office of The Director, National Institutes of Health (OD)
The purpose of this Notice is to remind the extramural research community that providing the name of the single IRB (sIRB) of record at Just-in-Time submission suffices to fulfill the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research requirement to provide an sIRB plan for NIH grants.
Background
Per NOT-OD-16-094, NIH applicants proposing multi-site studies involving non-exempt human subjects research are expected to provide a plan describing the use of an sIRB that will be selected to serve as the IRB of record for all study sites.
Applicants for NIH funding using the FORMS-F or later grant application packages are instructed not to submit a plan describing the use of an sIRB at the time of application submission. However, applicants required to use an sIRB are required to provide the name of the sIRB of record during Just-in-Time submission before an award is issued. If, in delayed-onset research, an sIRB has not yet been identified, the recipient will provide the name of the sIRB to the funding NIH Institute/Center (IC) prior to initiating the multi-site research study/project. Providing the name of the sIRB of record satisfies the NIH sIRB policy requirement for an sIRB plan for NIH grant applicants.
Guidance for NIH Grant Applicants
Applicants should follow the instructions corresponding to their grant application package in the application guide when completing PHS Human Subjects and Clinical Trials Information Form questions regarding use of an sIRB.
Resources
NIH Office of Extramural Research
Email: SingleIRBPolicy@mail.nih.gov