The National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board (sIRB) of Record for Multi-Site Research establishes the expectation that all sites participating in NIH-funded, multi-site studies, involving non-exempt human subjects research, will use a sIRB to conduct the ethical review required by the Department of Health and Human Services (HHS) regulations for the Protection of Human Subjects at 45 CFR 46.114.

If you answer YES to all three of the following questions, the proposal must follow NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research. 

1. Does the proposal involve conducting non-exempt human subject research?
2. Will there be multiple U.S. sites conducting the same protocol involving the non-exempt human subject research?
3. Will the proposal be funded by NIH through a grant, cooperative agreement, or contract (excluding training awards)?

If you answered YES to all three questions (above), submit a sIRB consultation request to [email protected].

Start planning at least 90 days prior to the application submission due date. 

The proposal will require:

1. SELECT A SINGLE IRB OF RECORD TO BE NAMED IN THE PROPOSAL: If you have not already done so, contact the UCSF IRB office to collaborate with you in the selection process. Early involvement with UCSF IRB staff is critical to determine the sIRB that will serve as the IRB of record. It is recommended that you contact the IRB office at least 90 days prior to the application/proposal submission due date.
2. COMPOSE A PLAN FOR THE USE OF A SINGLE IRB: a plan for the use of a single IRB to accomplish IRB review will need to be included in the proposal, in response to Section G.500, Question 3.2 of the Human Subjects and Clinical Trials Information form in the SF 424 FORMS-E PACKAGE unless otherwise stated in the RFP or solicitation for contracts. Contact the UCSF IRB office for template language that can used for the application.  The plan will include the following information (For full details, see NIH Application Instructions, Section G.500, Question 3.2):  
   • Describe how you will comply with the NIH Policy on the Use of sIRB for Multi-Site Research.
   • Provide the name of the IRB that will serve as the sIRB of record.
   • Indicate that all identified participating sites have agreed to rely on the proposed sIRB and that any sites added after award will rely on the sIRB.
   • Briefly describe how communication between sites and sIRB will be handled 
   • Indicate that all participating sites will, prior to initiating the study, sign an authorization/reliance agreement that will clarify the roles and responsibilities of the sIRB  and participating sites.
   • Indicate which institution or entity will maintain records of the authorization/reliance agreements and of the communication plan.
   • Note: Do not include the authorization/reliance agreement(s) or the communication plan(s) documents in your application.
   • Note: If your human subjects study meets the agency definition of “Delayed Onset,” include information regarding how the study will comply with the NIH sIRB policy prior to initiating any multi-site study in the delayed onset study justification.
3. DETERMINE ALLOWABLE DIRECT COSTS that are associated with the establishment and review of the multi-site study by the sIRB, to be included in the proposal budget, with appropriate justification. Costs must be reasonable and consistent with cost principles, as described in the NIH Grants Policy Statement and the Federal Acquisition Regulation (FAR) 31.302 (Direct Costs) and FAR 31.203 (Indirect Costs).
   • NOTE:  If a commercial sIRB or another institution (that is not a participating site on the study) is selected, work in collaboration with the UCSF IRB (see Obtaining Annual Cost Information for sIRB Review). When a Single IRB is selected, contact the vendor/IRB directly to discuss the study, IRB review needs, and request annual quotes for each budget period. Submit quotes with application budget information to your Research Services Coordinator to prepare the application budget. 
   • NOTE: If UCSF IRB is selected to act as the sIRB:  you may only budget for costs to perform Secondary Activities (e.g. IRB review for study sites). This should be done through an approved recharge process. Primary Activities (e.g. review of the Lead PI’s protocol) is covered by F&A. Contact UCSF IRB for charges to perform Secondary Activities per budget period and include with the application budget information for your Research Services Coordinator to prepare the application budget. 
   • NOTE: If a participant institution is selected to act as the sIRB:   the participant institution will include allowable direct costs in their budget.
   • NOTE: If direct costs are anticipated to be over $500,000 Applicant/offeror is required to contact the IC Program staff six (6) weeks prior to the application submission due date.

1. It will be the responsibility of the applicant/offeror to assure that the sIRB is qualified to serve; the applicant’s plan will not be evaluated in peer review.
2. Exceptions to the sIRB policy will be granted if the use of a sIRB is prohibited by federal, state, or tribal laws or regulations.  In order to be considered for an exception, a formal request must be submitted to funding NIH Institute/Center, including a compelling justification for why an exception is needed.