Single IRB Plan for the Funding Application
NIH requires most multi-site funding applications to include a plan for the use of a single IRB (sIRB). For details, see Section 3.2 of the PHS Human Subjects and Clinical Trials Form Information Application Guide.
NIH has not issued policies requiring a plan for collaborative research that does not meet the definition of multi-site.
Other funding agencies such as the National Science Foundation (NSF) have not issued policies requiring a written sIRB plan for any type of studies. The information on this page is designed for NIH multi-site studies, however, if you are asked to provide a plan, this information may be useful.
NIH requires that specific information about the single IRB arrangement be included. This is called the “Single IRB Plan”.
- A description of how you will comply with the NIH Single IRB (sIRB) policy.
- 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.
- If you are requesting an exception for some or all participating sites, follow the NIH Guidance Requesting an Exception.
- 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.
- Briefly describe how communication between sites and the sIRB will be handled. See this link for a possible template.
- Indicate which institution or entity will maintain records of the authorization/reliance agreements and of the communication plan.
Some IRBs, such as independent IRBs like WCG IRB and Advarra, may provide you with this information along with any fee estimates you have requested. If the IRB has not provided this information, you will need to compile it yourself. UW investigators who have obtained HSD’s permission to serve as the sIRB may use HSD’s template plan.
Delayed-onset Multi-site Research
Delayed-onset human subjects studies are those for which there is no well-defined, detailed plan for human subjects involvement at the time of submission. If the delayed-onset research is likely to involve multiple sites, the delayed onset justification attachment must:
- Include information about how the study will comply with the sIRB policy, and
- State that a sIRB plan will be provided prior to initiating the study.
Location in the funding application
NIH Multi-site Research
The Human Subjects and Clinical Trial Information form (also known as FORMS-E) must be included in funding application packages for all human subjects and/or clinical trial research applications. The single IRB plan is uploaded as a PDF attachment to Question 3.2 of the new FORMS-E. See Section D “NIH Grant Application/Contract Proposal Preparation” of the NIH FAQ Single IRB Policy and Multi-site Research and (for specific details) Section 3.2 of the PHS Human Subjects and Clinical Trials Information Form Application Guide.
NIH Multi-site Delayed-onset Studies
FORMS-E has specific questions for delayed-onset studies. The sIRB plan should be uploaded with the answers to those questions.
NIH Collaborative Research
NIH has not published policies or instructions about the inclusion of information about the sIRB in funding applications for collaborative research. Follow any instructions given to you by program officers or other agency representatives.
Other Funding Agencies
Other funding agencies have not published policies or instructions about the inclusion of information about the sIRB in funding applications. Follow any instructions given to you by program officers or other agency representatives.
Additional supporting documents
From the UW IRB
It is UW policy that you consult with HSD to confirm that the proposed sIRB is acceptable or that HSD is willing to serve as the single IRB. HSD may issue a Letter of Support documenting its support. You may include this letter in your funding application at your discretion; however, it is not specifically required by NIH.
From the non-UW Single IRB
NIH does not specifically require a letter of support from the sRB indicating its willingness to serve as the sIRB. However, HSD believes that including one in the funding application is a best practice.
From the non-UW Participating Sites
NIH does not specifically require any supporting documents, but it states that the sites should agree to a sIRB arrangement prior to the grant submission, and “the applicant should indicate the participating sites’ willingness to rely on the selected single IRB”. This can be accomplished by a statement from the Lead PI in the single IRB plan or by inclusion of letters of support.