Single IRB Plan for the Grant Application
This information is drawn from the NIH FAQs on the Single IRB Policy for Multi-site Research and the PHS Human Subjects and Clinical Trials Information Form Application Guide. It describes a new requirement for NIH multi-site grant applications.
Beginning on January 25, 2018, NIH requires most multi-site grant applications to include a plan for the use of a single IRB. For details, see Section 3.2 of the PHS Human Subjects and Clinical Trials Form Information Application Guide.
- Describe how you will comply with the NIH Single IRB (sIRB) policy. If you are requesting an exception for some or all participating sites, follow the NIH Guidance Requesting an Exception.
- 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 the sIRB will be handled. See this link for a possible template.
- 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.
Some IRBs, such as independent IRBs like WIRB and Advarra, will provide you with this information prepared in a letter of support along with any fee estimates you have requested. If the IRB has not provided this information, you will need to compile it yourself.
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 Grant Application
A new Human Subjects and Clinical Trial Information form called FORMS-E must be included in NIH grant application packages and contracts for all human subjects and/or clinical trial research applications. This new form is a “smart” (i.e., branching) webform that consolidates all human subjects and clinical trial-related information into one place, and also expands the information required for studies that meet the NIH definition of a clinical trial. The sIRB plan is uploaded as an attachment to Question 3.2 of the new FORMS-E.
FORMS-E has specific questions for delayed-onset studies. The sIRB plan should be uploaded with the answers to those questions.
From the single IRB
NIH does not specifically require a letter of support from the single IRB indicating its willingness to serve as the sIRB. However, HSD believes that this is a best practice.
From the UW IRB
It is UW policy that you consult with HSD to confirm that the proposed single IRB is acceptable. HSD may issue a Letter of Support documenting its support for the use of the identified sIRB. You may include this letter at your discretion; however, it is not specifically required by NIH.
From 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. letters of support from each participating site are another way to accomplish this. Note: Formal, written and signed IRB reliance agreements are not required to be in place prior to receiving NIH funding.