IRB Guidance: IRB Review of Grants
This page provides guidance for IRB review of grants and the process for submitting these to the IRB.
Federal regulations (45 CFR 46.103(f)) require that the grant application or proposal for most federally-supported human subjects research be reviewed by an IRB. As part of this review, IRBs are required to ensure that the activities described in the grant are consistent with the proposed IRB-approved protocol. Any discrepancies between the IRB protocol and grant must be resolved or accounted for. As part of its review, the IRB may request a research team to do one or more of the following to resolve such discrepancies:
- revise an IRB application to add new procedures described in the grant that will be conducted
- submit a new initial review application when the grant appears to describe a new study, OR
- provide clarification regarding the reason for the differences (e.g. when only part of the grant appears to support the IRB application).
UW-Madison Campus Requirements
The University of Wisconsin-Madison also requires an IRB to review a federal grant that involves human subjects in order for an account to be set up by Research and Sponsored Programs (RSP) and funds to be released.
When drafting grant proposals and the subsequent IRB applications, consider that RSP and many funding agencies prefer (some may require) that the grant title match the IRB protocol title. While this is not always possible because some protocols cover multiple projects and multiple grants, keep in mind that the funding agency and RSP must be able to connect an IRB approval to a particular grant. For more detail on how to link an IRB protocol to an RSP record, see here.
IRB Submission and Grant Review
The IRB is expected to review a copy of the entire grant proposal, including budget, in order to understand the scope of the project and collaborations outside the institution that may be planned.
If a federal grant has been awarded, it should be provided to the IRB for review at the time of initial review of the protocol OR if the IRB has already approved the research study, a Change should be submitted to add the grant as a funding source.
The ARROW application includes a section on funding. For studies that have funding administered through UW-Madison (includes federal grants), study teams are asked in ARROW to select a funding source from the RSP database and upload a copy of the grant application for review. For all federal grants, the study team must upload a copy of the full grant application (when available) for review so the IRB can ensure congruency with the ARROW application.
If a grant supports more than one research study, the research team should submit the grant for IRB review of each protocol it supports and clarify which components of the grant apply to the protocol in question.
Submission for Protocol Development Activities and Just-in-Time Awards
A grant may also be proposed for a project where components involving human subjects are planned, but would not occur until sometime in the future during the proposed period of support (generally at least 6 months or more). In this case, there may not be sufficient information to submit a full IRB application for review of those human subjects components yet, but grant funds are needed to conduct activities prior to IRB review/approval. Such activities include: development of study instruments, hiring of staff, obtaining space in facilities, etc. In these cases, it may be appropriate for the research team to submit an Application for Protocol Development Activities (PDA) to the IRB. The PDA is a simplified application that allows the IRB to review in concept those activities described in the grant that do not involve human subjects, while the research team prepares its full application for IRB review. Approval of a PDA application will allow RSP to release the funds. However, it is understood that a full application must be submitted to and approved by the IRB before beginning any research activities involving human subjects.
If the grant has not been awarded yet but the research team has been informed that it is likely to receive the award (e.g. Just-in-Time notification), the research team can handle this one of two ways:
- If the research study has not yet been submitted to the IRB, and a PDA is deemed appropriate, submit the PDA application to the IRB. Approval of a PDA application will allow RSP to release the funds.
- If the grant will be used to support a research study that has already been submitted to and approved by the IRB, submit a Change to add the funding information once the grant has been awarded.