Guidance Regarding Requirements for Federal Grants
1. Why is this guidance relevant to me?
If you are the Principal Investigator on a primary or direct federal award to Northwestern University, where you have indicated the involvement of human subjects within the grant, then this guidance offers practical tips for assuring adherence to the requirements of the federal regulations. Typically, a federal award that indicates the inclusion of human subjects cannot be reviewed as non-human research (see more on this topic later in the guidance).
2. What if I am the primary awardee of the grant, but I am only receiving de-identified data/samples, can I get a non-human research determination?
If Northwestern University is the Primary Awardee of a federal grant, where a subaward institution or organization will conduct non-exempt human subjects research then the non-human research determination is not the appropriate application. A full IRB application should be prepared and submitted with full details outlining how the data/samples will be obtained and which portions of the work will be conducted at Northwestern and/or by other institutions and organizations.
If Northwestern University is the Primary Awardee of a federal grant and any/all subaward institution or organizations are conducting non-human research the NU Investigator must still maintain a current IRB application with continuing reviews, etc., unless the federal funding agency determines the award is a non-human research category.
3. Does the title of my grant need to match the title of my IRB protocol?
Although most funding agencies, as well as Sponsored Research (SR), prefer for the grant title to match the IRB protocol title, this is not always possible because some IRB protocols cover multiple projects and multiple grants. That being said, the funding agency and SR must be able to connect an IRB approval to a particular grant. To facilitate this match, the NU IRB requires that any funding sources for an IRB project be added to the funding section of the IRB application. The PI should include information about the award/grant on the Funding page of the eIRB+ application to ensure that the appropriate award/grant is referenced in the IRB approval. No assumptions should be made regarding IRB approval of a specific award/grant without that information identified specifically within the funding section of the IRB application.
4. Why do I have to include the grant number in the funding section of the IRB application?
This is done for matching purposes and to assure that there is alignment between what is submitted to the IRB and SR, thus, facilitating accurate documentation submission to the federal agencies regarding review activities. Simply using terms like NIH, NCI, etc. is too ambiguous and will not facilitate appropriate documentation match up as required by the funding agencies.
5. Is my grant subject to the NIH data management and sharing policy?
Effective January 25, 2023, all new grant applications, and competitive renewals from the NIH are subject to the data management and sharing policy. This policy requires a data management and sharing (DMS) plan be submitted with the grant application submitted to the NIH. Northwestern has developed a website to provide resources to develop your DMS plan. The IRB does not need to review the DMS plan submitted to the NIH; however, the protocol submitted to the IRB should reflect any data management and sharing plans.
6. What if it is a federally funded NCI cooperative group project?
In these instances it is best to reference the Cancer Center grant as the source of funding.
7. What if a grant supports several IRB protocols?
If a grant supports more than one research study approved by the IRB, then the Funding page of each eIRB+ application must include information about the grant.
8. What if an IRB project is supported by more than one federal grant?
It is possible to have several sources of funding, both federal and non-federal, but the activities as described in the IRB protocol must be consistent with the research activities as described across all of the grants. In addition, it is strongly encouraged that you receive clarification from the Sponsored Research (SR) if the multiple funding sources are in compliance with the terms of all awards referenced.
9. When should Just-In-Time funded projects be submitted to the IRB for review?
If the grant has not been awarded but the research team has been informed that it is likely to receive the award (e.g., Just-in-Time, JIT, notification or any other indications that that funding is likely), the research team can proceed one of two ways:
- If the research is greater than minimal risk, requiring full committee review, then the research proposal and documents (e.g., IRB application, consent, advertisements, etc.) must be fully developed and ready for eIRB+ submission for the IRB review and approval process to occur. Without fully developed documents the convened IRB cannot grant approval. The Funding page of the eIRB+ application should also include the grant information.
- If the research is minimal risk and qualifies for expedited review, AND the research plan and corresponding documents are complete, with the exception of participant-facing documents (e.g., consent form, recruitment materials, etc.), and IRB approval is needed for the release of funds, then the IRB application should be submitted for review and approval. As long as the grant information is included on the Funding page of the eIRB+ application, and sufficient information is provided to conduct a Criteria for Approval review, the participant-facing documents can be submitted when available before enrollment of human participants.
- NOTE: In your approval letter, you will receive specific instructions that no enrollment may occur prior to IRB review and approval of all participant -facing documents. Should you miss this critical step and commence the research, you will be in non-compliance with the determinations of the IRB.
10. What happens if I am transferring a grant to Northwestern University?
Regardless of what stage the research may be in – if the grant was funded with the inclusion of human subjects – then an IRB application is required. In the protocol, or a local protocol addendum, the PI can provide specific details on the stage of the research. This process may require some dialogue between the Principal Investigator and the IRB to assure that the review meets federal requirements as [45 CFR 46.103(f)]applies and now the primary or direct awardee institution will be Northwestern University. Please see the Principal Investigator Responsibilities, Eligibility, and Permissions webpage for more information on incoming investigators with ongoing research.
11. What if I am serving as the lead PI or coordinating center of a multi-center federally funded research project, but I am not serving as the enrolling Investigator?
Any time an Investigator participates in human research, IRB approval must be in place as the lead PI or the coordinating center PI will typically have the potential for access to identifiable human information. NOTE: Non-exempt human research with multiple sites is subject to Single IRB requirements. More information is on the Single IRB Planning webpage.
12. What if I receive a multi-center collaborative grant?
In these cases, it is imperative that you work with your SR representative to assure understanding of the terms of the award. Many of these unique funding awards do indicate that more than one institution is a prime or direct awardee. NOTE: Non-exempt human research with multiple sites is subject to Single IRB requirements. More information is on the Single IRB Planning webpage.
Portions of this webpage were adapted with permission from the University of Wisconsin IRB.