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Guidance Regarding Federal Requirements for IRB Review of Grants

(adapted with permission from the University of Wisconsin Health Sciences IRB.)

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).

What is the basis of the requirement for IRBs to review federal grants?

Federal regulations [45 CFR 46.103(f)] require that each grant application or proposal for most federally supported human subjects research be reviewed and approved 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 or IRB-approved protocol.  The NU IRB is required to review all grants where Northwestern University is a primary awardee.

Does the title of my grant need to match the title of my IRB protocol?

Although most funding agencies, as well as the NU Office of Sponsored Research (OSR), 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 OSR 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 the award/grant number and title of the award/grant 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.

What if the grant does not match the IRB application?

Any discrepancies between the IRB protocol and grant must be resolved or accounted for before the project can be approved. The IRB may request a research team revise an IRB application to reconcile discrepancies (e.g., to add new procedures described in the grant that will be conducted), submit a new initial review application (e.g., 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-approved application). Anytime there is a modification to a project that is grant funded, the IRB will review the grant to ensure that the modification is part of the approved grant. If not, then the PI will be asked by the IRB to provide documentation from the funder that the additional research activity is approved by the funder.

Why do I have to give the grant number as well as the grant title 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 OSR, 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.

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; however, you will not be required to attach the grant in this situation as it is a program grant.

What if a single grant supports several IRB protocols?

If a grant supports more than one research study approved by the IRB, the research team should submit the grant for review for each protocol it supports and clarify which components of the grant apply to each protocol.

What if a single IRB project is supported by more than one federal grant?

All of the grants must be uploaded into the IRB project application and the research activities of the project as proposed must fit within the activities approved within each of the grants. It is possible to have several sources of funding, both federal and non-federal, but the activities as described in the IRB protocol have to 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 Office of Sponsored Research (OSR) if the multiple funding sources are in compliance with the terms of all awards referenced.

When should a federal grant be submitted to the IRB for review?

  • 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 already has approved the research study, a modification should be submitted to add the grant. The modification will include edits to the actual application as well as the relevant documents such as the protocol and consent(s).
  • If the human research was submitted and reviewed by the IRB Office and determined to be exempt human research prior to indicating a funding source, the research team will need to submit a new proposal with the federal award attached, as research given an Exempt determination cannot be modified.
  • 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 handle this 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 grant must be attached in the funding section of the application for review and approval.  OR
    • 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 is attached in the funding section of the 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.  

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 with the grant attached.  In the local protocol addendum of the application, 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.

What sections of the grant application does the IRB need to review?

The IRB is expected to review a copy of the entire grant proposal in order to understand the scope of a project, including any potential collaborations outside the institution that may be planned. Appendices do not need to be submitted for review. Note: ANY information regarding salaries may be redacted from the submission prior to submitting to the IRB.

Do training grants or program grants that have cores require IRB review?

If a grant does not directly support human subject research, IRB review and approval is not needed unless required by the funding agency. NOTE: Any human subject research studies that receive funds from the grant to support the proposed research will require IRB review and approval.

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, then [45 CFR 46.103(f)] applies and 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.  If portions of the work outlined in the grant will be conducted by other institutions/organizations, then the organization conducting that work will be responsible for assuring compliance with IRB review of the work at its institution.  However, the NU Investigator must maintain a current IRB application with continuing reviews, etc., unless the federal funding agency determines the award is a non-human research category (rare).

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.  If Northwestern University is the Primary Awardee of the grant, then [45 CFR 46.103(f)] applies and this guidance should be followed.

What if I receive a multi-center collaborative grant?

In these cases, it is imperative that you work with your OSR 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.  If this is the case, then [45 CFR 46.103(f)] applies and this guidance should be followed.