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  5. What is human subjects research grant congruency review?

What is human subjects research grant congruency review?

Grant congruency review is an evaluation of a grant award/proposal compared to the associated research protocol to ensure consistency in the research activities that will be conducted and human subjects research protections.  Congruency review is required by the Department of Health and Human Services (HHS) for all HHS-supported human subjects research and requires review and approval by an Ohio State Institutional Review Board (IRB) prior to research initiation.

NIH’s policy 4.1.15 Human Subjects Protections:  In accepting an award that supports human subjects research, the grantee institution assumes responsibility for all research conducted under the award, including protection of human subjects at all participating and consortium sites, and for ensuring that a Federalwide Assurance (FWA) and certification of IRB review and approval exists for each site before human subjects research may begin.

Department of Health and Human Services (HHS) regulations (45 CFR 46.103 (f)):  Certification is required when the research is supported by a federal department or agency and not otherwise exempted or waived under §46.101(b) or (i). An institution with an approved assurance shall certify that each application or proposal for research covered by the assurance and by §46.103 has been reviewed and approved by the IRB. Such certification must be submitted with the application or proposal or by such later date as may be prescribed by the department or agency to which the application or proposal is submitted.

When is a congruency review required?
Congruency review is required for all non-exempt HHS-supported human subjects research. Exempt research projects do not require full congruency review, but proposals are checked to ensure that an exemption is appropriate for the work proposed.

How is congruence between a grant proposal and research protocol assessed?
Congruence is evaluated for several parts of the protocol and the grant application.  Information to be reviewed includes, but is not limited to:

  • Type of human subjects research (Exempt, Non-Exempt)
  • Key personnel
  • Specific aims/protocol objectives
  • General scope of work – participant population, disease, intervention, etc.
  • Protection of human subjects
  • Source of materials
  • Potential risks and benefits
  • Recruitment and informed consent process
  • Privacy and confidentiality
  • Data and safety monitoring plan
  • Protection of personally identifiable and/or protected health information

What is the review process?
The IRB is responsible for assessing whether the grant proposal/contract and protocol are in alignment. If the comparison identifies significant discrepancies, the Office of Sponsored Programs (OSP) cannot release the award  until those discrepancies have been resolved either by clarification or by an amendment to the IRB protocol or the grant proposal, as appropriate. The Office of Responsible Research Practices (ORRP) will work with the Principal Investigator (PI) to facilitate and expedite the process so that funding is not jeopardized; however, significant discrepancies between the two can lead to delays, including the release of funding.

Please note that you can add a new grant application to an existing IRB-approved protocol via an amendment or at the time of continuing review through Buck-IRB. Approval of this amendment or continuing review is evidence that the grant application has been successfully reviewed for congruency. The approval letter corresponding to the submission with which the grant application was provided serves as confirmation of congruency.

Who do I contact for guidance on the congruency review process and when do I initiate a review?
As soon as the investigator learns that he or she has a score that is likely in the fundable range, the PI should contact their Sponsored Program Officer (SPO) and the ORRP Grant Congruency Inbox, or call 614-688-8457 to obtain guidance on the congruency review process.  The SPO will work with ORRP staff to confirm IRB congruency review. Waiting for the Notice of Award (NOA) from the sponsor, may increase the possibility for a delay in HHS release of funds.

What if I am notified that my grant’s scope of work is not congruent with my approved protocol?
ORRP staff will email the PI and additional contact(s) regarding the discrepancies that need clarification and require the investigator to submit an amendment to modify his/her existing IRB approved protocol or create a separate protocol to cover the work outlined in the award.

Once congruency is IRB approved, the PI will be notified in writing.  This approval letter will then need to be provided to the SPO in order to process the award/account setup.

What can a PI do to ensure as little delay as possible?
Because the majority of research proposals are not funded, it is unnecessary to submit all proposals for a congruency review at the time of proposal submission. However, when the PI receives a score that places the proposal in the fundable range, or if there is reason to believe that the work will be funded, s/he should begin the process. This is the best way to ensure sufficient time for the congruency review and an amendment, if necessary, before the award arrives.

I’m confused – how do I know what to do and when?
Your SPO and ORRP staff will guide you through the process! The most important thing to do is to tell your SPO when your grant application has a score in the fundable range – that will start their internal review, and you will be given the steps you need to take to initiate the congruency review.

Contact ORRP with questions by email through the Grant Congruency Inbox or call 614-688-8457.

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