Grant Congruency

Grant congruency is the process by which Institutions ensure that all animal activity outlined in a grant application has been approved by the IACUC in an approved animal protocol.

The principal funding source for live vertebrate animal research at TAMU-CC is the U.S. Department of Health and Human Services (HHS), primarily through the Public Health Service (PHS) and its National Institutes of Health (NIH). HHS/NIH funding accounts for the majority of all award dollars granted at TAMU-CC. In order to receive funds for live vertebrate animal research, the University is required to follow PHS and NIH policy. Excerpts from both the HHS and NIH Grants Policy Statements are noted below.

HHS Grants Policy Statement

“The PHS Policy on Humane Care and Use of Laboratory Animals (the PHS Policy) requires applicants proposing to use vertebrate animals in HHS-supported activities to file a written Animal Welfare Assurance with OLAW. An awarding office will not make an award for research involving live vertebrate animals unless the applicant's organization and all performance sites are operating in accordance with an approved Animal Welfare Assurance and provide verification that the IACUC has reviewed and approved those sections of the application that involve use of vertebrate animals, in accordance with the requirements of the PHS policy. If an application is selected for award and the verification of IACUC review has not been submitted, the awarding office will contact the organization with instructions for negotiating an assurance or submitting the IACUC verification.”

NIH Grants Policy Statement

“NIH will not make an award for research involving live vertebrate animals unless the applicant's organization and all performance sites are operating in accordance with an approved Animal Welfare Assurance and provide verification that the IACUC has reviewed and approved those sections of the application that involve use of vertebrate animals, in accordance with the requirements of the policy.”

“Verification of the IACUC review may be filed at any time before award unless required earlier by the institutional committee. Therefore, following peer review and notification of priority score/percentile, applicants' organizations with approved assurances should proceed with IACUC review for those applications that have not yet received IACUC approval and that appear to be in a fundable range. Regardless of when the review occurs, the IACUC should ensure that the research described in the application is consistent with any corresponding protocols reviewed and approved by the IACUC. If an application is selected for award and the verification of IACUC review has not been submitted, the awarding office will contact the organization with instructions for negotiating an assurance or submitting the IACUC verification.”

The NIH funding process has continued to become more competitive, therefore receiving a “JIT Notification” from the NIH is no longer a guarantee of funding. The NIH has changed its Just-In-Time policy to include all grants that were scored, as opposed to only those grants that have a high probability of being funded. 

At the time that a PI receives a fundable score from the NIH, he/she should contact the ORC to start the IACUC and grant congruency review.

A side by side comparison of the grant application and the corresponding IACUC protocol(s) is performed. All animal work outlined in the grant application must be approved by the IACUC in a corresponding IACUC protocol(s). The following areas of the grant application and corresponding IACUC protocol(s) are reviewed during the comparison of the documents:

• Species
• Procedures (including custom generation of antibodies contracted off-site)
• Drugs (Agents, Dosages and Route of Administration)
• Experimental Endpoints
• Method(s) of Euthanasia

The following are common types of discrepancies:

• Proposed use of agents (analgesics, anesthetics and/or experimental drugs) in the grant application that are not included in the IACUC protocol or are included at different doses than the doses indicated in the grant application;
• Proposed procedures in the grant application that are not included in the IACUC protocol;
• Methods of euthanasia are different in the grant application than the methods indicated in the protocol;
• Proposed custom generation of antibodies in the grant application;
• Proposed animal work performed off site by a collaborating site, a subcontract, or a fee-for-service arrangement; or
• The experimental endpoints in a grant application are different than those described in the protocol. For instance, the length of time an animal survives after a survival surgical procedure is longer in the grant application than in the protocol.

Principal Investigators will be contacted with the results of the grant congruency review through the protocol feedback form.

The PI will be notified if discrepancies between the grant and submitted IACUC protocol are identified. Discrepancies between the grant application and the IACUC protocol(s) are usually resolved by providing an explanation or by submitting a new amendment or protocol.

If the protocol review does not coincide with the monthly IACUC meeting, the protocol may be reviewed by a designated member rather than Full Committee review. Please be aware that all efforts will be made to accommodate funding/award deadlines, but federal regulations require all IACUC members to receive a copy of all submitted amendments and full protocols. Upon receipt and review, any IACUC member can request a Full Committee review which requires review of the amendment or protocol at the next scheduled monthly IACUC meeting, which may delay time of approval.