Congruency Policies & Procedures
For the NIH and other sponsors utilizing JIT notices:
- The Office of Animal Care & Use (OACU) is automatically notified anytime an NIH award is changed to “Just-In-Time (JIT) Request Received” in RAMSeS. The OACU will contact the PI at this time to initiate the review. The NIH generally affords a 2-week due date for JIT materials from the date of JIT notice. The OACU strives to complete all Congruency Review requests within 5 business days depending on current volume. If a PI receives notice that their grant is likely to be awarded based on their impact score, it is advisable to initiate the congruency review as soon as possible to avoid a
- The Sponsored Programs Office and Office of Sponsored Research may contact the OACU to request a congruency review if funding for a grant looks favorable.
- A congruency review can be requested using this webform located on the IACUC website: https://research.unc.edu/offices/iacuc/forms/request-for-review/
Ensuring that all animal activity outlined in a grant application has been approved by the IACUC is an institutional responsibility; however, the Office of Animal Care and Use (OACU) has been tasked with this responsibility. The grant application/protocol congruency reviews will be performed by OACU staff members.
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. Accordingly,OACU staff are only reviewing those grants that are likely to be funded.
At the time that a PI receives a fundable score from the NIH, he/she should complete the online form entitled “Request for Grant Application/IACUC Protocol Congruency Review.” This form allows the PI to indicate any additional information he/she would like to communicate to OACU staff about the grant application prior to the review of the grant application.
Upon completion of this online form, OACU staff will receive an email notification of the request for congruency review. Requesting the congruency review at this time is advantageous because it will allow for any discrepancies between the grant application and the IACUC protocol(s) to be resolved prior to the award of grant funds.
Alternatively, if the PI does not request a grant application/protocol congruency review at the time he/she receives a fundable score from the NIH, OACU staff will be notified via email once the status of a grant application has been updated in RAMSeS to “JIT Request Received.” Once OACU staff receive this notification, they will call and/or email the PI to inquire about the likelihood of the grant being funded. If it is likely that the grant will be funded, OACU staff will conduct a congruency review of the grant application with the corresponding IACUC protocol(s). Reviewing the grant application and corresponding IACUC protocol(s) at this time is not ideal because IACUC approval has already been submitted to the NIH by UNC-CH grants administration staff. This issue can be problematic if there are procedures proposed in the grant application that are not typically approved by the IACUC. (For example, LD50 studies, the use of death as an endpoint, etc.) If OACU staff identifies serious discrepancies between the grant application and the IACUC protocol(s), the NIH may have to be notified of these issues.
Regardless of the time and/or methods by which the review is requested, OACU staff will perform a side by side comparison of the grant application and the corresponding IACUC protocol(s). PIs should ensure that their grant application has been uploaded into RAMSeS for review. Grant applications will be reviewed by OACU staff in the order in which they were received or in order of priority. Grant applications will be reviewed within one week of receiving a request from the PI or email notification from RAMSeS. Grant applications requiring review on an emergency basis will be given priority and reviewed immediately. OACU staff will make every attempt to accommodate funding/award deadlines but PIs should allow sufficient time for OACU staff to review the grant application.
All animal work outlined in the grant application must be approved by the IACUC in a corresponding IACUC protocol(s). OACU staff will focus on the following areas of the grant application and corresponding IACUC protocol(s) during the side by side comparison of the documents:
- Procedures (including custom generation of antibodies contracted off-site)
- Drugs (Agents, Dosages and Route of Administration)
- Experimental Endpoints
- Method(s) of Euthanasia
PIs will be contacted with the results of the grant congruency review no later than 24 hours of completion of the grant review, or sooner, as necessary. If there are no discrepancies between the animal work described in the grant application and the corresponding IACUC protocol(s), an email will be sent to the PI indicating that the documents were congruent. (See https://research.unc.edu/files/2012/11/Grant-Congruency-Letter-Template-Congruent.pdf)
If an OACU staff member identifies discrepancies between the grant application and the IACUC protocol, the PI will be emailed with a detailed description of the discrepancies and suggestions on how the discrepancies can be resolved. (See http://research.unc.edu/files/2012/11/Grant-Congruency-Letter-Template-Incongruent.pdf) Discrepancies between the grant application and the IACUC protocol(s) are usually resolved by providing an explanation or submission of a new amendment or protocol.
PIs should respond to the email regarding grant/protocol application discrepancies as soon as possible. PI responses to grant congruency discrepancies will be reviewed and processed within 72 hours of their receipt or sooner, if necessary, to accommodate funding/award deadlines.
If resolution of the discrepancies requires submission of a new amendment or protocol, the Chair of the IACUC has initiated a process by which grant application and animal protocol congruency can be established with potentially minimal delays. Specifically, in instances where there is a lack of congruency between the grant and an IACUC protocol, the PI can submit an amendment with rapid turnaround request. Such amendments will be processed as quickly as possible. If an amendment is not sufficient and a full protocol is required in order to establish congruency, or if a protocol is currently under review, the protocol will be processed by the IACUC Chair and a Division of Comparative Medicine (DCM) veterinarian in order to ensure a rapid and thorough review. If this protocol review does not coincide with the monthly IACUC meeting, the protocol will be reviewed by designated member review 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, and this may delay time to approval.
Open communication will be maintained between OACU staff and the PI until all discrepancies have been resolved and the grant application and IACUC protocol(s) are determined to be congruent. Once the PI has resolved all of the discrepancies, OACU staff will email the PI indicating that the documents are now congruent.