Perhaps you have received a notice of award recently only to be informed by grants and contracts preaward unit that there was no indication of “congruency” between the soon to be funded award or non-competing renewal and the IACUC protocol(s) associated with the proposal. While the requirements for congruency between awards and protocols is longstanding, your brush with this potential hurdle may be a first encounter, additionally you may be wondering why this is necessary, what do I have to do to meet the requirements, and how does this effect my ability to charge animal related costs to my award both directly and via a cost-transfer.
Why?
NIH requires the University to provide verification that the Institutional Animal Care and Use Committee (IACUC) has reviewed and approved those sections of the application/proposal that involve use of vertebrate animals, in accordance with the requirements of the Policy prior to award. The IACUC review ensures that the research described in the application is congruent with any corresponding protocols reviewed and approved by the IACUC.
The NIH Just in Time process provides a mechanism for submitting verification of IACUC review and approval after peer review but prior to funding. Other funding agencies have similar requirements for verification of IACUC review and approval, although the timing of the verification process may vary
What to do.
Congruency Process
To comply with Federal requirements regarding IACUC approval of the proposal and protocol, the University has in place a process to ensure congruence between an approved protocol and the proposal/application associated with that protocol.
The following definitions are provided to assist you in understanding the process description:
- Protocol: a description of proposed live vertebrate animal work to be conducted at the University and submitted to the IACUC for review and approval.
- Proposal/Application: A request for financial support of a project or activity submitted to a sponsor.
- Congruency: A review of the protocol and proposal for consistency between the two documents.
1. Prior to award, after receipt of a fundable priority score, or a score in the top 20 percent, The Principal Investigator must submit a copy of the proposal to the IACUC along with an indication of the protocol(s) to be linked to the award.
2. A subcommittee of the IACUC reviews the application for consistency with the IACUC approved protocol(s). Congruency approval is granted for applications that are consistent with the approved protocol(s), in regard to, Preliminary Data, Specific Aims, Materials and Methods, & Vertebrate Animals.
3. Congruency approvals are in effect for the duration of the award. However, individual protocol approvals are reviewed for consistency at the three year anniversary date and progress reports are requested for all awards with 3 year anniversary dates
**For proposals with experiments that are not consistent with the approved protocol(s), the sponsored projects office of the IACUC will contact the investigator to outline the modifications to the approved protocol required for congruence approval.
Detailed information regarding the animal protocol and proposal approval process can be found on the IACUC website at: http://iacuc.yale.edu/research/index.html along with FAQs that should help you through the process.
HOW THIS EFFECTS DIRECT CHARGES AND COST TRANSFERS
The terms and conditions of NIH awards incorporate the Policy with regard to animal care and use. Failure to comply with the terms and conditions of award could lead the agency to suspend the grant, pending corrective action, or to terminate the grant for cause. Therefore direct charges to an NIH grant award for work with animals are not allowable
- In the absence of a valid institutional Assurance on file with the Office of Laboratory Animal Welfare, and
- In the absence of a valid IACUC approval of the research activity.
Cost Transfers
Cost transfers involving animal related charges are verified by the Office of Grant and Contract Financial Administration (GCFA) to comply with the requirements above. The process of verification is described below:
A. Required Information/Documentation
To expedite the process for cost transfers involving animal care-related charges, the department should provide GCFA with the following information in the JSA, cost transfer justification form, and the supporting documentation:
The proposed receiving award(s)
- The active protocol numbers for the proposed receiving awards
- The species of animal used
- The attached form filled out and submitted w/ the cost transfer documentation
- All associated YARC invoices
B. GCFA Review Process
When GCFA reviews cost transfers for animal care charges there are several different elements that will be verified with IACUC records.
The proposal/award (sponsored project) receiving the charge must be linked to an active protocol. The protocol number given to GCFA by the department will be verified with IACUC records.
The expenditure item date of the animal care-related charge must fall within the active dates of the protocol
- The congruency date for the protocol and award must be prior to the date of the animal care-related charges.)
- The species or animal used as identified by the department must be specifically referenced on the protocol.
If any of these criteria are not met, GCFA will not approve the cost transfer. In these situations, GCFA will work closely with the department to verify the accuracy of the information provided. If the department is unable to provide information and documentation that fulfills each of the criteria, the proposed cost transfer will be rejected.
To avoid potential issues with funding of awards and/or cost transfers the following steps should be followed:
- Prior to award ensure that each proposal has a congruent active IACUC protocol.
- Ensure that any cost transfers proposed falls after the congruency date.
The IACUC sponsored projects office along with YARC, G&C preaward and the business transformation initiative are working to create and implement a streamlined system that will reduce the burden on Principal Investigators by automating some processes and limiting the paperwork burden as it relates to proposal submission going forward. Look for changes to be announced in this venue soon that will make compliance more seamless and transparent.