It is a requirement of both Federal law and NIH Grants Policy to ensure that an in vivo project that has been selected to be funded is congruent with an approved Institutional Animal Care and Use Committee (IACUC) protocol(s). Funding agencies ask for this verification by requesting an IACUC approval date. It is the release of the approval date that verifies to the agency that a congruency comparison has been completed. Therefore, the approval date cannot be released until the Institution has verified that the proposal and the protocol(s) are congruent. Please see IACUC Policy on Requiring a Congruency Comparison.
It is important to remember that funding agencies define the receipt of an IACUC Approval date as confirmation that the Institution has performed a congruency review between the proposal and the IACUC protocol. Thus, IACUC Approval dates cannot be released unless a congruency letter has been obtained that verifies this specific comparison has been completed. This requirement pertains to all sources of funding.
*It is non-compliant to provide an IACUC Approval date without obtaining a congruency letter.
If you need a congruency review/IACUC approval date, the following procedures must be followed:
The animal use in the proposal will be compared with the corresponding animal protocol(s). Depending on how congruent the documents are:
You are all set! – If no relevant discrepancies are noted, an IACUC staff member will send you a CONGRUENCY LETTER, which provides confirmation that the grant is congruent with the protocol(s) and releases the approval date(s).
Minor discrepancies – If minor discrepancies are noted, the Principal Investigator will be notified of these items, but a congruency letter will be provided so that the approval date can be released.
Significant discrepancies – If significant discrepancies are noted, the Principal Investigator will be notified and will need to amend the protocol(s) OR the proposal before the approval date(s) can be released.
What do I do if my work is part of a collaboration with another institution?
The congruency requirement is always applicable, but there may be different routes to take depending on the characteristics of the proposal. If the proposal includes animal activities to be performed at another institution, the IACUC staff members will help you determine how to proceed. Please follow the same steps as described above, by submitting the Congruency Request Form and the final version of the proposal to the IACUC office, but also let us know of all other in vivo collaborations and performance sites.
If Tufts or TMC is the primary recipient of the funding, then the IACUC office will need the IACUC protocol (or equivalent) and confirmation of approval from the collaborating institution(s). Additionally, a formal written document, called a Memorandum of Understanding (MOU), must be signed by both institutions before the approval date(s) can be released. See IACUC Policy on Collaborative Work with Outside Organizations. If you have any questions or wish to initiate the MOU process, please contact the IACUC office.
I already know my approval date, so can’t I just include it in my proposal?
Even if you know the approval date, it cannot be submitted to the funding agency until a congruency has been confirmed by the IACUC office. If the proposal has not yet been reviewed and/or selected for funding, please put the word “pending” in the area that requests an IACUC approval date. Once the proposal has been selected for funding AND the final version decided upon, then a congruency request can be made to the IACUC.
I have already sent the protocol approval date regarding this proposal, why are they asking for it again?
Some agencies ask for IACUC approval dates on annual basis or any time the animal work has changed. Some agencies even keep track of the when the protocol expires and therefore ask for the congruency review to be completed again for the de novo animal protocol even if the proposal hasn’t changed. We have encountered a broad array of other reasons why an approval date may be re-requested from the funded institution. Basically, whenever an approval date is requested, it means that a congruency review must be performed again and a new congruency letter submitted.
I have received a document that requests protocol title and approval date with signatures from the IACUC Chair and the Institutional Official.
This may be an Inter-Institutional Agreement, which means that an outside entity is receiving funds from NIH and they want to use one of our Public Health Service (PHS) Assurance numbers in order to receive the funding. This is another version of a collaborative agreement, but with specific requirements from the Office of Laboratory Animal Welfare (OLAW) at NIH. This and any documents that need IACUC information should be submitted to the IACUC office for completion and final submission. Only the IACUC office has authorization to complete a form that requires IACUC information.
Do I need a congruency review if my proposal involves custom antibody generation?
Yes, a review is necessary since the primary recipient’s IACUC is responsible for the use of the animals needed for custom antibody production, even if it is conducted off-site. The IACUC has provided a list of approved vendors. However if an investigator wants to use a vendor that is not on this list and/or does not meet the required standards in the IACUC Policy on Off-Site Commercial Vendors for the Production of Polyclonal and Monoclonal Vendors they must request approval from the Attending Veterinarian for that campus. This request must include a justification for why use of that specific vendor is necessary. More information and a list of approved vendors can be found here.