Requesting an IACUC Congruency Certificate/Approval Letter
What to Include When Requesting an IACUC Approval Letter
To avoid delays, please include the following in your email request to [email protected]
- Grant PI Name
- Project Title
- Name of Funding Agency (with grant number if NIH)
- All relevant IACUC protocol numbers under which the work will be performed
If this is a first-time request for this grant, please include a copy of the grant application in its entirety, not just partial sections**. Providing all information upfront will result in a more timely fulfillment of your request.
Please allow 5 full business days for us to complete our initial review, and a second reviewer’s concurrence, although we will make every effort to complete your request sooner, if possible. If we find the grant and protocol to be congruent, we will issue the letter at this point. We generally address requests in the order in which they were received, so if many requests come in at the same time, the process could take longer. Keep in mind that if modifications to the protocol are required to achieve congruency, that will take additional time and these modifications must be approved by the IACUC before issuing the approval letter. (if this is the case, see FAQ 2, below).
**for subawards, in lieu of the entire grant, a copy of the subcontract, if available, including the Statement of Work will suffice, along with the name of the Prime institution and Prime PI
Pro Tip: If your request is for an update/renewal of a previously issued letter, all you need provide is a copy of the previous letter, with the word “renewal” in your email. A second review of the grant vs the protocol is not required. Otherwise, please submit your renewal request with all the information in the bullet points above, or a copy of the NOA (Notice of Award).
Frequently Asked Questions About Obtaining an IACUC Approval Letter
A congruency review is a comparison between the proposed work in a grant application and the Columbia University IACUC protocol, to assure that all proposed work has been seen by and approved by the IACUC. The NIH Grants Policy Statement, Chapter 4.1.1.2 requires that the Institution verify there is congruence between the application and the Institutional Animal Care and Use Committee (IACUC)-approved protocol when it provides the IACUC approval date. We apply this same standard to all outside funding sources whose proposals contain work with live vertebrate animals. The resulting congruency certificate also contains the approval and expiration dates of the applicable protocol (s).
Time frames for protocol modifications vary, depending on their nature, and whether or not the changes require a veterinarian consult and/or need to go to a meeting of the IACUC (held twice monthly) or can be approved by Designated Reviewers (who generally have five business days to either approve, or return the protocol to the PI with further comments). In the meantime, work with your Project Officer in SPA (Sponsored Projects Administration) to submit all your other Just in Time documents as scheduled. Your P.O. can include an email that states the IACUC approval is pending, and the approval letter will be uploaded to the file as soon as the congruency review is complete and any necessary modifications have been approved.
Requests can be made at any time between application submission and Notice of Award (NOA). However, we recommend you contact the IACUC office with your request when you are notified your grant is within the “fundable range,” but no later than upon the request for Just in Time (JIT) materials. Keep in mind that if the congruency review and subsequent approval has not been completed by the time the grant is awarded, SPA will restrict those funds related to animal work until the approval is in place.
Unfortunately, no, unless they’ve stated otherwise, your funder wants to know at the outset if you have institutional approval to perform the work proposed, at least within the first three years of a grant, as protocols have a three-year lifespan.
Currently, we have no requirement that says everything must be contained in a single protocol. We can list multiple protocols in the approval letter, if more than one protocol is needed to achieve congruency.
Use the same process as you would if you needed to modify an existing protocol: work with your Project Officer in SPA to submit all your other documentation on time, marking the IACUC piece as “pending.” Once the protocol has been submitted in RASCAL, we can begin the review process and issue your approval letter for your funder once the protocol has been approved.
No. The reason for this is that while your protocol may be congruent with one grant, it might not contain all of those components of a subsequent grant. Therefore, we perform a separate congruency review for each outside funding source, and each of the resulting approval letters are grant-specific. Therefore, you can’t use the same letter for multiple funding sources, even if they all use the same protocol.
No! Protocols contain quite a bit of sensitive and personally identifiable information that we do not want to send outside of Columbia. If you get a request like this, please contact us at [email protected] and we will assist you. The one exception is requests for copies of protocols from the Department of Defense, who perform their own congruency reviews. Any other requests should be referred to us in the IACUC office.
The good news is no, only the initial review is required. As long as the scope of the work is unchanged, request a renewal letter from us and we will update the information from the previous letter. To expedite this type of request, please submit the most recent/previous approval letter, or the RPPR form so we can locate the previous letter in our files for easy updating. If neither of those is available, we will need the Grant PI name, Project Title, Granting Agency/Grant Number, and relevant IACUC protocol number(s).
Yes! Please let us know so we can negotiate an MOU (Memorandum of Understanding) with the off-site institution to cover the proposed work. You should obtain a copy of their IACUC approval letter to include with your JIT materials for the NIH. Nothing further is required for you to obtain from our IACUC.
Didn’t see the answer here to your question? Please contact us at [email protected].