Frequently Asked Questions - Research Animals and Grants
- What is an IACUC?
- Who has to approve my eGC1?
- Who has to approve the eGC1 prior to OAW?
- What paperwork do I need to submit for OAW eGC1 approval?
- What does the UW OAW reviewer actually do with my eGC1 and proposal after I leave them for review?
- What is the IACUC approval date?
- What is the Animal Welfare Assurance #?
- Since my proposal is going to a private agency or a UW “in-house” fund and therefore does not involve Public Health Service (PHS) funds, do the PHS rules requiring IACUC approval apply?
- Does the UW OAW have to review my proposal when the animal work is done elsewhere, such as under a subcontract, or by a Co-Investigator who is physically located elsewhere?
- My collaborator at another institution will do some of the animal work described in my proposal. What do I do about determining the IACUC approval date for that work?
- I will be purchasing custom antibodies from a private company. While production of monoclonal or polyclonal antibodies involves animal use procedures, these won't be conducted at the UW. Does this constitute use of vertebrate animals in the proposal?
- The animal work in my proposal is approved under more than one IACUC protocol. What approval date do I use?
- I plan to use live vertebrate animals in years 2, 3, or later, but not in year 1 of my proposal. Accordingly, some details of the animal work may need to be revised based on findings during the prior years. What do I do?
- What do I do about IACUC approval for animal use on a training grant, when some as yet unidentified trainees may use animals but this is not certain?
- The vertebrate animal work described in the proposal differs from the work described in the IACUC protocol(s) cited on the eGC1.
IACUC is the acronym for "Institutional Animal Care and Use Committee". This is the "formal" name, and the name most commonly used in federal documents.
This depends on who is participating in the proposal and what facilities will be used. An OAW reviewer must approve the eGC1 if the proposal includes the use of live vertebrate animals anywhere (e.g., at the UW, in the field, at another institution, by a private company for custom antibody production, etc.).
Competing Proposals: OAW reviews the eGC1 last for competing proposals because the University uses a "just-in-time" (JIT) process for these proposals. JIT allows submission of the proposal to the sponsor prior to review by OAW and prior to IACUC approval for the animal work. As such, the eGC1 is not routed to OAW during the submission process. Virtually all sponsors allow JIT but you must read the instructions from your sponsor to be certain. If the sponsor does not allow JIT then contact OAW for help. If funding appears likely based on sponsor review then a hard copy of the eGC1 and proposal must be delivered to OAW for the review process.
Non-competing Continuations and other non-competing items: OAW reviews the eGC1 based on the electronic routing process. OAW reviewers can view the eGC1 in SAGE and do not need a paper copy. However, a paper copy of the non-competing item must be delivered to OAW for review and you must indicate the eGC1 number associated with it so the OAW reviewer can locate it in SAGE.
- Original proposal
- For competing proposals submit a copy of the original eGC1. Provide OAW with a list of the associated IACUC protocol numbers if the eGC1 indicated "pending" or does not include all the associated protocols (for example, in the event there have been changes since the original eGC1 was routed).
- Letter of approval from cooperating institution’s IACUC if some work is contracted to another institution. The letter needs to reference the proposal so that the OAW reviewer can see that the IACUC approval is for that institution’s work in the particular proposal being reviewed.
As required by federal policy, the OAW reviewer reads the animal work described in the proposal and compares it to the work described in the associated IACUC protocol(s) cited on the eGC1.
Competing Proposal: If the work described in the proposal is approved under the IACUC protocol(s) noted, then the reviewer signs the paper copy of the eGC1 for routing to OSP and the reviewer also writes a letter for submission to the sponsor. Most sponsors require written confirmation that the animal work is all approved prior to making the award to the UW.
Non-competing Continuation: If the work described in the continuation is approved under the IACUC protocol(s) noted, then the reviewer approves the eGC1 in SAGE. If the continuation proposes new work that is not yet approved, that work will need to be approved by the IACUC via a new IACUC protocol, or a Significant Change to an existing IACUC protocol, prior to approval of the eGC1. If the reviewer has any questions during the review the PI is contacted for clarification.
The IACUC approval date is the date of approval of the IACUC protocol that describes the work proposed in your proposal or non-competing continuation. It is not the same as the date of approval of the University’s Animal Welfare Assurance. Most sponsors do not request the latter. If you are submitting to a sponsor that does, please contact OAW for the most recent approval date.
The UW Animal Welfare Assurance # is A3464-01. This number refers to a document that the UW has on file with, and approved by, the NIH Office of Laboratory Animal Welfare (OLAW). It is often referred to as the “PHS Assurance”.
Please note that the Assurance number cited on a proposal, if required, must be the number for the institution administering the proposal. If the UW administers the proposal then use our number, even if some, or all, of the animal work will be performed at another site that has a different Assurance number.
Yes.The University’s Animal Welfare Assurance (A3464-01) on file with the NIH Office of Laboratory Animal Welfare (OLAW) assures that federal laws and guidelines are followed for all animal work performed at the UW, supported by UW funds, or performed by UW faculty, students or employees.
Yes. If the UW is administering the proposal then the UW is taking responsibility for informing the sponsor of the IACUC approval information (even if the IACUC approval is from another institution).
You can obtain a letter of approval directly from the IACUC office at the cooperating institution. The letter should include 1) the protocol number, title and approval date and 2) it should indicate that the cited IACUC protocol covers the work to be performed at their institution as described in the UW proposal.
When you submit your documents to the UW OAW for review, include a copy of the letter from the other institution.
Since animals (usually mice or rabbits) are used, your proposal must indicate "yes" for vertebrate animal use. Therefore:
• Indicate "yes" for vertebrate animals on the proposal and eGC1
• Use the UW Animal Welfare Assurance number (A3464-01) on the proposal
• Under performance sites list the name of the company from whom you will purchase the antibodies. Please note that you must use a company that holds an Animal Welfare Assurance with PHS (though the UW number is still used on the proposal because the UW will be the awardee). Call the OAW if you need help determining whether the company you wish to use has an Animal Welfare Assurance. If you choose a foreign company, the company must have a foreign Animal Welfare Assurance and the UW IACUC must review and approve the company’s animal protocol for production of the custom antibody.
• The IACUC approval date if the chosen company is in the US is the date that the company’s IACUC approved the custom antibody production. Contact the company for this information and include a copy of their IACUC approval letter when you submit your eGC1 and proposal to the UW OAW for review. If you intend to use a foreign company the approval from the company’s ethics committee and from the UW IACUC are pertinent and both should be indicated on the eGC1. Both the company’s ethics committee approval information and the UW IACUC approval must be included on the eGC1 and any letter regarding approval to the sponsor.
On the eGC1 include all pertinent IACUC protocols in the appropriate sections as instructed on the form. For competing proposals if the protocols are not yet determined you may indicate "pending" or "JIT" (i.e., just-in-time). For non-competing continuations include all relevant protocols and the most recent approval dates. Follow the instructions on the eGC1 with regard to required documentation from other institutions when some, or all, of the animal work will be conducted at non-UW locations. If you have any questions or need help determining the most recent approval dates please contact OAW for help.
Most sponsors, including NIH, require IACUC approval for all proposed animal work that will occur at any time during any year of the proposal. You must obtain approval from the IACUC for the animal work that you are proposing to the sponsor. You may, as always, submit Significant Changes to your IACUC protocol as your work progresses and you determine changes that will need to be made in your plan.
For situations where trainees and projects are not yet identified (i.e., a new submission without a progress report), indicate "yes" for vertebrate animals on the eGC1 and provide a statement of assurance that trainees who are recruited and decide to use animals will have their work submitted to the IACUC and approved under their mentor’s protocol prior to initiation.
Per instructions from NIH, if animal involvement is anticipated but not yet determined then indicate "yes" for the use of animals and in the proposal provide an explanation. Please note that if an award is made, vertebrate animals cannot be used until a Vertebrate Animals section and verification of IACUC approval has been submitted to NIH.
If animal projects are already known or if the training grant is a continuation and some trainees are already working with animals, cite the relevant IACUC protocol numbers on the eGC1. On the grant you must include the relevant approval date(s). When the grant is reviewed by the OAW, the work of the trainees that is described in the grant will be compared to the IACUC protocols cited.
This is the most common error and results in significant loss of time in processing proposals (and continuations) through the OAW. This problem comes to light when the proposal is compared side-by-side with the IACUC protocol(s).
If there are procedures in the proposal that are not in the cited IACUC protocol(s) then the proposal PI is notified by the reviewer and:
• The PI or someone very familiar with both the proposal and the IACUC protocol(s) must review the discrepancy and then submit a Significant Change to the IACUC relevant protocol(s) or a new IACUC protocol if needed, or advise OAW of a corrected list of IACUC protocols in the event that the proper ones were not on the eGC1