Frequently Asked Questions - Research Animals and Grants
- A word from the IACUC Office regarding grant sign off:
- What is an IACUC?
- Who has to sign my grant?
- Who has to sign the grant prior to IACUC sign-off?
- What paperwork do I need to submit for IACUC sign-off?
- What does the UW IACUC actually do with my GC-1 and grant after I leave them for sign-off?
- What is the IACUC approval date?
- What is the Animal Welfare Assurance #?
- Since my grant 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 IACUC have to sign-off on my grant 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 in my grant. 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 does involve animal use procedures, these will be conducted by the private company. Does this constitute use of vertebrate animals in the grant?
- The animal work in my grant is approved under more than one IACUC protocol. What approval date do I put in the space provided on my grant (such as the NIH face page)?
- I plan to use live vertebrate animals in years 2, 3, or later, but not in year 1 of my grant. 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 will or may use animals?
- The vertebrate animal work described in the grant differs from the work described in the IACUC protocol(s) cited on the GC-1.
It is the PI’s responsibility to provide correct and accurate information both to the IACUC and indeed to the funding agency. However, the federal and University compliance rules are sometimes confusing. Although guidance is provided in grant instructions and on the NIH web site, it is not always so easy to find and interpret. In our endeavor to be helpful and to work cooperatively, we are forwarding to you a list of Frequently Asked Questions and their answers. Please carefully read this document and share it with others in your department who you believe would benefit from having this information (i.e., anyone who is helping process grants).
Many of the grants submitted for IACUC sign-off have multiple errors or omissions that must be addressed prior to signature. These errors are significantly impacting our ability to attend to other required business, such as processing of protocols. The most frequent errors include:
- Incorrect IACUC protocol(s) cited on the GC-1
- Animal use procedures in the grant that are not included in the cited IACUC protocol(s)
- Work proposed at non-UW sites with no documentation of IACUC approval
Please review the FAQ’s and Frequently Made Errors below, and do your part to help make the grant review process faster and smoother. Please also feel free to consult with us ahead of time if you have grant questions or issues that are not addressed below. Thanks!! Nona Phillips, 543-3818, nonap@u.washington.edu
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. The UW has adopted the use of “IACUC” instead of “ACC” in order to reduce the number of different acronyms in use, and in order to be consistent with documents from other sources such as federal guidelines.
This depends on who is participating in the grant and what facilities will be used. The IACUC must sign the GC-1 if the grant proposes the use of any live vertebrate animals anywhere (e.g., at the UW, in the field, at another institution, by a private company for antibody production, etc.).
In all cases, the IACUC should sign after the PI and prior to submittal of the grant to Grant and Contract Services.
Some Schools may require IACUC signature prior to submittal to their dean’s office. Others do not, so please consult with your dean’s office on this issue.
- Original grant
- Original GC-1 with all relevant IACUC protocol(s) cited
- Letter of approval from cooperating institution’s IACUC if some work is contracted to another institution
As required by federal policy, the UW IACUC reviews the animal work proposed in the grant and compares it to the work described in the IACUC protocol(s) cited on the GC-1.
If the work described in the grant is approved under an IACUC protocol, then the approval date is noted on the grant and GC-1.
If the work described in the grant has been submitted to the IACUC but does not yet have approval, then the word “pending” is noted on the grant and GC-1.
If the work described in the grant has not been submitted to the IACUC then the grant cannot be signed and cannot be submitted to the funding agency until all required paperwork has been submitted to the IACUC office.
The IACUC approval date is the date of approval of the IACUC protocol that describes the work proposed in your grant. It is not the same as the date of approval of the Animal Welfare Assurance. Most agencies do not request the latter. If you are submitting to one that does, please call the IACUC office 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 PHS. It is often referred to as the “PHS Assurance”.
Please note that the Assurance number cited on the grant should be the number for the institution administering the grant. If the UW administers the grant then use our number, even if some of the work will be performed at another site that has a different Assurance number.
The University of Washington has an Animal Welfare Assurance (A3464-01) on file with the PHS Office of Laboratory Animal Welfare (OLAW). All animal work performed at the UW, or supported by UW funds, or performed by UW faculty, students or employees is covered under that Assurance, regardless of the actual source of the funds for a particular project.
Yes. If the UW is administering the grant then the UW is taking responsibility for informing the granting agency of the IACUC approval date (even if the IACUC approval is from another institution).
The signatories on the grant (usually the PI and the director of Grant and Contract Services) are both responsible for providing correct and true information to the granting agency. The Public Health Service has issued strongly worded “guidance” on this issue, stating that providing incorrect IACUC approval information can result in civil and criminal penalties. With that in mind, our UW IACUC requires documentation of IACUC approval for proposed live vertebrate animal work in grants, regardless of the proposed site for the work.
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 protocol includes the work proposed in the subcontract.
When you submit your GC-1 and grant to the UW IACUC office for review and signature, include a copy of the IACUC approval letter from the other institution.
Since the UW does not want to officially own animals that reside at another institution, make sure that all funds for animal work proposed at a non-UW site are included as a subcontract to the cooperating institution. There are 2 notable exceptions to this policy. The UW has an inter-institutional agreement with the VA Puget Sound Health Care System and the Fred Hutchinson Cancer Research Center. In those two cases only, a sub-contract is not required - UW animals can be purchased and housed at those locations.
The Office of Laboratory Animal Welfare has provided guidance on this issue. Since animals (usually mice or rabbits) are used, NIH requires that your grant indicate “yes” for vertebrate animal use. Therefore, for NIH grants.
Indicate “yes” for vertebrate animals on the grant face page
Use the UW Animal Welfare Assurance number (A3464-01) on the face page
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 their number is not used on the face page). Call the IACUC office if you need suggestions.
The IACUC approval date is the date that the chosen company’s IACUC approved the antibody production. Contact the company for this information and include a copy of their IACUC approval letter when you submit your GC-1 and grant to the UW IACUC office for signature.
Granting agencies do not usually provide spaces for more than one approval date, though often the grant work is approved on 2 or more IACUC protocols. The work may even be approved on IACUC protocols from more than one institution in the case of collaborative work. In such cases, the UW IACUC provides the granting agency with the oldest approval date, in keeping with the intent of the information being provided. In general, the granting agency wants to know that the work has a “current” approval and whether a protocol is approved, but will soon expire. Therefore, if two protocols are involved and one was approved 6 months ago and one more recently, then the 6 month old date will be provided to the granting agency.
In some cases, the agency may want a list of the various protocols involved along with the approval date for each one. In that case, provide the information in the format requested by the agency.
Most funding agencies, including NIH, require IACUC approval for all proposed animal work that will occur at any time during the funding period. You must obtain approval from the IACUC for the animal work that you are proposing to the funding agency. 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 grant funds are for salary only and trainees and projects are not yet identified (i.e., a new submission without a progress report), indicate “yes” for vertebrate animals on the GC-1 and provide a statement of assurance (GC-1 second page) 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.
Per instructions from NIH (see page 64, NIH form 398 instructions), if animal involvement is not yet determined then insert the word “Indefinite” in the box on the grant facepage where you would normally put the IACUC approval date. Please note that if an award is made, vertebrate animals cannot be used until a verification of IACUC approval date 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 GC-1. On the grant you must include the relevant approval date(s). Per NIH instructions, if all approval dates will not fit in the box provided on the grant facepage you must type in “Sec. g” and list the appropriate information there (see form 398 instructions on this issue). When the grant is review by the IACUC, 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 grants through the IACUC office. This problem comes to light when the grant is compared side-by-side with the IACUC protocol(s).
If there are procedures in the grant that are not in the cited protocol then the grant will have to be returned to the PI without further review or signature.
- The PI or grant contact will be notified to pick up the grant.
- The PI or someone very familiar with both the grant and the protocol(s) must determine the discrepancy and then re-submit the grant and a Significant Change to the relevant protocol(s).
- If an approval date was noted on the grant, the date will be changed to the word “pending” since the Significant Change will not yet have approval