The OAW reviews grants and contracts along with the associated IACUC protocol(s) to assure concordance and if applicable, assures that approvals from other institutions are documented. The OAW provides a letter to the sponsor regarding IACUC approval based on sponsor requirements.
NOTE: Award and/or disbursement of funds depends on your sponsor requirements. View our process flow chart here.
QUICK GUIDE – Grant Review Process
Additional information is provided in the Grant & Contracts FAQ.
The review cycle is comprised of five phases or steps and may iterate through these steps, if questions are requested by the OAW scientist reviewer. Also, if the OAW reviewer determines that the protocol(s) cited for the grant or contract are not congruent, then you will be asked to submit a Significant Change or New Protocol Review form to the IACUC.
This latter step will add additional time to the review. For this reason you should check that your proposal and associated protocols are in alignment early in your preparation process. The side-by-side grant review work flow is provided in this flow chart and explained in the following sections.
The PI or other department contact must bring the entire grant document to the Office of Animal Welfare (OAW). In addition, we ask that you bring a paper copy of your eGC1 (if you have one) along with your grant document.
OAW requests other documents that may be required by the sponsor. You will need to let us know which documents they have requested. For example, some sponsors require actual copies of USDA inspection reports, AAALAC accreditation letters, the latest letter from the NIH Office of Laboratory Animal Welfare (OLAW) verifying approval of the UW Animal Welfare Assurance, etc.
The OAW administrative review is a quick review pass that checks for administrative information. This includes, tracking the submission in SAGE, sending reminders to the PI to bring their documentation to the OAW, checking that the protocol(s) listed are valid, contacts the PI for a valid protocol number. The grant along with any associated protocol documents are placed in queue to be reviewed by an OAW scientist.
The OAW scientist reviews all portions of the grant/contract, e.g., face page, aims, progress report, if applicable. The scientist reviewer will compare the grant/contract with the associated protocol to ensure they concur. If they do not, the reviewer may recommend that a Significant Change or New Project be submitted to the IACUC. Ideally, the PI or Department will ensure that the documents are indeed accurate and in sync.
The OAW scientist also checks section A, B and C of the Animal Use section of the eGC1 for the following information. The reviewer will contact the PI for this information if it is missing from the eGC1.
|A: Project includes use of animals||Location, protocol number, protocol approval date|
|B: Project involves work at other US location(s).||AAALAC certification number of other institution; copy of approved protocol from other institution and PDF of the associated IACUC approval letter.|
|C: Project involves work at foreign (outside US) location(s)||Accreditation certification number of other institution; English copy of foreign protocol and associated IACUC approval letter.|
The OAW scientist waits for the PI to answer questions, supply additional information and/or for the approval of any Significant Change or New Project approval by the IACUC, if required.
The OAW scientist signs off on the eGC1 when all issues have been resolved. The OAW scientist writes an approval letter to the sponsor, including any required additional information, e.g., grant specified euthanasia method is not what will be used, etc. The eGC1 is stamped with an approval date. OAW provides the PI with the stamped eGC1 and approval letter in PDF via email.
It is the PI’s responsibility to provide correct and accurate information both to the IACUC and indeed to the sponsor. 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 providing FAQs.
Many of the proposals and eGC1s submitted to OAW for review have multiple errors or omissions that must be addressed prior to OAW approval of the associated eGC1. These errors can significantly impact the turn-around time and our ability to attend to other required business, such as processing of IACUC protocols. Some of the frequent errors include:
- Incorrect IACUC protocol(s) cited on the eGC1
- Animal use procedures in the proposal that are not included in the cited IACUC protocol(s)
- Animal work proposed at non-UW sites with no documentation of IACUC approval
Please review the FAQ below, and do your part to help make the proposal and eGC1 review process faster and smoother. If you have questions that are not covered in the FAQ, please contact OAW.
NOTE: The Office of Sponsored Programs website lists a broad set of FAQs for researchers.What is an IACUC?
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. Wikipedia has a good description of the IACUC.
What is a grant side-by-side review?
PHS Policy and the NIH Grants Policy Statement (Part II, Terms and Conditions) require that institutions verify, before award, that the IACUC has reviewed and approved those components of grant applications and contract proposals related to the care and use of animals. OAW manages the side-by-side comparison of an application/proposal with the associated IACUC protocol(s) to ensure that the information the IACUC reviews and approves is congruent with what is in the application/proposal. After a successful review, OAW provides an approval letter to the PI and OSP.
When should I submit my grant to OAW for review?
For NIH grants, submit a copy of your grant and eGC1 to OAW as soon as you receive notice of a potentially fundable score from NIH. Be sure to list all pertinent protocols in the eGC1.
If a new IACUC protocol, or a change to an existing IACUC protocol is necessary to cover all the work described in the grant or contract, please submit the new protocol and/or Significant Change along with the grant and copy of the eGC1. It is the responsibility of the PI to ensure the grant or contract and associated protocols are congruent.
Other sponsors may require confirmation of IACUC approval within a very short time after your proposal submission deadline. **It is the responsibility of the PI and research team to read the sponsor instructions and plan the IACUC paperwork submission timeline accordingly.**
If we do not receive the above documents promptly, your award could be delayed depending on sponsor requirements.
Who has to approve my eGC1?
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.).
Who has to approve my eGC1 prior to OAW?
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.
What paperwork do I need to submit for OAW eGC1 approval?
Bring the following documents to OAW:
- Entire 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.
What does the UW OAW reviewer actually do with my eGC1 and proposal after I leave them for review?
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.
What is the IACUC approval date?
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.
What is the Animal Welfare Assurance #?
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.
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?
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.
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?
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).
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?
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.
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?
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.
The animal work in my proposal is approved under more than one IACUC protocol. What approval date do I use?
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.
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?
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.
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?
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.
What if my vertebrate animal work described in the proposal differs from the work described in the IACUC protocol(s) cited on the eGC1?
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.