Grant Verifications FAQ
Last Updated: August 2, 2018 2:09:09 PM PDT
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Expand section General Questions & Answers
Which proposals does this apply to?
NIH, NSF, and some private extramural funding agencies require verification that the IACUC has approved all proposed animal care and use procedures before they will fund research proposal applications.
When a proposal application that involves the use of live vertebrate animals is submitted to the Office of Contract and Grant Administration (OCGA), the SIO Contract and Grant Office, or the Health Sciences Sponsored Project PreAward office (HSSPPO), a copy of the application is forwarded to the IACUC Staff for verification.
What is the IACUC approval date?
The IACUC approval date is the most recent date(s) of approval of the IACUC protocol(s) that describes the work proposed in your research project. It is not the same as the date of approval of the Animal Welfare Assurance.
If the grant proposal has animal work that is covered by more than one animal use protocol, then you must report all IACUC approval dates.
What is the Animal Welfare Assurance # ?
The old UCSD Animal Welfare Assurance # is A3033-01. The new Assurance # is D16-00020. This number refers to a document that UCSD has on file with and approved by the PHS. It is often referred to as the “PHS Assurance”.
Effective July 25, 2016, OLAW implemented a new Animal Welfare Assurance database that utilizes a new numbering format (D00-00000). However, the old numbers (A000-01) will be retained for the life of the Assurance. Institutions may use either the new or old Assurance number in communications with the NIH.
Please note that the Assurance number cited on the proposal should be the number for the institution administering the proposal.
What exactly does the IACUC do to verify grant proposals with animal protocols?
Each proposal is checked by the IACUC staff via a side by side comparison with the animal protocol(s) listed on the RES form.
The IACUC staff verifies that the animal work described in the proposal is essentially the same as that described in the listed approved animal use protocols. If the IACUC staff finds no discrepancies they will notify the appropriate office (OCGA, SIO, or HSSPPO) that the verification between grant proposal and animal protocol is complete. If discrepancies are found, the investigator and the pre-award office will be notified.
What information must be included in the Vertebrate Animal Section (VAS)?
1. Description of animals and how they will be used
2. Justification for the use of animals
3. Veterinary care
4. Provisions to minimize discomfort, distress, pain and injury
5. Euthanasia
Does the IACUC have to verify my proposal when the animal work is done elsewhere, such as under a subcontract, or by a Co-Investigator who is physically located elsewhere?
NIH, NSF and most federal extramural funding agencies require verification that the IACUC has approved all proposed animal studies before they will fund grant proposals. This is termed “congruency verification”.
Any animal work being conducted at other institutions (where the funding is coming through UCSD) must also be verified as congruent. A copy of the animal use protocol and IACUC approval letter from the other institution(s) must be provided to the IACUC office in order to verify congruence.
Most privately owned funding agencies (e.g., non-profit, industry, State of Calif) do not require a formal side-by-side congruence verification be performed. It is the responsibility of the principal investigator to ensure that the study description as outlined in the grant proposal, is identical in principle to that which is approved in the applicable animal use protocols.
All subcontracted work involving animals must be performed at an AAALAC accredited institution. For more information please refer to IACUC Policy 21 on Inter-Institutional Research.
Does the IACUC have to review proposed animal research activities at the time of grant award if the animal research activities will not be conducted until year 4 or 5 of a grant?
Yes, with the rare exception. OLAW has given the following guidance:
In rare cases, IACUC review of animal activities is conducted later in the life cycle of a grant or contract. This occurs if a delayed onset of animal activities is a component of the experimental research design described in the VAS of the grant application or contract proposal (e.g., the initial development of a drug or devise with subsequent animal testing projected into the futures).
In these circumstances, the funding component will issue a Notice of Award with a special term and condition indicating that no funds may be drawn from the grant or contract for animal activities until a valid IACUC approval date has been provided to the funding component.
Additional OLAW Guidance regarding IACUC review of grant applications can be found at http://grants.nih.gov/grants/olaw/faqs.htm#pronto_10.
I’m a faculty member moving to UCSD and I will be transferring animals from my current institution to UCSD.
We hope that you discussed this with UCSD Attending Veterinarian and the Animal Care and Use Program’s Facility manager prior to accepting a position at UCSD. If not, do it NOW. Contact the Animal Care Program at 858-534-4262 or email acp-vetservices@ucsd.edu.
Contact the Animal Transfer coordinator at acp-animals@ucsd.edu to get instructions for submitting an online form to transfer your animals. Please be aware that all animals at UCSD must be housed in an ACP animal housing facility.
Expand section Some Questions & Answers that are specific to NIH Grant Proposals:
What should I insert on the Resources Page; Animal Facilities?
Insert “The University of California, San Diego is fully accredited by the Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC), and holds an approved NIH Assurance and USDA License.
There are currently approximately 204,000 square feet of animal facilities at 32 locations. Support includes quarantine rooms, sterile operating rooms, post surgical recovery rooms, radiology and diagnostic laboratory services.
There is a farm facility that provides indoor and outdoor housing for farm animals and other species. Veterinary care is provided on a 24 hour basis, including weekends and holidays, by a staff comprised of veterinarians and animal health technicians. Research support services include training classes, seminars and wet labs offered throughout the year.”
What should I do if an NIH study section asks for revisions of my animal studies? What should I do if the IACUC asks for revisions to my animal use protocol?
It is the responsibility of the investigator to assure that all animal procedures in both the grant proposal application and the animal use protocol(s) are the same. Investigator responsibilities are defined by federal laws and regulations, University of California rules, and are accepted by the PI when he/she submits an animal use application. (see Principal Investigator Responsibilities). If there is a discrepancy you must correct by notifying your funding agency or submitting a protocol amendment.
Expand section Frequent errors that slow down the IACUC proposal review and sign-off:
The vertebrate animal work described in the proposal differs from the work described in the IACUC protocol(s) cited on the RES Form.
This is the most common error and results in significant loss of time in processing proposals through the IACUC office. 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 animal protocol then the proposal cannot be verified.
Approval documentation (IACUC approval letter and complete protocal) for work to be performed at a non-UCSD site is not provided.
UCSD cannot inform a funding agency that all the work in the proposal is approved (or pending) without documentation that this is true.
The wrong IACUC protocol number is cited on the RES Form.
It’s easy to make an error if the PI has several IACUC protocols. However, the IACUC review process is significantly hampered when this happens.
Please remember that the IACUC protocol cited on the RES Form is directly compared to the proposal. The PI or someone very familiar with both the proposal and the protocol(s) must determine that all proposal work is included in the cited protocol(s) prior to submitting the proposal to the IACUC office.
An approval date older than 12 months is listed on the RES form.
This will result in a delay in the process as OCGA, HSSPO or SIO must contact the PI again to get current information prior to routing the proposal to the IACUC office.
Contact the IACUC office, (858) 534-6069.