BACKGROUND

The Office of Laboratory Animal Welfare (OLAW) administers the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS Policy). PHS Policy states that "PHS awarding units may not make an award for an activity involving animals unless ... the awardee institution has provided verification of approval by the IACUC of those components of the application or proposal related to the care and use of animals." This policy also applies to American Heart Association (AHA) and National Science Foundation (NSF) awards, as well as contracts awarded through PHS. The Department of Health and Human Services (HHS), primarily through the Public Health Service (PHS) and the National Institutes of Health (NIH) is the principal funding source for research using live vertebrate animals at Wayne State University. The PHS and NIH Grants Policy requires institutions to verify, before award, that all proposed animal work has been reviewed and approved by the Institutional Animal Care and Use Committee (IACUC). The NIH Grants Policy Statement (10/12), Terms and Conditions of NIH Grants Award (4.1.1.2 Verification of IACUC Approval) states "It is an institutional responsibility to ensure that the research described in the application is congruent with any corresponding protocols approved by the IACUC."

Procedure

As outlined above, grant congruency verification to ensure IACUC approval is required prior to final award for all PHS grants; to maintain the highest standard of compliance and program consistency, Waybe State University applies this requirement to all grant proposals. Funding proposals using live vertebrate animals must be reviewed by the IACUC to ensure that all of the work proposed has received IACUC approval before the award can be processed.

The Principal Investigator (PI) is responsible for providing an IACUC approval letter to Sponsored Program Administration (SPA) prior to award. Preferably the title of the IACUC protocol should closely match the awarded grant (with the number) so that SPA can easily verify approval. Currently, multiple grants can be associated with one IACUC protocol; the protocol title field can accommodate multiple grant titles. Due to Department of Defense (DoD) protocol review and approval requirements, the IACUC requires that all DoD funded research be described in its own protocol application. DoD funded protocols should remain a 1:1 document for the entire funding period.

Upon notification of awarded funding (new or competing renewal) involving the use of live vertebrate animals for teaching and/or research, the IACUC Office will perform a congruency review. The IACUC Office will review the award proposal and corresponding IACUC protocol(s) to verify that all live animal use activities described in the proposal are covered by one or more IACUC-approved protocols. If any discrepancies between animal use activities described in the award proposal or contract and the corresponding IACUC-approved protocols are identified, the principal investigator will be notified so that appropriate actions can be taken (e.g., submitting a protocol modification request or a new IACUC protocol application).

When the IACUC office has determined that the vertebrate animal use activities described in the award proposal or contract are consistent with one or more IACUC-approved protocols, notification will be made to SPA.

If work with live animals is being done externally by collaborators through a sub-award or a sub-contract, and Wayne State University is the awardee institution, the terms and conditions of the grant flow through to the sub-awardee. Wayne State is held accountable for ensuring that the work conducted by the sub-awardee meets all applicable regulations and guidelines. Therefore, such projects are subject to review by the Wayne State University IACUC. The extent of the review will depend upon the accreditation and the Assurance status of the sub-awardee institution/agency. If the sub-awardee has a current PHS Assurance, is AAALAC accredited, and the work proposed has been approved by the sub-awardee’s IACUC, Wayne State may elect not to perform a duplicate IACUC review. Instead, Wayne State may elect to enter into an administrative Memorandum of Understanding with the sub-awardee institution. If the sub-awardee has a current PHS Assurance, but is not AAALAC accredited, the Wayne State University IACUC will decide on a case-by-case basis whether it will perform a full review of the protocol or will choose to rely on the other institution’s IACUC to oversee animal care and use on the protocol.

References:

• PHS Policy on Humane Care and Use of Laboratory Animals Frequency Asked Questions
• PHS Policy on Humane Care and Use of Laboratory Animals
• OLAW Online Seminar "Grants Policy and Congruence" by Dr. Patricia Brown, Director OLAW

Approved: December 2016

Revision Approved: December 2017, July 2022, July 2023

Reviewed: June 2021, July 2022