University Requires New Process for Projects Involving Animals

[From Kim Carter, Executive Director, Office of Sponsored Projects Administration and Associate Director, University of Kentucky Research Foundation]

The National Institutes of Health and National Science Foundation require the university to establish appropriate policies and procedures to ensure the humane care and use of animals. Specifically, NIH Grants Policy 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.” (4.1.1.2 Verification of IACUC approval in the NIH Grants Policy Statement dated 11/2016 ). Therefore, a congruency review is required for all NIH- and NSF-funded projects that use live vertebrate animals to ensure that the work described in the proposal corresponds to an active, approved protocol. To ensure UK complies with this requirement, OSPA is coordinating a process with the Office of the Attending Veterinarian to confirm congruency before the award is accepted (i.e. funds are drawn down from the sponsor by Research Financial Services). 

I am bringing this to your attention since faculty will begin receiving emails from their OSPA Research Administrator asking them for a copy of the IACUC approval, informing them of the required congruency confirmation and explaining potential impacts on establishment of an account. 

NIH-funded projects:

At Just-In-Time and only for projects that involve animals, the RA will send an email to the PI requesting JIT information and explaining the congruency confirmation requirement.  The PI will be informed that the award will likely be delayed or animal activities restricted if the congruent IACUC approval is not provided with the JIT materials.  A copy of the proposal and IACUC approval will be sent to Dr. Noe Tirado-Muniz (Office of the Attending Veterinarian) so that he can confirm that the IACUC approval and proposed project are congruent.  He will work directly with the PI if revisions are necessary to the protocol to confirm it is congruent with the scope of the proposed project.  Please note that OSPA typically would not submit the IACUC approval to NIH with the JIT materials until Dr. Tirado-Muniz has confirmed that the congruency requirement has been met. The congruency confirmation is estimated to take from 1 to 5 days so it should typically be completed by the JIT deadline.  If the congruency check is not completed by the JIT due date, however, OSPA will communicate with the PI to let them know that the IACUC will be marked as pending and submitted with the remaining JIT materials to meet the deadline (unless an extension of the deadline is approved by NIH). 

NSF-funded projects:

When an award is received from NSF and the project involves animals, the RA will send a copy of the proposal and IACUC approval to Dr. Noe Tirado-Muniz (Office of the Attending Veterinarian) so he can confirm that the IACUC approval and awarded project are congruent. He will work directly with the PI if revisions are necessary to the protocol to confirm it is congruent with the scope of the funded project. Typically, OSPA would not establish an account until Dr. Tirado-Muniz has confirmed that the congruency requirement has been met, however, if the PI verifies that there is work to be done on the project that does not involve the animals, OSPA will create an account in “E” status for the project (so that Research Financial Services does not to draw down any funds). Please note that no costs associated with animals could be charged to the account until Dr. Tirado-Muniz has confirmed that the IACUC approval is congruent with the awarded project.   

Specifically, for compliance with the Animal Welfare Act and the PHS Policy on Human Care and Use of Laboratory Animals, we must ensure that all research projects involving animals have IACUC approval before the award is accepted or the work with the animals begins. To that end, OSPA will not establish accounts for those projects that do not have any IACUC approval unless the PI confirms that there is specific work to be performed that does not involve animals and agrees that no costs related to animals would be charged to the account. 

Through my recent discussions with Drs. Hal Stills and Noe Tirado-Muniz, it became clear that OSPA’s process needed to be more well-defined and structured in a way that ensured compliance with NIH and NSF’s specific congruency requirement and the federal regulations that require IACUC approval before any research involving animals is conducted at the university.  

Please let me know if you have questions or concerns.  I am committed to working with you and the faculty to facilitate their research while meeting compliance requirements and welcome your suggestions for further improving our processes.

Kim 

Kim C. Carter, CRA, CPRA, CFRA
Executive Director, Office of Sponsored Projects Administration, University of Kentucky
Associate Director, University of Kentucky Research Foundation
112 Kinkead Hall, 172 Funkhouser Drive
Phone:  859-257-8310