Prime Organizations Without an ACUP or IACUC

User-submitted question:  What happens if a grant is awarded to a prime institution/organization, and the prime does not have its own Animal Care and Use Program (ACUP), facilities in which to house animals, or an Institutional Animal Care and Use Committee (IACUC)? In rare instances, VUMC can/will serve as the OLAW office of record for an external party. The agreement process is part of an Interinstitutional Assurance. The Assurance is signed by the VUMC IACUC Office and approves an outside institution’s use of our IACUC to review and issue an IACUC approval for its animal research.  Please note, VUMC’s Interinstitutional Assurance is approved and signed by the IACUC Office Chairperson, as well as by VUMC’s Chief Operating Officer.  If you have questions or faculty inquiring, please direct communications to: iacucsubmissions@vumc.org

IACUC Protocols

All externally funded grant awards involving animal work must be reviewed properly by VUMC’s IACUC. This animal work must be linked to an investigator, protocol, and project (no umbrella protocols); however, work can be linked to an existing protocol using the congruency review process. VUMC’s Animal Care and Use Program outlines some common examples for when review and approval is or is not needed on their website: Examples that do not require IACUC review and approval and can be administratively reviewed by the Office of Animal Welfare Assurance (OAWA): Harvesting additional tissues during a terminal procedure Addition or deletion of personnel (not the PI) Deletion of a funding sources Examples that do require IACUC review and approval: PI change Addition of funding source (no new proposed procedures) Addition of a species Increase in animal numbers Addition of procedures Modification of current procedures or additional sampling These are not exhaustive lists. VUMC’s IACUC team must review and approve all work described in the

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IRB and IACUC Amendments

Are you looking to add a funding source to an existing IRB or IACUC protocol as part of your grant application? Please note that any IRB or IACUC protocol amendments must be completed at JIT. If the protocol amendment is not completed in time for submission with other JIT materials, OSP will only be able to submit the respective IRB or IACUC protocol as ‘pending.’ Once these materials have been received, OSP will submit the final approvals to NIH. Please note that the failure to submit approved IRB or IACUC protocols during JIT may result in a delay in award issuance or a restriction on an issued award. For further questions please contact your OSP specialist.

When to Request IACUC and IRB Approvals for a Pending Application

OSP often receives questions regarding whether a PI should wait to submit an IRB and IACUC application to the respective VUMC office until he or she receives a grant award. The answer is no–PIs should contact the IRB and IACUC office (as applicable) to submit an application for approval or link an existing approval to a new project as soon as NIH or another sponsor has requested information indicating that a project may be funded.  These central offices will then work with the PI to ensure all information required for approval is received and processed in a timely manner. If a project includes human subject research, please ensure that all individuals involved have up-to-date CITI certifications. This is especially imperative because a sponsor could either delay an award or issue an award with a spending restriction due to the absence of an approved IRB and/or IACUC protocol. Some sponsors will not formally request approvals; instead, they may specify within the award notification

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