Prior Approval of Planned Research Involving Live Vertebrate Animals

Date: June 15, 2018
Last Revision: April 11, 2023

Prior Approval of Planned Research Involving Live Vertebrate Animals

Under governing Public Health Service (PHS) Policy, federal funds administered by the PHS shall not be expended for research involving live vertebrate animals without prior approval by the Office of Laboratory Animal Welfare (OLAW) of an Animal Welfare Assurance to comply with the PHS Policy on Humane Care and Use of Laboratory Animals and the project has been reviewed and approved by the Institutional Animal Care and Use Committee (IACUC).
Prior approval is required for any change in the approved use of live vertebrate animals and/or any substitution of one animal model for another. Any new study involving animal subjects that was not reviewed in the competing application, must be submitted for prior approval. Requests for prior approval of planned research involving vertebrate animals conducted through NCATS UL1/UM1 pilot projects, UM1 element E, and KL2/K12 scholar projects must be submitted in writing to NCATS no later than 30 days before the proposed implementation of research involving live vertebrate animals. Documentation must be submitted by an Authorized Organizational Official (See Grants Policy Statement Section 8.1.3.) to with a copy to the assigned GMS and PO. The request should be submitted via email including the complete grant number in the subject line.

NCATS CTSA Program Instructions for Submitting Prior Approval Requests for Planned Research Involving Live Vertebrate Animals

Additional guidance has been posted here.

NIH FAQs have been posted here.

NIH Notice: Grant and Contract Submission Requirements Regarding the Updated AVMA Guidelines for the Euthanasia of Animals: 2020 Edition (NOT-OD-20-143)

Additional Resources:
• NIH Worksheet for Applications Involving Animals: This worksheet describes the information that must be included in applications submitted to NIH for activities involving the care and use of animals. It provides an overview of the requirements, a checklist for applicants and reviewers, detailed instructions, responsibilities of applicants, reviewers and NIH staff, and an example of an acceptable application.
• NIH Notice: Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (NOT-OD-16-006)
NIH Office of Laboratory Animal Welfare website
Animals in NIH Research

Comments and questions about this process?
Please contact your Program Official.