Which policy governs the care and use of vertebrate animals in NIH-, FDA-, and other PHS-funded research and is overseen by OLAW?

• A. Good Laboratory Practice
• B. Guide for the Care and Use of Laboratory Animals
• C. Public Health Service Policy on Humane Care and Use of Laboratory Animals
• D. Animal Welfare Act

Answer: (C)

The Public Health Service Policy on Humane Care and Use of Laboratory Animals is the formal rule governing how vertebrate animals are treated in research funded by NIH, FDA, and other PHS agencies, with oversight by the Office of Laboratory Animal Welfare (OLAW). This policy lays out the requirements institutions must meet, including having an active Assurance on file, establishing and following an Institutional Animal Care and Use Committee (IACUC) for review and approval of all animal use, ensuring appropriate training and facility standards, and conducting ongoing oversight and annual reporting. The Guide for the Care and Use of Laboratory Animals is used as the practical reference to implement those humane-care standards, but the policy itself is the binding authority that institutions must follow and that OLAW enforces. The Good Laboratory Practice framework and the Animal Welfare Act are separate regulatory frameworks with different scopes and oversight, not the policy governing PHS-funded vertebrate animal research.