The Health Research Extension Act of 1985 (Public Law 99-158) provides the legislative mandate for the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy). It directs the Secretary of Health and Human Services to establish guidelines for the proper care and treatment of animals used in research, and for the organization and operation of animal care committees. The law requires that the guidelines address appropriate use of tranquilizers, analgesics, anesthetics, paralytics, and euthanasia, and appropriate pre-surgical and post-surgical veterinary medical and nursing care for animals. The requirements for reporting minority views of animal care committee members, for Animal Welfare Assurances, and for instruction or training in methods that limit the use of animals or limit animal distress, are all embodied in this Act. The PHS Policy implements the Health Research Extension Act of 1985.
The Office of Laboratory Animal Welfare (OLAW) (formerly the Office for Protection from Research Risks, Division of Animal Welfare) implements the PHS Policy. While OLAW is located organizationally at the National Institutes of Health (NIH) in Bethesda, Maryland, OLAW's responsibility for laboratory animal welfare extends beyond NIH to all PHS supported activities involving animals.
Specific OLAW responsibilities include:
- implementation of the PHS Policy;
- interpretation of the PHS Policy;
- negotiation of Animal Welfare Assurances;
- evaluation of compliance with the PHS Policy; and
- education of institutions and investigators receiving PHS support.
From time to time OLAW issues policy guidance, interpretation, or general notices regarding the PHS Policy, which may be accessed through a Topic Index. OLAW guidance is issued as FAQs, journal articles and commentary, and Notices in the NIH Guide for Grants and Contracts.
Another educational OLAW activity is the cosponsorship of animal welfare workshops that are held in different locations across the country each year.
The PHS Policy applies to the use of live, vertebrate animals in any activity supported or conducted by the PHS agencies and U.S. Department of Health and Human Services components. These include:
- Agency for Health Care Research and Quality;
- Agency for Toxic Substances and Disease Registry;
- Biomedical Advanced Research and Development Authority;
- Centers for Disease Control and Prevention;
- Food and Drug Administration;
- Health Resources and Services Administration;
- Indian Health Service;
- National Institutes of Health; and
- Substance Abuse and Mental Health Services Administration.