The Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy) requires PHS-supported institutions maintain an "Animal Welfare Assurance" to carry out any activities involving live, vertebrate animals. This Assurance sets forth the responsibilities and procedures regarding the care and use of animals, and is applicable to all biomedical research, research training, experimentation, biological testing, and related activities involving live, vertebrate animals conducted at Harvard Medical School, Harvard T.H. Chan School of Public Health, and Harvard School of Dental Medicine (collectively the Harvard Longwood Campus), or at another institution as a consequence of the sub-granting or subcontracting of a PHS-conducted or -supported activity by the university. This document demonstrates institutional compliance with PHS Policy, and ensures an program for animal care and use is in place and an IACUC monitors the program.
As outlined in PHS Policy IV.B.1-8, IACUCs must:
- Review and approve animal use protocols, including significant changes to previously approved protocols;
- Monitor the animal care and use program, including conducting semiannual program review and facility inspections, and reporting evaluations to the Institutional Official (IO);
- Review concerns involving the care and use of animals;
- Make recommendations to the IO on the animal program, facilities, or personnel trainining;
- Be authorized to suspend previously approved animal use protocols in instances of noncompliance;
- Evaluate compliance with institutional policies;
- Report annually and notify regulatory bodies of suspensions and instances of serious noncompliance with PHS policy; and
- Ensure that personnel working with animals are appropriately trained and qualified.
Animal Welfare Act
The AWA was originally passed by the United States Congress in 1966. It defines the minimum standard of care and treatment that must be provided for all covered animals used in research and testing. Institutions housing species covered by the AWA are required to be licensed/registered with the USDA and are subject to on-site inspections.
USDA inspectors conduct three types of inspections for institutions licensed under the AWA:
- Pre-licensing inspections, to make sure the applicant can meet the federal standards prior to being licensed/registered,
- Routine, unannounced compliance inspections, to make sure the institution is adhering to the federal standards and regulations, and
- Inspections based upon public complaints or allegations of unlicensed activities.
During routine inspections, the USDA reviews the premises, records, husbandry practices, program of veterinary care, and animal handling procedures. The frequency of inspections is based on several factors – including the institution’s history of compliance. The USDA inspects licensed institutions at least once a year.
The institution is accredited by the AAALAC International (previously known as the Association for the Assessment and Accreditation of Laboratory Animal Care). The program evaluates organizations that use animals in research, teaching, or testing. Those that meet or exceed AAALAC standards are awarded accreditation. The accreditation process includes an extensive internal review conducted by the institution applying for accreditation. During this review, the institution creates a comprehensive document called a “Program Description” which describes all aspects of the animal care and use program (policies, animal housing and management, veterinary care, and facilities). The Program Description is then submitted to AAALAC. Evaluators review the Program Description and conduct their own comprehensive on-site assessment. The site visitors’ report is then reviewed by the entire Council on Accreditation and accreditation status is determined. After an institution earns accreditation, it must be re-evaluated every three years in order to maintain its accredited status.
The NIH's Office of Laboratory Animal Welfare (OLAW) provides guidance and interpretation of the PHS Policy, supports educational programs, and monitors compliance with the Policy to ensure the humane care and use of animals in research, testing, and training.
This institution's PHS Assurance # is D16-00270.
The Animal Care unit of the USDA’s Animal and Plant Health Inspection Service (APHIS) upholds and enforces the Animal Welfare Act primarily through annual, unannounced inspections of the program.
While the following animals are not covered under the AWA, some are still covered by the PHS Policy:
- Farm animals used for food or fiber (e.g. fur, hide, etc.),
- Coldblooded species (e.g. amphibians and reptiles),
- Horses not used for research purposes,
- Invertebrates (e.g. crustaceans, insects, etc.), or
- Rats of the genus Rattus and mice of the genus Mus that are bred for use in research.
This institution's USDA Registration # is 14-R-0019.