A Review of the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals Created by Marc S. Hulin, DVM, Dipl. ACLAM

History PHS Policy was revised after Health Research Extension Act of 1985: – guidelines for the proper care & treatment of animals used in research – appropriate use of tranquilizers, analgesics, anesthetics, paralytics & euthanasia – appropriate pre-surgical & post-surgical care

History PHS policy applies to all PHS conducted or supported research projects Office for Laboratory Animal Welfare (OLAW) at NIH is charged with ensuring compliance with the policy

Definitions Animal: any live, vertebrate animal (cold or warmblooded) used in research, training, or testing Animal facility: any building, room, or area used for confinement, transport, or experiments including surgery – if animals are kept there for more than 24 hrs. it is considered an animal facility

Animal Welfare Assurance Each institution which receives PHS funds must submit an assurance to OLAW Assurances are valid for up to 5 yrs. Must be signed by the Institutional Official Assurance must describe 3 components of animal care program – Institutional animal care & use program – Institutional status – Institutional animal care & use committee

Institutional Animal Care & Use Program PHS requires institutions to use the Guide for development & implementation Program description should include: – List of branches/components of institution – Lines of authority – Qualifications & Responsibility of Vets. – IACUC membership & procedures – Occupational Health Program – Gross square footage of each animal facility

Institutional Status Category 1: AAALAC, Int. accredited, evaluated by the IACUC every six months, and reports prepared Category 2: Evaluated by IACUC every six months & reports prepared. Initial IACUC report submitted with assurance.

Institutional Anima Care & Use Committee (IACUC) Members appointed by CEO IACUC should consist of at least 5 members including: – Veterinarian with training or experience in lab animal medicine and science – Practicing scientist with experience in animal research – A nonscientist (e.g., ethicist, lawyer) – Individual not affiliated with institution

Functions of the IACUC Review animal care program & inspect the animal facilities every 6 months using the Guide as the standard Prepare reports from program review & animal facility inspections Review concerns involving animal welfare

Functions of the IACUC Review & approve animal use protocols Be authorized to suspend animal use protocols involving animals that are not conducted in accordance with the Animal Welfare Act, PHS Policy, The Guide, and Animal Welfare Assurance

IACUC Protocol Review IACUC must conduct a review of the components of research projects – procedures conducted to minimize pain, distress and discomfort to animals – procedures with more than monetary pain or distress should use anesthetics, analgesics, tranquilizers or euthanized if unrelieved pain persists

IACUC Protocol Review Research personnel must be qualified and trained Euthanasia standards must conform AVMA Panel on Euthanasia

Recordkeeping Requirements Copy of Animal Welfare Assurance Minutes of IACUC meetings Records of Animal Use Protocol Records of Semiannual Reports Records of accrediting body (AAALAC, Int.) determinations Records should be kept for at least 3 yrs. Animal use protocols kept for 3 yrs. after completion of the research project

Reporting Requirements IACUC must report through Institutional Official (IO) to OLAW at least annually even if no changes to program Must report through IO on issues of noncompliance with PHS policy – any serious or continuing noncompliance with PHS policy or any serious deviations from Guide – any suspension of protocol by IACUC