A Review of thePublic 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