Transcript Public Health Service (PHS) Policy on Humane Care and Use

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