Section Three: Terms and Concepts

Program of Animal Care and Use

The PHS Policy not only addresses the humane use of animals, but the entire institutional program of animal care and use. There are many components to a program and although no two institutional programs are identical, all programs are expected to include:

designation of an Institutional Official;
appointment of an Institutional Animal Care and Use Committee (IACUC);
administrative support for the IACUC;
standard IACUC procedures;
arrangements for a veterinarian with authority and responsibility for animals;
adequate veterinary care;
formal or on-the-job training for personnel that care for or use animals;
an occupational health and safety program for those who have animal contact;
maintenance of animal facilities; and
provisions for animal care.

The next section, Animal Programs, describes in detail each component of a program of animal care and use.

Institutional Official

The Institutional Official is a formally designated senior official with the authority to administer the program of animal care and use, and to make commitments on behalf of the institution to ensure compliance with the PHS Policy.

The Institutional Official relies on the IACUC to oversee the program, to develop plans to correct program deficiencies, to address concerns that may arise regarding the institution's use of animals, and to make recommendations with regard to the program. Through semiannual reports to the Institutional Official and open channels of communication, the IACUC keeps the Institutional Official informed of the status of the program and alerts the Official to potential noncompliance with the PHS Policy.

Documents submitted to OLAW, such as an Animal Welfare Assurance, annual report, or reports of noncompliance, are submitted by the IACUC, through the Institutional Official, and should bear his or her signature as the official responsible for animal welfare at the institution.

Animal Welfare Assurance

Before the PHS may award a grant or contract that involves the use of animals, the recipient institution and all performance sites involving or using animals must have on file with OLAW an approved Animal Welfare Assurance.

The Assurance is the cornerstone of a trust relationship between the institution and the PHS. Included in the Assurance are:

a commitment that the institution will comply with the PHS Policy, with the Guide for the Care and Use of Laboratory Animals, and with the AWA and the Animal Welfare Regulations;

a description of the institution's program for animal care and use; and

the designation of the Institutional Official responsible for compliance.

A Sample Assurance is available to aid institutions in developing an Assurance in accord with the PHS Policy. Assurances should only be submitted to OLAW upon receipt of a request from OLAW.

Enforced Self-Regulation

The PHS Policy is based on a concept of enforced self-regulation. Once an institution has prepared an Animal Welfare Assurance and the Assurance has been approved by OLAW, the institution is in a position to regulate itself. This concept is described as enforced self-regulation because if the institution fails to self-regulate, the approval of the Assurance may be restricted or withdrawn by OLAW.

The concept of enforced self-regulation encompasses:

institutional commitment through an Assurance;

the designation of an Institutional Official authorized to assume the obligations imposed by the PHS Policy;

regular monitoring of the program for animal care and use by an Institutional Animal Care and Use Committee (IACUC);

IACUC review of protocols that involve the use of laboratory animals;

institutional identification and correction of deficiencies;

institutional reporting to OLAW;

performance standards wherever possible; and

use of professional judgment.

Go to Next Section: Program of Animal Care and Use

Table of Contents
Introduction || Relevant Documents || Terms and Concepts
Animal Program || IACUC || Reports and Records
Glossary and Resources

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