Terms and Concepts

Program of Animal Care and Use Institutional Official Animal Welfare Assurance Enforced Self-Regulation

Program of Animal Care and Use

The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (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, Program of Animal Care & Use, describes in detail each component of a program of animal care and use.
 

Institutional Official

The Institutional Official (IO) is “The individual who, as a representative of senior administration, bears ultimate responsibility for the Program and is responsible for resource planning and ensuring alignment of Program goals with the institution’s mission.” (Guide, p. 13) The IO makes commitments on behalf of the institution to ensure compliance with the PHS Policy.

The IO 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 IO and open channels of communication, the IACUC keeps the IO 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, and reports of noncompliance, are submitted by the IACUC, through the IO, 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 (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 Animal Welfare Act and Regulations;
• a description of the institution's program for animal care and use; and
• the designation of the Institutional Official responsible for compliance.

There are 3 types of Assurances:

• Domestic
• Interinstitutional
• Foreign

Each institution conducting PHS funded research using animals must have one of these types of Assurances.

Domestic Assurances are negotiated with U.S. institutions that control their own animal facilities, conduct animal research on-site, and have an animal care and use program with an Institutional Official, an IACUC, and a veterinarian with program authority.

An Interinstitutional Assurance is required if the grantee organization has no animal facility and will do the work at an Assured performance site. The Interinstitutional Assurance binds the awardee institution with the Assured performance site to ensure the humane care and use of animals.

A Foreign Assurance is required if the direct award is made to an institution outside the U.S, or if the domestic awardee has a foreign performance site. In the situation where there is collaboration between a domestic awardee and a foreign institution, the domestic institution must provide IACUC approval. The foreign institution agrees to follow the International Guiding Principles for Biomedical Research Involving Animals (PDF) developed by the Council for International Organizations of Medical Sciences (CIOMS) and to comply with all laws, regulations, and policies regarding the humane care and use of laboratory animals in their country of origin.
 

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 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 & Use.