Regulations and Standards,SOPs

A Program Built on Compliance

Article Posted: November 01, 2003

Accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) is a demonstration of a research institution's commitment to quality scientific research and animal care. A fully accredited program can be achieved with dedication to four broad categories of activities:

* development of an effective institutional animal care and use committee (IACUC)
* centralization and empowerment of the animal care and use program administration to obtain accreditation
*preservation of idealized standard operating procedures (SOPs) based on the "Guide" and other applicable regulations
*development of an energized program for self-evaluation/self-correction that includes documenting detailed records of activities
 
The infrastructure of a facility contributes to the humane care and use of animals and includes the physical design elements as well as the environmental conditions which must be considered throughout the accreditation process. Achieving compliance through detailed planning, protocol development, operating procedures, and adequate records results will result in a program that should be eminently accreditable.
 
Development of an Effective IACUC
One of the single most important components of the animal care and use program is an effective Institutional Animal Care and Use Committee (IACUC). The key word in this statement is "effective." The committee has to be well-chosen and committed to the development of a quality program. The committee also has to be delegated sufficient authority to oversee the program. Part of this authority is required by law since a named institutional official responsible for the animal care and use program must appoint the committee. Membership on the IACUC is specified by law to include at least five members (Public Health Service Policy on the Humane Care and Use of Laboratory Animals). One of the members must be a non-scientist (a non-user of laboratory animals) and one member must be unaffiliated with the institution.
 
In many programs, the IACUC is managed by the administration of the animal care and use program. This arrangement could be seen as a serious conflict of interest wherein the IACUC is managed by the program that it is charged to oversee. Conflict of interest by committee membership should be carefully evaluated in whatever administrative structure is chosen.
 
The IACUC is charged with many responsibilities, including program review and oversight. Any aspect of the animal care and use program is under the purview of this committee. An effective IACUC is familiar with requirements of the laws and policies, is familiar with the standard operating procedures that assure compliance with those laws and policies, and maintains a mechanism for educating users about program requirements and assuring user adherence to laws, policies, and procedures. An effective committee maintains surveillance of the program through protocol review and semi-annual program and facilities reviews. The program is strengthened by detailed records of the committee's activities and incorporation into a broader more comprehensive institutional program (safety, occupational health, grant accounting, conflict of interest, etc.) that has authority to manage issues of non-compliance.
 
The IACUC is perhaps one of the most scrutinized components of the animal care and use program. The United States Department of Agriculture, the Public Health Service, and AAALAC all review the records of activities of this committee. Thus, one might expect that many of the common deficiencies noted by AAALAC site visitors involve IACUC function.
Related Topics: Regulations and Standards SOPs November/December 2003 ALN