Module 1:
AAALAC International's Expectations for Animal Care and Use/Ethics Committees.

The Guide for the Care and Use of Research Animals (Guide) states that the responsible administrative official must appoint an Institutional Animal Care and Use Committee (IACUC, also called the Ethics Committee or Animal Care Committee) to oversee and evaluate the institution's animal program, procedures, and facilities. While these committees are called a variety of names based on geographical location, national legislation, or institutional preference (e.g., Institutional Animal Care and Use Committee, Ethical Review Committee, Animal Care Committee, etc.), they will be referred to in this module synopsis as "the Committee." As described in the Guide, the Committee is ultimately the lynchpin of the animal care and use program and has a wide variety of duties and responsibilities. As the primary means of oversight for animal care and use, their effective operation is crucial for maintaining an accreditable program. Each submodule provides a point-by-point analysis of the described topic from an AAALAC perspective, with practical examples included to help bring home key issues.

Submodule 1.a.:
AAALAC International's Use of Performance Based Standards to Evaluate Animal Care and Use Programs and Facilities (~1 hour)

AAALAC International relies heavily on the use of performance based standards for evaluating animal care and use programs during the accreditation site visit. Understanding of performance based standards among research, teaching, and testing facilities is variable. This submodule begins by describing how the AAALAC International process is one of peer-reviewed evaluation and not inspection, and how performance standards are a crucial component of the evaluation process during a site visit. It defines professional judgment and the role professional judgment plays in developing performance standards and how AAALAC International evaluates an institution's process of developing performance standards. Several examples of how performance standards compare to engineering standards and how they can be applied within an animal care and use program are provided in order to help the Committee understand their correct application.

Submodule 1.b.:
Maintaining a Healthy and Well Balanced Committee (~0.5 hour)

How do you know if your Committee is functioning to its full potential? This submodule discusses the key components of an animal care and use program and explains AAALAC International's expectations of the roles and responsibilities we look for in key individuals such as the Institutional Official, Attending Veterinarian/Named Veterinarian, scientists, and Committee members. Examples of Committee training topics that site visitors frequently look for and common characteristics of the "weak" or "overpowering" Committee are provided as a self-evaluation tool. Committee related deficiencies that are most frequently seen on AAALAC International site visits are discussed as well.

Submodule 1.c.:
Performing an Effective Semiannual Program Review (~1 hour)

The importance of a distinct and thorough semiannual Committee review of the animal care and use program is often overlooked. This submodule discusses the purpose of a program review and provides some methods and tools for accomplishing it. What constitutes a program of animal care and use is defined as well as what AAALAC International's expectations are for the review of the program, to include follow-up actions and documentation.

Submodule 1.d.:
Performing an Effective Semiannual Facility Inspection (~1 hour)

While most Committee members have participated in multiple semiannual facility inspections as part of their responsibilities, this submodule is designed to provide supplemental information that will help to clarify some gray areas. Issues such as who is responsible for animals housed off-site or used in collaborative research projects with investigators from other institutions, and what areas should the facility inspection include are discussed. A review of each section of the Guide dealing with the physical plant and what site visitors will be expecting is also provided. The most frequently cited facility deficiencies found during AAALAC International site visits are also discussed.

Submodule 1.e.:
Review of Animal Protocols and Post-Approval Monitoring (~1.5 hours)

Performing an effective review of research, teaching, and testing protocols can provide Committees with some of their greatest challenges. This submodule explains what AAALAC International considers as the goals of the review process and provides insight to the expectations of what the Guide considers required elements of an animal use protocol. An overview of full and designated Committee review processes is included. Once an animal use protocol is approved, AAALAC International's expectations for review and monitoring don't stop. Different approaches to post-approval monitoring are presented as well as the most frequently seen deficiencies in the area. Since reporting of adverse events related to the animal care and use program is a required part of accreditation, clarification on this issue is provided as well.

Submodule 1.f.:
Committee Documentation, Policies, and Guidelines (~0.5 hour)

AAALAC International site visitors routinely request to see documentation of Committee activities. This submodule discusses those documents most frequently requested by site visitors and provides guidance on what types of policies and guidelines are typical of accredited institutions. The most frequent deficiencies involving documentation, policies, and guidelines are also discussed.

Submodule 1.g.:
The Committee's Role in Occupational Health and Safety (~0.5 hour)

Who is responsible for providing a healthy and safe work environment? Who is responsible for establishing an occupational health and safety (OHS) program in your institute? Who is responsible for implementing the OHS program? What are the Committee's responsibilities for occupational health and safety? These are all commonly encountered questions that this submodule addresses. This presentation also provides guidance to the Committee by reviewing a checklist of OHS issues in which a Committee generally should be involved.

Submodule 1.h.:
Committee Oversight of Agricultural Animals in Agricultural Research Programs (~0.5 hour)

While most Committee's are very experienced in providing effective oversight to animals used in traditional biomedical research programs, there is often confusion regarding their role in overseeing agricultural animals and programs. This submodule discusses the differences in providing oversight to agricultural programs and the challenges of issues such as veterinary care, husbandry and management, special agricultural practices, occupational health and safety, and the physical plant. It is designed to assist your IACUC/Ethics Committee/Animal Care Committee in understanding its roles and responsibilities in providing oversight to agricultural research and teaching programs.

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