Institutions conducting research involving animals have established operational frameworks, referred to as animal care and use programs (ACUPs), to ensure research animal welfare and high-quality research data and to meet ethical and regulatory requirements. 1-4 The Institutional Animal Care and Use Committee (IACUC) is a critical component of the ACUP and is responsible for the oversight and evaluation of all aspects of the ACUP. 5 However, investigators, IACUCs, institutions, the research sponsor, and the federal government share responsibilities for ensuring research animal welfare.
Effective policies, procedures, practices, and systems in the ACUP are critical to an institution’s ability to ensure that animal research is conducted humanely and complies with applicable regulations, policies, and guidelines. To this end, considerable effort and resources have been devoted to improve the effectiveness of ACUPs, including external accreditation of ACUPs by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International) and implementation of science-based performance standards, postapproval monitoring, and risk assessments and mitigation of identified vulnerability. 6-9 However, the impact of these quality improvement measures remains unclear. There have been no valid, reliable, and quantifiable measures to assess the effectiveness and quality of ACUPs.
Compliance with federal regulations is not only required, but also essential in protecting laboratory animals. However, the goal is not to ensure compliance but to prevent unnecessary harm, injury, and suffering to those research animals. Overemphasis on compliance and documentation may negatively impact the system by diverting resources away from ensuring research animal welfare. The authors propose that although research animal welfare cannot be directly measured, it is possible to assess the quality of ACUPs. High-quality ACUPs are expected to minimize risk to research animals to the extent possible while maintaining the integrity of the research.
The authors previously developed a set of quality indicators (QIs) for human research protection programs (HRPPs) at the VA, emphasizing performance outcomes built on a foundation of compliance. 10 Implementation of these QIs allowed the research team to collect data to assess the quality of VA HRPPs. 11 It also allowed the team to answer important questions, such as whether there were significant differences in the quality of HRPPs among facilities using their own institutional review boards (IRBs) and those using affiliated university IRBs as their IRBs of record. 12
Background
The VA health care system (VAHCS) is the largest integrated health care system in the U.S. Currently, there are 77 VA facilities conducting research involving laboratory animals. In addition to federal regulations governing research with animals, researchers in the VAHCS must comply with requirements established by VA. 1-4 For example, in the VAHCS, the IACUC is a subcommittee of the Research and Development Committee (R&DC). Research involving animals may not be initiated until it has been approved by both the IACUC and the R&DC. 13,14 All investigators, including animal research investigators, are required to have approved scopes of practice. 14 Furthermore, all VA facilities that conduct animal research are required to have their ACUPs accredited by the AAALAC International. 13