Assessing the Quality of VA Animal Care and Use Programs
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
Based on the experience gained from the VA HRPP QIs, the authors developed a set of QIs that emphasize assessing the outcome of ACUPs rather than solely on IACUC review or compliance with animal research regulations and policies. This report describes the proposed QIs for assessing the quality of VA ACUPs and presents preliminary data using some of these QIs.
Methods
The VA ACUP QIs were developed through a process that included (1) identification of a set of potential indicators by the authors; (2) review and comments on the potential indicators by individuals within and outside VA who have expertise in protecting research animal welfare, including veterinarians with board certification in laboratory animal medicine, IACUC chairs, and individuals involved in the accreditation and oversight of ACUPs; and (3) review and revision by the authors of the proposed QIs in light of the suggestions and comments received. After 6 months of deliberation, a set of 13 QIs was finalized for consideration for implementation.
Data Collection
As part of the VA ACUP quality assurance program, each VA research facility is required to conduct regulatory audits of all animal research protocols once every 3 years by qualified research compliance officers (RCOs).15 Audit tools were developed for the triennial animal protocol regulatory audits (available at https://www.va.gov/oro/rcep.asp).11,12 Facility RCOs were then trained to use these tools to conduct audits throughout the year.
Results of the protocol regulatory audits, conducted between June 1, 2011, and May 31, 2012, were collected through a Web-based system from all 74 VA facilities conducting animal research during that period. Information collected included IACUC and R&DC initial approval of human research protocols; for-cause suspension or termination of animal research protocols; compliance with continuing review requirements; research personnel scopes of practice; and investigator animal research protection training requirements.
