Assessing the Quality of VA Animal Care and Use Programs
Because this study did not involve the use of laboratory animals, no ACUC review and approval was required.
Data Analysis
All data collected were entered into a database for analysis. When necessary, facilities were contacted to verify the accuracy and uniformity of data reported. Only descriptive statistics were obtained and presented.
Quality Indicators
As shown in the Box, a total of 13 QIs covering a broad range of areas that may have significant impact on research animal welfare were selected.
QI 1. ACUP accreditation status was chosen, because accreditation of an institutional ACUP by AAALAC International, the sole widely accepted ACUP accrediting organization, suggests that the institution establish acceptable operational frameworks to ensure research animal welfare. Because VA policy requires that all facilities conducting animal research be accredited, failure to achieve full accreditation may indicate that research animals are at an elevated risk due to a less than optimal system to protect research animals.13
QI 2. IACUC and R&DC initial approval of animal research protocols was chosen because of the importance of IACUC and R&DC review and approval in ensuring the scientific merit of the research and the adequacy of research animal protection. The number and the percentage of protocols conducted without or initiated prior to IACUC and/or R&DC approval, which may put animals at risk, is a good measure of the adequacy of the institution’s ACUP.
QI 3. For-cause suspension or termination of animal research protocols was chosen, because this is a serious event. Protocols can be suspended or prematurely terminated by IACUCs due to investigators’ serious or continuing noncompliance or due to serious adverse events/injuries to the animals or research personnel. The number and percentage of protocols suspended reflect the adequacy of the IACUC oversight of the institution’s animal research program.
QI 4. Investigator sanction was chosen, because investigators and research personnel play an important role in protecting research animals. The number and percentage of investigators or technicians whose research privileges were suspended due to noncompliance reflect the adequacy of the institution’s education and training program as well as oversight of the ACUP.
QI 5. Annual review requirement was chosen because of the importance of ongoing oversight of approved animal research by the IACUC. The number and percentage of protocols lapsed in annual reviews, particularly when research activities continued during the lapse reflects the adequacy of IACUC oversight.
QI 6. Unanticipated loss of animal lives was chosen, because loss of animal lives is the most serious harm to animals that the ACUP is intended to prevent. The number and percentage of animals whose lives are unnecessarily lost due to heating, ventilation, or air-conditioning failure reflect the adequacy of the institution’s animal care infrastructure and effectiveness of the emergency response plan.
QI 7. Serious or continuing noncompliance resulting in actual harm to animals was chosen, because actual harm to animals is an important outcome measure of the adequacy of ACUP. The number and percentage of animals harmed due to investigator noncompliance or inadequate care reflect the adequacy of the institution’s veterinarian and IACUC oversight.
QI 8. Semi-annual program review and facility inspection was chosen because of the importance of semi-annual program review and facility inspection in IACUC’s oversight of the institution’s ACUP. This QI emphasizes the timely correction and remediation of both major and minor deficiencies identified during semi-annual program reviews and facility inspections. Failure to promptly address identified deficiencies in a timely manner may place research animals at significant risk.
QI 9. Scope of practice was chosen because of the importance of the investigator’s qualification in ensuring not only high-quality research data, but also adequate protection of research animals. Certain animal procedures can be safely performed only by investigators with adequate training and experience. Allowing investigators who are unqualified to perform these procedures places animals at significant risk of being harmed.
QI 10. Work- or research-related injuries was chosen because of the importance of the safety of investigators and animal caretakers in the institution’s ACUP. The importance of the institution’s occupational health and safety program in protecting investigators and animal care workers cannot be overemphasized. The number and percentage of investigators and animal care workers covered by the occupational health and safety program and work- or research-related injuries reflect the adequacy of the ACUP.
QI 11. Investigator animal care and use education/training requirements was chosen because of the important role of investigators in protecting animal welfare. The number and percentage of investigators who fail to maintain required animal care and use education/training reflect the adequacy of the institution’s IACUC oversight.
