A Commentary on Fasting of Nonclinical Research Animals.

This commentary discusses the implementation of fasting in nonclinical animal experimental subjects. The short-term removal of food from cages of experimental animals is in all respects innocuous. The term "stress" is ill-defined and the statutes and regulations governing animal research laboratories that exert their authority in the performance of their operations do so without substantive grounds to base compliance. The legislative and administrative history of the implementation of the Animal Welfare Act (AWA) has evolved into the development of laboratory management strategies that focus on the reduction of the biological cost of stress to the animals and the determination of when subclinical stress (eustress) becomes distress. Animal welfare is based on the tenet that in laboratories conducting animal research in compliance with Good Laboratory Practices (Title 21 USC, Chapter 13,§58), it is the study protocol and the study director that establish procedures and processes that are approved by each Institutional Animal Care and Use Committee to ensure the humane care and use of animals in research, teaching, and testing and to ensure compliance with guidelines and regulations. This approval process establishes the justification of eustress in the environment that do not rise to the threshold of distress under the AWA.

Knowledge, Attitudes, and Practices on Ethics in Biomedical Animal Research in Mexico.

The most widely accepted ethical concept for the mitigation of harm to animals used in biomedical research is known as the 3Rs, which refer to replacement, reduction, and refinement. The aim of our study was to determine the ethical and regulatory criteria that researchers in Mexico consider when developing their animal research protocols and that members of the ethics committees use when they evaluate and approve these protocols. We circulated a survey to 300 individuals from different research institutions and received responses from 179 researchers and members of ethics committees on questions related to their knowledge, attitudes, and practices toward the use of animals in research based on the 3Rs. The responses obtained indicate that the respondents were aware of the 3R concept, and they claim to apply these principles. However, the responses revealed resistance to using alternatives for research, testing, and teaching (66%). Nineteen percent of the researchers reported that their institutions do not have an integrated Institutional Animal Care and Use Committee (IACUC). Around 80% of respondents were aware of Mexican regulations. The knowledge and application of the 3Rs by researchers and members of the IACUC is a fundamental concept in animal research. Such knowledge contributes the use of ethical standards, attitudes, and practices relevant to the use of animals in research.

Trends among Institutional Animal Care and Use Committees and Animal Resource Programs for Providing Oversight and Animal Care during the (COVID)-19 Pandemic and Beyond.

To assess the impact of the COVID-19 pandemic on facility oversight and animal care at 2 y after declaration of the pandemic, we distributed a comprehensive survey to targeted groups within the broader animal research community in early 2022. A total of 265 surveys were returned (161 responses to IACUC questions, 193 responses to animal resource program [ARP] questions, and 89 responses to both). IACUC questions focused on the use of virtual interactions for IACUC activities and on remote work for IACUC support staff during and after the pandemic. ARP questions focused on remote work arrangements, altered work schedules, personnel shortages, and operational changes made during and after the pandemic. Results indicate that IACUCs readily adopted remote work options for staff and virtual meetings, changes that are now largely viewed as permanent, and are using modified methods for postapproval monitoring (PAM), while largely rejecting virtual semiannual facility inspections. This pattern reflects available guidance for virtual IACUC meetings, whereas new guidance for virtual semiannual facility inspections might have caused confusion and regulatory compliance concerns. Remote work options were available for some ARP staff, depending on job responsibilities, but were mostly eliminated by 2 y after the start of the pandemic. ARP staff expressed a strong desire for continued in-person presence of supervisors; this preference was not expressed by IACUC staff. Based on the timing of the survey (April 2022), substantial disruptions in the labor market had resulted in a considerable number of job openings and lack of entry level staff. Long-term assessment of effects on compliance and IACUC engagement would be useful given the widespread use of virtual IACUC meetings and other changes related to institutional and programmatic adoption of remote work options in ARPs.

Development of Two Korean IACUC Guidance Documents to Foster Implementation of the Three Rs.

In Korea, Institutional Animal Care and Use Committees (IACUCs) have been legally required to apply the Three Rs principles (i.e. replacement, reduction and refinement) and undertake the ethical review of animal study protocols, since 2008. According to Korean law, each IACUC is required to appoint at least one lay member recommended by a non-governmental animal protection organisation, who participates in the ethical review process as part of this role. Despite the importance of the Three Rs and the ethical review process, limited information and practical resources are available for IACUC members in the Korean language, particularly for lay members who are inexperienced in animal experimentation. In January 2020, the Animal and Plant Quarantine Agency announced the funding for a six-month research project to develop guidance to assist IACUC members in carrying out effective and efficient protocol reviews in line with Korean legislative requirements. This funding was awarded for the production of two IACUC guidance documents - 'Guide for Animal Study Protocols' and 'Guide for the IACUC Lay Member' - which were published in December 2020. These guidance documents aim to foster the implementation of the Three Rs and provide practical resources for IACUC members, researchers and other relevant personnel. This paper describes the framework for animal use in Korea and the overall production of these two IACUC Guidance Documents.

Perspectives on implementing veterinary clinical studies committees.

To address the limitations of traditional IACUC review of clinical research studies involving client-owned animals, the AVMA issued a policy describing the use of a veterinary clinical studies committee (VCSC), analogous to an institutional review board, as a way to ensure the adequate review and oversight of such studies. While IACUC composition, review, approval processes, and responsibilities are well established, uniform guidance for VCSCs is not readily available and not included in the guidance for IACUCs. In this manuscript we describe suggested best practices for scientific and ethical review of veterinary clinical research studies, regardless of the specific research setting. This resource complements the AVMA policy mentioned above by providing additional thoughts on aspects of VCSCs, including considerations necessary for the adequate review and oversight of clinical research studies using client-owned animals by VCSCs or IACUCs.