The Guide for the Care and Use of Laboratory Animals (Guide; (NRC, 2011), developed by a committee under the auspices of the National Academies of Sciences, Engineering, and Medicine’s Institute for Laboratory Animal Research (ILAR), defines a performance standard as “a standard or guideline that, while describing a desired outcome, provides flexibility in achieving this outcome by granting discretion to those responsible for managing the animal care and use program, the researcher, and the IACUC (Institutional Animal Care and Use Committee). The performance approach requires professional input, sound judgment, and a team approach to achieve specific goals.” Performance standards facilitate good science and animal welfare, explained roundtable Co-Chair Lynn Anderson, Vice President for Global Animal Welfare and Comparative Medicine at Covance Laboratories, and they allow individuals and teams to apply sound judgment, professionalism, and expertise to the problem at hand. As science evolves, the use of evidence-based performance standards will become increasingly important and essential.
To better understand the critical issues pertaining to the concept of performance standards for laboratory animal use, the ILAR Roundtable on Science and Welfare in Laboratory Animal Use held a public workshop in Washington, DC, on April 20-21, 2015. The purpose of the roundtable, Anderson noted, is to promote the appropriate and responsible care of animals in research, to provide a balanced and civil forum for discussion
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1 The planning committee’s role was limited to planning the workshop, and the workshop summary has been prepared by the workshop rapporteur as a factual summary of what occurred at the workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants, and are not necessarily endorsed or verified by the National Academies of Sciences, Engineering, and Medicine, and they should not be construed as reflecting any group consensus.
and collaboration, and to help build transparency and trust among stakeholders (the Statement of Task for the workshop can be found in Appendix C). The roundtable’s members determined that an informed discussion of performance standards would further that mission.
Invited speakers at the workshop addressed the challenges of defining, developing, implementing, assessing, and validating performance standards to ensure “optimal practices, management, and operations.” Expected outcomes of this workshop included:
- Interactive sessions for the workshop attendees to draft a mock performance standard on post-approval monitoring (PAM) of ongoing research projects with laboratory animals, to better understand the process involved in the development and implementation of performance standards;
- Opportunities for the workshop audience to discuss ways to share performance standards; and
- A rapporteur-prepared summary of the presentations and discussions at the workshop.
In her introductory remarks, Roundtable Director Lida Anestidou, National Academies Senior Program Officer, noted that this is the third workshop the roundtable has held in its 18 months of existence. A workshop on Reproducibility in Research with Animals and Animal Models was held in June 2014, and a workshop on Transportation of Laboratory Animals was held in September 2014. Summaries of the first two workshops will be published, said Anestidou, as would a transportation checklist be developed as part of the second workshop.
Workshop Planning Committee Co-Chair David Kurtz, Veterinary Staff Scientist at the National Institute of Environmental Health Sciences, then explained that developing performance standards is not a one-size-fits-all process. He expressed hope that the attendees would return to their institutions with a better understanding of how to develop and implement their own performance standards.
The workshop (see Appendix A for a copy of the workshop agenda) was organized by an independent ad hoc planning committee in accordance with the procedures of the National Academies of Sciences, Engineering, and Medicine. The planning committee consisted of Co-Chairs David Kurtz and Patricia Turner, Professor in the Department of Pathobiology and Program Leader of Laboratory Animal Science at the
Ontario Veterinary College, University of Guelph, along with David Anderson, Executive Director of Health Sciences Administration at the University of Washington; Janet Garber, Private Consultant; Andrew Grady, Director of Laboratory Animal Facilities at the University of Mississippi Medical Center; Donna Matthews Jarrell, Attending Veterinarian at the Center for Comparative Medicine, Massachusetts General Hospital; Guy Mulder, Executive Director of Veterinary and Professional Services at Charles River Laboratories (CRL); Randall Nelson, Association Vice Chancellor for Research and Professor of Anatomy and Neurobiology, The University of Tennessee Health Science Center; and Mary Ann Vasbinder, Head of Corporate Responsibility for 3Rs and Training Strategy for Animals at GlaxoSmithKline (GSK).
This publication summarizes the presentations and discussions that occurred throughout the workshop. Chapter 2 presents an overview of performance standards for the humane care and use of laboratory animals. Chapter 3 discusses the perspectives of four regulatory agencies with regard to the development, implementation, and assessment of performance standards, and Chapter 4 describes how various end-users view the process of developing, implementing, and assessing performance standards. Chapter 5 summarizes the detailed steps involved in the development and implementation of performance standards and includes some examples of how one institution designs new performance standards. Chapter 6 presents the results of the breakout sessions during which working groups drafted a mock performance standard on PAM for ongoing research projects with laboratory animals. Chapter 7 recounts a presentation on the idea that performance standards can increase efficiency and reduce waste and on how the community might best share acceptable performance standards. Chapter 8 provides a brief summary of some of the messages conveyed at the workshop.
In accordance with the policies of the National Academies of Sciences, Engineering, and Medicine, the workshop did not attempt to establish any conclusions or recommendations about needs and future directions, focusing instead on issues identified by the speakers and workshop participants. In addition, the organizing committee’s role was limited to planning the workshop. The workshop summary has been prepared by workshop rapporteurs Joe Alper and Lida Anestidou as a factual summary of what occurred at the workshop.
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