Online Issues

Journal Vol 48 (1)

Introduction

Recent Studies, New Approaches, and Ethical Challenges in Animal Research

Janet C. Gonder

Janet C. Gonder, D.V.M., Ph.D., is Principal Consultant, Garber Consulting LLC, Pinehurst, NC.

Address correspondence and reprint requests to Dr. Gonder, 17 Troon Drive, Pinehurst, NC 28374, or email jgonder@nc.rr.com.

Many ILAR Journal issues focus on particular topics or scientific areas of study, such as the recent issue on Type 2 Diabetes and Obesity (NRC 2006b). The Journal also frequently publishes issues that have very broad application to research programs, such as Preparation of Laboratory Animals for Research (NRC 2006a) and an upcoming issue on Education and Training for Laboratory Animal Care and Use Programs (in preparation). In this issue we have the opportunity to explore a number of divergent topics of interest to those involved in management of research animal care and use programs. Broadly, the articles in this issue provide the reader with an “update” or enhanced discussion of topics that are currently relevant.

To set the stage, Klein and Bayne (2007) put our search for and utilization of new knowledge into the context of a culture of care. Their approach builds on programs that have a strong institutional commitment to humane care and use of animals, and where expectations of conscience and responsibility are clearly communicated. The importance of establishing policies and procedures based on scientifically sound performance standards is stressed, as is the importance of ongoing critical evaluation of existing processes. The development and application of performance standards, rather than strict engineering standards in all cases, is an approach that was included in the regulatory framework of the Animal Welfare Regulations published in 1985 (CFR 1985). Since that time, the concept of performance standards has come into widespread use (Gonder et al. 2001).

In this issue Klein and Bayne build on new approaches for evaluating program components and procedures. This method is accomplished by setting up a process to evaluate performance standards in terms of the value they provide. The “Critical to Quality” method they describe involves defining a need or outcome (based on value), outlining approaches to reaching the goal, and continuously monitoring the process and results. The method incorporates the application of ethical principles at all stages of the process. Applying the concept of performance-based standards provides a great deal of flexibility in managing expectations and outcomes while meeting regulatory requirements. In fact, using this approach, it is easy to understand how the process could result in an institutionally defined engineering standard based on scientific assessment of a need and a specific means (performance) of consistently achieving that goal. With this approach facility personnel can exercise sound professional judgment to meet the needs of a diverse research environment.

Many questions and challenges that are inherent in animal research facilities today have become the focus of the institutional animal care and use committee (IACUC¹). One example is the review of research proposals submitted to granting agencies. For large institutions this review can pose a significant burden for review of research protocols that may not be funded and, thus, may never be conducted. In 2002, the Public Health Service introduced a process to address this concern. Called just-in-time (JIT¹), this optional process allows for submission of a grant proposal with funding dependent on subsequent verification of IACUC approval. While the process has been utilized successfully by some institutions, many difficulties have been encountered in practice. In this ILAR Journal issue, Mann and Prentice (2007) provide a detailed discussion of the JIT process. They review results of an electronic survey of institutions regarding the use and success of JIT, and further discuss the implications.

Late in 2005, the National Institutes of Health published a Request for Information (RFI¹) in the Federal Register (2005), soliciting comments and potential reasons for revising the Guide for the Care and Use of Laboratory Animals (Guide¹; NRC 1996). This RFI prompted many in the research community to review the current Guide in the context of current knowledge and standard practice. Not surprisingly, since publication of the seventh edition of the Guide in 1996, many examples of studies and information have been published that have had an impact on our understanding of laboratory animal science and on the management of research animal facilities.

In this broader context, Gonder and Laber (2007) bring together a summary of recent publications related to rodent husbandry and management. The review includes recent studies associated with cage size and housing density, enrichment strategies, and environment of the primary housing enclosure (ventilation, bedding). While it is beyond the scope of this article to review all pertinent publications in this area, it does serve to provide new science-based information that may enable managers to make decisions regarding modification to current practices for the housing and care of rodents.

A key component of animal care and use programs is adequate veterinary care for the research animals. One element of any veterinary care program—medical records—is extremely important and has received much attention over the years. Guidelines published both by regulatory agencies and by many animal care professionals have been inconsistent (and sometimes exceedingly rigid). In 2004, the American College of Laboratory Animal Medicine (ACLAM¹) approved a public statement regarding medical records for animals in research, teaching, and testing. In this issue, Field and colleagues (2007) summarize that public statement, which provides comprehensive guidelines for the form and content of medical records. In the statement, a “medical record” is distinguished from a “research record” (data), and the authority of the attending veterinarian is defined. The need for professional judgment is stressed, permitting flexibility in complex research programs. In the context of applicable regulations, this statement and summary should be adopted (and adapted) for use by all animal research programs.

As mentioned above, consideration of ethical principles is critical in establishing a “culture of care.” In 2005, the Nuffield Council on Bioethics published a report titled “The Ethics of Research Involving Animals” (NCB 2005). A summary of this report, which is presented in this ILAR Journal issue (Perry 2007), represents a perspective from the United Kingdom. Several important issues are discussed, representing a continuum of ethical positions on animal research. The discussion should help readers analyze the scientific and ethical issues in various research environments. The report poses specific questions that should be addressed whenever an ethical review of proposed research with animals is conducted. The debate centers on the following two questions: (1) What are the absolute limits? (2) How do we weigh moral considerations within those limits?

Although the Council concluded that there was no single ethical position, they did agree to a consensus statement on several important issues. They concluded that animal research benefits society in many ways, and that the ultimate goal is to achieve those benefits without the animals' pain and suffering. Finally, they called for more access to relevant information in an effort to improve the debate on these issues.

The final article in this issue continues and clearly complements the discussion of the importance of ethical considerations in the use of animals in research. Dr. Bernard Rollin (2007) presents a thought-provoking commentary on why ethical review of protocols is a key component of research animal care and use programs.

Hopefully, this ILAR Journal issue successfully pulls together topics of contemporary interest to those involved in the management of animal research programs. Together the articles stress the importance of continually assessing and adopting new technology and scientific information, as well as routinely evaluating all components of a research program.

Abbreviations used in this Introduction: ACLAM, American College of Laboratory Animal Medicine; Guide, Guide for the Care and Use of Laboratory Animals; IACUC, institutional animal care and use committee; JIT, just in time; RFI, Request for Information.

References

CFR [Code of Federal Regulations]. 1985. Title 9 (Animals and Animal Products), Subchapter A (Animal Welfare). Washington DC: Office of the Federal Register.

Federal Register. 2005. “Request for Information (RFI): Standards for the Care and Use of Laboratory Animals” (Notice Number NOT-OD-06-011, November 9, 2005).

Field K, Bailey M, Foresman LL, Harris RL, Motzel SL, Rockar RA, Ruble G, Suckow MA. 2007. Medical records for animals used in research, teaching and testing: Public statement from the American College of Laboratory Animal Medicine. ILAR J 48:37-41.

Gonder JC, Laber K. 2007. A renewed look at laboratory rodent housing and management. ILAR J 48:29-36.

Gonder JC, Smeby RR, Wolfle TL, eds. 2001. Performance Standards and Animal Welfare: Definition, Application and Assessment, Parts I & II. Greenbelt MD: Scientists Center for Animal Welfare.

Klein HJ, Bayne KA. 2007. Establishing a culture of care, conscience, and responsibility: Addressing the improvement of scientific discovery and animal welfare through science-based performance standards. ILAR J 48:3-11.

Mann MD, Prentice ED. 2007. Verification of IACUC approval and the just-in-time PHS grant process. ILAR J 48:12-28.

NCB [Nuffield Council on Bioethics]. 2005. The Ethics of Research Involving Animals. London, UK: Nuffield Council on Bioethics. Available online (www.nuffieldbioethics.org/go/ourwork/animalresearch/introduction).

NRC [National Research Council]. 1996. Guide for the Care and Use of Laboratory Animals. 7th ed. Washington DC: National Academy Press.

NRC [National Research Council]. 2006a. Preparation of Animals for Use in the Laboratory. ILAR J 43;281-375.

NRC [National Research Council]. 2006b. Type 2 Diabetes and Obesity. ILAR J 43:181-271.

Perry P. 2007. The ethics of animal research: A UK perspective. ILAR J 48:42-46.

Rollin BE. 2007. Overcoming ideology: Why it is necessary to create a culture in which the ethical review of protocols can flourish. ILAR J 48:47-53.