Introduction

"Good Animal Care and Good Science Go Hand in Hand." This caption on a poster developed by the United States National Institutes of Health's (NIH's) Office of Animal Care and Use, was intended to remind NIH employees and visitors that sound science relies on high-quality animal care and use practices. More than 50 years before this poster was produced, Dr. Milton J. Rosenau, the director of NIH's predecessor organization (the Hygienic Laboratory), sent much the same message to his employees when he wrote in 1904, "Animals are to be used in the proper work of the lab, but anything [that] inflicts pain upon them will not, under any circumstances, be allowed."1

This recognition that consistent, high-quality animal care and use programs are vital in producing research results of corresponding high quality, has led to the development of several programs that we will refer to in this chapter as "assessment systems." The three such systems to be presented here are: accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care

International (AAALAC International), Good Laboratory Practice (GLP) regulations, and certification or registration by the International Organization for Standardization (ISO). In addition to describing these three systems, this chapter will provide information on the historical bases for their development and how the differences in origins influence their procedures and ultimate aims. We will also attempt to show that, despite these differences, all three can be integrated at the institutional level.

Why is consistent, high-quality animal care important as it relates to biomedical and behavioral research? There are at least three different motivators that underlie the need for quality: legal necessity, an ethical imperative, and the validity of scientific results.

For most scientists and institutional staff who support the activities of research involving animals, the baseline for an animal care and use program is established in laws or other governmental requirements. Minimum requirements for animal welfare in science are laid down in the United States by the Animal Welfare Act2 and the Public Health Service Act3, and in countries of the European Union (EU) by Directive EEC 86-609.4 Other countries have animal welfare laws of varying stringency, ranging from general anticruelty statutes to near-prohibition of using animals in research. Additional legal requirements are imposed if the experimental data generated through animal research (as well as in vitro methods) are to be submitted to a governmental authority, such as the United States Food and Drug Administration (FDA), for pre-marketing approval.

However, meeting the minimum legal requirements for animal research is increasingly viewed by both the public and the scientific community as merely a foundation on which to build programs that optimize animal welfare. To those who hold this view, using animals in research brings with it an ethical imperative to go beyond the strict letter of the law to strive for the highest standards of animal care and use. Indeed, scientists themselves recognize that using animals to further scientific knowledge is a privilege that they are ethically obliged as individuals to not only acknowledge, but also to constantly factor into their research decisions. Validation that institutions and individuals are striving to achieve high standards in this specific area is one function of external assessment groups, such as AAALAC International.

Scientific inquiry is guided by the scientific method, one principle of which is that a hypothesis must withstand the scrutiny of other scientists. This scrutiny involves not only the validity of the hypothesis itself, but also the methods originally used to test the hypothesis. When scientific methods include animal experiments, a number of variables are introduced that can significantly affect the reproducibility of data, and hence, the ability to validate a study. These variables include the genetic "purity" of the animal strain; the animals' health and immune status, including latent infections; potential animal stressors, including those involved with routine maintenance as well as experimental manipulations; and the animals' macro- and micro-environments. Minimizing these and other animal-related variables is a goal that is advanced by applying consistent high standards of procurement, husbandry, veterinary care, and experimental use. Systems such as GLP and ISO provide methods and measures to ensure the requisite consistency and, along with participation in AAALAC International's accreditation program, demonstrate that high standards in these broader areas are met and maintained.

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