ILAR Journal Online, Volume 37(2) 1995: Laboratory Animal Care Policies and Regulations

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ILAR Journal V37(2) 1995
Laboratory Animal Care Policies and Regulations

Introduction
John P. Hearn

John P. Hearn, Ph.D., is director of the Wisconsin Regional Primate Research Center and chairman of the Institute of Laboratory Animal Resources Committee on International Activities.

To those doing research that requires the study of animals, the array of legislative and regulatory guidelines, instructions, or orders that have multiplied in the past 20 years can be bewildering. During the same period, the Institute of Laboratory Animal Resources (ILAR) has charted a responsible, balanced course by producing highly respected, science-based guidelines and advice for the biological research community. Many of ILAR's documents have won international acclaim. Yet the multiplication of regulations continues, coming from an alphabet soup of national or international organizations whose committees may sometimes decide to start afresh, without the benefit of already tested knowledge.

Guidelines and regulations must retain the flexibility for improvement as knowledge advances. Therefore it is vital to adopt performance-based standards that are open to improvement, and not engineering standards that can block or inhibit further progress. By the same token guidelines are far more positive in encouraging improvements than are standards or regulations. The international research committee is committed to improved animal care and welfare based on advancing knowledge. The state of the art is not static art. Flexibility is needed because local conditions may vary enormously, for example in climatic, financial, or cultural differences between developed and less developed countries. Often there is no single answer to suit these local variables. With the best of intentins, rigidity in "standards" or "regulations" can be self-defeating.

This issue of ILAR Journal examines and compares national laws and guidelines, in the hopes that we can move towards greater synthesis and simplicity. It is important that we do so. Animal science is about new discoveray and knowledge, but it is also about the international adoption and transfer of that knowledge to all aspects of human and animal life, including the improvement of the procedures for experiments and for animal care.

Among the reasons this is important are (1) the quality of the science, (2) the need for efficiency in costs of research, (3) the need for similar standards to govern the care and use of animals involved in international research protocols, (4) facilitation of the movement and exchange of research animals ad animal products, (5) conservation of the time of scientists on the bench, (6) the achievement of optimal care of traditional or nontraditional animal or cell stocks, and (7) the need to identify the critical research questions that will lead to further improvements in animal care and use.

As we witness encouraging developments with the North American Free Trade Agreement (NAFTA) and the World Trade Organization, we in ILAR would like to see science-based advice included early in the process to influence and help develop rational, efficient guidelines, regulations, and legislation, both nationally and internationally. The results will be vital for human health, pharmaceuticals, many aspects of trade and also for animal welfare and conservation. Time spent now in providing expert knowledge and in liaising with the numerous regulatory agencies will save much more time later, especially if untenable regulations were to be developed by default.

In this issue we have presented a range of national approaches to animal research and some opportunities for the future. We have compared national laws and regulations in a table on page 78. We ask that those driven to write new regulations consider what is already tried and true, in furthering and improving the field rather than in reinventing the wheel. We welcome comments in a future issue. ILAR looks forward to working with all interested parties to benefit science and improve animal care and welfare.

EDITOR'S NOTE:

With this issue, ILAR Journal brings together perspectives on laboratory animal care programs in Canada, Japan, New Zealand, the United States and the United Kingdom. In an effort to focus each piece, contributors were asked to describe animal care policies and regulations in their country and comment on how, in their opinion, these policies and regulations affect biomedical research. Authors responded to a set of questions (below), which broadly cover oversight, funding, and enforcement; applicability/ administration and costs; strengths and weaknesses; ad thefuture. The final sections include the authors' personal assessments of each system and their predictions for the future. For purposes of this issue, we have used the words "law or policy" very broadly to refer to whatever system a country has in place to ensure that research animals are cared for humanely.

This issue is the beginning of what we hope will become a continuing forum of perspectives, commentary, and information about laboratory animal care around the world. Expect to see submissions from Mexico and Australia in the near future. As alwasy, we welcome all comments (ILAR Journal, Institute of Laboratory Animal Resoucrces, 2101 Constitution Avenue, N.W., Washington, D.C. 20418. Tel: 202-334-2590; Fax 202-334-1687; emal: ilarj@nas.edu.

QUESTIONS ADDRESSED BY EACH AUTHOR

Oversight, Funding, and Enforcement

1. Is oversight of animal care and use in your country provided by national law, state or local law, institutional policy or guidelines, or another system? Please explain.
2. How is this law or policy funded on a national level?
3. How is this law or policy enforced? Who is disciplined for noncomliance? Can infractions by a single investigator adversely impact on the institution's ability to do animal research? Please explain.

Applicability

3. Does this law or policy apply to the institution, the investigator, or other? Please explain.
4. Does this law or policy apply to the animals, protocols, housing, anesthetics, or other?

Administration and Cost

6. Describe the method by which your animal care and use program is administered, including the role of the institutional official, deans, investigators, veterinarians, oversight committees, or others who may have some responsibility.
7. How is the cost of this administration defrayed? By individual research grants, institutional overhead, or other means?

Strengths and Weaknesses

8. In your opinion, what are the current strengths and weaknesses of the administration and oversight of the care and use of animals for research in your country?

The Future

9. How is the administration and oversight of the care and use of animals for research in your country likely to change in the next 10 years?