INTERNATIONAL GUIDING PRINCIPLES FOR BIOMEDICAL RESEARCH INVOLVING ANIMALS

The International Guiding Principles for Biomedical Research Involving Animals were developed by the Council for International Organizations of Medical Sciences (CIOMS) as a result of extensive international and interdisciplinary consultations spanning the three-year period 1982-1984.

Animal experimentation is fundamental to the biomedical sciences, not only for the advancement of man's understanding of the nature of life and the mechanisms of specific vital processes, but also for the improvement of methods of prevention, diagnosis, and treatment of disease both in man and in animals. The use of animals is also indispensable for testing the potency and safety of biological substances used in human and veterinary medicine, and for determining the toxicity of the rapidly growing number of synthetic substances that never existed before in nature and which may represent a hazard to health. This extensive exploitation by man of animals implies philosophical and moral problems that are not peculiar to their use for scientific purposes, and there are no objective ethical criteria by which to judge claims and counterclaims in such matters. However, there is a consensus that deliberate cruelty is repugnant.

Suggestions had been received from several quarters that CIOMS, as an international nongovernmental organization representative of the biomedical community, would be ideally placed to propose a broadly based statement, acceptable worldwide in different cultural and legal backgrounds, and designed to create a greater understanding on the subject of biomedical research involving animals. Moreover, in several countries political action was being taken to stop or severely limit animal experimentation, and the Council of Europe had for some time been engaged in the elaboration of a convention to regulate the use of vertebrate animals for experiments or toxicity tests.

While many countries have general laws or regulations imposing penalties for ill-treatment of animals, relatively few make specific provision for their use for scientific purposes. In the few that have done so, the measures adopted vary widely, the extremes being: on the one hand, legally enforceable detailed regulations with licensing of experimenters and their premises together with an official inspectorate; on the other, entirely voluntary self-regulation by the biomedical community, with lay participation. Many variations are possible between these extremes, one intermediate situation being a legal requirement that experiments or other procedures involving the use of animals should be subject to the approval of ethical committees of specified composition.

In elaborating and publishing the International Guiding Principles the objective of CIOMS is not to duplicate such national regulations or voluntary codes as already exist but to provide a conceptual and ethical framework, acceptable both to the international biomedical community and to moderate animal welfare groups, for whatever regulatory measure each country or scientific body chooses to adopt in respect of the used animals for scientific purposes. The Principles strongly emphasize that there should not be such restrictions as would unduly hamper the advance of biomedical science or the performance of necessary biological tests, but that, at the same time, biomedical scientists should not lose sight of their moral obligation to have a humane regard for their animal subjects, to prevent as far as possible pain and discomfort, and to be constantly alert to any possibility of achieving the same result without resort to living animals.

The International Guiding Principles are the product of the collaboration of a large and representative sample of the international biomedical community, including experts of the World Health Organization, and of consultations with responsible animal welfare groups. They have constituted the agenda for three international meetings, the first of these being a Working Group that met in March 1983 to consider a preliminary draft prepared by CIOMS with consultant aid and the collaboration of the WHO Secretariat. The next meeting was the XVIIth CIOMS Round Table Conference, held in December 1983, to give the draft International Guiding Principles, as amended by the Working Group, a much wider exposure to criticism and suggestions. The third and last meeting, which took place in June 1984, was of a CIOMS Expert Committee which met for a final review of the International Guiding Principles as revised in the light of comments made during the Round Table Conference and subsequently by correspondence.

The International Guiding Principles have already gained a considerable measure of acceptance internationally. European Medical Research Councils (EMRC), an international association that includes all the West European medical research councils, fully endorsed the Guiding Principles in 1984. Proposed U.S. Government Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research and Training formulated in 1984 by the U.S. Interagency Research Animal Committee, were to a considerable extent based on the CIOMS Guiding Principles. In the same year, the Guiding Principles were endorsed by the WHO Advisory Committee on Medical Research at its 26th Session.

It is the hope of CIOMS that these Guiding Principles will provide useful criteria to which academic, governmental and industrial bodies may refer in framing their own codes of practice or legislation regarding the use of laboratory animals for scientific purposes.

Zbigniew Bankowski, M.D.
Executive Secretary, CIOMS

Full text of the "GUIDING PRINCIPLES":  

http://www.cioms.ch/frame_1985_texts_of_guidelines.htm