International Guiding Principles for Biomedical Research Involving Animals

Preamble: Experimentation with animals has made possible major contributions to biological knowledge and to the welfare of man and animals, particularly in the treatment and prevention of diseases. Many important advances in medical science have had their origins in basic biological research not primarily directed to practical ends as well as from applied research designed to investigate specific medical problems. There is still an urgent need for basic and applied research that will lead to the discovery of methods for the prevention and treatment of diseases for which adequate control methods are not yet available notably the noncommunicable diseases and the endemic communicable diseases of warm climates. Past progress has depended, and further progress in the foreseeable future will depend, largely on animal experimentation which, in the broad field of human medicine, is the prelude to experimental trials on human beings of, for example, new therapeutic, prophylactic, or diagnostic substances, devices, or procedures. There are two international ethical codes intended principally for the guidance of countries or institutions that have not yet formulated their own ethical requirements for human experimentation: The Tokyo revision of the Declaration of Helsinki of the World Medical Association ( 1975); and the Proposed International Guidelines for Biomedical Research Involving Human Subjects of the Council for International Organizations of Medical Sciences and the World Health Organization (1 982). These codes recognize that while experiments involving human subjects are a sine qua non of medical progress, they must be subject to strict ethical requirements. In order t o ensure that such ethical requirements are observed, national and institutional ethical codes have also been elaborated with a view to the protection of human subjects involved in biomedical (including behavioural) research. Because of differing legal systems and cultural backgrounds there are varying approaches to the use of animals for research, testing, or training in different countries. Nonetheless, their use should be always in accord with humane practices. The varying approaches in different countries to the use of animals for biomedical purposes, and the lack of relevant legislation or of formal self-regulatory mechanisms in some, point to the need for international guiding principles elaborated as a result of international and interdisciplinary consultations. The guiding principles proposed here provide a framework for more specific national or institutional provisions. They apply, not only to biomedical research but also to all uses of vertebrate animals for other biomedical purposes, including the production and testing of therapeutic, prophylactic, and diagnostic substances, the diagnosis of infections and intoxications in man and animals, and to any other procedures involving the use of intact live vertebrates.