Adopted by the 3rd World Congress on Alternatives and Animal Use in the Life Sciences, Bologna, Italy,31 August 1999
The "Three Rs" of Russell and Burch, reduction, refinement and replacement, had their origin in a project initiated in 1954 by the Universities Federation for Animal Welfare (UFAW), which led to the publication in 1959 of The Principles of Humane Experimental Technique, by W.M.S. Russell and R.L. Burch (1). In 1978, David Smyth used the word alternatives to define the Three Rs (2).
In their book, Russell and Burch stated that "The greatest scientific achievements have always been the most humane and the most aesthetically attractive, conveying that sense of beauty and elegance which is the essence of science at its most successful". They defined: Reduction alternatives as methods for obtaining comparable from the use of fewer animals in scientific procedures, or information from the same number of animals.
Refinement alternatives as methods which alleviate suffering and distress, and which enhance animal Replacement alternatives as methods which permit a given purpose to be achieved without conducting experiments or other scientific procedures on animals.
The participants in the 3rd World Congress on Alternatives and Animal use in the Life Sciences strongly endorse and reaffirm the principles put forward by Russell and Burch in 1959. Humane science is a prerequisite for good science, and is best achieved in relation to laboratory animal procedures by the vigorous promotion and application of the Three Rs.
The "Three Rs" should serve as a unifying concept, a challenge, and an opportunity for reaping benefits of every kind - scientific, economic and humanitarian.
BACKGROUD TO THE THREE Rs DECLARATION OF BOLOGNA
Conclusions and Recommendation on the Reduction, Refinement and Replacement of Laboratory Animals Procedure
Adopted by the 3rd World Congress on Alternatives and Animals Use In the Life Sciences, Bologna, Italy, 31 August 1999
Laboratory animals procedures have made significant contributions to biomedical research in the past, as well as to the safety and efficacy evaluation of chemicals and products of various kinds. Some such use of vertebrate animals will continue to be necessary for the foreseeable future, in the interests of human beings and other animals.
The Origins of the Three Rs Concept
What are now known as the Three Rs of Russll and Burch, namely reduction, Refinement and replacement, had their origin in a project initiated in 1954 by the Universities Federation for Animal Welfare(UFAW), which led to the publication in 1959 of The Principles of Humane Experimental Technique, by W.M.S. Russell and R.L.Burch(1).
Russell and Burch defined reduction as a means of lowering "the number of animals used to obtain information of a given amount and precision", refinement as any development leading to a "decrease in the incidence or severity of inhumane procedures applied to those animals which have to be used, and replacement as animal experimentation replace methods which use conscious living vertebrates". They summed up their main message, as follows:
If we are to use a criterion for choosing experiments to perform, the criterion of humanity is the best we could possibly invent.
The greatest scientific achievements have always been the most humane and the most aesthetically attractive, conveying that sense of beauty and elegance which is the essence of science at its most successful.
The Acceptance of the Three Rs Concept
Relatively little attention was paid to the Three Rs concept during the 1960s, but a number of significant developments took place during the 1970s, including the publication of a survey of Alternatives to Animal Experiments, conducted for the Research Defence Society by Professor David Smyth, in which he provided a Three Rs definition of alternatives (2).
AII procedures which can completely replace the need for animal experiments, reduce the number of animals required or diminish the amount of pain or distress suffered by animals in meeting the essential needs of man and other animals.
The 1980s saw the introduction of a number of national and international laws and conventions with a Three Rs basis, notably, in Europe, the Council of Europe Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes (3) and Council Directive 86/609/EEC of 24 November 1986 on the Approximation of Laws, Regulations and Administrative Provisions of the Member States Regarding the Protection of Animals Used for Experimental and Other Scientific Purposes (4).
Also in 1986, a report by the US Congress Office of Technology Assessment on Alternatives to Animal Use in Research. Testing and Education (5) provided detailed evidence of the broad scope and potential value of the Three Rs concept of alternatives, while in 1985, the Council of International Organization in the Medical Sciences (CIOMS) published a set of International Guiding Principles for Biomedical Research Involving Animals (6).
The Three Rs Concept Today
By the end of the 1980s, new laws and guidelines were in place various parts of the world, which not only recognized Russell and Burch's concept, but placed legal and moral obligations on all concerned, to seek to reduce, refine and/or replace laboratory animal procedures wherever possible.
Much will have been achieved by the end of the 1990s, but, for some time to come, securing the universal implementation of the Three Rs concept will remain a major challenge confronting all those who are in any way involved in the use of laboratory animals in research, testing and education.
The 1st and 2nd World Congresses on Alternatives and Animal Use in the Life Sciences were held in Baltimore, USA, In 1993, and in Utrecht, The Netherlands, in 1996. The Executive Committee for the 3rd World Congress put this Declaration before participants In the Congress, in Bologna, Italy, on 31 August 1999, in a year which marked the fortieth anniversary of the publication of The Principles of Humane Experimental Technique. The Declaration is based on the conclusions and recommendations of The Three Rs: The Way Forward, a workshop held in Sheringham, UK, on 30 May to 3 June 1995, under the auspices of the European Center for the Validation of Alternative Methods (ECVAM) and the Johns Hopkins Center for Alternatives to Animal Testing (CAAT).
CONCLUSIONS AND RECOMMENDATIONS
Legal Controls, and Scientific and Ethical Justification
a. The improved storage, exchange and use of information from animal experiments already carried out, so that unnecessary repetition can be avoided.
b. The use of physical and chemical techniques, and of prediction based on the physical and chemical properties of molecules.
c. The use of mathematical and computer modeling, including modeling of structure-activity relationships, molecular modeling and the use of computer graphics, and modeling of biochemical, pharmacological, physiological, toxicological and behavioral processes.
d. The use of "lower" organisms with limited sentience (e.g. invertebrate animals, plants and microorganisms.
e. The use of early developmental stages of vertebrates, before they reach the point at which their use for experimental and other scientific purposes is controlled.
f. The use of in vitro methods, including the short-term maintenance of perfused organs, tissue slices and cell suspensions, and cell and tissue culture proper. For most in vitro studies, human cells and tissues should be used in preference to those isolated from laboratory animals, provided that the unavoidable ethical, legal and safety considerations have been fully satisfied.
g. Human studies, including epidemiology, post-marketing surveillance, and the ethically approved us of human volunteers.
Education and Training
21. A clear distinction should be made between education, which aims to contribute to the development of proper attitudes toward the use of animals and alternatives, and the training, which aims to contribute to the proper care and use of animals and to ensuring that experiments are of the highest quality.
22. The responsible authorities should require all those with any practical involvement in laboratory animal work to take accredited courses, with emphasis on the Three Rs and the legal obligation to use replacement alternative methods wherever possible.
23. School, college and undergraduate university students should not be forced to conduct regulated procedures, but should be provided with alternative options.
The participants in the 3rd World Congress on Alternatives and Animal Use in the Life Sciences endorse the principles put forward by Russell and Burch in 1959 (1), and reaffirm that only humane science is good science, which is best achieved by vigorous promotion and application of the Three Rs (reduction, refinement and replacement alternatives).
The only acceptable animal experiment is one which has been approved by an ethical review committee, uses the smallest possible number of animals, and causes the least possible suffering which is consistent with the achievement of its scientific purpose.
The Three Rs should be seen as a unifying concept, and as a challenge and an opportunity for reaping benefits of every kind ? scientific, economic and humanitarian.
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