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Theme C Posters: Policy and EthicsC1: Policymakers Support Non-animal Alternative Methods: An Overview of New Laws in the United States Scientists assert that sound science must drive sound policy. However, policymakers must first support innovative science, including funding research, development, and validation of non-animal, alternative test methods and, in turn, demonstrate the will to require the use of valid, more humane test methods. Since 2000, the United States Congress and the State of California have passed new laws to further the goal of acceptance of scientifically valid, non-animal, alternative test methods by federal and state regulators and the regulated industries. In addition, for the first time ever, the Congress appropriated funds for the Environmental Protection Agency to research, develop, and validate these test methods. The specific mandates included in the Interagency Coordinating Committee for the Validation of Alternative Methods Authorization Act, Public Law 106-545, and the California alternatives law are pragmatic approaches to endorsing the premise that sound science should drive policy, while ensuring that policymakers also challenge the current scientific paradigm for making regulatory decisions. C2: Welfare Implications of Different Approaches to Investigate Gene Function and Regulation FRAME has undertaken several initiatives to investigate the positive and negative impact of various gene functions and regulation methodologies. FRAME has commented on a UK mutagenesis study that involves the generation of large numbers of mouse phenotypes, some of which are detrimental to animal welfare. In another initiative, FRAME has investigated the possible implications for animal welfare of microarray (gene chip) technology in scientific research. FRAME has also been involved with the UK-based rodent refinement working group, which is considering refinements in the various techniques used to produce and maintain GM rodents. A report is being completed to enable research establishments to minimize animal wastage, improve the efficiency of generating genetically modified mice, and improve their welfare. The outcome of these studies will be presented in detail. C3: The Alternatives Toxicological Group in Cuba--Developments and Perspectives The Three R's principle was defined by Russell and Burch in 1959, and it has continued to develop, with especially significant vigor in the 90's. Today the Three R's concepts are widely recognized, and people are mindful that an ever-increasing number of scientifically valid alternatives are now available. Cuba's scientific community endeavors to implement the most novel and useful procedures that arise, and toward that goal, The Alternatives Toxicological Group was formed in 1996. The Group's fundamental objective is the introduction of the Three R's to scientific investigations and teaching. This poster will outline the activities of this group in diverse spheres, such as: building relations among the investigators in this branch; establishing technical capacity to allow the substitution of the Draize Ocular Irritation Test with red blood cells or the Hen's Embryo (Het Cam) or other tests, such as Photohemolisis, to study the phototoxicity of chemicals. The establishment of Guideline 423, Acute Toxicity Class method with a view to the future substitution of the Technical Guide 401, or the introduction at the University the studies of Alternative Toxicology. Cuban professionals also participated in International Events, Bologna (1999). These and other activities of the group will be detailed in this poster, and future plans will be outlined, including the implementation of procedures that are inside the protocols of the INVITTOX or in the Organization for the Cooperation and Economic Development (OECD), as the study of Phototoxicity with the employment of the cells 3T3 of mouse fibroblast, and the substitution of the technical Guide 401 with the norms FDP (Fixed Dose Procedure) and Up and Down. Everything contributes to the development of an awareness of the need for change and readies our country to adapt to the Three R's principles. C4: Iacuc's and Ethics Any research project involving animals must be assessed by an animal care committee (IACUC) regarding ethics. Hence, ethics appears to be a major component of animal research and evaluation. However, no systematic study has been undertaken to determine the ethical principles underlying IACUCs' evaluation of animal research projects. In the present study, IACUC's were observed for one year and comments were analyzed. Results revealed first, that IACUCs' ethical evaluation was based on respect for animal life, beneficence, and justice. Second, most of the comments could be categorized as technical, scientific, and political, whereas only a few comments could be categorized as ethical (as defined by the Three R's). Further analysis showed that these three categories had strong repercussions on the ethical valuation made by IACUC's. Such results suggest that a multidimensional ethical framework underlies IACUCs' decisions. Semi-structured interviews were also carried out with members of IACUC's. These interviews revealed that the negative bias against animal experimentation strongly influenced IACUC members' implicit framework regarding the role of animals in research. C5: A Handbook for Lay Members of Local Ethical Review Processes In many countries, regulatory controls on the use of animals in research and testing incorporate lay perspectives. The value of extending consultation in this way is widely agreed. Lay people can ask challenging questions from impartial, non-technical perspectives and can provide a measure of 'public' input into decisions. However, to receive the benefit of their input, they must be made to feel confident and supported in their roles. Widespread lay involvement in ethical review of animal research in Britain began in April 1999, with the introduction of local ethical review processes (ERP's) in addition to central licensing. Individual lay members have subsequently identified a variety of needs for support, and this Handbook has been prepared in response. It includes:
Although the Handbook has been written for lay readers, it should be useful for anyone who participates in ethical review. Copies can be obtained from Research Animals Department, RSPCA, Wilberforce Way, Southwater, Horsham, West Sussex RH13 7WN, England. C6: Implementation of EU Directive on Animal Experimentation at the University of Barcelona: Role of the Ethical Committee The University of Barcelona has five Animal Experimentation Units, four of them located at the Health Sciences Area and one at the Faculty of Biology. Each Unit is headed by a qualified individual who is responsible for animal welfare. In addition, he/she gives advice to research groups about the use of alternative methods while contributing to the reduction and refinement of the procedures. Implementation of EU Directive on Animal Experimentation (EEC 806/609) in the Catalonia Autonomous Community (Spain) enabled the University of Barcelona to establish the Ethical Committee for Animal Experimentation in 1998. This committee is chaired by the Research Vice-Chancellor and consists of 13 members, including specialists in animal welfare, academics representing the researchers, the Head of the Quality Assurance Unit, and an external consultant. The structure and the working system of the ethical committee of the University of Barcelona will be explained in detail. C7: Xenotransplantation--Costs Versus Benefits A few years ago, it was prognosticated that the transplantation of animal organs into human patients would be almost a routine procedure in the short term. Meanwhile, first cross-species barriers have been overcome by genetical manipulation of source animals that results in a reduction of hyperacute rejection of xenografts. However, it is still unknown if animal organs are able to fulfil the physiological functions of the original organs in the human recipients. There are increasing concerns that xenotransplantation bears the risk of virus transfection between species. These and other important open questions narrow the vision of using animals as an unlimited available source of organs for humans, significantly. On the other hand, this research field involves an extensive use of animals in experiments. For example, pigs are genetically manipulated, primates are used to measure the survival time after receiving a xenograft, and rodents are used to study rejection mechanisms. According to schemes for the evaluation of animal suffering, it can be stated that the suffering in these experiments range from moderate to substantial. Therefore, it can be concluded that the questionable benefits of xenotransplantation research cannot justify the use and the involved suffering of laboratory animals. C8: The Work of Schweizer Tierschutz Sts (Swiss Animal Protection, Sap) in the Area of Laboratory Animal Welfare and Experimentation Swiss Animal Protection (SAP) is the largest, national animal welfare organization of Switzerland. We aim at reduction and refinement of animal use in experimentation with the ultimate goal of a complete replacement of all animals currently used in testing and experimentation. The SAP uses lobbying and political campaigns, as well as educational tools, to raise public awareness of the problem of animal use in experimentation. The SAP publishes brochures on animal experimentation and alternative methods, while also raising national petitions for improved animal welfare laws and collaborating with the ethical committee of the federal veterinary office. Every year, SAP also organizes a symposium on animal experimentation, a national platform on which scientists, animal welfare institutions, representatives of the pharmacological industry, federal officials, and the press meet. Issues of animal use in science such as: ethical issues of animal use in science, animal welfare legislation and its enforcement, and continuing education of animal technicians and experimenters are addressed and discussed. C9: History of The Humane Society of the United States' Work Related to Animal Research The Humane Society of the United States (HSUS) was founded in 1954. In its early years, the organization opposed the research community's practice of procuring dogs and cats from animal shelters. In the 1960s, an HSUS investigation of animal dealers led to an article in Life Magazine, which spurred passage of the Animal Welfare Act (AWA), the nation's primary law governing animal research. In the 1970s, The HSUS adopted the Three R's (replacement, reduction, and refinement) as the core of its policy on animal research. In the 1980s, The HSUS helped secure passage of the 1985 amendments to the AWA (which established oversight committees and mandated attention to alternative methods). In the 1990s, The HSUS established the Russell & Burch Award for excellence in promoting alternative methods, helped pass legislation establishing the Interagency Coordinating Committee on the Validation of Alternative Methods, and launched its Pain & Distress Initiative to eliminate suffering from animal research. The HSUS recently published an authoritative monograph on dissection and alternatives. The HSUS recently published an authoritative monograph on dissection and alternatives, entitled The Use of Animals in Higher Education: Problems, Alternatives, and Recommendations. For further information, or to request a copy, contact Animal Research Issues, The HSUS, 2100 L Street, NW, Washington, DC 20037, USA. C10: The "Problem R"--Replacement Despite commitments by government agencies in North America to embrace the Three R's in regulatory toxicology, there continues to be 1) a relative dearth of government-financed research to develop and validate non-animal testing methods, 2) a protracted delay in the regulatory acceptance of replacement methods that have been validated and/or adopted in other jurisdictions, and 3) a failure to delete in vivo test guidelines and data requirements in a timely manner following the validation of replacement methods. Regulatory agencies' ambivalence or outright resistance to replacement methods results in a significant amount of unnecessary animal testing, as is evident from numerous test plans proposed under the US Environmental Protection Agency's High-Production Volume chemical-testing program. Opportunities for the immediate replacement and/or deletion of animal tests are discussed, as are priority targets for research funding to accelerate the development and/or validation of promising non-animal tests and testing strategies. C11: The Regulation of Animal Experimentation in Lithuania The Lithuanian Laboratory Animal Science Association (organized in 1996) has recently focused effectively on promoting the Three R's. State laws and regulations now affect the use of animals in research. These include the following documents: Lithuanian Republic Law on Animal Care, Rearing, and Use; Veterinary Regulations on Breeding, Handling, and Transportation of Laboratory Animals; and Requirements for the Use of Laboratory Animals in Scientific Experiments. From a legal point of view, the important step was the establishment of the Ethics Commission at the Lithuanian State Veterinary Service in 1999. Its members have prepared requirements for the evaluation of research protocols. The Ethics Commission independently reviews the conduct of studies to ensure that all ethical obligations and issues are satisfactorily met. Based on the conclusions of the Ethics Commission, the State Veterinary Service decides whether or not to issue licenses to perform experiments on animals. In general, animal experimentation is controlled in Lithuania. C12: Animal Experiments Outside the Laboratory Door: Different Norms and Values? As in most countries, animal experiments are regulated in (laboratory) animal experimentation acts, which are rooted in the idea of humane use of laboratory animals according the Three R's of Russell & Burch. The detailed provisions implicitly refer to the paradigm of the standard lab animal in a standard cage. However, a lot of scientific animal research is done outside the laboratory by researchers with similar education but without similar regulation. Biologists investigate animals in relation to zoo practices and nature conservation; veterinarians perform pharma tests on farm animals and pets. This poster will present the methodology and results of an inventory of 28 persons with various interests related to the topic. One of the conclusions is that the definition of animal experiment in a legal sense is applicable to commercial tests on farm animals and pets. Researchers in the fields of zoo's and nature conservation tend to join under an equal regulation. The key role of moral concepts like "natural" and "suffering" is addressed.
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