Balls M
European Centre for the Validation of Alternative Methods (ECVAM), JRC Environment Institute, Ispra (Va), Italy.
Lab Anim. 1994 Jul;28(3):193-211. doi: 10.1258/002367794780681714.
The origins of the concept of replacement alternatives in the 1950s, and the impact of societal changes in the 1960s and 1970s, resulting in stricter controls on animal experimentation from the 1980s, based on the Three Rs of Russell and Burch (reduction, refinement and replacement), are reviewed. The range of replacement alternative methods, and some of the ethical issues they raise, and progress toward their incorporation into fundamental and applied research, education, and, in particular, toxicity testing, are discussed. It is concluded that much greater effort should be put into overcoming the barriers to the acceptance of replacement alternatives, which currently limit the contributions they have to make toward greater humanity and better biomedical science. Particular emphasis is place on the need to ensure that the validation of non-animal tests (for their reliability and relevance for specific purposes) is conducted fairly and objectively, and that greater heed is paid to the warning of Russell and Burch about the high fidelity fallacy and the questionable relevance of data provided by animal models for human hazard and risk assessment. Finally, the role of ECVAM in the promotion of valid replacement alternatives, and the opportunities afforded by the Sixth Amendment to the EC Cosmetics Directive, are discussed.
回顾了20世纪50年代替代方法概念的起源，以及20世纪60年代和70年代社会变革的影响，这些变革导致自20世纪80年代起基于罗素和伯奇的“3R”原则（减少、优化和替代）对动物实验实施更严格的控制。讨论了替代方法的范围、它们引发的一些伦理问题，以及将其纳入基础研究、应用研究、教育尤其是毒性测试方面的进展。得出的结论是，应付出更大努力来克服接受替代方法的障碍，这些障碍目前限制了它们对实现更大人道性和更好生物医学科学所做的贡献。特别强调需要确保对非动物测试（针对其可靠性和对特定目的的相关性）进行公平、客观的验证，并且要更加重视罗素和伯奇关于高保真谬误以及动物模型提供的数据对人类危害和风险评估的可疑相关性的警告。最后，讨论了欧洲替代方法验证中心（ECVAM）在推广有效替代方法方面的作用，以及欧盟化妆品指令第六修正案带来的机遇。
