Abstract: Conducting “Harm-Benefit Analysis” before animal experiments has become an internationally recognized prerequisite for the use of animals in research and testing. The use of animals for research should be ethically evaluated based on the understanding that the use will provide significant new knowledge facilitating relevant benefits and no unnecessary harm imposed on the animals. In China, the “ Laboratory animal—Guideline for ethical review of animal welfare ” ( GB / T 35892—2018 ) also presents corresponding requirements in the section on the “ principle of balance of interests” . It explicitly mandates filling out the “Experimental Animal Welfare Ethical Review Form” appendix with a “ summary of potential harms and benefits ” . However, both local and international institutions may face the challenge in implementing the harm and benefit analysis. This paper is based on the report from the American Association of Laboratory Animal Science-Federation of European Laboratory Animal Science Association ( AALAS-FELASA ) expert working group on Harm-benefit analysis. It introduces the framework and approach for HBA, and its concepts, two models ( discourse model and metric model) of harm-benefit analysis, how to utilize the harm / benefit assessment framework system for analysis, and current focal points for discussions. The aim of this paper is to provide guidance for local institutions or organizations on evaluating the ethical use of animals in research and testing by the use of harm-benefit analyses. 

Key words: experimental animal, welfare and ethical review, Harm-benefit analysis

摘要： 在动物实验开展前进行“伤害—利益分析”已成为国际惯例。 在我国,国家标准《 实验动物 福利伦理审查指 南》 (GB / T 35892-2018)在“利益平衡性原则”部分也提出相应要求,并在其附录《实验动物福利伦理审查表》 中明 确要求填写“利害分析的小结” 。 但如何开展“伤害—利益分析” 是国内外同行面临的共同挑战。 本文以美国实验 动物科学协会-欧洲实验动物科学协会联合会( AALAS-FELASA) 专家工作组关于“ 伤害-利益分析” 的报告为基 础,从“伤害—利益分析”的发展历程、基本概念、话语模式( discourse model) 和度量模式( metric model) 两种常见模 式、如何运用伤害 / 受益评估框架系统进行分析以及目前讨论的焦点等多方面对其进行介绍,以期为国内同行开展 “伤害—利益分析”工作提供借鉴。

关键词: 动物实验, 福利伦理审查, 伤害—利益分析