Jörgensen Svea, Lindsjö Johan, Weber Elin M, Röcklinsberg Helena
Department of Animal Environment and Health (HMH), Swedish University of Agricultural Sciences, P.O. Box 7068, 750 07 Uppsala, Sweden.
Department of Animal Environment and Health (HMH), Swedish University of Agricultural Sciences, P.O. Box 234, 532 23 Skara, Sweden.
Animals (Basel). 2021 Mar 5;11(3):708. doi: 10.3390/ani11030708.
The use of animals in research entails a range of societal and ethical issues, and there is widespread consensus that animals are to be kept safe from unnecessary suffering. Therefore, harm done to animals in the name of research has to be carefully regulated and undergo ethical review for approval. Since 2013, this has been enforced within the European Union through Directive 2010/63/EU on the protection of animals used for scientific purposes. However, critics argue that the directive and its implementation by member states do not properly consider all aspects of animal welfare, which risks causing unnecessary animal suffering and decreased public trust in the system. In this pilot study, the ethical review process in Sweden was investigated to determine whether or not the system is in fact flawed, and if so, what may be the underlying cause of this. Through in-depth analysis of 18 applications and decisions of ethical reviews, we found that there are recurring problems within the ethical review process in Sweden. Discrepancies between demands set by legislation and the structure of the application form lead to submitted information being incomplete by design. In turn, this prevents the Animal Ethics Committees from being able to fulfill their task of performing a harm-benefit analysis and ensuring Replacement, Reduction, and Refinement (the 3Rs). Results further showed that a significant number of applications failed to meet legal requirements regarding content. Similarly, no Animal Ethics Committee decision contained any account of evaluation of the 3Rs and a majority failed to include harm-benefit analysis as required by law. Hence, the welfare may be at risk, as well as the fulfilling of the legal requirement of only approving "necessary suffering". We argue that the results show an unacceptably low level of compliance in the investigated applications with the legal requirement of performing both a harm-benefit analysis and applying the 3Rs within the decision-making process, and that by implication, public insight through transparency is not achieved in these cases. In order to improve the ethical review, the process needs to be restructured, and the legal demands put on both the applicants and the Animal Ethics Committees as such need to be made clear. We further propose a number of improvements, including a revision of the application form. We also encourage future research to further investigate and address issues unearthed by this pilot study.
在研究中使用动物涉及一系列社会和伦理问题，人们普遍认为应保护动物免受不必要的痛苦。因此，以研究之名对动物造成的伤害必须受到严格监管，并经过伦理审查以获得批准。自2013年以来，欧盟通过关于保护用于科学目的的动物的第2010/63/EU号指令实施了这一规定。然而，批评者认为该指令及其成员国的实施并未充分考虑动物福利的所有方面，这有可能导致动物遭受不必要的痛苦，并降低公众对该体系的信任。在这项试点研究中，对瑞典的伦理审查过程进行了调查，以确定该体系是否存在缺陷，如果存在，其潜在原因可能是什么。通过对18份伦理审查申请和决定的深入分析，我们发现瑞典伦理审查过程中存在一些反复出现的问题。立法规定的要求与申请表的结构之间存在差异，导致提交的信息在设计上不完整。这反过来又使动物伦理委员会无法履行其进行危害-利益分析并确保替代、减少和优化（3R原则）的任务。结果还表明，大量申请在内容上不符合法律要求。同样，没有一个动物伦理委员会的决定包含对3R原则的评估，大多数决定也没有按照法律要求进行危害-利益分析。因此，动物福利可能会受到威胁，同时也无法满足仅批准“必要痛苦”的法律要求。我们认为，结果表明在所调查的申请中，在决策过程中进行危害-利益分析和应用3R原则的法律要求的合规水平低得令人无法接受，并且在这些情况下，通过透明度实现公众监督也未达成。为了改进伦理审查，需要对审查过程进行重组，并明确对申请人和动物伦理委员会的法律要求。我们还提出了一些改进建议，包括修订申请表。我们鼓励未来的研究进一步调查并解决这项试点研究中发现的问题。
