Differences in the EU regulations for biomedical research on humans and animals: an ethical analysis.

IF 2.3 2区哲学 Q1 ETHICS

Medicine Health Care and Philosophy Pub Date : 2025-05-08 DOI:10.1007/s11019-025-10270-x

Katarzyna Żebrowska

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Abstract

The European Union regulations for research on human and nonhuman participants differ significantly. This study aims to present a thorough analysis of these differences in the field of biomedical research. The study consists of a review of regulations issued by the European Union and Council of Europe institutions, supported by two UNESCO documents. The regulations are compared between three types of research: on humans, on nonhuman animals, and research using human embryos, within five categories: (1) Justification and scope of the regulations; (2) Inclusion criteria; (3) Consent procedures; (4) Participants' welfare; and (5) Values in research. In each category, significant differences between regulations for humans and animals are presented. These differences can be ethically analyzed in terms of values pursued in the protection of participants (intrinsic value of humans vs. value of animal welfare) and hierarchies of values in regulations (priority of participant-centered values in research on humans vs. priority of research-centered values in research on animals). Since the current protection of animals in biomedical research based on the '3Rs' principles seems not adequate, two possible ways forward are analyzed: replacement of all animals in research with other methods and a shift to research on companion animals.

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欧盟对人类和动物生物医学研究规定的差异：伦理分析。

欧盟对人类和非人类参与者的研究规定有很大不同。本研究旨在对生物医学研究领域的这些差异进行全面分析。这项研究包括审查欧洲联盟和欧洲理事会各机构发布的条例，并得到教科文组织两份文件的支持。对人类研究、非人类动物研究和利用人类胚胎研究三种研究类型进行了比较，分为五类：(1)法规的依据和范围；(2)入选标准；(3)同意程序；(4)参与者福利；(5)研究价值。在每个类别中，人类和动物的法规之间存在显著差异。这些差异可以从保护参与者所追求的价值观（人类的内在价值与动物福利的价值）和法规中的价值观等级（人类研究中以参与者为中心的价值观优先与动物研究中以研究为中心的价值观优先）两方面进行伦理分析。鉴于目前基于“3r”原则的生物医学研究中对动物的保护似乎不够充分，本文分析了两种可能的前进道路：用其他方法替代所有动物研究和转向伴侣动物研究。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Medicine Health Care and Philosophy Multiple-

CiteScore

4.30

自引率

4.80%

发文量

期刊介绍： Medicine, Health Care and Philosophy: A European Journal is the official journal of the European Society for Philosophy of Medicine and Health Care. It provides a forum for international exchange of research data, theories, reports and opinions in bioethics and philosophy of medicine. The journal promotes interdisciplinary studies, and stimulates philosophical analysis centered on a common object of reflection: health care, the human effort to deal with disease, illness, death as well as health, well-being and life. Particular attention is paid to developing contributions from all European countries, and to making accessible scientific work and reports on the practice of health care ethics, from all nations, cultures and language areas in Europe.