Ethics and law of medical research—Drug clinical trials

Q3 Medicine

Ethics, Medicine and Public Health Pub Date : 2025-01-01 DOI:10.1016/j.jemep.2025.101102

A.M. Duguet

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Abstract

Depending on the country, medical research is regulated by law or by international ethical guidelines. Clinical drug trials are highly regulated, to ensure that new medicines present no danger to users. A very strict procedure is organised, the various stages of which are supervised and controlled by the health authorities (FDA in the USA, EMA in Europe, ANSM in France).

Clinical trials are essential to test the efficacy of drugs on humans, and to ascertain whether the anticipated benefits outweigh the potential undesirable side effects of the tested product.

In this article, after a brief review of the historical context of medical research, the first part presents the legal framework for the protection of research subjects in France. Since Law 88-1138, drug trials have been carried out in accordance with the provisions of this law (regularly updated since then), which set up committees for the protection of individuals (equivalent to RECs, Research Ethics Committees, in other countries). The committee’s favourable opinion is now the essential prerequisite, in addition to authorization from the ANSM (French national drug agency), for the trial to begin. Other legislation applies to these trials, such as data protection (GDPR), legislation on collections of biological samples and, depending on the case, the use of genetic biobanks.

The second section looks at ethical aspects, respect for patients' rights, informed consent and safeguards for vulnerable people, with a particular focus on social vulnerability in developing countries.

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医学研究的伦理与法律-药物临床试验

根据不同的国家，医学研究受法律或国际伦理准则的管制。临床药物试验受到严格监管，以确保新药不会对使用者构成危险。组织了非常严格的程序，其各个阶段由卫生当局（美国的FDA，欧洲的EMA，法国的ANSM）监督和控制。临床试验对于测试药物对人体的功效，以及确定预期的益处是否超过测试产品潜在的不良副作用至关重要。在本文中，在简要回顾了医学研究的历史背景之后，第一部分介绍了法国保护研究对象的法律框架。自第88-1138号法律以来，根据该法的规定（自那时起定期更新）进行了药物试验，该法设立了保护个人的委员会（相当于其他国家的研究伦理委员会）。除了法国国家药品管理局（ANSM）的授权外，委员会的赞成意见现在是开始试验的必要先决条件。其他立法适用于这些试验，例如数据保护（GDPR），关于生物样本收集的立法，以及根据具体情况使用遗传生物库。第二部分着眼于伦理方面、对患者权利的尊重、知情同意和对弱势群体的保障，特别关注发展中国家的社会脆弱性。

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

Ethics, Medicine and Public Health Medicine-Health Policy

CiteScore

2.20

自引率

0.00%

发文量

107

审稿时长

42 days

期刊介绍： This review aims to compare approaches to medical ethics and bioethics in two forms, Anglo-Saxon (Ethics, Medicine and Public Health) and French (Ethique, Médecine et Politiques Publiques). Thus, in their native languages, the authors will present research on the legitimacy of the practice and appreciation of the consequences of acts towards patients as compared to the limits acceptable by the community, as illustrated by the democratic debate.