[A comparative study of autonomous communities' legislation on accreditation of Research Ethics Committees as part of the principle of good governance].

Revista espanola de salud publica Pub Date : 2025-01-27
Berta Martín Jiménez, Miguel Ángel Ramiro Avilés
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Abstract

Objective: Following a consultation received at the Legal Clinic of the University of Alcalá, it was necessary to determine whether or not a Research Ethics Committee was accredited. This led us to consider the need to determine whether the autonomous communities had reformed their legislation to establish the accreditation procedure for Research Ethics Committees, therefore adapting their legislation to Act 14/2007.

Methods: An analysis of the european, national and regional legislation regulating biomedical research in Spain was carried out to determine what the accreditation procedure for Research Ethics Committees was like in each autonomous community and whether it conformed to the provisions of Act 14/2007.

Results: Most of the autonomous communities had not reformed their legislation to establish the accreditation procedure for Research Ethics Committees, especially if they were part of universities, which could affect the principle of good administration.

Conclusions: The principle of good administration could be affected by the fact that most of the autonomous communities do not adequately regulate the procedure for setting up and accrediting Research Ethics Committees, especially those linked to universities, which undermines the guarantees that these bodies provide for clinical biomedical research and generates legal uncertainty.

[作为善治原则一部分的自治区科研伦理委员会认证立法的比较研究]。
目的:在alcal大学法律诊所接受咨询后,有必要确定研究伦理委员会是否被认可。这促使我们考虑是否有必要确定自治区是否已经改革了他们的立法,以建立研究伦理委员会的认证程序,从而使他们的立法适应第14/2007号法案。方法:分析了西班牙规范生物医学研究的欧洲、国家和地区立法,以确定每个自治区的研究伦理委员会认证程序是什么样的,以及它是否符合第14/2007号法案的规定。结果:大多数自治区尚未对其立法进行改革,以建立研究伦理委员会的认证程序,特别是如果他们是大学的一部分,这可能会影响良好的管理原则。结论:良好管理的原则可能受到以下事实的影响:大多数自治区没有充分规范设立和认可研究伦理委员会的程序,特别是那些与大学有关的委员会,这破坏了这些机构为临床生物医学研究提供的保障,并产生法律上的不确定性。
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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