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[转型中的欧洲伦理委员会:新要求带来的挑战]

[European ethics committees in transition: challenges of new requirements].

作者信息

Lanzerath Dirk

机构信息

Deutsches Referenzzentrum für Ethik in den Biowissenschaften (DRZE), Universität Bonn, Bonner Talweg 57, 53113, Bonn, Deutschland.

出版信息

Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2019 Jun;62(6):697-705. doi: 10.1007/s00103-019-02952-8.

Abstract

Guided by the example of ethics committees in medicine, the ethical review system of research projects in Europe is increasingly expanding to other disciplines such as psychology, the social sciences, and engineering, especially when human subjects are directly involved or personal data are collected. However, ethical reviews are not uniformly regulated in most European countries.With the new EU Regulation No. 536/2014, which is expected to come into force in 2020, it is intended to standardize the work of medical research ethics committees for clinical trials. Clear deadlines and the use of a central electronic EU portal are also given in order to accelerate the approval process for economic reasons. Member states are left free in terms of the scope of the ethical review, but this would run counter to unification and could lead some to choose a test model that excludes the evaluation of the methodology and risks of a study and thus contributes less to the protection of the participants.The European Research Ethics Committees have been working together since 2005 within the European Network of Research Ethics Committees (EUREC). For a discussion on the impact and implementation of the new EU Regulation and on the development of the EU portal, EUREC has provided a forum for a qualified debate.In this period of change, it is not clear yet which direction the ethics committees will develop. Professional management can have a positive impact on the quality of the ethics review. However, the marginalization inherent in the EU Regulation is counteracting the increasing evaluation of nonmedical research projects and adequate protection of subjects.

摘要

以医学伦理委员会为范例,欧洲研究项目的伦理审查体系正日益扩展至其他学科,如心理学、社会科学和工程学,尤其是在直接涉及人类受试者或收集个人数据的情况下。然而,在大多数欧洲国家,伦理审查并未得到统一规范。随着预计于2020年生效的欧盟第536/2014号新法规的出台,旨在规范医学研究伦理委员会在临床试验方面的工作。为了出于经济原因加快审批流程,还规定了明确的期限并使用欧盟中央电子门户网站。成员国在伦理审查范围方面享有自主权,但这可能与统一相悖,并可能导致一些国家选择一种排除对研究方法和风险进行评估的测试模式,从而对参与者保护的贡献较小。自2005年以来,欧洲研究伦理委员会一直在欧洲研究伦理委员会网络(EUREC)内开展合作。为了就新欧盟法规的影响和实施以及欧盟门户网站的发展进行讨论,EUREC提供了一个进行高质量辩论的论坛。在这个变革时期,伦理委员会将朝哪个方向发展尚不明朗。专业管理可能会对伦理审查的质量产生积极影响。然而,欧盟法规中固有的边缘化正在抵消对非医学研究项目日益增加的评估以及对受试者的充分保护。

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