北欧国家基于注册库的研究的伦理问题。
Ethical aspects of registry-based research in the Nordic countries.
作者信息
Ludvigsson Jonas F, Håberg Siri E, Knudsen Gun Peggy, Lafolie Pierre, Zoega Helga, Sarkkola Catharina, von Kraemer Stephanie, Weiderpass Elisabete, Nørgaard Mette
机构信息
Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden ; Department of Pediatrics, Örebro University Hospital, Örebro, Sweden.
Norwegian Institute of Public Health, Oslo, Norway.
出版信息
Clin Epidemiol. 2015 Nov 23;7:491-508. doi: 10.2147/CLEP.S90589. eCollection 2015.
National health care registries in the Nordic countries share many attributes, but different legal and ethical frameworks represent a challenge to promoting effective joint research. Internationally, there is a lack of knowledge about how ethical matters are considered in Nordic registry-based research, and a lack of knowledge about how Nordic ethics committees operate and what is needed to obtain an approval. In this paper, we review ethical aspects of registry-based research, the legal framework, the role of ethics review boards in the Nordic countries, and the structure of the ethics application. We discuss the role of informed consent in registry-based research and how to safeguard the integrity of study participants, including vulnerable subjects and children. Our review also provides information on the different government agencies that contribute registry-based data, and a list of the major health registries in Denmark, Finland, Iceland, Norway, and Sweden. Both ethical values and conditions for registry-based research are similar in the Nordic countries. While Denmark, Finland, Iceland, Norway, and Sweden have chosen different legal frameworks, these differences can be resolved through mutual recognition of ethical applications and by harmonizing the different systems, likely leading to increased collaboration and enlarged studies.
北欧国家的国家医疗保健登记处有许多共同特点,但不同的法律和伦理框架对促进有效的联合研究构成了挑战。在国际上,人们缺乏对北欧基于登记处的研究中如何考虑伦理问题的了解,也缺乏对北欧伦理委员会如何运作以及获得批准需要什么的了解。在本文中,我们回顾了基于登记处的研究的伦理方面、法律框架、北欧国家伦理审查委员会的作用以及伦理申请的结构。我们讨论了知情同意在基于登记处的研究中的作用,以及如何保护研究参与者的完整性,包括弱势群体和儿童。我们的综述还提供了有关提供基于登记处数据的不同政府机构的信息,以及丹麦、芬兰、冰岛、挪威和瑞典主要健康登记处的列表。北欧国家基于登记处的研究的伦理价值观和条件相似。虽然丹麦、芬兰、冰岛、挪威和瑞典选择了不同的法律框架,但这些差异可以通过相互承认伦理申请和协调不同系统来解决,这可能会促进合作并扩大研究规模。
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