Legislative regulation and ethical governance of medical research in different European Union countries
Legislative regulation and ethical governance of medical research in different European Union countries
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DOI：
10.1136/medethics-2012-101282
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发表时间：
2014-06-01
影响因子：
4.1
通讯作者：
Hemminki, Elina
中科院分区：
文献类型：
--
作者：
Veerus, Piret;Lexchin, Joel;Hemminki, Elina
目的了解欧盟（EU）对不同类型医学研究监管的异同。方法通过网络检索2009年9月至2011年1月的数据。关于预定主题的注释被系统地从网页上删除。结果在一些国家，监管立法仅适用于药物和医疗器械的临床试验;在另一些国家，各种类型的研究也受到监管，但监管法律与试验法律不同;在许多国家，一些研究领域根本不受立法控制。从法律的观点来看，很少有国家对所有医学研究都采取类似的处理方式。一个国家的研究伦理委员会（REC）数量从1个到264个不等。它们的责任领域、工作原则和授予研究许可的时间长短以及获得弱势群体知情同意的规则各不相同。在10个欧盟国家，有没有上诉机制后，一个REC的负面决定。REC不负责任何组织在5个EU countries.Conclusions有必要进行一个根本性的辩论，关于是否和哪些种类的变化是必要的，为进一步协调医学研究治理在欧盟和如何跨国医学研究可以促进在未来。
Objective To obtain information about the similarities and differences in regulating different types of medical research in the European Union (EU).Methods Web searches were performed from September 2009 to January 2011. Notes on predetermined topics were systematically taken down from the web pages. The analysis relied only on documents and reports available on the web, reflecting the situation at the end of 2010.Results In several countries, regulatory legislation applied only to clinical trials on drugs and medical devices, in other states various types of research were also regulated but by laws different from those concerning trials, and in many countries, some research areas were not controlled by legislation at all. In very few countries was all medical research handled similarly from a legal point of view. The number of research ethics committees (RECs) in a single country varied from one to 264. Their areas of responsibility, working principles and length of time to grant research permission varied as well as the rules for obtaining informed consent from vulnerable groups. In 10 EU countries, there was no appeal mechanism after a negative decision by an REC. The RECs were not accountable to any organisation in five EU countries.Conclusions There is a need for a fundamental debate regarding whether and which kinds of changes are needed for the further harmonisation of medical research governance in the EU and how cross-country medical research could be facilitated in the future.