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首页> 外文期刊>Journal of Academic Ethics >Regulating Human Participants Protection in Medical Research and the Accreditation of Medical Research Ethics Committees in the Netherlands
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Regulating Human Participants Protection in Medical Research and the Accreditation of Medical Research Ethics Committees in the Netherlands

机译：规范荷兰医学研究中的参与者保护并认可荷兰医学研究伦理委员会

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摘要

The review system on research with human participants in the Netherlands is characterised as a decentralised controlled and integrated peer review system. It consists of an independent governmental body, the Central Committee on Research Involving Human Subjects (or Central Committee), which regulates the review of research proposals by accredited Medical Research Ethics Committees (MRECs). The legal basis was founded in 1999 with the Medical Research Involving Human Subjects Act. The review system is a decentralised arrangement since most research proposals are reviewed by the 30 accredited MRECs in the country. It is a controlled system in which the Central Committee is responsible for the accreditation and oversight of the MRECs and can make legally binding directives for these committees. The assessment of research proposals is an integrated peer review process in which all documents of the research file are reviewed by experts in one committee only. A small number of research proposals are assessed by the Central Committee and not by accredited MRECs. These proposals are on specific research categories such as gene therapy, cell therapy and embryo research. The review of research with surplus human embryos is regulated separately in the Embryos Act. The Central Committee provides support to the accredited MRECs and to researchers and sponsors. It is currently developing an internet portal to reduce the bureaucracy and make the review process more efficient and transparent. The Central Committee stimulates confidence on medical research in society by providing a public trial registry with core data on reviewed research proposals.
机译：荷兰的人类参与研究审查制度的特点是分散控制和整合的同行审查制度。它由一个独立的政府机构，即涉及人类研究的中央研究委员会（或中央委员会）组成，该委员会负责管理经认可的医学研究伦理委员会（MRECs）对研究计划的审查。法律依据是1999年《涉及人体研究的医学研究法》建立的。审查制度是一种分散式的安排，因为大多数研究建议书均由该国30家获得认可的MREC进行审查。这是一个受控制的系统，由中央委员会负责对MREC的认证和监督，并可以为这些委员会制定具有法律约束力的指示。研究计划书的评估是一个集成的同行评审过程，其中研究文件的所有文件仅由一个委员会的专家进行评审。少数研究计划是由中央委员会评估的，而不是由经认可的MREC评估的。这些建议涉及特定的研究类别，例如基因疗法，细胞疗法和胚胎研究。 《胚胎法》单独规定了对剩余人类胚胎研究的审查。中央委员会为经认可的MREC以及研究人员和赞助者提供支持。目前，它正在开发一个互联网门户网站，以减少官僚作风并使审查过程更加有效和透明。中央委员会通过向公共试验注册中心提供有关已审查研究建议的核心数据，激发了人们对医学研究的信心。

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