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[评估涉及人类受试者的医学研究的欢迎指南]

[A welcome guide for evaluating medical research involving human subjects].

作者信息

Borst-Eilers E

出版信息

Ned Tijdschr Geneeskd. 2003 May 10;147(19):898-900.

Abstract

In 1999, the Dutch Medical Research Involving Human Subjects Act came into force. The principal aim of this Act is to provide protection for human subjects who take part in medical research. Medical research involving human subjects may only be carried out after it has been approved by a recognised medical ethics committee. A central committee (Dutch acronym: CCMO) regulates the recognition of the local medical ethics committees and monitors their performance. For some types of research the protocol has to be reviewed by the CCMO itself. These are: non-therapeutic research involving children and mentally incompetent patients and research on gene therapy, xenotransplantation and embryos. The CCMO has recently published a guide for the local medical ethics committees. It presents an excellent overview of all the legal and practical aspects of the work of medical ethics committees. The guide is highly recommended.

摘要

1999年,荷兰《涉及人类受试者的医学研究法》生效。该法案的主要目的是保护参与医学研究的人类受试者。涉及人类受试者的医学研究只有在获得认可的医学伦理委员会批准后才能进行。一个中央委员会(荷兰语缩写:CCMO)负责规范地方医学伦理委员会的认可程序并监督其工作表现。对于某些类型的研究,方案必须由CCMO本身进行审查。这些研究包括:涉及儿童和无行为能力患者的非治疗性研究以及基因治疗、异种移植和胚胎研究。CCMO最近为地方医学伦理委员会发布了一份指南。它对医学伦理委员会工作的所有法律和实际方面进行了出色的概述。强烈推荐该指南。

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