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目前有关人体医学研究的伦理指导原则主要来自《赫尔辛基宣言》,并已获得世界上大多数国家的普通认可,主要包括以下几个方面。1、保护受试者权益原则《赫尔辛基宣言》第9条指出:“医学研究要符合尊重所有人类受试者、保护他们健康和权利的伦理标准,一些研究涉及的人口尤其脆弱,需要特别保护”。2、预先审核原则《赫尔辛基宣言》第15条指出:“在研究开始前,研究过程必须提交伦理委员会,供其考虑、评论、指导和同意,且该委员会必须独立于研究人员、赞助者和任何不正当影响之外”。“研究人员必须向该委员会提供监督的信息,特别是关于严重负面事件的信息,未
At present, the ethical guiding principles for human medical research mainly come from the Declaration of Helsinki and have gained the general approval of most countries in the world, and mainly include the following aspects. Principle of protecting the rights of subjects Article 9 of the Declaration of Helsinki states: ”Medical research should meet the ethical standards of respecting all human subjects and protecting their health and rights. Some of the studies involved are particularly vulnerable and require special protection “. Pre-Review Principle Article 15 of the Declaration of Helsinki states: ”Prior to the start of the study, the research process must be submitted to the Ethics Committee for consideration, comment, guidance and consent, and the committee must be independent of the research staff, sponsors and Any undue influence “. ”Researchers must provide the committee with supervisory information, especially information about serious negative events, not yet