临床试验伦理审查中风险与受益评估初探

发布时间：2018-01-24 02:11

本文关键词： 临床试验伦理审查风险与受益评估　出处：《中国医学伦理学》2016年04期 　论文类型：期刊论文

【摘要】：风险与受益的评估是临床试验伦理审查中的重要部分。风险与受益评估的重要意义是使风险最小化,受益最大化,保障受试者的权益。从简单阐述临床试验风险的性质、等级及受益情况入手,分析基于试验风险考量情况的审查方式,探讨了风险与受益评估需要关注的最小风险问题、弱势群体的风险与受益问题、风险告知和试验受益的问题;受试者招募的公平性问题及加强伦理跟踪审查的重要性。认为伦理审查应起到"天平"的作用,既不能为了保护受试者的权益而阻碍临床试验研究的发展;也不能盲目地为了研究的利益而损害受试者的权益。
[Abstract]:Risk and benefit assessment is an important part of clinical trials in the ethical review. Significance of risk and benefit assessment is to minimize the risk and maximize the benefit, safeguard the interests of the subjects. From this simple nature of the risk of clinical trials, starting with the level and benefit analysis, test risk considerations of the review based on the discussion the minimum risk risk and benefit assessment need to pay attention to risk, vulnerable groups and benefit, and the benefit risk informed test problems; the fairness of the recruitment of subjects and strengthen the importance of ethics. The ethical review that track review should play the role of "balance", not only in order to protect the development of subjects the rights and interests of hindering clinical trials; also not blindly in order to study the benefit and harm the interests of the subjects.

【作者单位】：南京中医药大学附属八一医院医学伦理委员会;南京中医药大学附属八一医院药物临床试验机构;
【分类号】：R-052;R969.4
【正文快照】： 如何使风险最小化,受益最大化,保障受试者的权益,是伦理审查的重要目的。然而,风险与受益的评估是一个动态的过程,从试验项目的初始审查开始需要评估,一直到后续的跟踪审查,在整个的评估过程中,有一些值得关注的问题。1关于临床试验伦理审查风险与受益评估的相关规定及依据200

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