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。%The risk and benefit assessment is an important part of ethical review in clinical trials, of which the significance is to minimize the risk and maximize the benefit, thus to protect the rights of the subject. Begin with introducing the nature of the risk and benefit of clinical trial, this paper analyzed the way of ethical review based on risk consideration and discussed some key points of risk and benefit assessment including the minimum risk, the risk and benefit of vulnerable groups, risk informing, benefit of clinical trials, the fairness of recruitment and the importance of strengthening follow-up review. Ethical review should play a role as the balance, which neither-hinder the development of clinical trial to protect the rights of the subjects nor damage the rights and interests of subject to develop clinical trials.
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