从人体试验知情同意伦理审查谈目前伦理审查存在的问题与解决策略

Problems and Solving Strategies of Current Ethical Reviews from the Perspective of Informed Consent in Human Trials

人体实验是医学发展所必需的,但这种实验需要在受试者知情同意的情况下对其进行充分的伦理审查。我国现有知情同意伦理审查存在相应规范的法律位阶较低,知情同意的跟踪审查流于形式,伦理审查的配套机制不完备等不足,应通过强化人体试验伦理审查的立法规范,加大对人体试验知情同意的跟踪审查,以及完善伦理审查的配套机制等方面入手,维护人体试验受试者的生命健康权益和人格尊严。

Human trials are necessary to medical development,but the experiments need to be reviewed under the condition of informed consent.The current ethical review of informed consent in China exist some limits.For example,the corresponding normative legal status is low,the tracing review of informed consent becomes a mere formality,and the ethical review mechanism is not perfect,and so on.We should strengthen the examination of the ethical examination of human trials,increase the tracking and examination of informed consent of human trials,and improve the supporting mechanism of ethical review,and thus to safeguard the life and health rights and interests and personality dignity.