刍议人体试验伦理审查程序的正当化

医学伦理委员会在成立之初就明确了自身的使命:确保涉及人体试验研究的"科学"、"伦理"和"监管"。但在实际操作中, 很多伦理审查委员会将程序的正义简单地理解为是不是采用了标准化的审查流程, 是否通过了国外所谓权威机构的认证, 这导致伦理审查并没有遵循一个正当的程序进行, 使其在公平性、公正性等诸多方面受到质疑。因此, 为维护受试者的核心权益, 确保涉及人体试验的医学研究有序进行, 建立正当的程序并在伦理审查过程中实现程序正义有着极为重要的意义。

On Validity of the Ethical Review Procedure for Medical Research Involving Human Subjects

Medical ethics committee has clarified its mission at the very outset:to ensure "science, ethics and supervision" in any research that involves human beings.Unfortunately, many committees simply regard the legitimacy of procedure as whether standardized censorship is adopted in practice, or even whether it is approved by so-called overseas authoritative institutions.This leads to the lack of a proper procedure of conduct and the fairness, justice and related aspects are being suspected.Therefore, to establish a legitimate procedure and put it into practice during ethics approval is of great significance with respect to protecting the subjects' rights and ensuring the order of medical research involving human subjects.