临床研究知情同意权代理主体的规范问题探讨OA

The surrogate subjects have been gradually replaced from"legal representatives"to"guardians"in China's relevant norms regarding the surrogate system of the right to informed consent in clinical research recently.Although this change in the expression of surrogate subjects has not altered its legal essence,it may still lead to ambiguities,confusions and deviations,in the understanding of the surrogate subjects for the right to informed consent.Therefore,this paper summarized its characteristics from three aspects,namely,the changes in relevant norms regarding the surrogate system of the right to informed consent in China's clinical research,their differences from foreign norms,and their differences from surrogate subjects of the medical right to informed consent.On this basis,the formal identity and substantive emphasis between guardians and legal representatives were compared from a normative perspective.Subsequently,the major reasons for legislators to replace the expression of surrogate subjects were explored from three aspects,including institutional systematization,reinforcement of the best interest principle,and cultural values.Finally,corresponding implementation suggestions were proposed for situations where research participants lack guardians during the exercise of the right to informed consent in clinical research.