Ⅰ期药物临床试验受试者家庭参与决策的现状、影响因素及多学科辩护

Status quo, influencing factors and multidisciplinary defense of family participation in decision making of phase Ⅰ clinical trials

健康受试者的知情同意应把家庭参与决策纳入其中,但目前我国家庭参与程度并不高,表现为相关政策对家庭参与决策没有明确要求、研究者对家庭参与决策不鼓励和受试者对家庭参与决策态度不积极。家庭参与程度不高的原因包括政策来源中的个人主义理论基础、研究者期望不增加受试者招募难度和受试者避免家庭阻力。基于保障健康受试者更有效地行使知情同意权的根本目的,笔者认为家庭参与决策可在伦理学、传统文化、法学和社会学等多学科得到辩护。家庭参与决策符合伦理原则、与社会文化相适宜、符合民法基本原则且有助于为受试者去除污名。

The informed consent of healthy volunteers should include family participation in decision making.However,the level of family participation is low in China at present,which is reflected in the absence of explicit requirements for family participation in relevant policies,the researchers’and volunteers’negative attitude towards family participation.The reasons for the low level of family participation include three aspects:theoretical basis of individualism in the policy source,researchers’expectation not to increase the difficulty of volunteer recruitment,and volunteers’avoidance of family resistance.Based on the fundamental purpose of ensuring that healthy volunteers exercise informed consent more effectively,family participation in decision making can be defended in multiple disciplines such as ethics,traditional culture,law and sociology.Family participation in decision making is ethical,culturally appropriate,in accordance with the basic principles of civil law,and helps to remove stigma for the volunteers.