受试者获益分析的三重视角

Three Perspectives of the Subject's Benefit Analysis

受试者获益作为医学伦理审查的重要内容,应从受试者获益与医学研究的关系、获益与权益的辨析以及获益与风险的平衡三重视角加以分析。受试者获益的本质是受试者身体和心理层面的健康受益,而非其他各种形式的利益,医学研究的科学性和伦理性是受试者获益的根本前提。与作为受试者基本权利和利益的权益不同,受试者获益是非基本的、在原有身心状况基础上不确定的增量性健康利益。此外,受试者获益是基于风险评估的获益,与受试者获益相对应的风险是不可避免的“伤害”,它与违背医学伦理准则的“伤害”具有本质的区别。

The subject's benefit is an important part of medical ethics review,and its essential connotation should be grasped from three perspectives:the relationship between subject's benefit and medical research,the discrimination between benefit and rights,and the balance between benefit and risk.The essence of subjects'benefit is to benefit their physical and psychological health,rather than other forms of benefit.The scientific and ethical nature of medical research is the fundamental premise of the subject's benefit.Different from the subject's basic rights and interests,the benefit of the subject is non-basic incremental health benefit which is uncertain on the basis of the original physical and mental conditions.In addition,the benefit of the subject is based on the risk assessment,and the risk corresponding to the benefit of the subject is the inevitable"injury",which is essentially different from the"injury"that violates the medical ethics.