非治疗性人体医学试验的受试者保护问题研究

The Issue Research of Subjects Protection in Non-therapeutic Human Medical Experiments.

非治疗性人体医学试验是人体医学试验的一个重要分支,在新药和新医疗技术研发中具有重要作用。其特殊性在于受试者是健康人或者与该药品、技术针对的目标疾病没有直接相关性。在实践中,一些研究者受利益趋动,不惜损害受试者的利益,出现了受试者缺乏自主性、利用弱势群体进行试验、受试者招募不公平等问题,严重损害了受试者的权益。因此,在坚持人体医学实验一般性的伦理原则和审查制度的基础之上,针对非治疗性人体医学试验的特殊性,如何对现有原则和制度进一步完善、细化、补充,使之更符合实际要求,正是本文研究的重点和目标所在。

Non-therapeutic human medical trial is an important branch of human medical trial,which plays an important role in the development of new drugs and new medical technology.Its particularity lies in that the subjects are healthy people or have no direct correlation with the target diseases targeted by the drug or technology.In practice,some researchers are motivated by interests and do not mind to harm the interests of the subjects.Problems such as the lack of autonomy of the subjects,the use of vulnerable groups to conduct experiments and the unfair recruitment of the subjects occur,which seriously damage the rights and interests of the subjects.Therefore,on the basis of adhering to the general ethical principles and review system of human medical experiments,according to the particularity of non-therapeutic human medical experiments,how to further improve,refine and supplement the existing principles and systems,so as to make them more in line with the actual requirements,is the focus and goal of this study.