医学研究中与受试者相关的费用问题分析

Analysis of Subject Related Costs in Medical Research

医学研究的开展由申办者、研究者、受试者和伦理委员会等主体共同合作完成,临床上主要包括药械临床试验、临床医学及新技术研究。通过分析医学研究相关方博弈及权责利关系,同时结合医学研究涉及的相关成本及分担原则,发现补偿费用存在知情同意书中“免费”这一词语的使用易引起误会以及知情同意书中缺少有关补偿费用的问题,赔偿和保险费用则存在我国受试者赔偿机制不完善和申办者保险购买不充分等问题,从而无法保障受试者基本权益。因此,为规范临床医学研究费用管理问题,应采取规范知情同意的过程和内容、加强医学研究过程监督、建立医学研究损害赔偿基金、研究损害保险制度,更好地保障受试者的权益。

The development of medical research is completed by the cooperation of sponsors,investigators,subjects,and ethics committees.Clinically,it mainly includes clinical trials of medical devices,clinical medicine and new technology research.This paper analyzed the game and the relationship between rights,responsibilities and interests of relevant parties in medical research,combined with the relevant costs and sharing principles involved in medical research,and found that the use of the word“free”in the informed consent is easy to cause misunderstanding and the lack of relevant compensation costs in the informed consent,while the compensation and insurance costs had some problems,such as the imperfect subject compensation mechanism and the insufficient insurance purchase by the sponsor,which can not protect the basic rights and interests of the subjects.Therefore,in order to standardize the cost management of clinical medical research,it is necessary to standardize the process and content of informed consent,strengthen the supervision of medical research process,establish medical research damage compensation fund and research damage insurance system,so as to better protect the rights and interests of subjects.