论文部分内容阅读
人体试验受试者知情同意权的法律保护体系所要达成的目的,在于实现对每一位受试者的自我决定权的尊重,充分体现人作为主体的自由价值。我国关于受试者权益保护的法律体系建设起步较晚,且尚未能够上升到法律层面,在实践中也存在诸多问题。2014年,国家卫生和计划生育委员会向社会公布了《涉及人的生物医学研究伦理审查办法(征求意见稿)》,但我国的伦理审查委员会还存在独立性难以保证、委员会成员的学科构成不尽合理、评审过程草率、不够规范和科学、对试验的过程监督考察不足等问题。英美等国在伦理审查委员会制度建立方面起步较早,其关于伦理审查委员会的法律规定较为发达和完善,我国应当参考借鉴这些发达国家的成功经验,完善我国的伦理审查委员会制度。
The purpose of legal protection system of informed consent of human test subjects is to realize respect for the self-determination of each subject and to fully reflect the free value of human as the main body. China’s legal system on the protection of the rights and interests of the subjects started relatively late, and has not yet been able to rise to the legal level. There are also many problems in practice. In 2014, the National Commission on Health and Family Planning published “Approaches to Ethical Review of Biomedical Research Involving People (Draft for Soliciting Opinions)”, but it is difficult to guarantee the independence of ethical review committees in our country. The disciplines of committee members are not yet formed Reasonable, the review process sloppy, not enough norms and science, lack of inspection of the process of inspection and other issues. The countries such as Britain and the United States started earlier in the establishment of the system of ethics review committee, and their laws and regulations on ethics review committee are more developed and perfected. Our country should make reference to the successful experience of these developed countries and perfect the system of ethics review committee in our country.