The introduction of "The Regulations on Ethical Reviews of Biomedical Researches Involving Human Beings"regulated all the biomedical research involving human beings.The new regulation focused on informed consent,legal liability,six ethical review principles and seven criterions for ethics committee's approval.Meanwhile,it further standardized the management responsibilities of three levels,which were the national level,the provincial level and the institution level.However the new regulation,in practice,there must be some shortcomings,such as whether each institution needed to set up an ethics committee? Whether the voting results for the full board meeting was suitable? How to clarify the review mode on multi center studies and etc.As for the overlapping between different regulations,how to correctly comply with each laws and regulations were the key issues to better protect the participants.%《涉及人的生物医学研究伦理审查办法》在知情同意与法律责任方面予以了重点说明,同时详细阐述了伦理审查的六大原则和伦理委员会批准的七大标准,进一步规范了国家、省(市)级和机构层面的三级管理职责.但新法规在实践上存在着一些不足和不够细化的地方,例如,是否每个医疗机构开展涉及人的生物医学研究都要成立伦理委员会,会议投票结果计算的细节问题以及多中心伦理审查模式比较模糊等问题的存在.对于法规重叠和交叉的情况,如何正确做好法规的竞合是如何更好地保护受试者的关键.
展开▼
