《涉及人的生命科学和医学研究伦理审查办法》对生物样本的要求及对伦理审查的挑战OA北大核心CSTPCD

Regarding biological samples,compared to the Measures of Ethical Review of Biomedical Research Involving Humans,the newly released Measures of Ethical Review of Life Science and Medical Research Involving Humans updated the definitions,clarified the scope,defined the responsibilities of the subject,as well as emphasized the management system,ethical review,and informed consent.By comparing and analyzing the current management status of biological samples at home and abroad,it was found that there were still many problems in the management and ethical review of biological samples in China,such as a chaotic management system of biological samples,unclear responsible entities for management,lack of widely recognized management standards of biological samples in the industry,absence of ethics committee,the non-standard ethical review,the inadequacy or inability to implement informed consent,and the difficulty in providing feedback on research results.Therefore,it is recommended to establish a standardized management system of biological samples,conduct a standardized and effective ethical review,as well as sufficient and necessary informed consent,in order to comply with the requirements of the Measures of Ethical Review of Life Science and Medical Research Involving Humans on biological samples,and enhancing the quality of the management of biological samples in China.