加强对临床试验中人类遗传资源信息对外提供的管理

Strengthen the management of external provision of human genetic resource information in clinical trials

目的通过加强对医疗机构在开展临床试验过程中产生的人类遗传资源信息对外提供的管理, 提高人类遗传资源信息的监管效力, 促进信息的合法共享和有效利用。方法分析北京大学人民医院自2019年7月1日以来, 对临床试验所产生的人类遗传资源信息对外提供进行备案过程中出现的问题, 提出解决对策与建议。结果医疗机构在填报人类遗传资源信息对外提供的申请时, 对于对外提供的信息规格和时间、信息接收单位、信息的存储地点和最终处置方式等仍然存在一些不规范的情况。结论医院和监管部门可通过开展针对性培训、健全人类遗传资源信息管理的制度体系、细化管理流程和加强跟踪审查, 提高人类遗传资源信息管理的规范性。

Objective By strengthening the management of external provision of data generated by clinical trials in medical institutions,to improve the effectiveness of supervision of human genetic resource information,and to promote the legal sharing and effective use of data.Methods Analyzed problems identified in filing human genetic resource information in clinical trials since July 1,2019,put forward possible solutions and suggestions.Results Main problems were identified in external provision of human genetic resource information,including the specification and time limit of external provision of information,the information recipient,the storage location and the final disposal method of information.Conclusions Hospital and regulatory authority need to carry out more tailored training,optimize management systems and procedures in order to strengthen the management of the external provision of human genetic resources information.