人类遗传资源审批申请书审核要点解析

Interprestation of the key review points of human genetic resources application

目的为进一步加强临床试验中的人类遗传资源管理。方法本文结合医院药物临床试验机构在审核人类遗传资源申请书的丰富经验,对常见问题进行了回顾性分析,并提出了应对的解决措施。结果人类遗传资源申请书中的常见问题与审核人类遗传资源申请书时的要点一致,包括样本的采集收集计划与试验方案一致性、伦理审查与知情同意书规范性、知识产权归属合规性等。结论严格审核人类遗传资源申请,加强对人类遗传资源临床试验项目的管理,不仅使人类遗传资源的流动情况具有可追溯性,对临床试验结果的真实性、科学性也具有重要意义。

Objective To strengthen human genetic resource management in clinical trials.Methods This article analyzes the common problems in the process of reviewing human genetic resources application by the drug clinical trial institute in our hospital?and proposes solutions for solving the problems.Results Common questions are also the key points for future review of human genetic resources applications,including the collection of sample and consistency with clinical trial plan,ethical review and informed consents intellectual property rights etc.Conclusions Strictly reviewing applications of human genetic resources,as well as strengthen the management of human genetic resources in clinical trials,are not only make traceability of human genetic resources traceable,but also have important significance for the authenticity and scientific validity of trial results.