基于德尔菲法的《临床试验生物样本伦理管理指南》研究

Study on Guideline of Ethical Management of Biological Samples in Clinical Trials by Using Delphi Method

药物和医疗器械以及体外诊断试剂临床试验涉及生物样本的采集、保藏、使用和合作研究越来越普遍,其中涉及的伦理问题引起了学界与公众的广泛关注,通过国内外文献研究与综合分析,拟定《临床试验生物样本伦理管理指南》的条目与内容;经课题组专家讨论,形成《临床试验生物样本伦理管理指南征求意见稿》;通过两轮德尔菲法国内权威专家组问卷调研,召开课题组专家讨论会,形成伦理指南初稿,再经权威专家内审会讨论,最终形成指南终稿。旨在规范临床试验中生物样本的管理与伦理审查,保障样本提供者的权利和福利,为生物医药研究的健康发展提供良好的指导作用。

The collection, preservation, use and cooperative research of biological samples involved in clinical trials of drugs,medical devices and in vitro diagnostic reagents have become more and more common. The ethical issues involved have aroused widespread concern in the academic community and the public. The research group adopted the methods of literature research and comprehensive analysis to draft the items and contents of the Guideline of Ethical Management of Biological Samples in Clinical Trials. After discussion and consultation by the research group, a draft was formed. After two rounds of survey questionnaires among experts excel in Delphi method, research group consensus meeting was held to write the first draft of the guide. After an expert internal audit meeting, the final draft of the guide was finally formed. The purpose of the guideline is to provide good guidance for standardizing the management and ethical review of biological samples in clinical trials, ensuring the rights and welfare of sample providers, and promoting the healthy development of biomedical research.