用于保藏的人类遗传资源知情同意管理共识

Consensus on informed consent management for the preservation of human genetic resources

为规范人类遗传资源保藏活动知情同意,提升人类遗传资源保藏活动管理水平,助力中国人类遗传资源的有效保护和合理利用,中国人体健康科技促进会人类遗传资源保护与利用专业委员会组织国内相关领域专家,依据法律法规要求,结合人类遗传资源保藏及样本库工作实践中的经验,经多次讨论,形成《用于保藏的人类遗传资源知情同意管理共识》。共识内容涉及保藏前知情同意的准备、知情同意过程、保藏过程中知情同意书的管理、知情同意的特殊情况,以及共同治理与保障措施。共识旨在规范人类遗传资源保藏相关活动,提升人类遗传资源知情同意管理水平,保护研究参与者的合法权益,保障人类遗传资源的合规获得和合理利用,以促进生命科学和医学研究健康发展。

To standardize the informed consent for the preservation activities of human genetic resources,improve the management level of preservation activities of human genetic resources,and assist the effective conservation and rational utilization of human genetic resources in China,Professional Committee on the Conservation and Utilization of Human Genetic Resources,China Association for Promotion of Health Science and Technology organized domestic experts in relevant fields to form the Consensus on Informed Consent Management for the preservation of Human Genetic Resources after many discussions,according to the requirements of laws and regulations,combining with the experience in the work practices of human genetic resources preservation and biobank.The content of the consensus involved the preparation before preservation,the process,the management during preservation,and the special circumstances of informed consent,as well as joint governance and safeguard measures.The consensus aimed to regulate the activities related to the preservation of human genetic resources,improves the informed consent management level of human genetic resources,protect the legitimate rights and interests of research participants,and ensure the compliance acquisition and rational use of human genetic resources,to promote the healthy development of life sciences and medical research.