中国医学伦理学2024，Vol.37Issue(4)：392-398,7.DOI:10.12026/j.issn.1001-8565.2024.04.03
《涉及人的生命科学和医学研究伦理审查办法》对健康信息数据相关研究的新要求及审查要点
New requirements and key points for review for research related to health information data in the Measures of Ethical Review of Life Sciences and Medical Research Involving Humans
摘要
Abstract
To further standardize the ethical review of life science and medical research involving humans,the National Health Commission,the Ministry of Education,the Ministry of Science and Technology,and the State Administration of Traditional Chinese Medicine jointly issued the Measures of the Ethical Review of Life Science and Medical Research Involving Humans in 2023.The provisions concerning research related to health information data within it include:emphasizing the protection of personal information and privacy rights,personal information can only be collected,stored,and used under the premise that research participants know and permit,and must not be disclosed to third-party without the authorization of research participants;the ethical committee should focus on reviewing the adequacy of confidentiality measures of personal information;for research that provides information and data or cooperation with external organizations,it is necessary to fully understand the research,conduct a full ethical review,and clarify the use,processing,and disposal after completion of information data through an agreement.The research institutions should improve the information data governance and supervision system in conjunction with the key points of information data management in the new regulations.The initial ethical review should focus on the risk-benefit ratio of the research,the reasonableness of the informed consent procedure,the feasibility of the opt-out procedure,the protection measures for the privacy of the research participants,and the data management capability of the research team.The knowledge training of researchers should be strengthened,policy advisory services should be provided for them,and even a unified information data management platform should be built for them from the overall level of research institutions.The ethical follow-up review emphasizes whether the researchers continue to protect the participant's right to independent information or personal information,and privacy.It is believed that through a series of governance measures,the health information data of research participants in China will be better protected,thus safeguarding their legitimate rights and interests.关键词
涉及人的生命科学和医学研究伦理审查办法/信息数据/伦理审查Key words
Measures of Ethical Review of Life Sciences and Medical Research Involving Humans/information data/ethical review分类
医药卫生引用本文复制引用
陈璐,何艳,徐芳,周吉银..《涉及人的生命科学和医学研究伦理审查办法》对健康信息数据相关研究的新要求及审查要点[J].中国医学伦理学,2024,37(4):392-398,7.基金项目
贵州省卫健委科学技术基金项目"脓毒症专病队列数据库的构建"(gzwkj-2022-018) （gzwkj-2022-018）
贵州医科大学附属医院2021年度院级临床研究课题"房颤专病队列数据库的构建"(2021-GMHCT-020) （2021-GMHCT-020）
