2024年版《赫尔辛基宣言》的重大变化及实施思考  

Major changes and implementation considerations of the 2024 version of the Declaration of Helsinki

作　　者：江柯萱 周吉银 JIANG Kexuan;ZHOU Jiyin(Department of Medical Service,the 80th Group Army Hospital of the People’s Liberation Army of China,Weifang 261042,China;Clinical Medical Research Center,the Second Affiliated Hospital of Army Medical University,Chongqing 400037,China)

机构地区：[1]中国人民解放军陆军第八十集团军医院卫勤处,山东潍坊261042 [2]陆军军医大学第二附属医院临床医学研究中心,重庆400037

出　　处：《中国医学伦理学》2025年第4期403-411,共9页Chinese Medical Ethics

基　　金：2022年陆军军医大学人文社会科学基金重点项目“我市涉及人的健康相关研究伦理治理的现状与对策研究”(2022XRW02)。

摘　　要：世界医学会于2024年10月19日批准了最新修订版《赫尔辛基宣言》,这是时隔11年后的再次修订。作为全球涉及研究参与者的医学研究的国际伦理原则,为了应对研究环境的动态性和快速变化性,确保其相关性,此次修订主要内容包括受试者改为研究参与者,作为合作伙伴;实施主体增加了其他研究者,要求个人、团队和组织遵守;新增社会价值,始终为增进个人和公共的健康;要求自由和充分的知情同意,维护研究参与者自主性;公平分配、鼓励社群参与;负责任地纳入脆弱的个人、群体和社群;支持以维护独立审查和权威,明确国际合作研究双重伦理审查;为防范风险,需加强生物样本和数据的监管;强调临床试验结束后,应当继续维护研究参与者福利;新增环境可持续性,扩大关注范围;要求科学诚信,维护研究环境;论证研究方案的科学性,避免研究浪费;新增突发公共卫生事件期间应当遵守伦理原则;谨慎使用安慰剂,避免滥用;澄清未经证实的干预措施的使用条件。为落实《赫尔辛基宣言》的修订内容,可采取的措施包括:为维护研究参与者,需适用于所有涉及人的研究;以患者为中心,确保研究符合患者需求;落实负责任的纳入,需各方协同推进;严格监管生物样本和数据以保护隐私,确保健康发展;加强监管使用未经证实的干预措施,维护患者长远利益;持续建设伦理委员会,拥抱人工智能;规范有效知情同意,贯彻自由和充分的原则。《赫尔辛基宣言》旨在促进和确保在快速创新的医学研究生态系统中尊重和保护研究参与者,未来仍将面临新挑战带来的修订。The World Medical Association approved the latest revision of the Declaration of Helsinki on October 19,2024,which was revised again after 11 years.As the international ethical principles for medical research involving research participants worldwide,this revision aims to respond to the dynamic and rapidly changing research environment and to ensure its relevance.The main contents of this revision include changing subjects to research participants as partners;adding other researchers as the implementing subjects and requiring individuals,teams,and organizations to comply;adding social value,always for the purpose of improving individual and public health;requiring free and full informed consent and maintaining the autonomy of research participants;advocating fair distribution and encouraging community participation;responsibly integrating vulnerable individuals,groups and communities;supporting the maintenance of independent review and authority,and clarifying the dual ethical review of international collaborative research;strengthening the supervision of biological samples and data to prevent risks;emphasizing that the welfare of research participants should be continuously maintained after the end of the clinical trials;adding environmental sustainability and expanding the scope of attention;requiring scientific integrity and maintaining the research environment;demonstrating the scientific validity of research plans and avoiding research waste;adding ethical principles should be observed during public health emergencies;using placebos cautiously and avoiding abuse;clarifying the conditions for the use of unproven interventions.To implement the revised contents of the Declaration of Helsinki,measures that could be taken include applying to all human-related research to protect research participants;centering on patients to ensure that research meets patients’needs;implementing responsible inclusion through the collaboration of all parties;strictly supervising biological samples and data to protect privacy and

关 键 词：赫尔辛基宣言 研究参与者 知情同意 脆弱群体 科学诚信 

分 类 号：R-052[医药卫生]