|国家科技期刊平台
首页|期刊导航|中国医学伦理学|《科技伦理审查办法(试行)》的解读与实施思考

《科技伦理审查办法(试行)》的解读与实施思考OA北大核心CSTPCD

Interpretation and implementation reflection on the Measures for Scientific and Technological Ethics Review(for Trial Implementation)

中文摘要英文摘要

当今,国际国内科技创新活动均面临不同类别和不同程度的伦理风险,给人类社会带来诸多负面影响,甚至威胁个人生命和财产安全.为进一步规范科技伦理审查,强化风险防控,促进负责任创新,2023 年 9 月,十部委联合发布了《科技伦理审查办法(试行)》.《科技伦理审查办法(试行)》要求诸多领域的科技创新活动实施伦理审查,伦理审查应更加切实可行,加强了对重大突发公共事件的应急管理,提出研究机构应建立风险评估方法,新增无单位人员可申请委托伦理审查,建立伦理委员会认证制度等.《科技伦理审查办法(试行)》亮点突出、特色鲜明,明确了科技创新活动的责任主体,强化了责任主体对伦理审查的职责和管理,推出了科技活动清单管理制度,开创了针对较大伦理风险挑战的专家复核模式.对《科技伦理审查办法(试行)》进行解读和实施思考,为落实《科技伦理审查办法(试行)》提供参考,以期推动科技伦理审查成为规范性力量,促进科技创新活动向上向善发展以造福人类.

Nowadays,both international and domestic scientific and technological innovation activities are facing different types and degrees of ethical risks,which bring many negative impacts to human society and even threaten the safety of individuals'lives and properties.To further standardize the ethics review of science and technology,strengthen risk prevention and control,and promote responsible innovation,ten ministries and commissions jointly issued the Measures for Scientific and Technological Ethics Review(for Trial Implementation)in September 2023.The Measures for Scientific and Technological Ethics Review(for Trial Implementation)required that ethical review should be implemented for science and technology innovation activities in many fields,ethical review should be more practicable.It strengthened emergency management of major public emergencies,proposed that research institutions should establish risk assessment methods,new unorganized personnel can apply for entrusted ethical review,and an ethics committee certification system should be established.The Measures for Scientific and Technological Ethics Review(for Trial Implementation)had outstanding highlights and distinctive features,clarified the responsible parties for scientific and technological innovation activities,strengthened their responsibilities and management of ethical review,introduced a management system for the list of scientific and technological activities,and created an expert review model for addressing the challenges of greater ethical risks.The interpretation and implementation reflection on the Measures for Scientific and Technological Ethics Review(for Trial Implementation)can provide a reference for the implementation of it,with a view to promoting the ethical review of science and technology as a normative force,as well as facilitating the upward and positive development of scientific and technological innovation activities for the benefit of humanity.

周维佳;孙悦;周吉银

四川省肿瘤医院/电子科技大学附属肿瘤医院伦理委员会办公室,四川 成都 610041四川锦欣西囡妇女儿童医院,四川 成都 610066陆军军医大学第二附属医院临床医学研究中心,重庆 400037

科技创新活动伦理审查责任主体科技活动清单专家复核

scientific and technological innovation activityethical reviewresponsible partieslist of scientific and technological activityexpert review

《中国医学伦理学》 2024 (005)

542-549 / 8

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)

10.12026/j.issn.1001-8565.2024.05.07

评论