涉及人的生命科学和医学研究初始伦理审查申请材料要求解读

Understanding the update of application materials for initial ethics review of human life sciences and medical research

目的梳理2023年新版《涉及人的生命科学和医学研究伦理审查办法》(以下简称"《办法》")对初始伦理审查申请材料提出的新要求,探讨提出这些新要求背后的伦理考虑,对各项初始伦理审查申请材料的准备应注意的关键细节及实践操作提出可行性建议,为研究者、伦理审查委员会和机构规范推进伦理审查工作提供一定的参考。方法对比2016年《涉及人的生物医学研究伦理审查办法》相关规定,结合伦理理论前沿热点以及伦理审查工作实践进行讨论。结果初始伦理审查申请材料准备应基于对新版《办法》的精准理解,强调合规的同时,避免形式化落实法规要求,增加不必要的负担。结论准备高质量的伦理审查申请材料是研究者的责任,但是,机构和伦理审查委员会应该提供相应的支持,包括明确政策法规的最新要求、更新所在机构伦理审查标准操作规程,确保为研究者提供及时且持续的伦理培训和伦理咨询。伦理审查工作的规范和完善,需要更加全面的视角和系统的规划,强化各方主体的责任意识。

Objective To sort out the new requirements for the initial ethical review application materials put forward by the Measures for the Ethical Review of Life Science and Medical Research Involving Humans that issued in 2023,to explore the ethical considerations behind these new requirements,and to put forward feasible suggestions on the key details and practical operations that should be paid attention to in the preparation of various initial ethical review application materials,so as to provide a certain reference for researchers,ethical review committees and institutions to standardize and promote ethical review.Methods Compared with the relevant provisions of the 2016 Measures for the Ethical Review of Biomedical Research Involving Humans,this paper discusses the frontier hotspots of ethical theory and the practice of ethical review.Results The preparation of application materials for initial ethical review should be based on an accurate understanding of the Measures,emphasize compliance,and avoid formally implementing regulatory requirements and increasing unnecessary burdens.Conclusions It is the responsibility of researchers to prepare high-quality ethical review application materials,but institutions and ethical review committees must provide corresponding support,including clarifying the latest requirements of policies and regulations,updating the standard operating procedures of ethical review of their institutions,and ensuring timely and continuous ethical training and ethics consultation for researchers.The standardization and improvement of ethical review work requires a more comprehensive perspective and systematic planning to strengthen the responsibility of all parties.