运用6W2H分析法构建医疗卫生机构泛知情同意管理体系的探索与思考
Exploration and reflections on applying the 6W2H analysis method to construct a broad consent management system in healthcare institutions
张钰 1李海燕 1陈亚红2
作者信息
- 1. 北京大学第三医院科研处 100191
- 2. 北京大学第三医院呼吸与危重症医学科 100191
- 折叠
摘要
目的 探索在医疗卫生机构内实施泛知情同意的管理体系和程序,从而切实有效的实施泛知情同意,保护研究参与者的权益,提高研究效率.方法 运用6W2H分析方法从决策背景、目标定位、运行方式、时间节点、适用范围、关键角色、运行程序及运行成本等关键决策点进行探索与分析.结果 实施泛知情同意应以保护研究参与者权益为首要核心目标,协同多部门共同建立与之相匹配的管理体系.结论 实施泛知情同意仍面临诸多挑战,需完善科技伦理治理体系,加大科普宣传,赢得公众支持,加强个人信息保护监管.
Abstract
Objective This study aimed to explore the management system and procedures for broad consent in health-care institutions for the effective and efficient implementation of broad consent,to protect the rights and interests of research participants,and to improve research efficiency.Methods Using the 6W2H analysis method,key decision points such as back-ground,goal orientation,operating mode,time node,applicable scope,key roles,procedure operation,and operating costs were explored and analyzed.Results Broad consent should be implemented to protect the rights and interests of research par-ticipants as the primary core goal,and collaborate with multiple departments to establish a matching management system.Conclusions The implementation of broad consent still faces many challenges.It is necessary to improve the scientific ethics governance system,increase the popularization of science to win public support,and strengthen the supervision of personal in-formation protection.
关键词
6W2H分析法/泛知情同意/管理体系/医学伦理Key words
6W2H analysis/Broad consent/Management system/Medical ethics引用本文复制引用
基金项目
北京市医学伦理管理质量提高项目(京伦2024-4)
出版年
2024
NETL
NSTL
万方数据