摘要
加强对科研项目伦理审查和监督,是保护受试者安全与权益的重要举措。通过建立规范且具有儿科特色的伦理委员会、加强对儿童受试者保护内容的审查、提升委员的伦理审查能力、配备专职秘书、加强与科研管理部门的配合、开展科研人员伦理培训、加强对伦理委员会的监督等多种举措,可提升儿科科研伦理管理的规范性和科学性,推进儿童临床科研项目不断发展。
Strengthening the ethical review and supervision of scientific research projects is an important measure to protect the safety and rights of subjects.This study proposed that these measures could improve the standardization and scientific nature of pediatric research ethics management to promote the continuous development of children’s clinical research projects,including:establishing a standardized ethics committee with pediatric characteristics,strengthening the review of the protection of children subjects,improving the ethical review abilities of committee members,allocating full-time secretaries,strengthening cooperation with research management departments,carrying out ethics training for researchers,strengthening the supervision of ethics committee members,etc.
作者
丁雯
漆林艳
毛姗姗
倪韶青
DING Wen;QI Linyan;MAO Shanshan;NI Shaoqing(The Children’s Hospital,Zhejiang University School of Medicine,National Clinical Research Center for Child Health,Hangzhou 310052,China)
出处
《中国医学伦理学》
2020年第9期1053-1057,共5页
Chinese Medical Ethics
基金
浙江省基础公益研究计划项目“儿科临床研究协调员培养体系的构建和推广”(LGF19H310004)
“重大新药创制”科技重大专项“儿童示范性新药临床评价技术平台建设”(2017ZX09304029)。
关键词
科研伦理
儿童受试者
儿科
伦理审查
Research Ethics
Children Subjects
Pediatrics
Ethical Review
