摘要
采用问卷调查的形式,选取了来自全国各地46所医院的普外科临床研究者,从方案设计环节、知情同意环节、受试者招募环节、伦理审查环节四个方面,剖析外科研究人员在开展手术相关临床研究的过程中所遇到的常见的伦理学问题,其产生原因主要包括研究者的伦理意识不足、对医学伦理知识在实践应用中的能力存在缺陷以及伦理审查委员会的监管机制不到位等,建议采取加强对研究者的科研伦理培训、规范临床研究招募行为、加强伦理监管和法律法规等措施。
This study conducted questionnaire survey among clinical researchers of general surgery from 46 hospitals across the country.From the aspects of protocol design,informed consent,subject recruitment and ethical review,common ethical problems encountered by surgical researchers in the process of carrying out surgery-related clinical research were analyzed.The causes mainly include the lack of ethical awareness,application ability deficiency in practice,and inadequate regulatory mechanism of ethics review committees.It is suggested to strengthen the research ethics training for researchers,standardize the recruitment of clinical research,strengthen ethical supervision,and improve laws and regulations.
作者
唐秋实
范庆
王志宏
田利国
TANG Qiu-shi;FAN Qing;WANG Zhihong(Chinese Journal of Practical Surgery,Publishing House of Chinese Journals of Practical Medicine,China Medical University,Shenyang 110001,China)
出处
《医学与哲学》
北大核心
2022年第17期36-41,共6页
Medicine and Philosophy
基金
2020年辽宁省自然科学基金项目(No.2020-MS-143)。
关键词
临床研究
外科学
伦理学
知情同意
clinical research
surgery
ethics
informed consent
