摘要
为了探究综合医院临床研究的受试者权益是否得到有效保护,以某综合医院机构开展的临床研究项目伦理初始审查材料为例,进行了回顾性研究。选取2018年~2019年笔者所在医院开展的临床科研伦理审查项目存档资料进行评估。结果发现,在67项申请伦理审查的项目中,提出修改意见的项目占53.7%,其中知情同意书占47.8%;项目申请的主要问题集中于研究目的、研究内容和风险告知。研究方案设计的科学性、公平性、目的明确性、伦理合理性、风险告知充分等是研究者伦理意识和能力的关键。研究者和伦理委员会的工作能力仍需进一步提高以保护受试者的权益。
In order to explore whether the rights and interests of human subjects are effectively protected,the ethical materials and data of initial review are analyzed in a general hospital.The archived data of the review projects conducted in a hospital from 2018 to 2019 had been assessed through a retrospective study.Among a total of 67 applications for ethical review,53.7%of the projects were requested to revise,including 47.8%of informed consent form.The main issues were focused on the purpose and content of the study and the notification of risk.The scientific clinical research design,fairness,clear purpose,ethical rationality,and sufficient risk notification are the key of the ethical consciousness and ability of researchers.The working ability of researchers and ethics committee needs to be further improved to protect the rights and interests of subjects.
作者
安妮
乔田奎
许国雄
沈辉
AN Ni;QIAO Tian-kui;XU Guo-xiong(Institutional Ethics of Jinshan Hospital,Fudan University,Shanghai 201508,China)
出处
《医学与哲学》
2020年第5期40-43,共4页
Medicine and Philosophy
关键词
临床研究
初始审查
方案设计
知情同意
clinical research
initial review
research design
informed consent
