摘要
目的了解研究参与者在参加中医药临床试验的过程中对中医药临床试验以及知情同意过程的体验和看法,为中医药临床试验中研究参与者获得高质量的知情同意提供依据。方法采用定性研究方法,对6名既往参加过中医药临床试验的研究参与者进行半结构化个体深度访谈。结果根据资料分析得出研究参与者愿意参加中医药临床试验的原因、不愿意参加的顾虑、在知情同意过程中希望能够被告知的信息、中医药临床试验中特别想了解的内容以及对知情同意的理解度和满意度评价等五大主题和若干分主题。结论在中医药临床试验知情同意的过程中要注重对中医药不良反应的说明、注意合理安排和明确告知研究参与者参加研究的时间、在知情同意沟通的过程中要注重人文关怀、重视研究参与者的价值体现和对获取中医药特殊知识的期待等。
Objective:To understand subjectsexperiences and opinions on clinical trials of traditional Chinese medicine(TCM)and the process of informed consent during the process of participating in TCM clinical trials,and to provide reference for obtaining high-quality informed consent in TCM clinical trials.Methods:Using qualitative research methods,semi-structured individual in-depth interviews were conducted on 6 participants who had previously participated in TCM clinical trials.Results:Through data analysis,five major themes and several sub-themes were obtained,including the reasons why participants are willing to participate in TCM clinical trials,the concerns about unwillingness to participate,the information that they hope to be informed during the informed consent process,the specific content that they want to know in TCM clinical trials,and the evaluation of understanding and satisfaction with informed consent.Conclusion:In the process of informed consent in TCM clinical trials,attention should be paid to the explanation of adverse drug reactions of TCM,the reasonable arrangement and clear notification of the time for participants to participate in the trial,emotional humanistic care in the process of informed consent communication,and the value embodiment of subjects and their expectations for acquiring special knowledge of TCM.
作者
李晓彦
蒋璐
张茜
肖萧
温泽淮
LI Xiaoyan;JIANG Lu;ZHANG Xi;XIAO Xiao;WEN Zehuai(Office of Ethics Committee,the Second Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510120,China)
出处
《中国医学伦理学》
2023年第8期853-858,共6页
Chinese Medical Ethics
基金
广东省中医院中医药科学技术研究专项“中医药临床试验知情同意质量评价工具的研制与评价”(YN2019ML09)。
关键词
中医药临床试验
研究参与者
知情同意
人文关怀
Clinical Trials of Traditional Chinese Medicine
Research Participants
Informed Consent
Humanistic Care
