Qualitative Study on Research Participants Informed Consent of Research Characteristics in Clinical Trials of Traditional Chinese Medicine
10.12026/j.issn.1001-8565.2023.08.05
- VernacularTitle:中医药临床试验研究参与者对研究特性知情的定性研究
- Author:
Xiaoyan LI
1
;
Lu JIANG
1
;
Xi ZHANG
1
;
Xiao XIAO
1
;
Zehuai WEN
1
Author Information
1. Office of Ethics Committee, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510120, China
- Publication Type:Journal Article
- Keywords:
Clinical Trials of Traditional Chinese Medicine;
Research Participants;
Informed Consent;
Humanistic Care
- From:
Chinese Medical Ethics
2023;36(8):853-858
- CountryChina
- Language:Chinese
-
Abstract:
【 Objective:】 To understand subjects’ experiences 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.
