Evolution and ethical considerations of therapeutic misunderstandings under the new design scheme of clinical trials
10.12026/j.issn.1001-8565.2024.08.02
- VernacularTitle:临床试验新型设计方案下治疗性误解的演变及伦理学思考
- Author:
Weizhong ZHANG
1
Author Information
1. Ethics Committee， Wuyunshan Hospital of Hangzhou/Hangzhou Institute of Health Promotion， Hangzhou 310008， China
- Publication Type:Journal Article
- Keywords:
therapeutic misunderstanding;
clinical trial;
clinical treatment;
design scheme;
informed consent
- From:
Chinese Medical Ethics
2024;37(8):885-889
- CountryChina
- Language:Chinese
-
Abstract:
Through the voluntary participation of subjects， strictly designed clinical trials have generated new generalizable scientific knowledge to benefit more future populations. However， subjects participating in clinical trials often cannot distinguish between trials and clinical treatments， and they expect clinical trials to be able to treat their diseases. This phenomenon is called therapeutic misunderstanding， which needs to be prevented because it cannot meet the requirements of research ethics. With the advent of precision medicine， the scenario of clinical trials has changed significantly， manifested as the integration of trials and clinical treatments， and the prominent clinical benefits of subjects. The new treatment-oriented design scheme blurs the boundary between trial and treatment， giving subjects participating in clinical trials more opportunities for clinical treatment while increasing the risk of therapeutic misunderstanding， changing the connotation of therapeutic misunderstanding， and triggering more ethical thinking. Ethics committees should pay more attention to content related to the review of the design scheme of clinical trials， the opportunities for patients to participate in trials and enrollment of subjects， changes in communication and informed consent between researchers and subjects， the definition of roles for clinicians and researchers， and other aspects， to ensure that clinical trials better protect the rights， safety， and well-being of subjects while generating new knowledge.
