Analysis and discussion on the subject complaint in clinical drug trials
10.3760/cma.j.cn113565-20220808-00140
- VernacularTitle:药物临床试验中的受试者抱怨案例分析与对策探讨
- Author:
Cuicui CONG
1
;
Fang WANG
Author Information
1. 北京大学人民医院 100044
- Keywords:
Ethics Committee;
Subject complaint;
Management measures
- From:
Chinese Journal of Medical Science Research Management
2023;36(2):86-89
- CountryChina
- Language:Chinese
-
Abstract:
Objective:By exploring the management of subject complaints by the ethics committee, to identify and correct the problems that damage the rights of subjects in clinical drug trials, in order to improve the ability of the ethics committee of protecting the rights and interests of the subjects.Methods:We conducted a retrospective analysis of 13 cases of subject complaints accepted by the Ethics Committee of Peking University People′s Hospital from January to December 2021, analyzed the causes of complaints, and proposed countermeasures and suggestions.Results:Problems exist in the subject complaints regarding the payment of compensation, investigators′ communication attitude and skills, subjects′ understanding bias, etc.Conclusions:The ethics committee should attach great importance to subject complaints, adopt a closed-loop management process, carry out hierarchical management, strict ethical review, improve the ability of continuous supervision, conduct targeted training for investigators, and provide counseling services for subjects, to improve the communication between investigators and subjects, effectively reduce and avoid the occurrence of complaints. Relevant functional departments of medical and health institutions should work together to protect the rights and interests of the subjects.
