Ethical management of subjects′ complaints in drug clinical trials in a cancer hospital
10.3760/cma.j.cn113565-20220418-00063
- VernacularTitle:肿瘤专科医院药物临床试验受试者抱怨的伦理管理
- Author:
Lei ZHANG
1
;
Chunyi HAO
;
Jie LI
Author Information
1. 北京大学肿瘤医院医学伦理委员会 100142
- Keywords:
Drug clinical trials;
Subjects′ complaints;
Ethical management
- From:
Chinese Journal of Medical Science Research Management
2022;35(4):268-271
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze ethical management of subjects′ complaints in drug clinical trials in a cancer hospital.Methods:A retrospective analysis of the complaints of subjects received and properly handled by the ethics committee through telephone, e-mail and on-site reception during the drug clinical trial in our hospital. Case studies were conducted to analyze the reasons for the occurrence of some particular subjects′ complaints, processing procedures and resolution processes.Results:The number of subjects' complaints in clinical trials in our hospital decreased year by year. The ethics committee of our hospital would check it immediately and review it carefully after receiving the subjects′ complaints, and return the review decisions to the subjects and researchers, at the same time, follow up with board meeting report and documentation. Regarding to the reasons of the subject complaint, mainly identified were the failure to participate in clinical trials due to inclusion and exclusion criteria, withdraw by investigators due to safety concerns, and not satisfied with the compensation.Conclusions:When receiving subjects′ complaints, the ethics committee should manage them seriously, verify the reasons in time and follow up properly, act as a communication bridge between subjects, researchers and sponsors, try their best to resolve subjects′ complaints, and protect the rights and interests of subjects.
