Analysis of the Problem of Informed Consent in Clinical Trial
10.12026/j.issn.1001-8565.2018.01.05
- VernacularTitle:浅析临床试验知情同意问题
- Author:
Xiaoxiao WU
1
;
Lu WANG
;
Meiyou LIU
;
Xiaojuan YANG
;
Li PENG
;
Ying ZHANG
;
Yanyan JIA
;
Aidong WEN
Author Information
1. 第四军医大学西京医院药剂科
- Keywords:
Clinical Trial;
Vulnerable Groups;
Informed Consent
- From:
Chinese Medical Ethics
2018;31(1):20-23
- CountryChina
- Language:Chinese
-
Abstract:
Objective:By observing the process of informed consent in clinical trials of one top three hospital, to disclose the non - standard phenomenon existingin the process of informed consent in clinical trials, and put for-ward that there should be special protection mechanism for vulnerable groups to participate in clinical trials. Meth-ods:Combined with the actual situation of one top three hospital, we comprehensively analyzed the problems exist-ing in the process of informed consent of clinical trials in our center, put forward strict solutions, and also formula-ted strict standards for the informed consent process of vulnerable groups. Results:Through the strict requirements of the informed consent process of vulnerable groups, the test process of vulnerable groups participating in the clini-cal trial was standardized; meanwhile the vulnerable groups were given special protection. Conclusion:Informed consent is an important guarantee that protects vulnerable groups to participate in clinical trials.
