Investigation and Analysis of the Influencing Factors of Informed Consent of Subjects in Drug Clinical Trial

VernacularTitle:药物临床试验受试者知情同意的影响因素调查及分析
Author: Yue ZHANG ¹ ; Xiaoyun CHEN ; Shengfu YOU
Author Information

1. 上海中医药大学设备与房产管理处
Keywords: Drug Clinical Trials; Informed Consent; Subjects' Rights Informed
From: Chinese Medical Ethics 2018;31(2):213-219
CountryChina
Language:Chinese
Abstract: Taking a class A tertiary hospital in Shanghai as center, this paper understood the awareness of the subjects of drug clinical trials on their participation in the research and their own rights as subjects after the end of research (6～18 months) by questionnaire survey completed by telephone interview, analyzed the problems existing in the process of informed consent, compared with the foreign status, and summed up a variety of feasible ways of subject' s own right to be informed, to put forward feasible suggestions for the development and improvement of medical scientific research management and the ethical work in China.