中国医学伦理学2016,Vol.29Issue(5):801-803,3.DOI:10.12026/j.issn.1001-8565.2016.05.20
I期临床试验受试者招募过程中的伦理问题
Ethical Issues in the Recruitment of Subjects during Phase I Clinical Trial
摘要
Abstract
Subject recruitment is an important part of clinical researches. It should follow the ethical principles of fairness and representativeness. The recruitment process should pay attention to protecting the privacy of sub-jects. Various recruitment materials must be approved by the ethics committee before use. Whether could recruit el-igible subjects during Phase I clinical trials will have a significant impact on the results, which should attract the relevant persons′attention including the ethics committee, researchers, clinical research associate and the sponsor.关键词
I期临床试验/受试者/招募/伦理问题Key words
Phase I Clinical Trials/Subjects/Recruitment/Ethical Issues分类
医药卫生引用本文复制引用
谷旭放,仲伟琴,王保和..I期临床试验受试者招募过程中的伦理问题[J].中国医学伦理学,2016,29(5):801-803,3.基金项目
国家科技重大专项创新药物研究开发技术平台建设-心脑血管疾病中药新药临床评价技术平台及规范研究(项目编号:2012ZX09303-010-001) (项目编号:2012ZX09303-010-001)