An Exploration of the Protective Effects of Investigators' Ethical Awareness upon Subjects of Drug Clinical Trials in China

doi:10.1007/s11673-017-9826-5

科研成果详情

题名	An Exploration of the Protective Effects of Investigators' Ethical Awareness upon Subjects of Drug Clinical Trials in China
作者	Zhang L.1; Huang X.X.1; Chen H.F.2
发表日期	2018-03
发表期刊	JOURNAL OF BIOETHICAL INQUIRY 影响因子和分区
语种	英语
原始文献类型	Article
关键词	Ethics committees Insurance Informed consent Human subjects research Research ethics China
其他关键词	INFORMED-CONSENT
摘要	Up till now, China has not enacted any legal mechanisms governing certification or supervision for ethics committees. This article analyses deficiencies in the protection of subjects in clinical drug trials under China's current laws and regulations; it emphasizes that investigators, as practitioners who have direct contact with subjects, play significant roles in protecting and safeguarding subjects' rights and interests. The paper compares the status quo in China in this area to that of other countries and discusses ways China might enhance the protection of rights and interests of trial subjects, such as enhancing the ethical awareness of investigators through training, improving laws and regulations, and strengthening the communication between investigators and ethics committees.
资助项目	Wenzhou Municipal Science and Technology Bureau [R20160024] Funding Source: Medline
出版者	SPRINGER
出版地	NEW YORK
ISSN	1176-7529
EISSN	1872-4353
卷号	15 期号:1 页码:89-100
DOI	10.1007/s11673-017-9826-5
页数	12
WOS类目	Ethics ; Medical Ethics ; Social Issues ; Social Sciences, Biomedical
WOS研究方向	Social Sciences - Other Topics ; Medical Ethics ; Social Issues ; Biomedical Social Sciences
WOS记录号	WOS:000429959500014
收录类别	SSCI ; SCIE ; PUBMED ; SCOPUS
URL	查看原文
PubMed ID	29230696
SCOPUSEID	2-s2.0-85037695322
社科自定义期刊分类	F类
通讯作者地址	[Chen H.F.]Office of Drug Clinical Trial Institution,The Frist Affiliated Hospital of Wenzhou Medical University,Nanbaixiang, Ouhai District,Wenzhou,325003,China
Scopus学科分类	Health (social science);Health Policy
引用统计	被引频次：1[WOS] [WOS记录] [WOS相关记录]
文献类型	期刊论文
条目标识符	https://kms.wmu.edu.cn/handle/3ETUA0LF/3087
专题	附属第一医院_药物临床试验机构办公室
通讯作者	Chen H.F.
作者单位	1.Office of Drug Clinical Trial Institution,The First Affiliated Hospital of Wenzhou Medical University,Nanbaixiang, Ouhai District,Wenzhou,325003,China; 2.Office of Drug Clinical Trial Institution,The Frist Affiliated Hospital of Wenzhou Medical University,Nanbaixiang, Ouhai District,Wenzhou,325003,China
第一作者单位	附属第一医院; 第一临床医学院（信息与工程学院）、附属第一医院
通讯作者单位	温州医科大学
第一作者的第一单位	附属第一医院
推荐引用方式 GB/T 7714	Zhang L.,Huang X.X.,Chen H.F.. An Exploration of the Protective Effects of Investigators' Ethical Awareness upon Subjects of Drug Clinical Trials in China[J]. JOURNAL OF BIOETHICAL INQUIRY,2018,15(1):89-100.
APA	Zhang L., Huang X.X., & Chen H.F.. (2018). An Exploration of the Protective Effects of Investigators' Ethical Awareness upon Subjects of Drug Clinical Trials in China. JOURNAL OF BIOETHICAL INQUIRY, 15(1), 89-100.
MLA	Zhang L.,et al."An Exploration of the Protective Effects of Investigators' Ethical Awareness upon Subjects of Drug Clinical Trials in China".JOURNAL OF BIOETHICAL INQUIRY 15.1(2018):89-100.