International Journal of Pharmaceutical Medicine

, Volume 20, Issue 6, pp 367–372

Human Subjects Protections in Clinical Drug Trials in China

A Focus on the Institute Level
  • Jiaqi Xu
  • Benfu Li
  • Qiang Ma
  • Haitao Heidi Liu
  • Yali Cong
Special Section on Medicines Development in China Focus on China

DOI: 10.2165/00124363-200620060-00005

Cite this article as:
Xu, J., Li, B., Ma, Q. et al. Int J Pharm Med (2006) 20: 367. doi:10.2165/00124363-200620060-00005

Abstract

With the increasing number of clinical trials being undertaken in China over the last few years, stakeholders in human subjects protections (HSP) are facing many new challenges; currently, these challenges in HSP are largely taken up by the ethical review committees and study investigators. This article identifies a number of issues with the present system and suggests ways to resolve these issues at the institutional level. Though the Chinese government has developed a basic regulatory framework for HSP, further work still needs to be done.

It is imperative that China develops a robust and reliable HSP system at the institutional level as drug studies are increasingly being undertaken in mainland China.

Copyright information

© Adis Data Information BV 2006

Authors and Affiliations

  • Jiaqi Xu
    • 1
  • Benfu Li
    • 2
  • Qiang Ma
    • 2
    • 3
  • Haitao Heidi Liu
    • 4
  • Yali Cong
    • 5
  1. 1.Department of Drug Safety and InspectionState Food and Drug AdministrationBeijingChina
  2. 2.Chinese Medical Ethics AssociationBeijingChina
  3. 3.Shanghai Health BureauShanghaiChina
  4. 4.Forum for Ethical Review Committees in Asia and the Western Pacific (FERCAP)BangkokThailand
  5. 5.Medical Ethics ProgramPeking University Health Science CenterBeijingPeople’s Republic of China