Human Subjects Protections in Clinical Drug Trials in China
- First Online:
- 23 Downloads
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.
- 1.Operational guidelines on clinical study sites. No. 14 file of “Wei Yao”. Beijing: Ministry of Health, 1995Google Scholar
- 2.Good clinical practice in drug clinical trials. Beijing: Ministry of Health, 1998Google Scholar
- 3.Good clinical practice in drug clinical trials. Beijing: Ministry of Health, 2003Google Scholar
- 4.Tian S. Drug clinical trials and GCP. Beijing: Peking University Medical Press, 2003: 97Google Scholar
- 5.CCMO [online]. Available from URL: http://www.ccmo-online.nl/main.asp?.pid=14&sid=15 [Accessed 2006 Jun 30]
- 7.Gunsalus CK, Bruner EM, Burbules NC, et al. Mission creep in the IRB world. Science 2006 Jun 9: 312 (5779): 1441 [online]. Available from URL: http://www.sciencemag.org/cgi/content/summary/312/5779/1441 [Accessed 2006 Sep 25]PubMedCrossRefGoogle Scholar
- 8.Federman DD, Hanna KE, Lyman L, et al., editors, for the Committee on Assessing the System for Protecting Human Research Participants. Responsible research: a systems approach to protecting research participants [online]. Available from URL: http://www.iom.edu/CMS/3740/4870/4459.aspx [Accessed 2006 Oct 4]Google Scholar
- 9.European Parliament. Directive 2001/20/EC: the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use [online]. Available from URL: http://eudract.emea.eu.int/docs/Dir2001-20_en.pdf [Accessed 2006 Sep 17]
- 10.Main results of the third investigation of national healthcare [online]. Available from URL: http://www.moh.gov.cn/uploadfile/200412/200412314857549.doc [Accessed 2006 Jun 20]