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Gene Therapy in PR China: Regulations and Ethical Concerns*

Author: Xinqing Zhang

Abstract:

In 2003, China became the first country in the world to approve a commercial gene therapy product. Yet serious moral doubts have been raised about the conduct of the experiment. The paper examines the ethical issues (e.g. review mechanism, family consent, and therapeutic misconception) in gene therapy in Chinese culture. It argues that China should review the clinical protocols more stringintly. One reason leading to therapeutic misconception is that investigators prefer to use the term ‘gene therapy’ rather than ‘human gene transfer research’ in the consent process. Family consent, from the point of view of the author, is not in itself sufficient to justify the experimental use of patients. Family-based individual consent could be a better option, especially if there are disagreements between a patient and his family in the consent process.

 

This is an electronic version of an article published in the Journal of International Biotechnology Law [JIBL]Vol. 2, Issue 5, pp. 212–216 , 2008. The Journal of International Biotechnology Law is available online at: http://www.degruyter.com/view/j/jibl.2005.2.issue-5/jibl.2005.2.5.212/jibl.2005.2.5.212.xml?format=INT