China’s New Research Ethics Guidelines
There has been plenty of concern, in North America and Europe, about Western drug companies conducting clinical trials in Africa and Asia. There have been calls for Western ethics boards to exercise extra scrutiny, but another piece of the puzzle, obviously, is good local regulations. In that regard, it’s interesting to note that just this week, the People’s Republic of China issued guidelines on the mandate and composition of research ethics committees. Here’s the story, from China Radio International: China Issues First Guidelines on Medical Ethics Committee
China on Monday issued its first guidelines regarding the operation and power of the medical ethics committee, which would strengthen the committee’s role of supervision and protecting the rights and interests of human subjects involved in clinical medical trials.
The guidelines, posted on the website of the State Food and Drug Administration (SDFA)….
Here’s the SDFA’s brief statement on the Guideline for Ethical Review of Drug Clinical Trials issued [Link no longer works]. The CRI article and the SDFA’s short statement are short on details, and the Guideline document itself does not yet seem to be available online. Stay tuned.
(Here’s the English-language version of the State Food and Drug Administration’s main website.)