Friday, August 28, 2009
Wednesday, August 19, 2009
A perusal of the Chinese regulations- at least the ones provided in this report- indicate the following:
• China places heavy emphasis on procedure (e.g. IRB review) and informed consent, rather than substance (e.g. prohibitions on certain practices; definitions of minimal risk; categories of patients)
• China seems to take a very permissive stand (like ICH) on the use of placebos. Indeed, there is no mention of studies involving placebo.
• There is no mention of justice considerations- for example, post-trial access or responsiveness.
(photo credit: 2 dogs, 07/03/25 12:32:09 Shanghai, 2007)