[Review of the 2008 revision of the ethical guidelines for clinical studies].

The ethical guidelines for clinical studies were revised in 2008 and enforced in April 2009. This was the second revision but first regular revision and largely reviewed. In particular, articles under the purview of the Institutional Review Board (IRB) for clinical studies are reviewed and enhanced. This additional role further increases the authority of the IRB, and those who fix the IRB must exhibit the activity of the IRB to the public and report to the MHLW annually. The provision of compensation for clinical studies on the evaluation of drugs and medical devices has been added to this version of the ethical guidelines. The compensation for interventional clinical studies using drugs and medical devices has not yet been decided, similar to "chiken," which is defined in pharmaceutical affairs laws (PAL). Since April 2009, some insurance offices have started offering special insurance covers for clinical studies. New registration rules have been established for clinical studies. Moreover, there is now a database for clinical study registration called "Japan Primary Registries Network (JPRN)," which is certified by WHO. This database comprises 3 open databases, which were originally independent, related to clinical trials in Japan. They are however under the purview of the National Institute of Public Health. This institution works in collaboration with the "International Clinical Trials Registry Platform (ICTRP)" of WHO.