Regulatory Standards for Surgical Trials in Asia: The Japanese Experience

Currently, regulatory standards for surgical trials are not consistent between countries around the world. Japan is a country of independent, non-western philosophy, religion, and tradition that has had a sometimes-challenging history regarding the adoption and subsequent adaptation to western medical ethical standards. Similarly to the other parts of the world, Japan has had several cases of research misconduct. Based on these incidents, strict regulations on clinical research have been established through the Clinical Trials Act. However, surgical trials can be exempt from strict regulations so long as the study is observational or exclusively involves a surgical technique without use of novel surgical devices. Alternatively, studies of novel surgical techniques are usually monitored to confirm conformity with the governmental ethical guideline by an internal regulatory administration. Additionally, a new surgical technique must be reviewed and approved by the hospital’s department head or medical safety administrator prior to surgery. As a whole, Japanese regulations on clinical trials are well organized, but surgical trials can be exempted when focusing solely on existing surgical techniques. However, novel surgical technique comparisons still need to follow ethical guidelines and clinical regulatory standards in Japan.