When a clinical study is carried out in Japan, it is necessary to comply with Japanese regulations, in addition to the Declaration of Helsinki.
The followings are the major two regulations issued by the Japanese Ministry of Health, Labour and Welfare.
There are some other regulations (e.g. for studies on the analysis of the genetic information of humans) issued by the Japanese Ministry of Health, Labour and Welfare.
Please comply with the relevant regulations.
1. Clinical Trials Act
This Act demonstrates procedures for conduct of clinical trials, measures to offer appropriate reviews by the certified review board, and systems and publication of information on funds or other benefits for clinical trials.
The following specified clinical trials must follow this act.
・Clinical trials using pharmaceuticals and medical devices which are funded by a related manufacturer.
・Clinical trials using pharmaceuticals and medical devices which are not approved by the Pharmaceuticals and Medical Devices Law.
For details, please refer to the link below.
2. Obtaining ethical approval
Ethical approval must be obtained before undertaking any medical research involving human subjects. Most research ethics committees in Japan operate within associated research institutions. Please follow the rules set out by each institutional ethics committee when submitting protocols.
Animal experiments for medical research should be managed and conducted based on the following guidelines. Animal experiment protocols should be approved by the institutional animal care and use committee.
3. Clinical trials registry
Based on the Japanese Clinical Trials Act, it is mandatory to register all interventional trials in the clinical trials registry. The following registration systems are commonly used in Japan.
4. Funding opportunities
There are several competitive funding programs which provide support for scientific research in Japan. The Grants-in Aid for scientific research (KAKENHI) is the largest competitive funding program in Japan. For the details and applications, please refer to the following website.