Recently, there have been attempts to promote drug development by constructing a large-scale registry system for patients with different illnesses in Japan. Although belated, a patient registry system for mental disorders was launched by collaboration between the National Center of Neurology and Psychiatry and the Japanese Society of Psychiatry and Neurology. The registry for mental disorders consists of three layers. The first layer involves basic information such as demography and/or diagnosis. The second layer involves more detailed clinical information, and the third comprises biological information. Each medical institution will decide which layer information can be collected from according to its organization. We are expecting a wide range of institutes nationwide to collect information from the first layer. There are several ethical issues to be considered with regards to the construction and utilization of the registry. First, informed consent must be obtained from the patients because their medical information may be utilized for either academic or industrial purposes, and may even be provided to a third party. Next, in terms of the social significance and scientific validity, it is highly probable that the outcome will advance research on the pathogenesis of mental disorders as well as improve the success rate in clinical trials. In addition, with the aim of subject protection and maintenance of research quality and transparency, a steering committee for the registry for mental disorders and provision of information review committee will be established to monitor the process, improve and maintain the operational system, deal with unexpected issues regarding human rights and advocacy, set up utilization rules, and construct the review system. The medical information treated in this study is considered to be special care-required personal information. Organizations or groups aimed at academic studies are exempt from complying with the Act on the Protection of Personal Information when the medical information is provided for use in academic studies. However, certain efforts to protect personal information are required from all persons concerned in each individual study.
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