Risk-based protection of participants in un-notified clinical trials No-fault Compensation & Informed Consent-

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Un-notified clinical trials to the authorities are still allowed in Japan, other than IND/IDE trials. The Ethical Guidelines for Clinical Studies, the only regulation for those, were fundamentally revised and enacted in April 2009, which obligate researchers to take measures on compensation such as insurance in clinical trials to assess pharmaceuticals or medical devices.Since casualty insurance companies have not accumulated know-how to estimate the risk of un-notified trials besides IND/IDE trials, compensation insurance remains inadequate in quality.In order to overcome the situation, we have set a working group of'Risk-based protection of trial participants in un-notified clinical trials' among academic clinical institutes and a casualty company. The working group has investigated legal restriction for insurance, medical expense reduction system in the academic hospital, and an academic guideline for compensation in researcher-initiated un-notified clinical trials.