Abstract
The Ethical Guideline for Clinical Research, issued by the Ministry of Health, Labor and Welfare of Japan in 2003 and revised in July 2008, requires compensation for subjects' injury related to investigator-initiated clinical studies. At the Osaka University Hospital, contracts with insurance companies were included in 26, 16, and 15 protocols in 2009, 2010 and 2011, respectively. These insurance products cover transient payment but do not include the cost of medical care. Since the implementation of the revised guideline, several issues on the contracts with insurance companies have been encountered during three years. The insurance fee estimates varied greatly among the companies. In some cases, all four companies rejected to insure due to high risk. In other cases, three rejected and one company requested high insurance fee. In multi-center studies, the compensation frameworks may differ for each hospital. The compensation for clinical trials aiming at ameliorating side effects caused by cancer treatment showed a gap between the guideline and the actual situation. The insurance for clinical trials using devices showed challenges in evaluating the risk and benefit. Considering these issues, better compensation frameworks including cost of medical care should be established to protect human subjects. (Jpn J Clin Pharmacol Ther 2013; 44(3): 201-206)
