治験依頼者より提出された補償資料と同意説明文書の記載内容に関する比較検討

概要

論文の詳細を見る
Compensation for health problems caused by clinical trials is a serious economic concern for their subjects. Documents concerning compensation arising from clinical trials considered by the Institutional Review Board (IRB) are "Compensation for Damage to Subject Health" and "Explanation of Informed Consent". In the present study, we conducted a comparison of the compensation details of these 2 documents. We found that until 2002, documents submitted for most clinical trials had only been a copy of an insurance policy. In 2002, liability insurance policies were submitted to the IRB more often than compensation insurance policies but after this, the number of compensation insurance policies gradually increased and there were more of this type of policy than compensation insurance policies from 2004 onwards. When we asked sponsors to present documents giving detailed information on compensation in 2003, more than 80% submitted them. On the other hand, the submission of documents concerning informed consent did not increase. This showed that the details of compensation had not been fully explained to trial subjects. It has been said that half of trial subjects do not understand compensation details and our study showed that this is because the explanatory materials on compensation are inadequate.
日本医療薬学会の論文
2008-05-10