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
スポンサーリンク
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
日本医療薬学会 | 論文
- O17-003 視覚障害者に対する手技指導の標準化を目的とした視覚障害擬似体験インスリン注射院内実習(一般演題 口頭発表,糖尿病/後発医薬品,医療薬学の創る未来 科学と臨床の融合)
- 20H-16 Basal-Bolus療法におけるインスリンデテミルの有効性(使用状況調査・意識調査,来るべき時代への道を拓く)
- 30-P2-43 2種類のインスリン試薬を用いた化学発光酵素免疫測定法によってFactitious hypoglicemiaを証明しえた一例(副作用・有害事象,社会の期待に応える医療薬学を)
- 28-04-20 ペン型インスリン注射器の精度に及ぼす注入時抵抗とカートリッジ内気泡の影響
- P-610 ファブリー病に対する「ファブラザイム^[○!R]」投与時の「過敏反応発現時の対処方法」の一部改変により副作用防止に至った1症例(8.有害事象・副作用(基礎と臨床)1,医療薬学の未来へ翔(はばた)く-薬剤師の薬剤業務・教育・研究への能動的関わり-)