治験におけるインフォームド・コンセントのための被験者用説明文書の作成とその評価

概要

論文の詳細を見る
In Nagoya City University Hospital, pharmacists evaluated the contents of consent forms in approximately 800 clinical trials from October 1990. The results showed different opinions among sponsors, investigators and pharmacists. These different opinions were related to the observation term, wash out time, comparisons with placebos, the gathering of blood samples for monitoring investigational agents and so on. As a result, it was deemed necessary to completely and objectively revise the consent form. We therefore conducted two surveys via questionnaires regarding informed consent. Investigators tend to spend time explaining clinical trials to patients. However, this resulted in fewer acceptances. Approximately 85% of the examinees asked the investigators about the possible effects and adverse reactions of a clinical trial. Our surveys via questionnaires suggest that the concept of informed consent has now become established in Japan. In order to conduct high quality clinical trials, it is important that completing a consent form is done by a pharmacist who has a good understanding of the pharmaceutical properties of the investigational agent to be used.
日本医療薬学会の論文
2001-10-10