小児臨床研究のアセント再考：“説明文書 ” に関する試論と試案

抄録

Many believe, based on the respect for persons ethical principle, that informed assent forms for pediatric clinical research should be prepared based on children's ability to understand the given information on a proposed research.

However, what the modality of an appropriate assent form for children should be, namely, how the form should be worded in Japanese and for which children it should be targeted, are yet to be answered in clinical research. This study tackled those profound questions through a 6-year longitudinal observation and interviews with one particular minor child and pedagogical analyses. At the age of 11.2 the observed child was asked to give her comments and make modifications to informed consent forms originally prepared for competent adults. Drawing on her elaboration as well as our analyses, we have created two models of informed assent forms and make seven proposals that elucidate the modality of child assent forms. Taking all 7 propositions is necessary to prepare an appropriate assent form for pediatric clinical research.