Abstract

It might be difficult for parents to understand the details of a clinical trial and give permission for their children's participation. In this research, we conducted a questionnaire survey of factors influencing the parents' decision on whether to give permission for their infant's participation in a randomized controlled double-blinded clinical trial on the prevention of atopic dermatitis. The number of valid responses were 131 (the response rate 70%), and no significant difference was observed in employment rate, time for travel, and distance to the hospitals between participant and non-participant groups. Parents who gave permission to participate in the clinical trial (105 parents) tended to feel the information given was easy to understand, and had better understanding of the randomized controlled trial, compared to the ones who did not give permission (26 parents). The most common reason for giving permission was the recommendation by their physicians who referred them to the trial sites, and the second most common reason was their interest in clinical research and contribution to the prevention in the future.

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