Abstract

More Institutional Review Boards (IRBs) are requiring written parental consent in school health intervention trials. Because this requirement presents a formidable challenge in conducting large-scale research, it is vital for investigators to share effective strategies learned from completed trials. Investigators for the recently completed Project SPLASH ( n = 3,716) smoking prevention trial, conducted in 20 Hawaii middle schools, were required to obtain active parental consent for three surveys across 2 years. This case study describes the consent procedures and incentives used in the trial, and their effectiveness. The overall parental response rate was 85.4%. The highest response rate (89.5%) came from the 7th grade baseline survey, where project staff distributed consent materials and provided class-based incentives. In addition, nearly all students (99.0%) with parental permission assented to participate in the three surveys. The experiences in this study lead to several recommendations for future research, including the importance of assuring adequate funds for recruitment and retention in research grants.

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