Innovative approach to parental consent and involvement in epidemiological study of pubertal development in children ages 7-15

The Growth and Puberty study conducted between 2007 and 2009, piloted approaches to enrollment in a puberty onset study. A subset of Iowa families with children ages 7-15 participating in the Agricultural Health was studied. One objective was to assess acceptability and challenges of enrolling and retaining families in such a study. The study used the Tanner Scale to assess puberty during three home visits over six months. Children provided biological samples, measurements, and interview data.

The IRB initially raised concerns about the explicitness of illustrations in the Tanner scale and of certain child interview questions about pubertal development. In response, study staff balanced the privacy of the child with parental prerogative to influence the level of sensitivity of study materials their child would be exposed to. Three versions of the Tanner form with varying levels of explicitness and staging were designed; and parents chose the version with which they felt most comfortable. Parents were allowed to review the child interview questions before the interview. Staff requested time alone with the child to conduct the confidential interview.

Among eligible parents refusing to participate, 50% did not provide a reason for refusal; 30% cited family schedules, and 10% indicated that the study was too invasive. All families who enrolled completed all home visits, all interviews, and all gave permission for their children, regardless of age, to complete the most sensitive version of the Tanner. Studies of puberty present challenges that can be partially met by attention to the sensitivities of parents.