225642 Innovative approach to parental consent and involvement in epidemiological study of pubertal development in children ages 7-15

Sunday, November 7, 2010

Christina Makarushka, MPH , Social & Scientific Systems, Inc., Durham, NC
Pamela Schwingl, PhD , Social & Scientific Systems, Inc., Durham, NC
N.B. Ragan , Epidemiology Branch, National Institute of Environmental Health Sciences, Research Triangle Park, NC
Michele Marcus, PhD , Rollins School of Public Health, Department of Epidemiology, Emory University, Atlanta, GA
Dale P. Sandler, PhD , Epidemiology Branch, National Institute of Environmental Health Sciences, Research Triangle Park, NC
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.

Learning Areas:
Public health or related research

Learning Objectives:
Identify five successful strategies for enrolling and retaining families with children ages 7-15 in a study of puberty and pesticides.

Keywords: Research, Child/Adolescent

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I am qualified to be an abstract Author on the content I am responsible for because I was the study manager responsible for developing and implementing the study with the principal investigator.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.