Bridging Disciplinary Boundaries (January 11 - 14, 2007)

Background: Increasingly institutional review boards and governmental research institutes are emphasizing the potential risks involved in psychosocial research involving children and adolescents. Over the past decade, increased attention has been given to the importance of full parental consent and child/adolescent assent as a prerequisite to subject participation in research studies. Previously, it was more common for studies to inform parents of the study's purpose and the risks/benefits, and provide mechanisms for them to withdraw their children/adolescents from the study. This approach is particularly beneficial for large cross-sectional studies, but possibly carries the attendant threat of increased risk of adverse events. The current study investigates the occurrence/non-occurrence of adverse events in three large school-based studies of children and adolescents that used this latter approach. Methods: This investigation uses data from 3 separate studies of children and adolescents conducted between 1993 -1998. The studies were designed independently and were conducted in different locations (Colorado, Ohio, Arizona); each investigated the relationship between children's/adolescents' reports of being a witness/victim of violence, emotional/behavioral problems (e.g., depression, anxiety, anger) and their own aggressive behaviors. One study focused on high-school students, the other two on children in elementary and middle school. Anonymous self-report questionnaires were administered during the usual school hours by classroom teachers. Students were informed verbally and in writing that if they had any upsetting thoughts or feelings after completing the questionnaire, they should tell their teacher or a guidance counselor. Both teachers and guidance counselors were prepared for this possibility. Parents/guardians were given written information on the purpose of the studies and the potential risks/benefits. They were also given the telephone numbers of school and research personnel to address their questions, and an exclusion form to sign to withdraw their child/adolescent from the study. Exclusion could also have been achieved by calling any of the supplied telephone numbers. Students were told (verbally and in writing) that their participation was completely voluntary. The combined sample of the studies represents a racially and ethnically diverse group of 9,487 respondents, about half of whom were female. Across the three studies, the percentage of whites ranged from 31% to 57%, Hispanics from 5% to 51% and African Americans from 6% to 35%. Subjects' ages ranged from 7-19 years, with a mean age of 12.9 years. High rates of student participation were achieved (68%, 80%, 85%). Results: Across studies 18 parents/guardians chose to exclude students. There were no reports from guidance counselors or teachers of student upset or of adverse effects and no reports/feedback from parents/guardians to either school or research personnel to indicate student upset or adverse effects. Additionally, there were no written comments by students in space provided at the end of the questionnaire to indicate adverse consequences from completing the questionnaire. Conversely, several students wrote positive comments about interest being given to their thoughts and feelings. Conclusions: The finding of no adverse events in these large cross-sectional studies raises the question of the type of consent needed to study children/adolescents using lower risk psychosocial research protocols.