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Adolescent Sexual Behavior Research: Perspectives of Investigators, IRB Members, and IRB Staff about Risk Categorization and IRB Approval

The ethical review of research on adolescent sexual behavior is challenging. Investigators and institutional review boards (IRBs) alike struggle with pediatric risk categorizations for research on sexual health and other sensitive topics, resulting in delays in approving research and in variable categorization of the same protocols among IRBs, not only from institution to institution but also between IRBs within the same institution. These variations suggest that the regulations and laws governing adolescent participation in research are neither uniformly understood nor applied. Studies show that IRBs frequently overestimate research risks of behavioral research and studies that involve sensitive topics, and thus may be less likely to consider a waiver of parental consent for such research, even if a study objectively falls within the requirements for this exception. While data exist on variability in the outcome of IRB evaluation of adolescent sexual behavior research, little is known about the process of that evaluation. Thus, the main objective of this study was to examine factors that influence how pediatric investigators, IRB members, and IRB staff members categorize risk in adolescent sexual behavior research and assess whether the IRB should approve such research. For this study, at a university in Indiana, IRB members, IRB staff members, and investigators who submitted protocols involving minor adolescents participated in an online survey about their knowledge, attitudes, and approach to research with vulnerable populations, including adolescents.

Key words: research on adolescents, adolescent sexual behavior research, pediatric risk categorization