lescents. Response rate was 52%. Predictor variables included knowledge about healthcare consent laws on emergency services, contraception, drug treatment and STIs, knowledge about reporting requirements on statutory rape, drug use and child abuse including sex with minors, knowledge of federal research regulations and SAHM guidelines, and self-efficacy in reviewing protocols. For the outcome variable, participants read a brief hypothetical research scenario of a single, anonymous survey of 11-14 year-olds about their sexual behaviors, including oral, vaginal, and anal sex. Participants were asked to provide a pediatric risk categorization and to state whether they felt it was approvable. We created a composite outcome variable combining correct risk classification (Category 1) and assessment of approvability, with higher scores indicating correct risk categorization and approvability. Structural equation modeling (AMOS 21.0; all p<.05) was invoked to evaluate structural relationships. Results: Participants (N total 1⁄4 159) included 9 IRB staff, 68 IRB membersand117 investigators (multiplerolespossible). Investigators included both adolescent researchers as well as subspecialists such as pediatric oncologists and gastroenterologists whose research includes adolescent aged participants. 41% of the sample correctly identified the scenario as a risk category 1 and 53% reported it as approvable. Respondents who correctly answered about Indiana healthcareconsent lawforsexually transmitteddiseasediagnosisand treatment scored better on their overall assessment of the scenario’s risk category and approvability (B1⁄4 .22). Knowing that providers do notneed to report consensual sex between two14-year-olds similarly scored better on their overall assessment of the scenario’s risk categoryandapprovability (B1⁄4 .12).However, beliefs thatadolescentmay consent for contraception services predicted lower scores (B 1⁄4 -.17). Other predictors were non-significant. Conclusions: Risk categorization and approval of adolescent protocols is related to clinical knowledge of health care consent laws and mandated reporting requirements. The negative association of beliefs about consent for contraception may be due to Indiana law’s silence on the issue and resultant misperceptions. Our findings suggest that adolescent providers, with their intimate knowledge of adolescent-related laws, regulations and best practices, may be positioned best to evaluate adolescent research, and that IRBs should have adolescent health representation on their boards. Sources of Support: IU Health Values Grant.
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