Effective implementation of federal regulations governing research assent requirements for minors has been hampered by scant empirical research and limited regulatory guidance on how to appropriately ensure voluntary assent from research participants who span the entire developmental spectrum of childhood and adolescence. This lack of guidance has resulted in disagreements about the most propitious and ethical methods of acquiring consent/assent from minors, with clinicians, investigators, and ethicists endorsing disparate philosophies and procedures for obtaining assent. The two studies proposed in this application begin the much-needed process of harnessing emerging empirical findings to develop testable interventions that enhance the assent process for children and adolescents. There is growing advocacy among scientists, ethicists, and policy makers for increasing the rights of adolescents to make more independent research participation and medical treatment decisions. Study 1 of the present application proposes to test an """"""""autonomy enhanced assent"""""""" intervention for obtaining adolescent research assent and parental permission against an """"""""assent as usual"""""""" intervention conducted in the context of an actual pediatric asthma clinical trial for adolescents (ages 12-17). Relationships between the assent intervention and completion/compliance with the asthma trial will also be evaluated. If the process for obtaining research assent from adolescents emphasizes autonomy, then research assent for younger children, who are more cognitively, psychologically, and functionally dependent upon parents, ought to be conceptualized in a qualitatively different manner. There is almost no empirical literature that addresses how parents and investigators approach research participation decisions for young children, how assent for young children is obtained, or what children are capable of understanding about research. Study 2 of this proposal examines both typical parent behavior and the influence of clinician-investigator recommendations, on permission and assent for the participation of young children (ages 6-11) in a hypothetical asthma research protocol. A brief educational intervention to enhance parents' understanding of the importance of child assent, will also be evaluated for its impact on the willingness of parents to honor child dissent and on the child's understanding of the research protocol.
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