Federal regulations governing the ethical participation of adolescents in research emphasize that adolescents be afforded as much decision-making autonomy as possible according to their developmental capabilities. Yet little empirical research has examined factors that may compromise an adolescent's voluntary assent to participate in research. We propose to conduct two studies that together will explore the influences of family, clinical investigator, and research risk/benefit on the ability of adolescents to provide a voluntary assent to participate in research. The focus in both studies is on examining parental influence strategies in a variety of circumstances where parents and adolescents disagree about research participation. In the first study we will examine investigator influences on assent decisions. In the second study we will hold investigator influences constant and then evaluate the impact of research risk and benefit on the process of adolescent and parent decision making about research participation. In both studies we will use hypothetical asthma research vignettes, presented to families with children diagnosed with asthma. An important preliminary step to the project is a vignette validation Pre-Study, where assessments of risks and benefits of the research vignettes will be independently evaluated by adolescents, parents, and clinical investigators. In both Study 1 and Study 2 all family members will first view the videotaped description of a single hypothetical research protocol. Private reactions and participation decisions will then be obtained from all family members. The family will then participate in a videotaped family interaction with instructions to discuss the research vignette and make a final participation decision. Private views of the final decision will then be obtained from all family members. The focus of the analysis for both studies will be on examining the videotaped communication interactions between adolescents and parents as they discuss the adolescent's participation in the research. We will examine the manner in which family communication patterns mediate the assent process in families. We also will examine the influence of important family factors such as illness severity and family relationships, by testing a structural model which characterizes relationships among these factors and their effects on voluntary assent. We anticipate that the findings of the proposed research will have a direct bearing on issues that facilitate compliance and retention into research protocols. As such we expect to make a significant contribution to enhancing both the effectiveness and ethics of adolescent research.
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