Objective: Since the 1950’s, children and adolescents have been defined as a vulnerable group for research participation. In 1998, in an attempt to expand options for innovative medical treatments to children, federal mandates were issued to include children in clinical research. Prior exclusion of children and adolescents from research, however, restricted researchers' understanding of what children, adolescents and parents think about research participation and what factors influence their decisions to participate. Therefore, the purpose of this paper is to present a model of factors influencing children's participation in research, specifically informed consent and assent. The model was developed based on the author's twenty years of experience conducting research with children and families, as well as data from an NIH funded study of children with chronic conditions, and their parents, who had been enrolled in clinical trials. The specific views of ill children and their families were sought as well as information about the impact of social and structural influences on those views using semi-structured interviews and narrative analytic techniques.
Findings: The "Involved Model of Informed Assent" for children in research acknowledges the role of relationships, the child's health status and developmental stage as three critical factors shaping the child's experience. Additionally, findings from interviews with 34 children and adolescents, 8 years to 22 years of age, who had a diagnosis of either diabetes or a hematological malignancy also illustrate how additional factors (sociocultural and study characteristics) are also influential in the child's understanding of research, their willingness to participate and stay involved overtime. Twenty-five (73 %) were Caucasian, 3 (9 %) African American, 3 (9 %) Hispanic, and 3 (9%) other. Nine themes were identified germane to the aims of this study. Three of these reflected the child’s perceptions about the initial recruitment process themes included: their understanding of research and how they differentiated between research and treatment, and their involvement in the decision to participate (Broome, Richards, & Hall, 2001). Six other themes illustrated the salience of relationships and structural factors that influenced participation. Three of these six themes were related to the relationships with powerful adults in the child/adolescents lives who influenced their decision to participate: faith in their parent(s), relationships with members of the research/medical team, and the child’s perception of what happens when a child/adolescent and his/her parent disagree about research participation. Lastly, there were three themes relate to structural and logistical aspects of the clinical trials and their disease that were factors that were imbedded in the context of the research: options for treatment if they decide not to participate in the clinical study, incentives to participate, and how the children talked about aspects of their lives outside the trial. This presentation discusses each of these factors and discusses implications for researchers obtaining meaningful consent/assent from children and adolescents.
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