INFORMED CONSENT IN CHILDREN AND ADOLESCENTS - AGE, MATURATION AND PSYCHOLOGICAL STATE

Purpose: The purpose of this investigation was to examine the relation ship of understanding of research participation to anxiety, control, a nd stage of cognitive development. Methods: Participants included 44 b oys and girls ages 7 to 20 years. All were inpatients for the first ti me in pediatric units of a research hospital. Twenty participants were admitted for experimental treatment of pediatric cancers and 24 were admitted for a 3-week treatment of extreme obesity. An interview was c onducted to assess 12 elements of knowledge of research participation of a medical protocol. The interview was coded for: 1) knowledge of re search participation score, 2) weighted knowledge of participation in research score (based on physician ratings of what was most-to-least i mportant for children and adolescents to know), and 3) global control (perceived control over life, illness and treatment). A measure of anx iety and one Piagetian task to measure stage of cognitive development also were administered. Results: Pearson correlations, significant at p less-than-or-equal-to .05, were as follows: knowledge of participati on in research and global control, (r = .40) and weighted knowledge of participation in research score and global control (r = .38). Hierarc hical regression showed that the best predictors of knowledge of resea rch participation or the weighted knowledge of research participation score was global control alone or an interaction of global control wit h anxiety. Conclusions: Emotional factors were more frequently related to understanding of research participation than age or cognitive deve lopment. Providing medical environments that decrease anxiety and incr ease control may enhance children's and adolescent's understanding of the research process.