This study described parent participation in the informed consent conference for randomized clinical trials (RCTs) in childhood leukemia and documented the relationship of physician communication to parent participation. Parents of 140 children with newly diagnosed leukemia who were eligible for RCTs were studied at six sites using comprehensive methods involving direct observation and transcripts of parent-physician communication based on audiotapes. Parent participation during the informed consent conference reflected a wide range of content categories. Consistent with hypotheses, Physician Rapport and Partnership (...) Building related to parent participation in the informed consent conference but Information Giving did not. Higher parent socioeconomic status also was related to greater parent participation for two of three measures of parent participation. Findings suggest that physician behaviors that provide support and facilitate communication may enhance parental participation in the informed consent conference for RCTs in childhood leukemia. (shrink)

This narrative review summarizes the empirical literature on children's competence for consent and assent in research and treatment settings. Studies varied widely regarding methodology, particularly in the areas of participant sampling, situational context studied (e.g., psychological versus medical settings), procedures used (e.g., lab-based vs. real-world approaches), and measurement of competence. This review also identified several fundamental dilemmas underlying approaches to children's informed consent. These dilemmas, including autonomy versus best interests approaches, legal versus psychological or ethical approaches, child- versus family-based approaches, (...) and approaches that emphasize consent versus those that emphasize assent, have implications for the measurement of children's competence and interpretation of findings. Recommendations for future research in the area of children's informed consent include the use of diverse samples and control groups, development of multidimensional and standardized measures of competence, utilization of observational methods and longitudinal designs, examination of noncognitive aspects of children's competence, and comparison of children's competence for treatment and research decisions. (shrink)