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)

Inclusion of children in medical decision making, to the extent of their ability and interest in doing so, should be the default position, ensuring that children are routinely given a voice. However, optimizing the involvement of children in their health care decisions remains challenging for clinicians. Missing from the literature is a stepwise approach to assessing when and how a child should be included in medical decision making. We propose a systematic approach for doing so, and we apply this approach (...) in a discussion of two challenging clinical cases. The approach is informed by a literature review, and is anchored by case studies of teenagers' refusal of clinical care, regulatory requirements for research assent, and the accepted approach to involving cognitively impaired adults in medical decisions. (shrink)