Parental opinions about clinical research.

OBJECTIVE: To characterize parental perception of clinical research, particularly in emergency settings. To identify specific aspects of clinical research that concern parents and to discuss how these concerns can be addressed. STUDY DESIGN: Quantitative and qualitative survey in tertiary care children's hospital and affiliated clinics. RESULTS: Family caregivers (n = 136) participated in this study; 81% of study participants agreed or strongly agreed that physicians should do research involving children, with 5% disagreeing. However, 18% felt that researchers care more about the research than about the patient, and 13% believed that when a child is in a research study, physicians must follow the research protocol even if it is not in the best interest of the child. Participants were significantly less likely to endorse the conduct of research in an emergency setting than in a nonspecified setting (P < .001). Parents' foremost concern about emergency research was that it could delay therapy or distract physicians' attention from the child's needs. CONCLUSION: Parents largely support pediatric clinical research, but they have specific concerns that should be addressed in research planning and in communicating with parents about clinical research.

A developmental approach to child assent for nontherapeutic research.

The question of when and how to obtain child assent for nontherapeutic research has received increasing attention in recent years. Although child assent and parent permission are grounded in the principle of respect for persons, assent is often understood from the more narrow principle of respect for autonomy. When viewed in this way, "assent" is frequently conflated with "consent," and children are held to a higher standard than what might be sufficient for meaningful involvement in decision-making about research participation. When nested within the requirement for parental permission, child assent functions as a way to promote children's moral growth and developing autonomy, rather than as an autonomous decision. A developmental approach to child assent is necessary to understand how children can be meaningfully involved in decision-making about research participation across development. This approach suggests that the content and process of child assent should be allowed to vary across development. In addition, a developmental approach requires that future research employ longitudinal designs, examine the developmental mechanisms underlying age variations in child assent, and attend to both cognitive and noncognitive variables that may influence the assent process as children mature.