Integrating science and ethics in child and adolescent psychiatry research

Research to elucidate the biological bases of psychopathology in children a nd adolescents is needed to understand pathogenesis and to develop effectiv e and safe treatment and preventive interventions. Because of the effect of development, data collected in adults are not always applicable to youth, and direct participation of children in research is necessary. Many medicat ions are currently used in the community to treat children and adolescents with neuropsychiatric disorders without adequate data about their safety an d efficacy. Conducting research in children requires attention to specific ethical and regulatory factors. In deciding whether miners can participate in a study with potential direct benefit to the research subjects, the most important variable to consider is the balance between risks and potential benefit, in the context of the seleriry of the child's condition and the av ailable alternatives. Research with no potential benefit to the participant s is guided by the concepts of minimal risk (which may apply more 20 normal children) and minor increase over minimal risk (perhaps more relevant to c hildren affected by psychopathology). Recently conducted studies relevant t o this issue are reviewed. Of paramount importance is the ratio of risk/sci entific value of the proposed experiment. In fact, no research is justifiab le, no matter how low the risk may be, unless the potential yield of the st udy is important and may help advance our understanding of normal functioni ng and mental illness.