Psychotropic medication research in children and adolescents: empirical findings and ethical implications

WITH THE ESCALATION IN PRESCRIPTIONS of psychotropic medicine to young people over the last 11.2 decades, there has been increased scrutiny of psychopharmacological research with children and adults. There is a small but growing literature on participant knowledge of consent form information and of subject satisfaction in psychopharmacological studies. The data thus far suggest that parents and their participating children generally have had a good knowledge of the purposes of the trials, experimental conditions, possibility of receiving placebo, and right to withdraw from pharmacological trials; however, understanding of randomization is relatively poor. Social validity surveys indicate high levels of satisfaction with choice of outcome measures, clinical recommendations emanating from the research, and treatment received; most participants indicate that they would recommend the studies to other parents and children having similar conditions. None of the studies reviewed appears in a journal dedicated to research ethics or bioethics and in this sense may be hidden from IRB members and bioethicists. Nevertheless, the findings are pertinent to IRB deliberations. More research on participant knowledge and satisfaction is needed, with some emphasis on the perspectives of the youth themselves.