Rethinking risk in pediatric research

This article reviews four areas of pediatric research in which we have identified questionable levels of allowable risk, exceeding those foreseen by the Commission. They are the following: (1) the categorization of increasingly risky interventions as minimal risk in a variety of protocols; (2) the increasing number of applications for federal panel review of research not otherwise approvable because of higher projected risk levels; (3) research on asymptomatic at risk children; and (4) the inclusion of children and adolescents in placebo-controlled trials for participants of all ages without performing subgroup analysis. While embracing the imperative to include children in research is an encouraging step towards providing the pediatric population with effective medical care and finally eradicating the therapeutic orphan, we must ensure that this research does not become overly permissive.     

Matching Judicial Supervision to Clients' Risk Status in Drug Court

This article reports outcomes from a program of experimental research evaluating the risk principle in drug courts. Prior studies revealed that participants who were high risk and had (a) antisocial personality disorder or (b) a prior history of drug abuse treatment performed better in drug court when scheduled to attend biweekly judicial status hearings in court. In contrast, participants who were low risk performed equivalently regardless of the court hearings schedule. This study prospectively matches drug court clients to the optimal schedule of court hearings based on an assessment of their risk status and compares outcomes to clients randomly assigned to the standard hearings schedule. Results confirmed that participants who were high risk and matched to biweekly hearings had better during-treatment outcomes than participants assigned to status hearings as usual. These findings provide confirmation of the risk principle in drug courts and yield practical information for enhancing the efficacy and cost-efficiency of drug courts.