title: Unique Ethical Concerns in Clinical Trials Comparing Psychosocial and Psychopharmalogical Interventions.
abstract: In recent years, there has been a particular emphasis placed on conducting randomized controlled trials (RCTs) that compare the relative efficacy of psychosocial and pharmacological interventions. This article addresses relevant ethical considerations in the conduct of these treatment trials, with a focus on RCTs with children. Ethical concerns, including therapeutic misconception, treatment preference, therapeutic equipoise, structure of treatments, and balancing risks versus benefits, are introduced through a clinical scenario and discussed as they relate to psychotherapy versus medication RCTs. In each case, suggestions are made for researchers seeking to minimize the impact of these ethical concerns on research participants.
authors.affiliation: Case Western Reserve University.
authors.forename: Lisa R
authors.initials: LR
authors.lastname: Stines
authors.forename: Norah C
authors.initials: NC
authors.lastname: Feeny