title: A retrospective study of children's perceptions of participation as clinical research subjects in a minimal risk study.
abstract: The purpose of the study was to evaluate children's perceptions of their participation as research subjects in a minimal risk research study (a methylphenidate population pharmacokinetic study conducted 8 months earlier). We identified 115 children of an original 189, aged 6 to 19 years, who were responding well to regular methylphenidate for attention-deficit hyperactivity disorder. By using a structured format, telephone interviewers unconnected to the original study questioned the children about what it had been like to be a subject in terms of voluntariness, accuracy of informed consent, reasons for participating, and satisfaction with their experience. Children overwhelmingly perceived their involvement as voluntary (89%) and the information about the study as accurately presented (80%), and they reported a high level of satisfaction with their participation (97%). Self-interest was the most frequently reported reason for participation (47%). In a subsample of 25 children, the percentage of agreement of a 1-week test-retest equaled or exceeded 72% for all answers.
authors.affiliation: Division of Child and Adolescent Psychiary, University of South Dakota School of Medicine, Sioux Falls 57105, USA.
authors.forename: B S
authors.initials: BS
authors.lastname: Fogas
authors.forename: J R
authors.initials: JR
authors.lastname: Oesterheld
authors.forename: R I
authors.initials: RI
authors.lastname: Shader
mesh_terms: D000293:Adolescent; D000328:Adult; D001289:Attention Deficit Disorder with Hyperactivity / Q000097:blood* / Q000188:drug therapy; D001294:Attitude to Health; D002648:Child; D002986:Clinical Trials as Topic; D005260:Female; D006805:Human Experimentation / Q000331:legislation & jurisprudence; D006801:Humans; D007258:Informed Consent; D008297:Male; D008774:Methylphenidate / Q000097:blood / Q000493:pharmacokinetics* / Q000627:therapeutic use; D009042:Motivation; D017410:Practice Guidelines as Topic; D012189:Retrospective Studies; D012649:Self Concept; D014481:United States
chemical_list: D008774:Methylphenidate