title: The Influence of Age, Health Literacy, and Affluence on Adolescents' Capacity to Consent to Research.
abstract: While adults are assumed to have the capacity to consent to medical research, and young children to have no capacity, adolescents' capacity to consent is not well described. Adapting the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), we describe adolescents' capacity to consent to medical research and factors influencing that capacity. Our pilot study included a community-based sample of 30 adolescents, 14 to 21 years of age, who completed the MacCAT-CR after undergoing a simulated informed consent process. We found that adolescents' capacity to consent to research was associated with age, health literacy, and family affluence. These findings suggest that investigators and institutional review boards should be aware that factors other than age may influence capacity to consent, and, for modifiable factors, such as health literacy, consent processes for medical research with adolescents can be modified.
authors.affiliation: Michigan State University, East Lansing, USA.
authors.forename: Lance R
authors.initials: LR
authors.lastname: Nelson
authors.affiliation: Indiana University School of Medicine, Indianapolis, USA.
authors.forename: Nathan W
authors.initials: NW
authors.lastname: Stupiansky
authors.affiliation: Indiana University School of Medicine, Indianapolis, USA maott@iu.edu.
authors.forename: Mary A
authors.initials: MA
authors.lastname: Ott
mesh_terms: D000293:Adolescent; D041923:Adolescent Development; D000328:Adult; D000367:Age Factors; D035843:Biomedical Research / Q000941:ethics*; D028744:Ethics Committees, Research; D032984:Ethics, Research; D005190:Family; D005260:Female; D057220:Health Literacy; D006801:Humans; D057828:Informed Consent By Minors; D008297:Male; D016743:Mental Competency; D010865:Pilot Projects; D012923:Social Class; D055815:Young Adult
keywords: adolescent; bioethics; capacity; consent; health literacy; socioeconomic status