title: Adolescents with substance use disorder and assent/consent: Empirical data on understanding biobank risks in genomic research.
abstract: OBJECTIVE
  This study assessed whether a customized disclosure form increases understanding for adolescents with substance use disorder (SUD) when compared to a standard disclosure for genomic addiction research.
  
  
  METHODS
  We gathered empirical data from adolescents with SUD, family members, former patients followed since adolescence, and community counterparts. The study was conducted in four stages. Stage 1: national experts (n=32) identified current, future, speculative risks of broadly shared biobanks. Stage 2 assessed participants' (n=181) understanding of current risks as a prerequisite for rating saliency of risks via a Visual Analog Scale. Salient risks were incorporated into a customized disclosure form. Stage 3 compared the understanding of customized disclosure by participants (n=165) at baseline; all groups scored comparably. Stage 4 conducted a direct comparison of the standard disclosure to standard disclosure plus customized disclosure (n=195). Independent t-tests compared understanding in those receiving the standard disclosure to standard disclosure plus customized disclosure within 6 groups.
  
  
  RESULTS
  The customized disclosure significantly improved understanding in adolescent patients (p=0.002) and parents of patients (p=0.006) to the level of their counterparts. The customized disclosure also significantly improved understanding in siblings of former patients (p=0.034). Understanding of standard disclosure in patients versus controls was significantly different (p=0.005). The groups receiving the customized disclosure scored significantly higher. Understanding of the standard disclosure plus customized disclosure in patients versus controls was not significantly different.
  
  
  CONCLUSIONS
  Adolescents with addictions understand the risks of participating in genomic addiction research as well as their community counterparts when information provided is salient to them.
authors.affiliation: The University of Colorado Anschutz Medical Campus, United States. Electronic address: marilyn.coors@ucdenver.edu.
authors.forename: Marilyn E
authors.initials: ME
authors.lastname: Coors
authors.affiliation: The University of Colorado Anschutz Medical Campus, United States.
authors.forename: Kristen M
authors.initials: KM
authors.lastname: Raymond
authors.affiliation: The University of Colorado Anschutz Medical Campus, United States.
authors.forename: Christian J
authors.initials: CJ
authors.lastname: Hopfer
authors.affiliation: The University of Colorado Anschutz Medical Campus, United States.
authors.forename: Joseph
authors.initials: J
authors.lastname: Sakai
authors.affiliation: The University of Colorado Anschutz Medical Campus, United States.
authors.forename: Shannon K
authors.initials: SK
authors.lastname: McWilliams
authors.affiliation: The University of Colorado Anschutz Medical Campus, United States.
authors.forename: Susan
authors.initials: S
authors.lastname: Young
authors.affiliation: The University of Colorado Anschutz Medical Campus, United States.
authors.forename: Susan K
authors.initials: SK
authors.lastname: Mikulich-Gilbertson
mesh_terms: D000293:Adolescent; D000328:Adult; D018070:Biological Specimen Banks; D005260:Female; D023281:Genomics; D006801:Humans; D007258:Informed Consent / Q000523:psychology*; D008297:Male; D016743:Mental Competency / Q000523:psychology*; D011996:Records / Q000592:standards*; D035842:Research Subjects / Q000523:psychology*; D018570:Risk Assessment; D019966:Substance-Related Disorders / Q000235:genetics* / Q000523:psychology*
keywords: Adolescents with substance use disorder; Assent; Biobanks; Genomic; Informed consent; Understanding