Decisional Capacity for Informed Consent in Males and Females with Fragile X Syndrome

Anne C. Wheeler, Amanda Wylie, Melissa Raspa, Adrienne Villagomez, Kylee Miller, Anne Edwards, Margaret DeRamus, Paul S. Appelbaum, Donald B. Bailey

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

Abstract

Although informed consent is critical for all research, there is increased ethical responsibility as individuals with intellectual or developmental disabilities (IDD) become the focus of more clinical trials. This study examined decisional capacity for informed consent to clinical trials in individuals with fragile X syndrome (FXS). Participants were 152 adolescents and adults (80 males, 72 females) with FXS who completed a measure of decisional capacity and a comprehensive battery of neurocognitive and psychiatric measures. Females outperformed males on all aspects of decisional capacity. The ability to understand aspects of the clinical trial had the strongest association with the ability to appreciate and reason about the decision. Scaffolding improved understanding, suggesting researchers can take steps to improve decisional capacity and the informed consent process.

Original languageEnglish (US)
Pages (from-to)1725-1747
Number of pages23
JournalJournal of autism and developmental disorders
Volume50
Issue number5
DOIs
StatePublished - May 1 2020

Keywords

  • Clinical trials
  • Decisional capacity
  • Fragile X syndrome
  • Informed consent

ASJC Scopus subject areas

  • Developmental and Educational Psychology

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