Measuring informed consent capacity in an Alzheimer's disease clinical trial

Peter D. Guarino, Julia E. Vertrees, Sanjay Asthana, Mary Sano, Maria D. Llorente, Muralidhar Pallaki, Susan Love, Gerard D. Schellenberg, Maurice W. Dysken

Research output: Contribution to journalArticlepeer-review

13 Scopus citations

Abstract

Introduction Accurately and efficiently determining a participant's capacity to consent to research is critically important to protect the rights of patients with Alzheimer's disease (AD). Methods Understanding of the informed consent document was assessed in 613 community-dwelling patients with mild-to-moderate AD enrolled in a randomized, placebo-controlled trial. Associations were examined between clinically determined capacity to consent and (1) patient demographics and clinical characteristics and (2) the Informed Consent Questionnaire (ICQ), an objective measurement of a participant's factual understanding and perceived understanding. Results A total of 453 (74%) participants were determined to have capacity to consent by clinical judgment. ICQ perceived understanding, race, measures of cognitive function, and caregiver time were all significantly associated with the determination of capacity in multivariate analyses. Discussion We found a significant association between capacity and disease severity level, caregiver time, race, and ICQ perceived understanding.

Original languageEnglish
Pages (from-to)258-266
Number of pages9
JournalAlzheimer's and Dementia: Translational Research and Clinical Interventions
Volume2
Issue number4
DOIs
StatePublished - 1 Nov 2016

Keywords

  • Alzheimer's disease
  • Clinical trials as topic
  • Comprehension
  • Consent forms
  • Informed consent
  • Mental competency
  • Third-Party consent

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