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

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

SUBMITTER: Guarino PD 

PROVIDER: S-EPMC5651363 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature