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. 2016 Sep 20;2(4):258-266.
doi: 10.1016/j.trci.2016.09.001. eCollection 2016 Nov.

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

Peter D Guarino  1   2 , Julia E Vertrees  3 , Sanjay Asthana  4   5 , Mary Sano  6   7 , Maria D Llorente  8   9 , Muralidhar Pallaki  10   11 , Susan Love  12   13 , Gerard D Schellenberg  14 , Maurice W Dysken  12
Affiliations

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

Peter D Guarino et al. Alzheimers Dement (N Y). .

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.

Keywords: Alzheimer's disease; Clinical trials as topic; Comprehension; Consent forms; Informed consent; Mental competency; Third-Party consent.

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Figures

Fig. 1
Fig. 1
Informed Consent Questionnaire.
See this image and copyright information in PMC

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