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ABSTRACT
Objectives: Optimizing the research consent process simultaneously fosters respect for autonomy and protection of those with diminished capacity for autonomy. This study evaluated the effectiveness of an enhanced research consent procedure, employing multimedia disclosure and corrective feedback, in improving decisional capacity among 114 people with mild-to-moderate Alzheimer’s disease (AD) and 134 non-psychiatric comparison (NC) subjects.
Methods: Participants were randomized to consent type (routine versus enhanced) and protocol type (lower versus higher risk). Outcomes included a 5-item questionnaire assessing immediate comprehension, MacArthur Competence Assessment Tool for Clinical Research assessing four components of decision-making capacity, and categorical decisional capacity (based on a cut-score established in reference to expert judgments for a subset of participants).
Results: There was no significant effect of the enhanced consent procedure, relative to routine consent, on immediate comprehension or decisional capacity.
Conclusions: Multimedia tools do not appear to be the solution to better consent for AD research.
Clinical Implications: Given the ethical primacy of informed consent and issues of justice for impaired populations who might be harmed by an absence of research-based treatment advances, continued search for ways to more meaningfully engage people with AD in the consent or assent process is warranted.
Acknowledgments
The authors express gratitude to Rebecca E. Daly for data management for this project, and to the participants and their families for involvement in the study.
Funding
This project was supported, in part, by National Institutes of Health Grants R01AG028827 and T32 MH019934, and by the Department of Veterans Affairs. The sponsor did not have a role in study design, methods, subject recruitment, data collection, analysis or preparation, revision, or approval of this manuscript.
Additional information
Funding
Notes on contributors
Barton W. Palmer
Dr. Palmer was Principal Investigator for the primary grant that funded this project, and was the primary individual responsible for overall study design, oversight of all data collection and research staff, data analyses and interpretation, and preparation and revision of the manuscript.
Alexandrea L. Harmell
Dr. Harmell was involved in data interpretation and assisted in manuscript preparation.
Laura B. Dunn
Dr. Dunn was a Co-Investigator on the primary grant that funded this project, and was involved in study design, data interpretation, and preparation and revision of the manuscript. She was also one of the expert judges for the categorical capacity determinations upon which the MacCAT-CR cut-score for this was established.
Scott Y. Kim
Dr. Kim was a Co-Investigator on the primary grant that funded this project, and was involved in study design, data interpretation, and revision of the manuscript.
Luz L. Pinto
Ms. Pinto was a study coordinator for this project, and assisted in oversight of data collection, and preparation of the manuscript.
Shahrokh Golshan
Dr. Golshan was a Co-Investigator on the primary grant that funded this project, and was involved in study design, statistical analyses, data interpretation, and revision of the manuscript.
Dilip V. Jeste
Dr. Jeste was a Co-Investigator on the primary grant that funded this project, and was involved in study design, data interpretation, and revision of the manuscript.