The U-ARE Protocol: A Pragmatic Approach to Decisional Capacity Assessment for Clinical Research

Article type: Review Article

Authors: Hamilton, Rachel K.B.^{a; b} | Phelan, Cynthia H.^c | Chin, Nathaniel A.^{d; e} | Wyman, Mary F.^{b; d} | Lambrou, Nickolas^b | Cobb, Nichelle^f | Kind, Amy J.H.^{b; d; e} | Blazel, Hanna^{d; e} | Asthana, Sanjay^{b; d; e} | Gleason, Carey E.^{b; d; e; *}

Affiliations: [a] Department of Psychology, University of Wisconsin – Madison, Madison, WI, USA | [b] Geriatric Research, Education, & Clinical Center, William S. Middleton Memorial Veterans Hospital, Madison, WI, USA | [c] Aurora Center for Nursing Research and Practice, Advocate Aurora Health Care, Milwaukee, WI, USA | [d] Department of Medicine – Division of Geriatrics, School of Medicine and Public Health, University of Wisconsin – Madison, Madison, WI, USA | [e] Wisconsin Alzheimer’s Disease Research Center, Madison, WI, USA | [f] Health Sciences IRBs Director, University of Wisconsin – Madison, Madison, WI, USA

Correspondence: [*] Correspondence to: Carey E. Gleason, School of Medicine and Public Health, University of Wisconsin-Madison, 750 Highland Ave, Madison, WI 53726, USA. E-mail: ceg@medicine.wisc.edu.

Abstract: With increased longevity and growth in the number of older adults comes rising rates of individuals with cognitive impairment and dementia. The expansion of this population has important implications for research on aging and dementia syndromes, namely increased enrollment of older individuals in clinical research. Ethical prerogatives, as well as historical underrepresentation of persons with dementia in research studies due to the perceived burden of traditional decisional capacity evaluations, necessitates the development of pragmatic approaches to ascertain decisional abilities in research settings. We outline a protocol used in the Wisconsin Alzheimer’s Disease Research Center (ADRC) that adopts a stepped approach to the evaluation of decisional capacity meant to maximize study visit efficiency while preserving participant safety and autonomy. The protocol specifies the structure of the consent process and incorporates a brief semi-structured interview based on Appelbaum & Grisso’s theoretical model for evaluating a patient’s decisional capacity to provide informed consent to participate in research. This protocol is easily implemented in a research study visit and is designed to minimize participant burden and ensure reliable assessment of decisional capacity in older adults across a wide range of research protocols. The protocol emphasizes capacity optimization, using memory aids and other compensatory strategies to preserve participant autonomy while protecting welfare.

Keywords: Clinical research protocol, dementia, informed consent, mental competence

DOI: 10.3233/JAD-190457

Journal: Journal of Alzheimer's Disease, vol. 73, no. 2, pp. 431-442, 2020