Objectives This study examined the decision-making process used by individuals asked to participate in dementia research and their opinions on how future proxy research decisions would or should be made, including participants’ preferred ethical standards for decision-making. Design Cross-sectional qualitative methods. Setting University research institutions. Participants Informants were 39 of 46 cognitively impaired individuals (i.e., subjects) who were asked to join one of six dementia studies and 46 study partners or surrogate decision-makers. Measurements Semi-structured individual interviews were audio recorded and transcribed for content analysis. Results Within dyads, subjects and surrogates often differed in their perspectives on how decisions were made regarding whether to join a study, and no single method was identified as a predominant approach. While there was only fair agreement within dyads on who ultimately made the decision, subjects and surrogates most often said it was the subject. For future proxy research decisions, subjects and surrogates most often preferred the ethical standard of best interests and least often favored substituted judgment. However, many participants preferred a combination of best interests and substituted judgment or a more complex approach that also considers the interests of others. Conclusions Individuals with mild to moderate cognitive impairment can and do engage to some extent in the decision-making process for dementia research and can discuss their opinions on how they would want such decisions made for them in the future. These findings support the recommended approach for obtaining proxy consent and subject assent if the individual lacks consent capacity.
Objectives-This study examined the decision-making process used by individuals asked to participate in dementia research and their opinions on how future proxy research decisions would or should be made, including participants' preferred ethical standards for decision-making.Design-Cross-sectional qualitative methods. Setting-University research institutions.Participants-Informants were 39 of 46 cognitively impaired individuals (i.e., subjects) who were asked to join one of six dementia studies and 46 study partners or surrogate decision-makers. Measurements-Semi-structured individual interviews were audio recorded and transcribed for content analysis.Results-Within dyads, subjects and surrogates often differed in their perspectives on how decisions were made regarding whether to join a study, and no single method was identified as a predominant approach. While there was only fair agreement within dyads on who ultimately made the decision, subjects and surrogates most often said it was the subject. For future proxy research decisions, subjects and surrogates most often preferred the ethical standard of best interests and least often favored substituted judgment. However, many participants preferred a combination of best interests and substituted judgment or a more complex approach that also considers the interests of others.Conclusions-Individuals with mild to moderate cognitive impairment can and do engage to some extent in the decision-making process for dementia research and can discuss their opinions on how they would want such decisions made for them in the future. These findings support the recommended approach for obtaining proxy consent and subject assent if the individual lacks consent capacity. KeywordsDementia; Clinical research; Decision making; Qualitative research Corresponding Author: Betty S. Black PhD; Department of Psychiatry and Behavioral Sciences; Johns Hopkins Hospital; 600 North Wolfe Street, Meyer 279; Baltimore, MD 21287; Fax: 410-614-1094; Telephone: 410-955-2003; bblack@jhmi.edu. Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. Conflicts of ObjectivesThere is a clear and urgent need for research into the causes, treatments and prevention of Alzheimer disease (AD) and other types of dementia, which affect millions of Americans (1). While individuals in early stage dementia may have the capacity to give informed consent for research, as dementia progresses it leads to a loss of decisional capacity (2). If consent capacity is lacking, research participation is dependent upon a legally authorized representative (i.e., surrogate decision-make...
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