Decision making for participation in dementia research

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 individuals with cognitive impairment (i.e., subjects) who were asked to join one of six dementia studies and 46 study partners or surrogate decision makers. Measurements: Semistructured 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. Although 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.