Barriers to obtaining consent in dementia research: implications for surrogate decision-making.

ABSTRACT

OBJECTIVE: To identify barriers to informed consent in research involving subjects with advanced dementia. DESIGN: A randomized controlled clinical trial of palliative care approaches, compared with usual care, in subjects with advanced dementia who are hospitalized. SETTING: A large metropolitan teaching hospital. PARTICIPANTS: All patients older than 65 years of age who have advanced dementia and a Functional Assessment Staging score of 6d to 7f and have been admitted to the hospital. MEASUREMENTS Surrogates for all eligible subjects were approached for consent to enroll their family members in the trial. Reasons for refusal to enroll in the study were recorded and categorized as either informed refusal (i.e., the surrogate understood the research protocol but declined to give consent for participation) or as a barrier to informed consent (i.e., the surrogates could not participate in the informed consent process or there was no functional surrogate). RESULTS: Forty-nine percent of 146 eligible subjects could not be enrolled in the study. Only four surrogates refused consent for their family members. Of the remaining 68 patients, 41 eligible subjects' surrogates could not be engaged in the informed consent process, and 22 subjects did not have a functional surrogate to consent for research. CONCLUSIONS: Absence of functional surrogate decision-makers is a major barrier to research and clinical decision-making for hospitalized patients with advanced dementia.