Predictors of providing informed consent or assent for research participation in assisted living residents

Objectives: This study's goal was to identify factors associated with providing either informed consent or assent for research in individuals at high risk for cognitive impairment. Design: Cross-sectional baseline data were used to identify predictors of consent or assent status. Setting: The study was conducted at 22 assisted living facilities in Maryland. Participants: A stratified random sample of 198 assisted living residents participated in the study. Measurements: Residents' consent or assent status was documented as providing informed consent, written assent, or verbal assent/no objection. Potential predictors included residents' demographic characteristics, measures of physical and mental health status, and neuropsychological test performance. Results: Most participants provided written assent (32.8%) or verbal assent/no objection (30.3%) rather than informed consent (36.9%). Although many resident characteristics correlated with consent or assent status based on bivariate analyses, few variables distinguished those who provided written assent from those in the verbal assent/no objection group. On the basis of multiple discriminant analysis, the best predictors of consent or assent status were Mini-Mental State Exam scores, impairments in instrumental activities of daily living, and dementia diagnosis, which together classified correctly 63.6% of residents. Conclusions: The relatively small proportion of participants who could provide informed consent highlights the importance of assessing decisional capacity for research in a high-risk population and identifying an appropriate surrogate decision maker to provide proxy consent if needed. Consensus on how to define assent is lacking, and specific measures of assent capabilities are needed to better characterize the assent capacity continuum.