Seeking assent and respecting dissent in dementia research

OBJECTIVES: Obtaining assent and respecting dissent are widely adopted safeguards when conducting dementia research involving individuals who lack consent capacity, but there is no consensus on how assent and dissent should be defined or what procedures should be used regarding them. Our objective was to provide recommendations on these issues based on the opinions of knowledgeable key informants. DESIGN: Cross-sectional qualitative research. SETTING: University research institutions. PARTICIPANTS: Forty informants, including 1) nationally known experts on dementia and research ethics, 2) dementia researchers, and 3) dementia caregivers and advocates. MEASUREMENTS: Semistructured individual and focus group interviews, audio recorded, and transcribed for content analysis. RESULTS: Assent and dissent should be defined broadly and based on an assessment of how adults who lack consent capacity can express or indicate their preferences verbally, behaviorally, or emotionally. Assent requires the ability to indicate a meaningful choice and at least a minimal level of understanding. Assent should be required whenever an individual has the ability to assent, and dissent should be binding if it is unequivocal or sustained after an effort to relieve concerns and/or distress. Standards for seeking assent and respecting dissent should not be linked to the risks or potential benefits of a study. Lacking the ability to assent and/or dissent should not automatically preclude research participation. CONCLUSIONS: Obtaining assent and respecting dissent from individuals who lack consent capacity for dementia research allows them to participate, to the extent possible, in the consent process. Assent and dissent are important independent ethical constructs.