Ethical considerations for decision making for treatment and research participation

Here we review issues of patient decision‐making and consent to treatment and research by persons with cognitive impairment and dementia. Clinicians and researchers must recognize their primary duty to care for the individual and must clearly distinguish their role as a clinician and/or researcher. Distinctions between standard care and research must be clearly understood by everyone, as must the clinician's role in each. Both actual and perceived conflicts of interest must be avoided. At present there is insufficient evidence to recommend specific methods for determining competency for decision‐making, but a diagnosis of cognitive impairment or dementia does not preclude such competence. Competency is not a unitary or static construct and must be considered as the ability to make an informed decision about participation in the particular context of the specific treatment or study. Clinicians and researchers should consider consent as a process involving both the patient with cognitive impairment and his or her family/caregiver, particularly given the potential that competency for decision‐making will change over time. As the availability of advance directives remains limited, clinicians and researchers must make efforts to ensure that decisions made by proxies are based on the prior attitudes and values of the patient.