title: Obtaining informed consent in Alzheimer's research.
abstract: While current drug studies focus on treating cognitive symptoms and pose little risk to dementia subjects who participate, future drug studies may very well impose greater risks. Investigators are challenged in both present and future AD research to respect and safeguard the rights and welfare of a vulnerable population while promoting the highest quality research to investigate the causes, treatment, and prevention of Alzheimer's disease. In procuring informed consent for research, researchers should exercise caution in concluding that an AD subject is not competent to consent to participate in research protocols based solely on the presence of dementia. Informed consent should be sought from a competent AD subject, and if indeed the participant is not fully competent, the investigator should obtain full informed consent from a proxy while obtaining assent from the subject. Finally, while the augmentation of advance consent directives with informal family consent or durable power of attorney may make for a qualitatively better informed consent for dementia research, it should not be legally required before research takes place. Advance consent directives should be seen as an adjunct to the current proxy consent/subject assent and not a substitution.
authors.affiliation: Johns Hopkins Alzheimer's Disease Research Center, Bayview Medical Center, Baltimore, MD 21224, USA.
authors.forename: L S
authors.initials: LS
authors.lastname: Resau
mesh_terms: D016223:Advance Directives; D000544:Alzheimer Disease / Q000188:drug therapy*; D004341:Drug Evaluation; D006801:Humans; D007258:Informed Consent; D016743:Mental Competency; D013619:Tacrine / Q000627:therapeutic use*
chemical_list: D013619:Tacrine