title: Advancing research with Alzheimer disease subjects: investigators' perceptions and ethical issues.
abstract: Advancement of Alzheimer disease (AD) research will not only depend on increased participation of patients with AD as subjects, but researchers will likely face increasingly difficult ethical issues. Presented are the results of a survey of researchers at the 15 federally funded Alzheimer Disease Research Centers concerning the ethical issues for subjects with AD participating in research. Experiences from 99 projects are assessed. Major findings include a significant lack of uniformity on the assessment of competency of subjects to consent to research, proxy informed consent overwhelmingly provided informally by family members, no wide use of durable powers of attorney and guardians, perception by the investigators that most projects present only minimal risks to the subjects, and Institutional Review Boards not being viewed by the investigators as preventing or inhibiting the advancement of AD research. It is recommended that research is needed to develop greater clarity in assessment of capacity of subjects to provide informed consent, that ethical and legal empowerment of family members to provide proxy consent be sustained, and that the issue of risk/benefit ratios for AD participants in research be reevaluated in the light of potentially greater risks to subjects.
authors.affiliation: Department of Philosophy, University of Kentucky, Lexington 40506-0027.
authors.forename: D M
authors.initials: DM
authors.lastname: High
mesh_terms: D000203:Activities of Daily Living / Q000523:psychology; D000328:Adult; D000368:Aged; D000544:Alzheimer Disease / Q000523:psychology*; D001291:Attitude of Health Personnel; D035841:Behavioral Research; D032882:Comprehension; D036262:Empirical Research; D028744:Ethics Committees, Research; D004992:Ethics, Medical; D035082:Federal Government; D005260:Female; D036281:Genetic Research; D033161:Government Regulation; D006805:Human Experimentation; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D007872:Legal Guardians / Q000523:psychology; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D010865:Pilot Projects; D035842:Research Subjects; D012109:Research Support as Topic; D018570:Risk Assessment