ADVANCING RESEARCH WITH ALZHEIMER-DISEASE SUBJECTS - INVESTIGATORS PERCEPTIONS AND ETHICAL ISSUES

Advancement of Alzheimer disease (AD) research will not only depend on increased participation of patients with AD as subjects, but research ers 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 s ubjects with AD participating in research. Experiences from 99 project s are assessed. Major findings include a significant lack of uniformit y on the assessment of competency of subjects to consent to research, proxy informed consent overwhelmingly provided informally by family me mbers, no wide use of durable powers of attorney and guardians, percep tion by the investigators that most projects present only minimal risk s to the subjects, and Institutional Review Boards not being viewed by the investigators as preventing or inhibiting the advancement of AD r esearch. It is recommended that research is needed to develop greater clarity in assessment of capacity of subjects to provide informed cons ent, that ethical and legal empowerment of family members to provide p roxy consent be sustained, and that the issue of risk/benefit ratios f or AD participants in research be reevaluated in the light of potentia lly greater risks to subjects.