(RxWiki News) More concrete ethical and legal guidelines are needed for practices involving the study of Alzheimer's disease in individuals, according to a study in IRB: Ethics & Human Research.
Alzheimer's disease and similar conditions in advanced stages make individuals incapable of giving informed consent in some studies and clinical trials, yet, according to the study, regulations and guidelines provide little direction to ethics review committees about how best to protect these patients and about who can make decisions on their behalf.
Some studies and trials may pose more than minimal risk to patients who are or who are likely to become cognitively impaired, researchers said, especially as the developed world aims to make dementia research a priority.
The study, part of the more comprehensive Substitute Consent for Research in Elderly Subjects (SCORES), involved telephone interviews with 46 research ethics board chairs in Canada. A total of 20 respondents said they had reviewed research protocols involving such persons during the past year and all allowed them to participate in research under certain circumstances, including minimal risks or consent from a substitute decision-maker. More than half of the respondents said they required more protections such as assessing decisional capacity for the cognitively impaired population.
"The fact that some REBs [research ethics boards] did not require these additional safeguards is cause for concern," wrote the researchers.
Based on their findings, researchers said they recommend lawmakers and stakeholders consider developing appropriate protective measures for the cognitively impaired.
About 10 million baby-boomers face a diagnosis of Alzheimer's disease in the United States alone. About 5.2 million Americans currently suffer from the most severe form of dementia.