Dec. 7, 2010 Practices for protecting human research subjects
with Alzheimer's disease and other conditions that make them
incapable of giving informed consent are widely variable and in
need of more concrete ethical and legal guidance, according to a
study in IRB: Ethics & Human Research. The findings are
significant for several reasons. First of all, the authors
write, many countries have made research on dementia a national
health priority and launched clinical trials that involve people
who are, or are likely to become, cognitively impaired. These
trials increasingly involve invasive interventions which may
pose more than minimal risk. And yet throughout the world,
regulations and guidelines provide little direction to ethics
review committees about how best to protect these people -- and
about who can make decisions on their behalf. The new study,
part of a larger Canadian research program called Substitute
Consent for Research in Elderly Subjects (SCORES), involved
telephone interviews with 46 research