ANN ARBOR, Mich. -- How far will Americans go in allowing people with Alzheimer's disease to take part in studies of promising -- but sometimes risky -- new treatments and other research when they cannot consent for themselves? A new University of Michigan and University of Rochester study examines this issue in depth for the first time, and finds surprising results.

In all, 90 percent of adults in the study said that it would be all right to allow a family member to enroll a person with Alzheimer's disease in studies that involved mild to medium risks, including studies of new drugs. A smaller percentage, but still a majority, approved of such surrogate decision-making for studies involving gene transfers, Alzheimer's protein "vaccines", spinal taps and brain tissue sampling.

When the 229 study participants were asked which kinds of studies they themselves would allow if they were acting as the surrogate for a loved one, the percentages dropped, but were still high, especially when they perceived the risk to be low.

The findings may help guide policymakers as they struggle to create a national standard for how and when surrogates can make decisions about enrolling adults who have lost their ability to give informed consent due to dementia in research studies. Currently, federal law allows surrogates but lets states set the conditions for such decisions. There is wide variation among states.

Consistent standards are needed, says lead author Scott Kim, M.D., Ph.D., a U-M assistant professor of psychiatry who specializes in the ethics of research involving people who cannot give their own permission because of dementia or mental illness.

"Right now, Alzheimer's studies being done in one state could be illegal in others, and most states such as Michigan have no clear law on this issue. Though individual research institutions such as universities do their best to protect research participants, they deserve better policy guidan
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Contact: Kara Gavin
kegavin@umich.edu
734-764-2220
University of Michigan Health System
7-Nov-2005

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