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Most support Alzheimer's research based on family consent
Date:1/14/2009

ANN ARBOR, Mich. By the time they have been diagnosed with Alzheimer's disease, many patients' decision-making ability is so impaired that they cannot give informed consent to participate in research studies.

Close family members are left with the decision, but there is no clear policy for this so-called "surrogate" consent. Because of that, research about the increasingly common disease is often stalled.

But a new study led by the University of Michigan Health System suggests that older Americans are very supportive of family surrogate-based research, and would support having their family members enroll them in research in case of future incapacity. The study appears in the new issue of the journal Neurology.

Because of uncertainties about federal policy, some institutions have gone so far as to not allow surrogate consent at all and research has been halted at other institutions, says lead author Scott Y. H. Kim, M.D., Ph.D., associate professor in the U-M Medical School's Department of Psychiatry; investigator in the U-M Center for Behavioral and Decision Sciences in Medicine; and core member of the U-M Bioethics Program.

The federal policy states that surrogate consent can be provided by legally authorized representatives of adult patients, but the federal government defers to states to define who these representatives are. The lack of a clear definition has caused widespread confusion and uncertainty for three decades, notes Kim.

If state policies are unclear, then it is the responsibility of hospitals and their Institutional Review Boards to determine the boundaries for surrogate-based research. Only three statesVirginia, New Jersey and Californiahave recently enacted research ethics laws that clearly address this issue.

Even though regulations remain unclear, however, the general public appears to accept the idea of family surrogate consentboth as a societal policy and for themselves, the new
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Contact: Katie Vloet or Margarita Bauza
kgazella@umich.edu
734-764-2220
University of Michigan Health System
Source:Eurekalert

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