Surrogates' decisions vital for treatment of dementia

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 U-M Health System (UMHS) 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 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 Dr. Scott Kim, associate professor in the Medical School Department of Psychiatry, investigator in the Center for Behavioral and Decision Sciences in Medicine, and core member of the 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, Kim says.

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 states — Virginia, New Jersey and California — have 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 consent — both as a societal policy and for themselves, the new study finds.

"We wring our hands about this issue in ethics circles," Kim says, "but people seem to understand that we need to do this kind of research to find ways of treating Alzheimer's." Kim also notes the U.S. Department of Health and Human Services has formed an advisory committee that is looking at this issue.

Additional U-M co-authors are Hyungjin Myra Kim, Center for Statistical Consultation and Research; and Dr. Kenneth Langa, Division of General Medicine at UMHS, Institute for Social Research, and Veterans Affairs Center for Practice Management and Outcomes Research.