Alzheimer's, Dementia & Mental Health
Most Senior Citizens Would Agree to Family Placing
Them in Alzheimer’s Research
Uncertainty among state government’s has caused
widespread confusion for three decades
Jan. 14, 2009 - 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
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
found.
“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 that the U.S. Department of Health and Human Services has formed
an advisory committee that is looking at this issue.
Methodology:Survey data was based on the
U-M Health and Retirement Study, a biennial survey of a nationally
representative sample of Americans ages 51 and older funded by the
National Institute on Aging.
Findings: Most respondents in the survey stated
that our society should allow family surrogate consent (68 percent to 83
percent, depending on the scenario) and would themselves want to
participate in surrogate-based research (57 percent to 80 percent). Most
also would grant some or complete leeway to their surrogates (55 percent
to 67 percent), though these numbers were higher among people who were
also willing to participate.
Although ethnic and racial minority groups were
slightly less willing to participate in surrogate-based research, there
was overall broad support for surrogate-based research even in these
groups.
Significance: Little research, and no national
research, has been conducted about public opinion of surrogate-based
research, Kim notes. The rates of Alzheimer’s disease are rising
rapidly; in 2000, there were 4.5 million Americans with the incurable
disease, and by 2050, this number is projected to be 12.5 million if no
effective treatments are found.
Background Information
Authors: In addition to Kim, co-authors from U-M
were Hyungjin Myra Kim, Sc.D.U-M Center for Statistical Consultation and
Research; and Kenneth M. Langa, M.D., Ph.D., Division of General
Medicine at the U-M Health System, U-M Institute for Social Research,
and Veterans Affairs Center for Practice Management and Outcomes
Research. Paul S. Appelbaum, M.D., from Columbia University was the
senior author; Jason H. T. Karlawish, M.D.,from the University of
Pennsylvania, and David S. Knopman, M.D., from the Mayo Clinic, also
were co-authors.
Funding: Kim was supported by a grant from the
National Institute on Aging and a Greenwall Foundation Faculty Scholars
in Bioethics award. Langa was supported by a grant from the NIA and a
Paul Beeson Physician Faculty Scholars in Aging Research award.
Karlawish was supported by a Greenwall Foundation Faculty Scholars in
Bioethics award and the Marian S. Ware Alzheimer Program. NIA also
provided funding for the Health and Retirement Study, which is performed
at the Survey Research Center, Institute for Social Research, University
of Michigan.
Reference: “Surrogate Consent for Dementia
Research: A National Survey of Older Americans,” Neurology, Jan. 13,
2009.
Meet the expert:
Scott Y. H. Kim, M.D., Ph.D.
Learn more:
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More Alzheimer's research at U-M
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U-M Health and Retirement Study
