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Most
support Alzheimer’s Research based on Family
Consent
Newswise — 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.
The participants answered questions regarding one of four
randomly assigned surrogate-based research
scenarios: lumbar puncture study, a drug
randomized control study, a vaccine study
and a gene transfer study.
Each participant answered three questions: whether our
society should allow family surrogate
consent, whether the individual would want
to participate in the research, and whether
the individual would allow a surrogate some
or complete leeway to override stated
personal preferences.
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.
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.
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