Most support Alzheimer's research based on family consent

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.

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.

Source: University of Michigan

Explore further: Travel restrictions could worsen Ebola crisis: experts

add to favorites email to friend print save as pdf

Related Stories

Tropical Storm Dolly forms, threatens Mexico

34 minutes ago

Tropical Storm Dolly formed off Mexico's northeastern coast on Tuesday and headed toward landfall in Tamaulipas state, threatening to spark floods and mudslides, forecasters said.

Halliburton pays $1.1 bn for Gulf of Mexico BP spill

44 minutes ago

Oil services company Halliburton said Tuesday it would pay a $1.1 billion settlement over its role in the 2010 Gulf of Mexico oil rig blowout that led to the United States' most disastrous oil spill.

Scientists make diseased cells synthesize their own drug

49 minutes ago

In a new study that could ultimately lead to many new medicines, scientists from the Florida campus of The Scripps Research Institute (TSRI) have adapted a chemical approach to turn diseased cells into unique manufacturing ...

Modern population boom traced to pre-industrial roots

51 minutes ago

The foundation of the human population explosion, commonly attributed to a sudden surge in industrialization and public health during the 18th and 19th centuries, was actually laid as far back as 2,000 years ...

Researcher looks at the future of higher education

53 minutes ago

Most forecasts about the future of higher education have focused on how the institutions themselves will be affected – including the possibility of less demand for classes on campus and fewer tenured faculty members as ...

Recommended for you

Travel restrictions could worsen Ebola crisis: experts

3 hours ago

Travel restrictions could worsen West Africa's Ebola epidemic, limiting medical and food supplies and keeping out much-needed doctors, virologists said Tuesday as the disease continued its deadly spread.

World 'losing battle' to contain Ebola: MSF (Update)

3 hours ago

International medical agency Medecins sans Frontieres said Tuesday the world was "losing the battle" to contain Ebola as the United Nations warned of severe food shortages in the hardest-hit countries.

Mutating Ebola viruses not as scary as evolving ones

4 hours ago

My social media accounts today are cluttered with stories about "mutating" Ebola viruses. The usually excellent ScienceAlert, for example, rather breathlessly informs us "The Ebola virus is mutating faster in humans than in animal hosts ...

War between bacteria and phages benefits humans

4 hours ago

In the battle between our immune systems and cholera bacteria, humans may have an unknown ally in bacteria-killing viruses known as phages. In a new study, researchers from Tufts University, Massachusetts ...

Ebola kills 31 people in DR Congo: WHO

6 hours ago

An outbreak of the Ebola virus in the Democratic Republic of Congo has killed 31 people and the epidemic remains contained in a remote northwestern region, UN the World Health Organization (WHO) said Tuesday.

User comments : 0