Surrogate consent for dementia research A national survey of older Americans

Bioethics Program, University of Michigan, Ann Arbor, MI 48109, USA.
Neurology (Impact Factor: 8.29). 02/2009; 72(2):149-55. DOI: 10.1212/01.wnl.0000339039.18931.a2
Source: PubMed


Research in novel therapies for Alzheimer disease (AD) relies on persons with AD as research subjects. Because AD impairs decisional capacity, informed consent often must come from surrogates, usually close family members. But policies for surrogate consent for research remain unsettled after decades of debate.
We designed a survey module for a random subsample (n = 1,515) of the 2006 wave of the Health and Retirement Study, a biennial survey of a nationally representative sample of Americans aged 51 and older. The participants answered questions regarding one of four randomly assigned surrogate-based research (SBR) scenarios: lumbar puncture study, drug randomized control study, vaccine study, and gene transfer study. Each participant answered three questions: whether our society should allow family surrogate consent, whether one would want to participate in the research, and whether one would allow one's surrogate some or complete leeway to override stated personal preferences.
Most respondents stated that our society should allow family surrogate consent for SBR (67.5% to 82.5%, depending on the scenario) and would themselves want to participate in SBR (57.4% to 79.7%). Most would also grant some or complete leeway to their surrogates (54.8% to 66.8%), but this was true mainly of those willing to participate. There was a trend toward lower willingness to participate in SBR among those from ethnic or racial minority groups.
Family surrogate consent-based dementia research is broadly supported by older Americans. Willingness to allow leeway to future surrogates needs to be studied further for its ethical significance for surrogate-based research policy.

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    • "Under the assumption that individuals with dementia are not able to report their symptoms accurately, regardless of dementia stage most studies used symptom ratings of caregivers or proxies on behalf of those people diagnosed with dementia (Bravo et al., 2004; Kim et al., 2009). For a comparison of tools used to measure anxiety changes, refer to Table 1. "
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    • "Our proposal to involve family members in the decision-making process is supported by empirical survey results. Family surrogate consent for AD research is supported both by the general public[47,48]and by people closer to the disease, such as caregivers and primary decision-makers for persons with dementia[49], and people at risk for AD[50]. A further argument in support of family members' involvement in dementia research relates to the above-mentioned evidence that people suffering from AD can retain the capacity to appoint a proxy decision-maker even when they lose the capacity to give consent to research participation[32]. "
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    • "Alternatively, models of informed consent or advanced directives should find ways to increase consistency between the proxies and the patients (Kim et al., 2009). "
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