Surrogate consent for dementia research
A national survey of older Americans
S.Y.H. Kim, MD, PhD
H.M. Kim, ScD
K.M. Langa, MD, PhD
J.H.T. Karlawish, MD
D.S. Knopman, MD
P.S. Appelbaum, MD
Background: 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.
Methods: We designed a survey module for a random subsample (n ? 1,515) of the 2006 wave of
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 partici-
pate in the research, and whether one would allow one’s surrogate some or complete leeway to
override stated personal preferences.
Results: 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.
Conclusions: 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. Neurology®2009;72:149–155
AD ? Alzheimer disease; CI ? confidence interval; HRS ? Health and Retirement Study; LAR ? legally authorized represen-
tatives; LP ? lumbar puncture; OR ? odds ratio; RCT ? randomized controlled trial; SBR ? surrogate-based research.
Alzheimer disease (AD) is common, incurable, and devastating. In 2000, there were 4.5 million
Americans with AD and by 2050, this number is projected to be 12.5 million if no effective
interventions are found to alter the trend.1Current treatments are of only modest benefit.
Much needed innovative and promising research on AD can involve invasive procedures with
unpredictable risks.2,3Although some patients with mild AD are capable of providing their
own research consent, the disease usually leads to early decisional incapacity4,5and surrogate
consent is necessary for research.6,7
Federal regulations allow surrogate consent by legally authorized representatives (LAR)
(45CFR46.116), but policy uncertainties have continued for three decades, for at least two
reasons. First, the regulations defer to states for defining the LAR but few states have done so.8
Thus, in most jurisdictions, the common practice of obtaining family consent with subject
Address correspondence and
reprint requests to Dr. Scott Kim,
Bioethics Program, 300 North
Ingalls St, 7C27, Ann Arbor, MI
Authors’ affiliations are listed at the end of the article.
Dr. Kim was supported by a grant from the NIA (R01 AG029550) and Greenwall Foundation Faculty Scholars in Bioethics award. Dr. Langa was
supported by a grant from the NIA (R01 AG027010) and a Paul Beeson Physician Faculty Scholars in Aging Research award. Dr. Karlawish was
supported by a Greenwall Foundation Faculty Scholars in Bioethics award and the Marian S. Ware Alzheimer Program. The National Institute on
Aging (NIA) provided funding for the Health and Retirement Study (U01 AG09740) which is performed at the Survey Research Center, Institute for
Social Research, University of Michigan.
Disclosure: The authors report no disclosures.
Copyright © 2009 by AAN Enterprises, Inc.
assent7occurs under a cloud of policy uncer-
tainty. This uncertainty has led to some institu-
tions not allowing any surrogate consent for
adults in research, the Federal government tem-
porarily shutting down such research in one in-
stitution, a self-imposed temporary moratorium
at another institution, and lawsuits.6Second,
there is no consensus on how much special pro-
tection is needed when subjects are enrolled
based on surrogates’ consent.9-11Perhaps the
the potential benefits of such research.6Three
recent state laws have diverged on this issue; in-
ternationally, there are discrepancies as well.12,13
For example, the California law14does not set a
limit on the level of allowable risk for nonthera-
peutic research, whereas both New Jersey15and
Virginia16laws limit such risk to minor increase
Because policy discussions regarding surrogate-
based research (SBR) have continued for three
decades without a clear resolution, it may be
especially important to assess the public’s
views about SBR in working toward a solu-
tion. However, there have been very few at-
tempts to understand the attitudes of the lay
public or of stakeholder groups regarding
SBR.17-19We therefore designed a survey to
assess the views of a nationally representative,
policy-relevant sample of the general public
(namely, older Americans) regarding surrogate
consent for four research scenarios of varying
degrees of risk and potential benefit. Because
racial and ethnic minorities are underrepre-
sented in AD research,20we also examined
their attitudes toward SBR. Finally, we exam-
ined how much latitude or leeway21,22people
are willing to confer on their surrogates.
Many studies examining clinical treatment
decisions have found that what people say
they would want and what their surrogates
think those people would want do not always
match.23These studies did not ask about lee-
way. But the significance of the discrepancy
may depend in part on how strictly people
want their preferences followed.
METHODS Health and Retirement Study. The HRS is
a nationally representative study of persons 51 and older, de-
signed to investigate the health, social, and economic implica-
tions of the aging of the American population with a sample of
more than 30,000 individuals.24Interviews are conducted with
all HRS respondents either by telephone or in person, with the
latter used preferentially for those aged 80 or older. The baseline
participation rate was 80%, and the reinterview participation
rates for subsequent waves have been 92 to 95%. Additional
HRS information is available at http://hrsonline.isr.umich.edu.
Informed consent is obtained orally from all respondents
prior to each HRS interview. The HRS was approved by the
Institutional Review Board of the University of Michigan.
Module on SBR. Our module survey was a modified version
of a paper-based survey that we had used in a previous study,17
adapted for the brief interview format of the HRS modules (ap-
pendix e-1 on the Neurology®Web site at www.neurology.org).
After a brief introductory background on AD and the rationale
for the survey, the subjects were given one of four SBR scenarios:
a lumbar puncture (LP) study, a randomized controlled trial
(RCT) of a new drug, a vaccine study, and a first-in-human gene
transfer neurosurgical study. These scenarios approximated real
studies in AD.2,3Then the subjects were asked three questions
(see table 2, column 1).
The module was administered to a random subsample of the
2006 HRS participants. Of the 1,517 subjects approached for
the module, two declined at the outset. The remaining 1,515
subjects were randomized to one of the four SBR scenarios: 374
to the LP scenario, 398 to the new drug RCT scenario, 375 to
the vaccine scenario, and 368 to the gene transfer scenario. De-
pending on the survey question, 52 to 71 persons (out of 1,515)
answered “don’t know” or refused to answer; they were excluded
from the analyses below. The randomization was successful in
that the groups were not significantly different on age, gender,
race/ethnicity, education, net worth, marital status, or religion.
Questions from Health and Retirement Study database. In
analyzing our module survey responses, we included additional
variables from the HRS parent survey listed in table e-1. We also
examined four additional HRS parent survey questions for the
leeway question analysis: 1) “How much do they [spouse or part-
ner] really understand the way you feel about things?” 2) “How
much can you rely on them if you have a serious problem?” The
same questions were also asked regarding their children. The
response choices were a lot, some, a little, or not at all. These
questions were chosen because surrogates of patients with AD
tend to be spouses and children. We wished to examine if the
nature of those relationships predict the respondent’s attitudes
regarding leeway, since identifying strong predictors of leeway
could have policy implications. Although responses to these extra
questions are available only in subsets of participants who have
spouses or children (ranging from n ? 494 to n ? 633 of our
module sample of 1,515, depending on the question), neither
the availability nor distribution of these variables was associated
with the four scenarios.
Analysis. Descriptive. For each SBR scenario, the proportions
of respondents who find the SBR research acceptable from a
societal perspective and from a self perspective were calculated.
The proportions of respondents willing to allow no, some, or
complete leeway were calculated for each scenario.
Scenario and perspective effects. The effect of the scenario
on willingness to allow family consent for SBR, on willingness to
participate in SBR, and on willingness to allow leeway were each
assessed using ?2tests. We assessed the effect of perspective for
each scenario, using the McNemar test.
Race/ethnicity effect. Race/ethnicity categories were defined
as non-Hispanic white, non-Hispanic black, Hispanic, or other.
Neurology 72January 13, 2009
A logistic regression model was fit for each scenario using re-
sponses to each of the three main survey questions as the depen-
dent variable. Since our primary interest was in assessing how the
responses to the three main survey questions vary by race/
ethnicity, adjusting for potential confounders and other variables
potentially related to attitudes toward SBR, the logistic regres-
sion models were adjusted for all of the variables in table 1 and
Leeway question analysis. We examined two types of mod-
els. First, we evaluated the predictors of willingness to allow lee-
way (dichotomized as some/complete leeway vs not) using
logistic regression models, where the potential predictors exam-
ined were the HRS variables in table 1 and table e-1, the scenario
dummy variables, as well as a variable for willingness to partici-
pate (because it turned out to be a strong predictor in bivariate
analysis). The covariates were modeled carefully to assess their
appropriate functional relationships to the response variable by
using polynomials (e.g., for variables such as age) and categorical
or dichotomized dummy variables. Second, similar but separate
logistic regression models were used to test if allowing leeway was
associated with relying on spouse or children and feeling under-
stood by spouse or children.
Statistical analyses were performed using Stata 9.2 (Stata
Corp, College Station, TX). All analyses except for McNemar
tests were adjusted for the complex sampling design of the HRS
survey using the HRS respondent level sampling weights (http://
H.M. Kim conducted the statistical analysis.
RESULTS Table 2 summarizes the responses for the
three main survey questions.
Most of the respondents are supportive of allowing
tia research (67.5% to 82.5%). Even for a first-in-
cisions. The response patterns were significantly differ-
ent across the four scenarios for the societal question
and for the self perspective question, and the pattern
trended toward a difference for the leeway question.
The proportion of those willing to participate in the
various SBR scenarios is generally similar to the level of
support for family surrogate consent, but a significantly
greater proportion would allow family consent in the
vaccine study than would themselves want to partici-
pate (odds ratio [OR] ? 3.09; 95% confidence interval
societal to self perspective comparisons showed an OR
of 1.24 (95% CI ? 0.77–2.00; p ? 0.42) for the lum-
bar puncture study, 1.59 (0.96–2.68; p ? 0.07) for the
the gene transfer scenario.
Race/ethnicity. The relationship between race/eth-
nicity and attitudes toward the various SBR scenarios
are summarized in table 3.
The direction of the race/ethnicity effect for the
societal perspective question is not consistent across
scenarios and none of the effects are significant. In
absolute terms, the majority in all race/ethnicity
groups responded that society should allow family
consent for all scenarios.
For the self perspective question, the overall pattern
trends toward black and Hispanic respondents being
less willing to participate in SBR, although the only sig-
than white respondents to participate in the drug RCT
and Hispanic respondents are less willing to participate
in the gene transfer study. For the leeway issue (not
shown in the table), the only significant difference is
that Hispanic respondents are less likely than white re-
spondents to allow some/complete leeway for the gene
transfer study (adjusted OR ? 0.26; 95% CI ? 0.09–
0.79; p ? 0.02).
Willingness to allow leeway. Depending on the sce-
nario, between 55 and 67% would allow their surro-
Table 1 Characteristics of 1,515 respondents
to the 2006 Health and Retirement
Study (HRS) module on surrogate
consent for dementia research*
Subject characteristicsTotal (n ? 1,515), n (%)
*Cell values are N (weighted percentages) with weighted
percentages derived using the HRS respondent population
Neurology 72 January 13, 2009
gates some or complete leeway to decide against their
stated wishes regarding SBR participation. Among
those who do not desire to participate in SBR, 26%
would allow some or complete leeway; among those
who desire to participate, 76% would allow some or
Table 4 summarizes the adjusted ORs of the vari-
ables retained in the final logistic regression model to
predict leeway question responses. The strongest pre-
dictor of whether one is willing to allow at least some
leeway remains whether one is willing to participate
in research, with an adjusted OR ? 8.31. There were
other significant, although weaker, predictors of will-
ingness to grant leeway. Married people, women,
those in excellent health, and respondents to the gene
transfer scenario (although not among those who
considered religion very important) were more likely
to give at least some leeway than not.
In separate models, the more the respondent felt
understood by a child, the more likely he or she
would allow leeway (adjusted OR ? 1.37, 95%
CI ? 1.07–1.75; p ? 0.01), corresponding to a 37%
increase in the likelihood of willingness to allow lee-
way with every one level increase in feeling under-
Table 2 Proportion* of respondents providing positive responses for each of the four surrogate-based
research scenarios for the three main survey questions
puncture Drug RCT Vaccine
Societal perspective: If patients cannot make their own decisions
about being in studies like this one, should our society allow their
families to make the decision in their place? (n ? 1,463)
[allow, not allow]
Self perspective: Suppose you wanted to give a close family
member instructions for the future, in case you ever became
unable to make decisions for yourself. Would you say you would
want to participate in the study? (n ? 1,444)
70.8 79.757.4 68.7
Leeway question: How much freedom or leeway would you give
the close family member to go against your preference and
instead [opposite of answer to 2: enroll/not enroll] you in the
study? (n ? 1,456)
[In descending order in the column: no leeway, some leeway,
39.3 40.6 37.939.20.09
*Weighted proportions. The respondents answered the three questions for one of the four scenarios randomly assigned.
Those responding “don’t know” or “refuse to answer” are not included.
†The responses are listed, from top to bottom: no leeway; some leeway; complete leeway.
RCT ? randomized controlled trial.
Table 3 Race/ethnicity and attitudes toward four surrogate-based dementia research scenarios of varying
risks and benefits
Lumbar punctureDrug RCTVaccine Gene transfer
%* OR† (95% CI)%* OR† (95% CI)%* OR† (95% CI) %*OR† (95% CI)
71.31.085.1 1.070.5 1.0 66.51.0
75.8 1.36 (0.43–4.37)76.7 0.40 (0.15–1.08)69.50.82 (0.29–2.31) 73.7 2.25 (0.93–5.43)
66.4 0.58 (0.15–2.27)70.30.35 (0.10–1.19) 69.2 1.10 (0.38–3.15)77.81.94 (0.52–7.19)
71.1 1.0 81.81.059.01.0 71.5 1.0
69.40.82 (0.32–2.07) 60.10.27‡ (0.08–0.86) 53.50.54 (0.17–1.69)63.8 1.00 (0.41–2.46)
65.30.68 (0.15–3.12) 78.60.80 (0.25–2.60) 47.5 0.97 (0.40–2.38)49.2 0.26‡ (0.08–0.88)
*All percents are weighted.
†Ratio of odds for allowing surrogate-based research for a race category relative to white Americans. See table 1 and table
e-1 for covariates included in the models to generate these adjusted odds ratios.
‡p ? 0.05.
RCT ? randomized controlled trial; OR ? odds ratio; CI ? confidence interval.
Neurology 72 January 13, 2009
stood (out of four levels, ranging from “not at all” to
“a lot”). Being understood by one’s spouse or partner
had a similar effect (adjusted OR ? 1.44, 95% CI ?
1.07–1.94; p ? 0.02). The degree of reliance on
one’s spouse or child, however, was not related to
one’s willingness to allow leeway.
DISCUSSION We found broad majority support—
ranging from 68% to 83%, depending on the scenar-
io—for a societal policy of family surrogate consent
for AD research. A previous survey of adults at in-
creased risk for AD also showed majority support for
family consent for the same four SBR scenarios.17
Another previous study of research participants at
risk for AD19found very high willingness to partici-
pate in SBR of relatively low risk. A survey in Que-
bec18showed similar results but its emphasis on
examining a variety of surrogate types (legal guard-
ian, family) makes it difficult to compare with our
The responses from the societal and self perspec-
tives are closely related, but they should not be
treated as equivalent. Personal willingness to partici-
pate is not a proxy for views about the ethical appro-
priateness of SBR because many people may choose
not to participate for a variety of reasons. If the point
is to characterize public opinion on the ethical per-
missibility of SBR, then respondents’ views from a
societal perspective should be primary. Of course, it
may not be ideal if many more people are willing to
allow SBR as a societal practice than those who are
willing to participate. However, even for the vaccine
study scenario, in which the gap is greatest, the ma-
jority (57%) of respondents still desire to participate.
The significant underrepresentation of racial and
ethnic minorities in AD research is a perennial con-
cern.20Recent studies have shown that racial and eth-
nic minorities, despite the legacy of abuses such as
the Tuskegee study, are similar to whites in their at-
titudes toward and participation in research.25,26We
found that regarding the social policy of family sur-
rogate consent for SBR, the differences among racial
and ethnic groups are small and the overall level of
support is high. In terms of a desire to participate in
SBR, the overall pattern among minority respon-
dents is a somewhat lower willingness to participate.
However, responses vary a great deal by scenario. For
instance, although black Americans are significantly
less likely to volunteer for a drug RCT, they appear
more likely than whites to endorse the gene transfer
neurosurgical study for AD with family consent (and
are no less willing to participate).
Leeway is an important concept because it may
signify a subject’s recognition that the future cannot
be pinned down in detail and it allows subjects to
convey their trust in their surrogates who will have
more complete information at the time of actual
decision-making. The majority of our respondents
would allow some or complete leeway for all the sce-
narios. However, it should be noted that a significant
minority (up to 45% for the gene transfer scenario)
would not allow leeway.
Those who are willing to participate in research
are highly likely to allow leeway. Relational factors
(such as feeling understood by their potential surro-
gates) clearly play a role as well—and this may have
important consequences on how we view current
practices. Because there is ample cross-sectional evi-
dence that even impaired dementia patients generally
express “reasonable” preferences (i.e., similar to
healthy controls) for treatment27and for research
participation,28if such preferences are predictive of a
desire for conferring leeway then the current practice
of surrogate consent with subject assent seems well
supported. However, only a longitudinal study
would provide direct evidence regarding whether a
potential subject’s current preference (as reflected in
the subject’s assent) is reflective of a longstanding
desire for granting leeway.
Even among those who state that they do not de-
sire to participate in SBR, a significant minority
(over a quarter) are willing to confer some or com-
plete leeway on their future surrogates. If these sub-
jects are added to those who are willing to participate
in the four SBR scenarios, the proportions of poten-
tial participants would rise to approximately 80% for
the LP study, 88% for the drug RCT, 79% for the
Table 4Factors associated with subjects’
willingness to allow some/complete
leeway to their surrogates
regarding future participation in
OR (95% CI)
Want to participate
(vs not want to)
Female (vs male)
Married (vs not married)
Excellent self-rated health
(vs less than excellent)
Gene transfer scenario
(vs other scenarios)
Religion is very important
(vs somewhat or not too important)
Interaction of gene transfer
scenario x religion very important
for race/ethnicity and religion in addition to variables in-
cluded in the table.
OR ? odds ratio; CI ? confidence interval.
Neurology 72January 13, 2009
vaccine study, and 74% for the gene transfer study. A
recent study of elderly subjects from senior centers
and primary care clinics regarding an LP SBR sce-
nario found similar results.22However, this point
needs to be balanced by the fact that the surrogates of
those who are willing to participate and are willing to
grant leeway will have the latitude to override that
willingness to participate; leeway does not necessarily
imply an increase in enrollment.
This study’s main limitation is that the scientific
and policy issues surrounding surrogate consent for
research are quite complicated. This brief survey cap-
tures only a snapshot impression regarding SBR. It
may be that as people learn and reflect more, their
attitudes may change. We are therefore currently
conducting a series of all-day deliberative democracy
sessions with laypersons and caregivers regarding
SBR.29Another limitation of the study is that it fo-
cuses on dementia research and may not generalize to
other areas of SBR.30,31
An important strength of this study is its large and
representative sample with an excellent response rate.
The Federal government is revisiting the issue of sur-
rogate consent and recently solicited public input.32
As a nationally representative study on the topic,
our study provides new data for an important policy
The primary ethical goals in overseeing SBR are
to minimize the potential harms of SBR (already
mandated by the current regulations) and to mini-
mize the potential for enrolling persons whose values
may not be compatible with participation in SBR. In
this regard, the current evidence, including the re-
sults of our study, provides some guidance. First, it
appears that even for invasive studies the prior prob-
ability of an older American’s willingness to partici-
pate in SBR is high. Second, even among those who
are not willing to participate, there is a sizable minor-
ity who are willing to confer some leeway on their
surrogates. More research on attitudes toward leeway
may provide further guidance to policy makers and
to researchers at the time subjects are approached for
research. Third, even when patients suffer from de-
mentia with impaired decisional capacity, they may
still retain some ethically relevant abilities. Persons
with AD express personal choices regarding research
participation that are similar to those expressed by
competent adults, suggesting that risk-related prefer-
ences are relatively preserved.28Thus, the practice of
requiring the assent of even incapable subjects may
provide another level of assurance. Patients with AD
may also have relatively preserved abilities to appoint
a trusted relative to help make research decisions for
them.33Finally, it is quite likely that persons acting as
family surrogates will be protective and provide a
gatekeeper function.17Future research should aim to
provide further guidance on how to minimize the
enrollment of those whose values are not compatible
From the Center for Behavioral and Decision Sciences in Medicine, Bio-
ethics Program, and Department of Psychiatry (S.Y.H.K.), Center for
Statistical Consultation and Research (H.M.K.), and Division of General
Medicine, Department of Medicine, and Institute for Social Research
(K.M.L.), University of Michigan, Ann Arbor; Veterans Affairs Center for
Practice Management and Outcomes Research (K.M.L.), Ann Arbor, MI;
Department of Medicine (J.H.T.K.), Division of Geriatrics, Alzheimer’s
Disease Center, Center for Bioethics, and the Leonard Davis Institute for
Health Economics, University of Pennsylvania; Department of Neurol-
ogy (D.S.K.), Mayo Clinic, Rochester, MN; and Division of Law, Ethics,
and Psychiatry (P.S.A.), Department of Psychiatry, Columbia University
and New York State Psychiatric Institute, New York, NY.
Received August 12, 2008. Accepted in final form October 3, 2008.
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Neurology 72 January 13, 2009