by Scott Y. H.
Kim, Renee Wilson, Raymond De Vries,
H. Myra Kim, Robert G. Holloway, and Karl Kieburtz
Could the High Prevalence of Therapeutic Misconception Partly
Be a Measurement Problem?
T
herapeutic misconception (TM) is said to occur
when an individual “inaccurately attributes a
primacy of therapeutic intent and individual-
ized care typically seen in ordinary clinical settings to
research procedures”1 or “when individuals do not un-
derstand that the defining purpose of clinical research
is to produce generalizable knowledge.”2 It is reported
that many research participants fail to understand the
purpose of research. For instance, some studies have
found that clear majorities of oncology clinical trial
participants failed to understand that the trial was
“mostly research,”3 and studies specifically designed
to detect TM reported that a majority of the research
participants showed evidence of TM.4 Although other
studies have found lower rates of misunderstanding
of the purpose of research (e.g., 25%5), a recent study
found that nearly 40% of patients enrolled in early-
phase oncology trials failed to understand that the pur-
pose of their clinical trials was not primarily to benefit
them.6 Indeed, the phenomenon of TM is sometimes
spoken of as ubiquitous.7 Is this conventional view
correct? Are research participants routinely making a
fundamental error in understanding?
A small but growing body of literature is beginning
to probe this issue and to challenge the conventional
view.8 These new studies draw on insights from the
linguistic field of pragmatics—the study of meaning
conferred by factors beyond the semantic meaning
of the words such as the context and function of the
communication.9 Ordinarily, mutual comprehension in
communication relies on the fact that context removes
ambiguities or even allows interpretations contrary
to literal semantic meanings (as with “Can you pass
the salt?,” which is not a question about an ability
Kim SYH, Wilson R, De Vries R, et al. Could the high prevalence of therapeu-
tic misconception partly be a measurement problem? IRB: Ethics & Human
Research 2015;37(4):11-18.
IRB: E t h i c s & H u m a n R e s e a rc h
© 2015 The Hastings Center. Permission is required to reprint.
but a polite request). Thus, what appear to be misun-
derstandings, misconceptions, or unrealistic beliefs of
research subjects may at least partly reflect the limita-
tions of the way such phenomena are measured.10 For
example, when a research participant uses a probability
statement about a potential outcome (such as personal
benefit), evidence shows that he or she may be using it
to express hope, faith, or wish for luck rather than stat-
ing his or her belief in a mathematical probability.11
We hypothesize that when people are asked about
the purpose of research in the context of considering
participation in research, they could be answering a dif-
ferent question than the one intended by the researcher
attempting to detect TM. This hypothesis is based
on two considerations. First, in our interviews with
research participants, some answer questions about
the purpose of research incorrectly (e.g., stating that
the primary purpose is to benefit them) but neverthe-
less show in other statements that they understood that
the research was not tailored for their benefit. These
patient-subjects seem to interpret the purpose of the re-
search question as asking what their own purpose is in
participating in a study. Second, this anecdotal obser-
vation is consistent with theories about how linguistic
context can have a profound effect on how we interpret
statements. The sentence “He overlooked the battery”
can have two very different meanings depending on
whether it is preceded by “The technician was incom-
petent” or by “The judge was lenient.”12 If what we
currently measure as misunderstandings of the purpose
of research are, at least partly, not misunderstandings
of the purpose of research but rather reports of re-
search participants’ motivation for participation, then
our current estimates of TM could be inflated. We do
not know to what extent, if any, people might interpret
TM survey questions in this unintended way.
J u ly -A u g u st 2015
11
 Figure 1.
Follow-up Question regarding Purpose-of-Research Question

Closed-ended follow-up to purpose question Open-ended follow-up to purpose question

Question asked “We would like to know how you interpreted the “Use the space below to tell us what was going
above question. Which of the following do you through your mind when you answered the last
think best captures how you understood question. In your opinion, what did you think
the question?” the question was asking? Why did you give the
answer you did?”

Response options A. “It was asking what my own intentions would Free text
(A-C presented be for participating (or not participating).
in random order) In other words, which of the intentions mentioned
best reflects why I would or would not participate
in the study.” [PERSONAL MOTIVATION]

B. “It was asking whether the research is being done

to create knowledge for knowledge’s sake or to help
actual people.” [KNOWLEDGE VS. PEOPLE]

C. “It was asking about the official purpose of the

research study. That is, the researchers’ overall main
goal in doing the study.” [OFFICIAL PURPOSE]

D. “I am still not sure what the question was asking.”

A key feature of our hypothesis is that what appears
to be TM (at least in regard to understanding of the
purpose of research) is not essentially tied to actually
being a patient-subject whose desire for benefit blinds
him or her to the real purpose of research. Rather, such
a misunderstanding is hypothesized to be due to the lin-
guistic context in which the purpose question is asked.
Thus, we envision two steps to test this idea. First,
if people incorrectly answer the purpose-of-research
question due to a linguistic effect (and not because
of some special psychological state essentially tied to
being a patient-subject), this should be detectable in
competent users of English hypothetically discussing
research participation, regardless of whether they are
actual patients considering real research participation.
If such effect cannot be observed in nonpatients, then it
is unlikely that a linguistic effect could account for high
prevalence of TM. Second, if the effect is observed by
merely creating the linguistic context even in nonpa-
tient-subjects, then the next step would be to repeat the
study in actual patient-subjects. This article reports on
our work with nonpatients.
We used a purpose-of-research question (which we
will refer to as the “purpose question”) from a study
by Pentz and colleagues13 to examine two questions:
1) whether the question is understood by people as
intended and 2) whether there is a relationship between
people’s answers to the purpose question and whether
they understood the purpose question as intended. A
confirmatory follow-up study was also conducted.
Study Methods
W e recruited 100 individuals through Amazon’s
Mechanical Turk (MTurk), one of Amazon’s
web services that allows users to post tasks, such as
surveys, and that is widely used in experimental surveys
in psychology, economics, and political science.14 Re-
spondents can browse and complete tasks for monetary
compensation (we paid $0.50 per subject for this five-
minute survey). All respondents were from the United
States, and the data were collected anonymously, as
Amazon handles the compensation.
The survey began with a hypothetical description
(Supplementary Figure A, available on the IRB: Ethics
& Human Research website) of an early-phase clinical
trial for amyotrophic lateral sclerosis (ALS), a usually
terminal and debilitating neurological condition with
no effective treatment. Using a scale anchored at one
end by “would not consider at all” (score of 0) and at
the other by “definitely would consider” (score of 10),

J u ly -A u g u st 2015 IRB: E t h i c s & H u m a n R e s earc h

12
respondents were asked whether they would consider
participating in the clinical trial if they had been diag-
nosed with ALS. They were invited to provide com-
ments to their responses.
The participation question was followed by a
purpose-of-research question from the study by Pentz
and colleagues: “Is the research study mostly intending
to help research and gain knowledge or mostly intend-
ing to help you as a person?”15 The response choices
consisted of “Mostly intending to help research and
gain knowledge” (the response that researchers would
ordinarily interpret as correct and not evidencing TM),
“Mostly intending to help you as a person” (the incor-
rect response ordinarily taken to exhibit TM), and
“Don’t know/Not sure.”
We then randomized the participants to two arms
and tested two modes of asking a follow-up question
(closed-ended and open-ended) to elicit the respon-
dents’ interpretation of the purpose question (Figure 1).
Half of the respondents were randomized to a closed-
ended question with three response options (plus a “not
sure” option), with the order of presentation for the
three options randomized. The other 50 respondents
in the second arm were presented with an open-ended
question that they were asked to answer in free text.
The purpose of the two randomized arms was to allow
validation of the closed-ended question responses by a
qualitative analysis of responses to the questions in the
open-ended arm.
Descriptive data (frequencies and percentages) were
calculated for demographic variables and responses
to the survey questions. For the open-ended follow-
up question arm, we conducted a qualitative content
analysis of respondents’ comments. First, two team
members read the comments and independently cre-
ated coding categories. These two team members then
compared their codes and merged them into one coding
scheme; two additional team members reviewed the
coding scheme and made further revisions. All four
coders tested the resulting coding scheme to code the
comments. Any discrepancies and further modifications
to the codes were made by group discussion. We tested
whether the responses to the purpose question were re-
The phenomenon of TM is sometimes spoken of
as ubiquitous, but is this accurate? Are research
participants routinely making a fundamental error
in understanding?
lated to the responses to the follow-up questions, using
the Fisher’s exact test.
Approximately nine months after the above experi-
ment, we conducted a confirmatory survey using the
closed-ended format with a sample of 135 participants
recruited via Amazon MTurk in a similar manner as
above.
Study Results
T he mean age of respondents was 32.8 (SD =
10.4). Eighty-six percent were Caucasian. Women
comprised 44% of respondents. Forty-two percent of
respondents had graduated from college. The income
distribution range included 14% earning less than
$20,000 a year, 59% earning between $20,000 and

Table 1.
Relationship between Purpose-Question Response and Interpretation of Purpose Question,
Closed-Ended Arm (N = 50)

Purpose-question response
Help research Help you as a person Don’t know Total (%)
and gain knowledge
Interpretation
Personal motivation 5 5 0 10 (20%)
Knowledge vs. people 8 2 2 12 (24%)
Official purpose 26 0 2 28 (56%)
Total (%) 39 (78%) 7 (14%) 4 (8%) 50 (100%)

Fisher’s exact test, p = 0.001

IRB: E t h i c s & H u m a n R e s e a rc h J u ly -A u g u st 2015

13
 Table 2.
Relationship between Response to Purpose Question and Interpretation of Purpose
Question, Open-Ended Arm (N = 49)
Help research and gain knowledge Help you as a person Don’t know. Total (%)
Interpretation
Personal motivation 8 5 2 15 (31%)
Knowledge vs. people and other 1 2 1 4 (8%)
Official purpose 27 0 3 30 (61%)
Total (%) 36 (73%) 7 (14%) 6 (12%) 49 (100%)
Fisher’s exact test, p = 0.001
$60,000, 16% earning $60,000 to $100,000, and 11%
earning more than $100,000. When asked whether
they would consider participating in the ALS trial (on
a scale where 1 = would not consider at all and 10 =
definitely would consider), most respondents said they
would consider participating, with a mean response of
9.1 (SD = 1.4). Sixty respondents gave 10 as an answer,
with only three responding on the negative side (i.e.,
5 or lower). All but one respondent provided written
comments. Content analysis of their comments showed
that 76% (76/99) made comments reflecting a strong
therapeutic motivation, such as “ALS is almost always
fatal so I would want a chance to live even if it is a
small chance.” The written comments reflect a strong
therapeutic orientation toward participation in a hypo-
thetical ALS study.
With regard to the purpose question, 75% gave the
“correct” answer, 15% gave the “incorrect” answer
(i.e., the answer that would be interpreted as exhibiting
TM), and the remaining 10% chose “don’t know/not
sure” (Supplementary Table A, available on the IRB:
Ethics & Human Research website). The rates were
similar in both arms (chi-square test, p = 0.75).
With regard to how our respondents interpreted the
purpose question, in the closed-ended question arm,
56% (28/50) of respondents chose the intended mean-
ing of the purpose question, with the remainder split
between the “personal motivation” interpretation and
“knowledge vs. people” interpretation (Supplementary
Table B, available on the IRB: Ethics & Human Re-
search website). Cross-tabulation of these results with
the response to the purpose question (Table 1) shows
a strong relationship between the purpose question re-
sponses and the interpretations of that question (Fish-
J u ly -A u g u st 2015
14
Purpose-question response
er’s exact test, p = 0.001). Thirty-three percent (13/39)
of those who correctly answered the purpose question
in fact misinterpreted the question. Most notably, no
respondent who interpreted the purpose question as
intended gave an incorrect (i.e., TM) response to that
question.
One of the respondents in the arm that was given an
open-ended follow-up question to the purpose ques-
tion did not provide a response. Of the remaining 49
comments, 30 were coded with unanimous agreement
among the four coders. Three of the four coders agreed
about 13 comments, and for 6 comments a group
discussion was required to reach a consensus. As can
be seen in Supplementary Table C (see the IRB: Eth-
ics & Human Research website), although there were
numerous subthemes, the comments generally fell into
three broad themes corresponding to our closed-ended
question response options. Sixty-one percent of respon-
dents (30/49) interpreted the purpose question as some
variant of its intended meaning, 31% (15/49) interpret-
ed it as a form of a personal motivation question, and
two respondents (4%) interpreted it as a “knowledge
vs. people” question. Cross-tabulating these results
against the responses to the purpose question reveals a
strong relationship (Fisher’s exact test, p = 0.001). As
in the closed-ended arm, no one who interpreted the
purpose question as intended gave an incorrect answer
to it. Twenty-five percent (9/27) of those who correctly
answered the purpose question in fact misinterpreted
the question (Table 2).
The results of our follow-up survey (identical to
the closed-ended arm, but with 135 participants) are
consistent with the results from the first survey (Table
3). Overall, 15.6% (21/135) chose the incorrect (i.e., in-
IRB: E t h i c s & H u m a n R e s earc h
dicative of TM) response to the purpose question, and
only 46.7% (63/135) interpreted the purpose question
as intended. Only 4.8% (3/63) of those who interpreted
the purpose question as intended answered it cor-
rectly (Fisher’s exact test, p < 0.001). Forty-six percent
(50/109) of those who gave the correct response to the
purpose question did not in fact interpret the purpose
question as intended.
Discussion
response to the purpose question (total of 35 respon-
dents in our two surveys), only three interpreted the
purpose question as intended (8.6%). In other words,
understanding the purpose question as intended virtu-
ally precludes a TM response, and a TM response is a
potent indicator that the person has misinterpreted the
purpose question. The apparent failure of the survey
respondents to understand the purpose of research by
providing a TM response is almost entirely a function
of how they interpreted the purpose question.

T he federal regulations governing research with hu-

mans specify that one of the general requirements
of informed consent is that research subjects be pro-
vided with a statement that the study involves research.
If research subjects routinely fail to understand that
research is not primarily to benefit them but to gener-
ate knowledge, then they are routinely enrolled without
understanding a cardinal requirement of informed
consent. But is it true that this kind of misunderstand-
ing is widespread? In order to attribute such a misun-
derstanding, one must first assume that the purpose
question (“Is the research study mostly intending to
help research and gain knowledge or mostly intending
to help you as a person?”) is interpreted as intended by
those who apparently exhibit TM.
Our study about a hypothetical ALS clinical trial
suggests that we should not rush to this assumption.
Almost no one who interpreted the purpose question as
intended provided a response indicative of TM (“most-
ly intending to help you as a person”). And by combin-
ing the responses from both surveys, we found that
only 2.5% (3/121) of respondents who interpreted the
purpose question as intended gave the TM response to
the purpose question. Among those who chose the TM
Understanding the purpose question as intended
virtually precludes a TM response, and a TM
response is a potent indicator that the person has
misinterpreted the purpose question.
About half of the respondents (46% when studies
are combined) did not interpret the purpose question as
intended. We suspect that had we used typical pretest-
ing procedures for survey research, such as cognitive
interviewing,16 we would not have picked up the fact
that nearly half of the persons in our survey did not
interpret the question as intended. First, pre-test cogni-
tive interviews are not intended to provide quantitative
estimates. For instance, even if we find only one incor-
rect interpretation in 10 cognitive interviews (a typical
number for pretesting),17 the 95% confidence interval
will extend to as high as a 45% misinterpretation rate.
Second, a slight majority (56%, 32/57) of the respon-
dents in our survey who interpreted the purpose ques-
tion as a personal motivation question expressed altru-
istic motivation. It is likely that none of these would be

Table 3.
Confirmatory Follow-up Survey Results of Relationship between Response to Purpose Question
and Interpretation of Purpose Question, Closed-Ended Format (N = 135)

Purpose-question response
Help research Help you as a person Don’t know Total (%)
and gain knowledge
Interpretation
Personal motivation 19 12 1 32 (23.7%)
Knowledge vs. people 31 6 3 40 (29.6%)
Official purpose 59 3 1 63 (46.7%)
109 (80.7%) 21 (15.6%) 5 (3.7%)

Fisher’s exact test, p < 0.001

IRB: E t h i c s & H u m a n R e s e a rc h J u ly -A u g u st 2015

15
 seen as misinterpreting the purpose question during a
cognitive interview for the following reason. Imagine a
cognitive interview with one such subject. This respon-
dent may not express confusion, appear hesitant, or ask
for clarification since the respondent feels that he or she
knows what the question is asking. Further, when he
or she talks about “helping future patients” (reflecting
the respondent’s altruistic motivation) in discussing the
purpose question, it will not be apparent to the cogni-
tive interviewer—unless the interviewer specifically
probes for it—that the respondent is talking about his
or her personal motivation. It would be natural for the
interviewer to assume that the purpose question is func-
tioning as intended in such cases.
It is remarkable, but consistent with our linguistic
hypothesis, that even nonpatients thinking about a hy-
pothetical scenario fail to understand the purpose ques-
tion as intended. Meaning is more than semantic. There
are pragmatic considerations (meanings conferred by
the context or function of communication) that are at
play. According to relevance theory—the most empiri-
cally tested theory of pragmatics—people “follow a
path of least effort in constructing an interpretation of
the utterance” they hear until their expectation of the
relevance of what they heard is satisfied.18 Whether in
a real study or in a hypothetical exercise, the context
for the potential research subject is one of making a de-
cision whether to enroll in a study. That is their overall
organizing focus because that is what the experimenter
(i.e., researcher attempting to detect TM) has up to that
point indicated to him or her as the focus of their com-
municative interaction. Thus, even if individuals fully
understand the purpose of research, many will organize
their conversation with the researcher studying TM
from the point of view of their own decision making. In
such a context, a question containing concepts such as
intention and purpose may naturally be interpreted by
some as a query about why they would participate in
research. Such an interpretation is efficient, consistent
with the context of the conversation, and consistent
with what relevance theory would predict. Note that
this does not mean that individuals are only self-inter-
ested; some will indeed be motivated by altruism to en-
roll in a study. But the point is that their focus is not on
demonstrating their understanding to the interviewer;
it is on the decision being considered. Thus, it should
not be surprising that almost half of the respondents
in our survey asked about participating in a hypotheti-
cal study tended to interpret the purpose question as a
J u ly -A u g u st 2015
16
personal motivation question. Weinfurt points out that
this discrepancy in perspective between the researcher
and the individual he is interacting with has a vener-
able history, labeled by William James in 1890 as “the
psychologist’s fallacy.”19
A strength of our study is that we complemented the
closed-ended follow-up question arm with an open-
ended question arm, allowing important validation.
Further, a confirmation of the results with a bigger and
entirely new sample provides robust validation that
is unusual in empirical studies about research ethics.
Our procedures also allowed us to see that one of our
response options (“create knowledge for knowledge’s
sake or to help actual people”) did not elicit a uniform
response across the two arms (24% vs. 4%) or in the
confirmatory study (8%). Although this could be due
to small sample size, we suspect that the meaning of
the response option was not clear. In future research, it
may be preferable to eliminate this option.
It is important to emphasize that the purpose of our
surveys was not to show that TM is rare among actual
clinical research participants. One would need to study
actual patient-subjects in order to prove such a claim.
Instead, our goal was to test and delineate a potential
mechanism to explain TM that could then be applied in
actual patient-subjects. If TM (at least the component
that has to do with answers to “purpose-of-research”
questions) is partly the result of a linguistic effect, then
that linguistic effect should be inducible even in non-
patients in hypothetical scenarios merely by engaging
them in that linguistic context. If such an effect cannot
be shown with nonpatients, the linguistic hypothesis
cannot be true. Showing that the linguistic effect does
occur with nonpatients provides evidence that the hy-
pothesis must be considered as a potential explanation
for the very high incidence of TM on the part of re-
search participants that some researchers report. Thus,
our results provide a compelling reason to conduct
future studies on the linguistic effect in actual patient-
subjects as an explanation for the high incidence of TM
phenomena.
It is unlikely that patient-subjects are in particular
“immune” to the linguistic effect that we have shown
in nonpatients. In fact, it seems likely that being a
patient would make one more, rather than less, prone
to the linguistic effect (i.e., more likely to interpret the
purpose question as a personal motivation question)
since the decision-making context is so much more
real for them than for the nonpatients. If so, then this
IRB: E t h i c s & H u m a n R e s earc h
could explain the higher prevalence of the TM response
among patient-subjects than was found in our study of
nonpatients.
Our results should not be taken to suggest that TM
does not exist. We are convinced that it does because
we have observed it.20 At times, people do truly fail to
understand that the purpose of research is not primar-
ily to benefit them. But when TM appears to be very
common even after it has been explained to prospective
participants that they are being asked to be in a re-
search study, the first impulse should be to assess how
we are measuring their understanding of the study.
That TM is ubiquitous is a long-standing view in the
world of research ethics. Therefore, a claim that TM is
not as prevalent must explain why it appears to be so
prevalent. Based on careful qualitative analyses of inter-
views with actual patient-subjects and borrowing from
insights from pragmatics (especially relevance theory),
we have developed a linguistic hypothesis regarding at
least one core aspect of TM: people appear to misun-
derstand the purpose of research because the questions
used to measure TM are not understood as intended.
Instead, the context allows some people to interpret the
purpose question as a question about their own motiva-
tions. As a linguistic phenomenon, this misinterpreta-
tion of the purpose question should be measureable in
nonpatients who are competent English users, and our
results robustly demonstrate this. The next step is to
test whether among patient-subjects who understand
the purpose-of-research question as intended, a high
proportion believe that research is primarily intended
to benefit them.
Supplementary Figure and Tables
Supplementary Figure A and Tables A, B, and C are
available on the IRB: Ethics & Human Research website.
Acknowledgments
This work was supported in part by the National
Institute for Neurological Disorders and Stroke (R01-
NS062770) and a Clinical and Translational Science
Award program award (UL1 RR024160) from the
National Center for Research Resources and the National
Center for Advancing Translational Sciences of the Na-
tional Institutes of Health.
The authors wish to thank David DeGrazia, Frank
Miller, and Luke Gelinas for helpful comments on previ-
ous drafts. We also thank Sonali Parnami and Kerry Ryan
for assistance in the development and implementation of
the survey.
The studies discussed in this manuscript were reviewed
by and deemed exempt from federal regulations by the
IRB: E t h i c s & H u m a n R e s e a rc h
University of Rochester and the University of Michigan
institutional review boards.
Disclaimer
The opinions in the article are the authors’ own and
do not represent the views of the National Institutes of
Health, the Department of Health and Human Services, or
the federal government.
n Scott Y.H. Kim, MD, PhD, is senior investigator in the Department
of Bioethics at the National Institutes of Health; Renee Wilson, MA,
is senior project manager at the Center for Human Experimental
Therapeutics at the University of Rochester; Raymond De Vries, PhD,
is professor at the Center for Bioethics and Social Sciences in Medi-
cine and the Department of Medical Education at the University of
Michigan; H. Myra Kim, ScD, is adjunct professor in the Department
of Biostatistics at the University of Michigan; Robert G. Holloway,
MD, MPH, is professor and chair of the Department of Neurology at
the University of Rochester; Karl Kieburtz, MD, MPH, is the Robert
J. Joynt Professor in Neurology and professor in the Department
of Environmental Medicine and the director of the University of
Rochester Clinical and Translational Science Institute and Center for
Human Experimental Therapeutics at the University of Rochester.
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