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Reducing risk in coronary artery disease

References
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Attitudes and views of the general public towards

research participation
K. E. A. Burns,1,2 N. Magyarody,3 D. Jiang1,2 and R. Wald1,2
1
Interdepartmental Division of Critical Care Medicine, University of Toronto, 2Keenan Research Centre and the Li Ka Shing Knowledge Institute, St
Michael’s Hospital, Toronto, 3Department of Clinical Epidemiology and Biostatistics, The University of Western Ontario, London, Ontario, Canada

Key words Abstract

general public, research participation, research
ethics, consent, survey method.
Correspondence
Karen E. A. Burns, Department of Medicine,
Divisions of Respirology and Critical Care
Medicine, St Michael’s Hospital, Toronto,
Ontario Canada, M5B 1W8.
Email: burnsk@smh.toronto.on.ca
Received 21 May 2010; accepted 27 November
2010.
doi:10.1111/j.1445-5994.2011.02433.x
Background: While the challenges of recruitment into clinical trials are well described,
little is known about the public’s perceptions towards research.
Aims: We sought to describe the attitudes, beliefs and knowledge of the public towards
research and research participation, focusing on clinical trials, contrast these attributes
among individuals with different relationships with the healthcare system and to iden-
tify predictors of willingness to participate.
Methods: We conducted a self-administered cross-sectional survey of patients and
their significant others in two clinics and two intensive care unit waiting rooms and in
three public venues.
Results: We analysed responses from 417 respondents (102 and 105 in dialysis and
oncology clinics, and 106 in intensive care unit (ICU) waiting rooms, 104 in public
locations). While most (68.3%) respondents favoured the use of humans in clinical
trials, 53% felt that trial participants always or almost always receive the best quality of
care, only 30.4% had participated in clinical research. Approximately 70% felt that
subjects are always advised of the risks and benefits of participation, and 30% expressed
ambiguity regarding whether participants are informed of their involvement. Oncology
and dialysis respondents were the most and least informed regarding research methods
and ethics. The perceived risks and benefits associated with clinical circumstances
influence research participation decisions and vary with healthcare experiences. We
identified six predictors of willingness to participate.
Conclusion: Attitudes of the public towards research participation are beleaguered by
misconceptions. Stakeholders in clinical research must educate the general public
regarding research methods and ethics.

© 2011 The Authors

Internal Medicine Journal © 2011 Royal Australasian College of Physicians 531
Burns et al.
Introduction
Recommendations for the treatment of patients are fre-
quently based on the results of randomised controlled
trials (RCT) and systematic reviews of the literature.1
Successful trial implementation requires thoughtful
design, rigorous implementation and patient participa-
tion. Research Ethics Boards require investigative teams
to obtain informed consent from patients or their sub-
stitute decision-makers (SDM) for participation in most
RCT and for the use of study data. While healthcare
consumers expect that the research community will
continue to develop novel, effective and safe approaches
for the management of health problems, patients and
their SDM approached for consent for clinical research
participation infrequently provide consent to enable
participation.
The public’s perceptions of research participation are
not well characterised. A survey of 1022 adults in
England found that the majority of respondents were
willing to participate in RCT for major illnesses (63%)
and cancer (65%).2 Robinson and co-workers found that
certain factors, including having a terminal illness, phy-
sician endorsement, a patient’s desire to prolong his/her
life, a perception that the researcher/physician is compe-
tent and location of conduct (favouring private facilities)
influenced willingness to participate in prostate cancer
clinical trials.3
At least one empiric investigation suggests that citizens’
perceptions of clinical research are characterised by mis-
conceptions, fears and inadequate information. Barriers
to patient participation in research include a suspicion of
being treated as a ‘guinea pig’, fear of side-effects, mis-
trust of the medical establishment, concerns regarding
study design, a perception that the physician is inexperi-
enced or incompetent and of being imparted minimum
information about clinical trials.3 Moreover, there
appears to be a widely held misconception as to whether
patients who enter clinical trials perceive that they
receive the best medical care.4
The primary aims of this study were to: (i) characterise
the attitudes, knowledge and beliefs of the general public
towards research participation; (ii) compare and contrast
responses among respondent groups with different heal-
thcare experiences; and (iii) identify important predictors
of willingness to participate in clinical research. In order to
achieve these goals, we conducted a self-administered
survey of selected respondent groups identified in public
Funding: K. E. A. Burns holds a Clinician Scientist award from
the Canadian Institutes of Health Research (CIHR). R. Wald
holds an RCT Mentorship Award with the CIHR.
Conflict of interest: None.
532
settings, and in clinics and family waiting rooms in a
teaching hospital in a large metropolitan centre.
Methods
We conducted a self-administered, cross-sectional sur-
vey to elucidate, compare and contrast the attitudes,
knowledge and beliefs of members of the general public,
including patients and their significant others, towards
participation in clinical research over an 8-week period.
Study population
We administered a questionnaire to (i) members of
the general public identified in three venues (Dundas
Square, Nathan Phillips Square and the University of
Toronto campus) in downtown Toronto, Ontario; (ii)
patients with end-stage renal disease (receiving haemo-
dialysis or peritoneal dialysis); (iii) patients with
chronic, often fatal, illnesses and their significant others
(identified in outpatient oncology clinics); and (iv)
family members and significant others of critically ill
patients (approached in two intensive care unit (ICU)
family waiting rooms serving three ICU (medical/
surgical, cardiovascular and neurotrauma)) at St
Michael’s Hospital (Toronto, Ontario, Canada). All three
locations in downtown Toronto are accessible to the
public; Dundas Square and Nathan Phillips Square are
venues for open-air markets and festivals in the
summer months, with the latter being in close proxim-
ity to Toronto City Hall. The University of Toronto
Campus is located in downtown Toronto. St Michael’s
Hospital provides care to an economically and ethnically
diverse local population, as well as to patients from
across the province of Ontario. Respondents over the
age of 16 who were able to comprehend written English
were eligible to participate.
Questionnaire development and testing
We developed an 18-item questionnaire to probe the
attitudes and perceptions of specific respondent groups
towards research and research participation. Our ques-
tionnaire included 12 questions adapted from a prior
publication5 and six new questions. The three domains
explored by the questionnaire were the public’s attitudes,
knowledge and beliefs towards clinical research. We
assessed participant attitudes regarding: (i) the use of
humans in medical research; (ii) risk of themselves or
others experiencing a severe complication or death as a
result of trial participation; (iii) whether the treatment
chosen was the best for the patient; and (iv) whether trial
participants received the best care possible. We explored
© 2011 The Authors
Internal Medicine Journal © 2011 Royal Australasian College of Physicians

respondent knowledge regarding: (i) how treatment is
determined for trial participants; (ii) the purpose of clinical
trials; (iii) the characteristics of clinical trial participants;
(iv) how trials are implemented; (v) informed consent
issues in the conduct of clinical trials; and (vi) the man-
dates of community (local) versus academic (university-
affiliated) hospitals. We explored respondent beliefs by
asking: (i) if they would participate in a trial under specific
clinical circumstances; (ii) how they would feel if they
were approached to participate in more than one clinical
trial; and (iii) whom they would want to make decisions
regarding their research participation if they were uncon-
scious and unable to do so by themselves. Finally, we
probed whether respondents would be willing to partici-
pate in a study focusing on their illness or health problem
or that of someone close to them. We formatted the
questionnaire to include nominal, ordinal and interval
(scale: 1(highly unimportant) – 10 (highly important))
response options. We pilot tested the questionnaire with
32 individuals and revised question stems and response
formats accordingly prior to its administration.
Questionnaire administration
One author (NM) administered the questionnaire to
potential respondents, including visitors to Toronto, with
the goal of obtaining at least 100 responses from each of
the four respondent groups, defined a priori. A standard-
ised script introduced the questionnaire and explained
the rationale for conducting the survey. The cover letter
provided the following context: clinical trials are used to
determine whether new drugs or treatments are safe and
effective. For the purpose of this survey, when people
participate in a clinical trial they typically receive one of
two treatments. When a therapy is not currently avail-
able for the disease or condition, the new therapy is
compared to an inactive therapy (also called a placebo).
We offered participants a $2 gift certificate for
a local coffee franchise upon hand return of their
completed questionnaire.
Statistical analyses
Descriptive statistics are presented in the text as means,
standard deviation or median for continuous variables
and frequencies and percentages for categorical variables.
We compared demographics and responses to questions
pertaining to attitudes, knowledge and beliefs among
the four respondent groups and comparing those willing
versus undecided versus unwilling to participate using
Chi-squared or Fisher exact test. We considered respond-
ents that acknowledged having a medical illness or health
problem in analysing a respondent’s willingness to par-
© 2011 The Authors
Internal Medicine Journal © 2011 Royal Australasian College of Physicians
Research participation: public attitudes
ticipate in a study focusing on their illness or health
problem. We collapsed categories, where appropriate, to
summarise data in a meaningful manner. For example,
we combined affirmative responses to two questions
addressing respondent willingness to participate in a
study evaluating their illness or health problem or that of
someone close to them. We conducted univariate and
multivariable multinomial logistic regression to identify
factors associated with willingness (willing vs undecided
or unwilling) to participate in a research study. We report
the odds of being willing to participate in relation to
those undecided or not willing to participate in clinical
research. We conducted multivariable logistic regression6
analysis using backwards selection to identify predictors
of willingness to participate. We predefined predictors
and interaction terms for inclusion using univariable
analysis and qualitative external information recognising
that the selection procedure (with a low a, for example
0.05) might result in poor model performance6–8 and
inaccurate selection of the most important predictors. We
report significant predictors of willingness to participate
in clinical research using the odds ratios (OR) and 95%
confidence intervals. We considered P < 0.05 to be statis-
tically significant. All analyses were conducted in SAS 9.1
(SAS Institute, Gary, NC, USA).
Results
Respondent characteristics
We administered the questionnaire to 427 individuals.
We excluded one questionnaire from a dialysis patient
that was less than one-third complete for which we
were unable to locate the respondent on a future occa-
sion and nine questionnaires due to participant with-
drawal. The 417 included questionnaires had similar
a priori representation from the four respondent groups
of interest (104 general public, 102 dialysis, 105 oncol-
ogy, 106 critical care waiting rooms) (Table 1). The
mean age of the participants was 45.6 ⫾ 18.3 years
with slightly more female (55%) respondents. Nearly
half (48.6%) of our respondents reported having an
ongoing illness for which they receive or should receive
treatment, and almost one-third (30.4%) had partici-
pated in clinical research.
Attitudes, knowledge and beliefs regarding
clinical research participation
The majority (68.3%) of our respondents favoured the
use of humans in clinical research with less than 10%
firmly objecting. Most respondents felt that the risk of
severe complications or death associated with participa-
533
Burns et al.

Table 1 Respondent demographic data

Characteristic Overall General Public Dialysis Oncology Critical care waiting room P value
(n = 416) (n = 104) (n = 101) (n = 105) (n = 106)

Age (years) <0.001

16–40 159 (38.8) 80 (50.3) 17 (10.7) 14 (8.8) 48 (30.2)
41–64 183 (44.6) 49 (10.4) 49 (26.8) 69 (37.7) 46 (25.1)
65+ 68 (16.6) 4 (5.9) 31 (45.6) 21 (30.9) 12 (17.7)
Gender <0.001
Male 187 (45.0) 62 (33.2) 65 (34.8) 27 (14.4) 33 (17.7)
Female 229 (55.0) 42 (18.3) 36 (15.7) 78 (34.1) 73 (31.9)
Education <0.001
High school or less 95 (23.2) 12 (12.6) 38 (40.0) 13 (13.7) 32 (33.7)
Some college 112 (27.4) 42 (37.5) 22 (19.6) 25 (22.3) 23 (20.5)
Completed college/graduate or higher 202 (49.4) 48 (23.8) 38 (18.8) 65 (32.2) 51 (25.2)
Do you have children? <0.001
Yes 223 (54.5) 24 (10.8) 63 (28.3) 72 (32.2) 64 (28.7)
No 186 (45.5) 79 (42.5) 37 (19.9) 32 (17.2) 38 (20.4)
Prior participation in medical research study or clinical trial <0.001
Yes 126 (30.4) 27 (21.4) 46 (36.5) 38 (30.2) 15 (11.9)
No 288 (69.6) 77 (26.7) 53 (18.4) 67 (23.3) 91 (31.6)
Ongoing illness <0.001
Yes 202 (48.6) 18 (8.9) 102 (50.5) 66 (32.7) 16 (7.9)
No 204 (49.0) 85 (41.7) 0 (0.0) 34 (16.7) 85 (41.7)

P values are derived from Chi-squared test. All data are presented as n (%), referring to the proportion of individuals within that respondent group with
that characteristic.

tion in a trial is moderate (56.6%) or low (27.8%). While 35

17.8% of respondents felt that the treatment received by 30
a trial participant is always the best for him/her, 63.1% 25
felt that it might be the best, 15.9% were uncertain, and 20
3.1% felt that it is never the best for him/her. In general, 15
only 53% of respondents felt that trial participants 10
always (22.3%) or almost always (30.7%) receive the 5
best care possible (Fig. 1). 0
Respondents largely understood that clinical trials Always Almost Sometimes Never Almost Don't know
always never
evaluate the differences between the two treatments
(81.2%), determine how well a treatment works (93.3%) Figure 1 Attitudes regarding whether trial participants receive the best
and identify treatment side-effects (84.6%). While most care possible.
respondents (82.2%) acknowledged that it takes several When a person participates in a clinical trial, would you say that they
years to conduct a clinical trial, only 53.7% of respond- always, almost always, sometimes, almost never or never receive the best
care possible? (Please check ONE response only).
ents felt that scientists, who conduct clinical trials, begin
with a set of research questions. In a clinical trial, 43.5%,
30.3% and 11.8% of respondents thought that treatment
is chosen for them by their physician, at random, or is offered a choice between experimental and regular care
self-determined, respectively, with 14.4% of respondents in the context of a clinical trial.
expressing uncertainty on this issue. With regard to Regarding the characteristics of participants, while over
informed consent, similar proportions of respondents felt 70% of respondents felt that poor individuals (70.1%),
that trial participants are sometimes or always advised of healthy subjects (77.2%) and sick (not dying)
risks (72.8%) and benefits (67.8%). Nearly 30% of patients(76.7%) sometimes or always participate in clini-
respondents were uncertain or thought that participants cal trials, a smaller proportion (57.2% and 40.4%) felt
are rarely or never informed of their participation in a that extremely sick or dying patients and wealthy indi-
clinical trial (Fig. 2). Moreover, nearly two-thirds viduals, respectively, participate. Respondents perceived
(62.4%) of respondents felt that trial participants are that community and academic hospitals provide

© 2011 The Authors

534 Internal Medicine Journal © 2011 Royal Australasian College of Physicians
 Research participation: public attitudes

80 80
70 70
60

Participation
60
50
50
40
40 30
30 20
20 10
10 0
Ongoing non Ongoing fatal Healthy Critically ill, Critically ill, Critically ill,
0 fatal disease, disease, no slim survival 50/50 survival high survival
no cure cure
Always Sometimes Never Don’t know
Clinical State
Figure 2 Knowledge regarding whether participants are informed they
are participating in a clinical trial. Figure 4 Beliefs regarding the clinical circumstances under which
When someone participates in a clinical trial do you think that they are respondents would participate.
always, sometimes or never. . . . told that they are participating in a clini- Would you participate in a clinical trial under any of the following circum-
cal trial? Please check ONE response per line only). stances? (Please check ONE response per line only). ( ), Yes; ( ), Maybe;
( ), No; ( ), Don’t know.

40
35
30
and unable to make decisions, the majority wanted their
25 most responsible family member (SDM or Power of
Percent

20 Attorney) (59.4%) to make decisions regarding their par-

15
10
5
0
Very burdened Somewhat Neither Somewhat Very grateful
burdened grateful
Request to participate in more than one clinical trial
Figure 3 Beliefs regarding how they would feel if approached to partici-
pate in more than one clinical trial.
How would you feel, if you were approached by research personnel to
participate in more than ONE clinical trial that you were eligible to partici-
pate in? Assume that both trials have been peer reviewed, evaluated and
approved by a Research Ethics Board and funded by a national granting
agency. (Please check ONE response only)
advanced healthcare (median 9.0 vs 9.0) and perceived
only slight differences in their mandates to provide basic
healthcare (median 10.0 vs 9.0), educate tomorrow’s
healthcare providers (median 9.0 vs 10.0) and advance
medical knowledge (median 9.0 vs 10.0) respectively.
While 43.6% of respondents reported that they would
feel grateful or very grateful to be approached to partici-
pate in more than one clinical trial for which they were
eligible, 20.8% acknowledged that they would feel very
or somewhat burdened by the request (Fig. 3). Regarding
the circumstances under which they would participate in
a clinical trial, most (67.8%) respondents would partici-
pate if they had an ongoing fatal disease with no known
cure, and few (28.8%) would participate in a healthy
state (Fig. 4). Respondents expressed the greatest nega-
tivity towards trial participation in the event that they
were critically ill with a high chance of survival (22.8%).
If respondents were unconscious, admitted to an ICU,
ticipation. Under these circumstances, 16.3% would
want the physician caring for them to make decisions
regarding trial participation, and less than 10% each
would want one or more physicians (not involved in
their care) to make the decision or to be enrolled under
deferred consent (deferred to their SDM or themselves).
Nearly 9.0% of respondents would not want to be con-
sidered for trial participation if they were incapacitated,
and 2.2% would agree to waived consent.
Differences among respondent categories
While members of the general public were most aware
that treatment in clinical trials is assigned at random
(41.8%), they were also the least likely to perceive that
the treatment received in a trial might be or is always the
best for the patient. Dialysis patients were the least
informed regarding the conduct of clinical trials and
issues of informed consent and perceived the risks of
experiencing a severe complication or death in clinical
trials to be highest. Participants identified in oncology
clinics were the most knowledgeable regarding clinical
trial implementation and consent issues and the most
likely to perceive that trial participants receive the best
care possible.
The majority of respondents in all four groups believed
that they would participate in a trial if they had either a
fatal or non-fatal ongoing illness with no known cure or
were critically ill with either a slim or 50/50 chance of
survival. Most family members of critically ill patients
and dialysis patients would participate in a trial in the
event of critical illness with a high chance of survival.

© 2011 The Authors

Internal Medicine Journal © 2011 Royal Australasian College of Physicians 535
Burns et al.
While over one-third of respondents expressed that they
would not be trial participants if they were critically ill
with a high chance of survival (low risk), approximately
one quarter of oncology respondents did not believe that
they would participate in a trial in a healthy state or in
the event of critical illness with a slim chance of survival.
Conversely, most dialysis patients felt they would partici-
pate in a trial in a healthy state. With regard to partici-
pation in medical research and clinical trials dialysis
patients (46.5%) were the most frequent participants
followed by respondents in oncology clinics (36.2%),
members of the general public (26.0%) and finally indi-
viduals identified in critical care waiting rooms (14.2%).
Finally, we did not identify a relationship between
respondent group and willingness to participate in clini-
cal research (P = 0.17).
Relationship of variables with willingness
to participate
We identified several variables significantly associated
with willingness (willing vs undecided vs unwilling) to
participate including having an ongoing illness (P = 0.01),
a favourable attitude towards the use of humans in
research (P < 0.001), a low perceived risk of suffering a
severe complication or death from participation (P <
0.001) and a perception that trial participants always or
almost always receive the best care possible (P < 0.001).
Similarly, respondent knowledge that clinical trials
always or sometimes determine how well a treatment
works (P < 0.001), that trial participants are always told
they are participating (P = 0.013) and that it takes several
years to conduct a trial (P = 0.002) were also significantly
associated with participation. However, we also identified
inaccuracies and misperceptions including the view that
impoverished individuals always or sometimes partici-
pate in clinical trials (P = 0.006) and that once a trial has
been completed it should never or rarely have to be
repeated (P = 0.026) as variables significantly associated
with willingness to participate. In Table 2, we present
variables significantly associated with willingness to par-
ticipate in univariate analyses. Being uncertain that trial
participants receive the best care possible was the only
variable significantly associated with reduced odds of par-
ticipation. We did not identify a relationship between
prior participation and willingness to participate (P =
0.14).
Predictors of willingness to participate in
clinical research
A multivariable logistic regression analysis identified six
variables significantly associated with willingness to par-
536
ticipate including espousing a favourable view towards
the use of humans in clinical trials, knowledge that clini-
cal trials determine how well a treatment works and that
trials take several years to conduct and three clinical
circumstances (having an ongoing, non-fatal diseases
with no known cure, being healthy or critically ill with a
50/50 chance of survival) (Table 3).
Discussion
Our findings provide insights into the attitudes of the
general public, with and without specific healthcare
experiences that inform decision-making regarding
research participation. While most respondents favoured
the use of humans in clinical trials (68.3%), less than
one-third (30.4%) had participated in a clinical trial or
research study. Moreover, nearly half (47%) of respond-
ents felt that research subjects did not always or almost
always receive the best quality of care, and 30%
expressed ambiguity regarding whether research subjects
were ever informed about trial participation. Contrary to
their favourable attitude towards research participation,
only 58.2% and 52.7% of respondents stated that they
would participate in a study focusing on their illness/
health problem or that of someone close to them respec-
tively. Participants identified in oncology clinics and
dialysis clinics were the most and least knowledgeable,
respectively, regarding clinical trial implementation and
consent issues. We identified six variables associated with
willingness to participate including espousing a favour-
able attitude towards the use of humans in research,
knowledge that trials determine how well a treatment
works and take several years to conduct and specific
clinical circumstances (having a non-fatal disease with no
known cure, being healthy, or critically ill with a 50/50
chance of survival).
Strengths of this study include the intentional sam-
pling of respondents with different healthcare experi-
ences, the large sample size and pilot testing of the
questionnaire prior to its administration. Administering
our questionnaire in three public venues in a large met-
ropolitan centre and in three locations within a teaching
hospital enhances the generalisability of our findings for
these segments of the population. However, since most of
our respondents were educated, results may differ if one
were to administer our questionnaire to different popu-
lations or in other venues. Moreover, our respondents
did not have unlimited time to reflect on the hypothetical
questions posed or to engage in discussions with others
about these issues. Consequently, responses may differ if
respondents were truly contemplating research participa-
tion. The possible influence of who approaches potential
respondents, the environment in which they are
© 2011 The Authors
Internal Medicine Journal © 2011 Royal Australasian College of Physicians
 Research participation: public attitudes

Table 2 Factors associated with willingness to participate in a clinical trial (univariate analysis)

Variable Crude odds ratio (95% CI)

Attitude towards use of humans in medical research

Favour 6.34 (2.88–14.0)***
Neutral/don’t know 2.52 (1.06–5.99)*
Opposed Ref
Beliefs regarding estimates of risk of suffering a severe complication or death
High (ⱖ50%) Ref
Moderate 1.40 (0.79–2.47)
Low (<10%) 2.15 (1.13–4.07)*
Knowledge regarding the purpose of medical research studies
Clinical trials determine how well a treatment works (always/sometimes vs rarely/never/don’t know) 6.00 (2.20–16.34)***
Knowledge regarding how clinical trials are conducted
Scientists start with a set of research questions (always/sometimes vs rarely/never/don’t know) 1.47 (0.98–2.20)
It takes several years to conduct a clinical trial (always/sometimes vs rarely/never/don’t know) 2.28 (1.31–3.97)**
Beliefs regarding who participates in clinical trials
Sick but not dying patients (always/sometimes vs rarely/never/don’t know) 1.81 (1.12–2.90)*
Poor individuals (always/sometimes vs rarely/never/don’t know) 1.83 (1.17–2.85)**
Participants receive the best care possible in clinical trials
Always/Almost always 1.46 (0.94–2.25)
Don’t know 0.40 (0.19–0.86)*
Sometimes/never/almost never Ref
Medical circumstances under which a person would participate in a clinical trial
Ongoing disease, not fatal (no known cure)
Yes 7.49 (3.61–15.54)***
No Ref
Maybe 2.33 (1.10-4.94)*
Don’t know 1.96 (0.69–5.59)
Ongoing disease, fatal (no known cure)
Yes 2.06 (1.01–4.19)*
No Ref
Maybe 0.88 (0.38–2.00)
Don’t know 1.08 (0.37–3.19)
Healthy, to help others
Yes 4.34 (2.38–7.90)***
No Ref
Maybe 2.45 (1.43–4.17)***
Don’t know 0.92 (0.39–2.17)
Critically ill, on life support with a slim chance of survival
Yes 2.04 (1.18–3.50)*
No Ref
Maybe 0.86 (0.45–1.64)
Don’t know 1.45 (0.54–3.87)
Critically ill, on life support with a 50/50 chance of survival
Yes 3.71 (1.96–7.05)***
No Ref
Maybe 1.44 (0.75–2.77)
Don’t know 2.29 (0.75–6.98)
Critically ill, on life support with a high chance of survival
Yes 3.03 (1.75–5.24)***
No Ref
Maybe 1.10 (0.64–1.87)
Don’t know 0.86 (0.34–2.15)

*P < 0.05; **P < 0.01; ***P < 0.001.

© 2011 The Authors

Internal Medicine Journal © 2011 Royal Australasian College of Physicians 537
Burns et al.
Table 3 Factors associated with willingness to participate (multivariate analysis)
Variable
Attitudes towards the use of humans in medical research
Favour
Neutral/don’t know
Oppose
Knowledge regarding the purpose of medical research
Trials determine how well a treatment works
Yes (always/sometimes)
No (rarely/never/don’t know)
It takes several years to conduct a clinical trial
Yes (always/sometimes)
No (rarely/never/don’t know)
Clinical circumstances under which respondents would participate in a trial
Ongoing disease, not fatal
Yes
No
Maybe
Don’t know
Healthy, to help others
Yes
No
Maybe
Don’t know
Critically ill, 50/50 chance of survival
Yes
No
Maybe
Don’t know
*P < 0.05; **P < 0.01; ***P < 0.001. The variables listed above remained in the multivariate model following the backwards selection procedure.
approached and low risk study characteristics on the
results of our survey are unknown. Finally, while we
identified knowledge of research methods as a predictor
of willingness to participate, we also found that certain
misconceptions (impoverished individuals always or
sometimes participate in trials and that once completed a
clinical trial should never have to be repeated) reflecting
deficiencies in knowledge were also predictors of willing-
ness to participate.
Positive attitudes towards research participation
appear to be surpassed by concerns regarding self-
participation. In a survey of 225 visitors to the
Heinrich-Heine University, Ohmann et al. found that
while 89.5% judged clinical trials to be important, only
25% would take part.9 These authors found that will-
ingness to participate was significantly higher among
individuals who considered trials to be important, pos-
sessed general knowledge about clinical trials, and had
participated previously in a clinical trial.9 In a qualita-
tive study involving 14 members of the general public,
Asai and colleagues noted greater willingness to partici-
pate in research if individuals perceived direct benefits
538
Willing vs undecided or unwilling
Adjusted OR (95% CI)
2.89 (1.19–7.05)*
1.62 (0.62–4.24)
Ref
4.19 (1.36–12.9)*
Ref
2.14 (1.11–4.12)*
Ref
2.76 (1.14–6.71)*
Ref
1.42 (0.58–3.49)
1.53 (0.45–5.20)
2.88 (1.44–5.80)**
Ref
1.85 (0.98–3.47)
0.90 (0.33–2.43)
2.14 (1.02–4.51)*
Ref
1.21 (0.55–2.65)
1.44 (0.39–5.23)
to themselves or to their families.10 In a telephone
survey of 489 American citizens identified by random
digit dialing, Trauth et al. found that prior research par-
ticipation, being middle aged, espousing a favourable
attitude towards the use of humans in medical research,
and having a friend or relative who was ill positively
influenced willingness to participate.5 We found that
58.7% of respondents, as compared to 46.0% in the
study by Trauth et al., were willing to participate in a
study focusing on a new treatment for a disease that
was of concern to them.5 Moreover, we found that
fewer respondents (52.7%) were willing to participate
in a trial focusing on a new treatment for a disease
affecting someone close to them, with more respond-
ents expressing uncertainty regarding research partici-
pation for illnesses experienced by others (35.3%)
versus themselves (26.1%). Robinson and colleagues
found that being terminally ill, having a desire to
prolong life, physician recommendation, and a belief in
the competency of healthcare providers are incentives
to participate in clinical research.3 Similar to our results,
Cassileth et al. noted that while most respondents
© 2011 The Authors
Internal Medicine Journal © 2011 Royal Australasian College of Physicians

(71%) believed that individuals should serve as
research subjects, responses regarding their research
participation reflected greater self-concern and less
altruism.4
The perceived risks and benefits associated with clini-
cal circumstances influence decisions regarding research
participation and may vary with healthcare experiences.
Coppolino and colleagues conducted interviews of 100
elective cardiac surgery patients and their SDM to assess
agreement among patients and their SDM regarding
research participation in minimum risk and greater-
than-minimal risk scenarios. Patients (72% and 73%)
and SDM (65% and 74%) expressed a comparable
degree of willingness to participate in low and greater-
than-minimal risk cardiac surgery scenarios respec-
tively.11 On the other hand, Ciroldi and colleagues
noted that patients, SDM and physicians were more
likely to participate in a low-risk critical care study.12
Our study did not evaluate the perceived risks associ-
ated with particular interventions, but rather the per-
ceived risks associated with specific clinical
circumstances. The majority of respondents in all four
groups would participate in a trial under circumstances
where they would likely benefit (if they had either a
fatal or non-fatal ongoing illness with no known cure
or were critically ill with a low chance of survival).
Unlike family members of critically ill patients and
dialysis patients who favoured participation under high-
risk/low-benefit circumstances (critical illness with a
high chance of survival), oncology respondents and
members of the general public did not favour participa-
tion under low-risk/low-benefit (healthy state) or high-
risk/low-benefit circumstances (critically illness with a
slim or a high chance of survival). Strategies for weigh-
ing the risks and benefits of research participation may
be influenced by prior healthcare experiences.
Previous studies suggest that substantial scepticism
exists regarding whether trial participants receive the best
care possible and highlight this as an important factor
limiting research recruitment.13 Casseileth observed that
while 52% of research participants stated that their main
reason for participating was to receive the best medical
care, only 13% believed that research participants actu-
ally receive better treatment.4 Similarly, while 53% of
our respondents felt that clinical trial participants always
or almost always receive the best care possible, 36%
believed that they would never, almost never, or only
sometimes receive the best care possible.
Apart from most respondents identified in oncology
clinics, our respondents’ understanding of clinical trials
were similar to those of Trauth et al.5 in that they were
beleaguered by misconceptions, suspicions, and insuffi-
cient information. Using a questionnaire administered to
© 2011 The Authors
Internal Medicine Journal © 2011 Royal Australasian College of Physicians
Research participation: public attitudes
950 Italian citizens, Apolone and colleagues demon-
strated unfavourable attitudes towards participation in
clinical studies and limited knowledge about clinical
research, which varied according to socio-demographic
and geographic variables.14 Others have highlighted that
a poor understanding of randomisation, treatment allo-
cation procedures and expectations by trial participants
represent important barriers to research participation.1 In
our survey, nearly 30% of respondents felt that they
would never or only sometimes be informed of their
participation in a trial and of the possible risks and ben-
efits associated with their participation.
Several important observations can be made from our
survey. First, comprehension of the principles underly-
ing clinical trials and consent issues differed between
members of the general public and patients; with
patients in different clinical settings also expressing dif-
ferent levels of knowledge regarding trial implementa-
tion. Based on these findings, we hypothesise that
strategies for research participation decision-making
may be influenced by experiences with the healthcare
system. Second, individuals who expressed a sense of
‘uncertainty’ as to whether patients in clinical trials
received the best care were less likely to be willing trial
participants. Third, we found only modest comprehen-
sion of clinical research methods and research ethics
among our survey respondents, nearly half of whom
had a post-secondary education. Finally, we found that
respondents who demonstrated a greater understanding
of the objectives of trails (trials determine how well a
treatment works) and who had a sense of the chal-
lenges associated with trial implementation (it takes
several years to conduct a clinical trial), were more
likely to be willing trial participants. Similarly, we found
that certain misconceptions (impoverished individuals
always or sometimes participate in trials and that com-
pleted trials should never have to be repeated) reflect-
ing a lack of knowledge were also predictors of
willingness to participate. These findings suggest that
better education of the public on the principles of clini-
cal trials may enhance research participation.
Conclusion
In order to ensure successful recruitment into clinical
trials, stakeholders in clinical research must engage the
public in a dialogue to dispel myths and misconceptions
regarding research methods and ethics. Potential research
participants must understand that the overall care that
they receive will not be compromised by trial participa-
tion and that the standard of care will always be met
regardless of the study arm to which they are ran-
domised. If clinical trials are to prevail in answering
539
Burns et al.

important research questions in a timely manner, a copy of the questionnaire used in their study and to
the needs of the public who are not only healthcare the participants who shared their time and thoughts on
consumers, but also potential trial participants and research participation with us.
consent providers, must be addressed.

Acknowledgements
The authors express their gratitude to Dr J Trauth
(University of Pittsburgh, Pittsburgh, PA) for providing

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