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Attitudes and Views of The General Public Towards Research Participation
Attitudes and Views of The General Public Towards Research Participation
References coronary syndromes. Int J Clin Pract 2009; risk: management of cardiovascular risk
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respondent knowledge regarding: (i) how treatment is ticipate in a study focusing on their illness or health
determined for trial participants; (ii) the purpose of clinical problem. We collapsed categories, where appropriate, to
trials; (iii) the characteristics of clinical trial participants; summarise data in a meaningful manner. For example,
(iv) how trials are implemented; (v) informed consent we combined affirmative responses to two questions
issues in the conduct of clinical trials; and (vi) the man- addressing respondent willingness to participate in a
dates of community (local) versus academic (university- study evaluating their illness or health problem or that of
affiliated) hospitals. We explored respondent beliefs by someone close to them. We conducted univariate and
asking: (i) if they would participate in a trial under specific multivariable multinomial logistic regression to identify
clinical circumstances; (ii) how they would feel if they factors associated with willingness (willing vs undecided
were approached to participate in more than one clinical or unwilling) to participate in a research study. We report
trial; and (iii) whom they would want to make decisions the odds of being willing to participate in relation to
regarding their research participation if they were uncon- those undecided or not willing to participate in clinical
scious and unable to do so by themselves. Finally, we research. We conducted multivariable logistic regression6
probed whether respondents would be willing to partici- analysis using backwards selection to identify predictors
pate in a study focusing on their illness or health problem of willingness to participate. We predefined predictors
or that of someone close to them. We formatted the and interaction terms for inclusion using univariable
questionnaire to include nominal, ordinal and interval analysis and qualitative external information recognising
(scale: 1(highly unimportant) – 10 (highly important)) that the selection procedure (with a low a, for example
response options. We pilot tested the questionnaire with 0.05) might result in poor model performance6–8 and
32 individuals and revised question stems and response inaccurate selection of the most important predictors. We
formats accordingly prior to its administration. 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-
Questionnaire administration
tically significant. All analyses were conducted in SAS 9.1
One author (NM) administered the questionnaire to (SAS Institute, Gary, NC, USA).
potential respondents, including visitors to Toronto, with
the goal of obtaining at least 100 responses from each of
Results
the four respondent groups, defined a priori. A standard-
ised script introduced the questionnaire and explained
Respondent characteristics
the rationale for conducting the survey. The cover letter
provided the following context: clinical trials are used to We administered the questionnaire to 427 individuals.
determine whether new drugs or treatments are safe and We excluded one questionnaire from a dialysis patient
effective. For the purpose of this survey, when people that was less than one-third complete for which we
participate in a clinical trial they typically receive one of were unable to locate the respondent on a future occa-
two treatments. When a therapy is not currently avail- sion and nine questionnaires due to participant with-
able for the disease or condition, the new therapy is drawal. The 417 included questionnaires had similar
compared to an inactive therapy (also called a placebo). a priori representation from the four respondent groups
We offered participants a $2 gift certificate for of interest (104 general public, 102 dialysis, 105 oncol-
a local coffee franchise upon hand return of their ogy, 106 critical care waiting rooms) (Table 1). The
completed questionnaire. 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
Statistical analyses
ongoing illness for which they receive or should receive
Descriptive statistics are presented in the text as means, treatment, and almost one-third (30.4%) had partici-
standard deviation or median for continuous variables pated in clinical research.
and frequencies and percentages for categorical variables.
We compared demographics and responses to questions
Attitudes, knowledge and beliefs regarding
pertaining to attitudes, knowledge and beliefs among
clinical research participation
the four respondent groups and comparing those willing
versus undecided versus unwilling to participate using The majority (68.3%) of our respondents favoured the
Chi-squared or Fisher exact test. We considered respond- use of humans in clinical research with less than 10%
ents that acknowledged having a medical illness or health firmly objecting. Most respondents felt that the risk of
problem in analysing a respondent’s willingness to par- severe complications or death associated with participa-
Characteristic Overall General Public Dialysis Oncology Critical care waiting room P value
(n = 416) (n = 104) (n = 101) (n = 105) (n = 106)
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.
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
While over one-third of respondents expressed that they ticipate including espousing a favourable view towards
would not be trial participants if they were critically ill the use of humans in clinical trials, knowledge that clini-
with a high chance of survival (low risk), approximately cal trials determine how well a treatment works and that
one quarter of oncology respondents did not believe that trials take several years to conduct and three clinical
they would participate in a trial in a healthy state or in circumstances (having an ongoing, non-fatal diseases
the event of critical illness with a slim chance of survival. with no known cure, being healthy or critically ill with a
Conversely, most dialysis patients felt they would partici- 50/50 chance of survival) (Table 3).
pate in a trial in a healthy state. With regard to partici-
pation in medical research and clinical trials dialysis
Discussion
patients (46.5%) were the most frequent participants
followed by respondents in oncology clinics (36.2%), Our findings provide insights into the attitudes of the
members of the general public (26.0%) and finally indi- general public, with and without specific healthcare
viduals identified in critical care waiting rooms (14.2%). experiences that inform decision-making regarding
Finally, we did not identify a relationship between research participation. While most respondents favoured
respondent group and willingness to participate in clini- the use of humans in clinical trials (68.3%), less than
cal research (P = 0.17). 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
Relationship of variables with willingness
always receive the best quality of care, and 30%
to participate
expressed ambiguity regarding whether research subjects
We identified several variables significantly associated were ever informed about trial participation. Contrary to
with willingness (willing vs undecided vs unwilling) to their favourable attitude towards research participation,
participate including having an ongoing illness (P = 0.01), only 58.2% and 52.7% of respondents stated that they
a favourable attitude towards the use of humans in would participate in a study focusing on their illness/
research (P < 0.001), a low perceived risk of suffering a health problem or that of someone close to them respec-
severe complication or death from participation (P < tively. Participants identified in oncology clinics and
0.001) and a perception that trial participants always or dialysis clinics were the most and least knowledgeable,
almost always receive the best care possible (P < 0.001). respectively, regarding clinical trial implementation and
Similarly, respondent knowledge that clinical trials consent issues. We identified six variables associated with
always or sometimes determine how well a treatment willingness to participate including espousing a favour-
works (P < 0.001), that trial participants are always told able attitude towards the use of humans in research,
they are participating (P = 0.013) and that it takes several knowledge that trials determine how well a treatment
years to conduct a trial (P = 0.002) were also significantly works and take several years to conduct and specific
associated with participation. However, we also identified clinical circumstances (having a non-fatal disease with no
inaccuracies and misperceptions including the view that known cure, being healthy, or critically ill with a 50/50
impoverished individuals always or sometimes partici- chance of survival).
pate in clinical trials (P = 0.006) and that once a trial has Strengths of this study include the intentional sam-
been completed it should never or rarely have to be pling of respondents with different healthcare experi-
repeated (P = 0.026) as variables significantly associated ences, the large sample size and pilot testing of the
with willingness to participate. In Table 2, we present questionnaire prior to its administration. Administering
variables significantly associated with willingness to par- our questionnaire in three public venues in a large met-
ticipate in univariate analyses. Being uncertain that trial ropolitan centre and in three locations within a teaching
participants receive the best care possible was the only hospital enhances the generalisability of our findings for
variable significantly associated with reduced odds of par- these segments of the population. However, since most of
ticipation. We did not identify a relationship between our respondents were educated, results may differ if one
prior participation and willingness to participate (P = were to administer our questionnaire to different popu-
0.14). 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
Predictors of willingness to participate in
about these issues. Consequently, responses may differ if
clinical research
respondents were truly contemplating research participa-
A multivariable logistic regression analysis identified six tion. The possible influence of who approaches potential
variables significantly associated with willingness to par- respondents, the environment in which they are
Table 2 Factors associated with willingness to participate in a clinical trial (univariate analysis)
*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 to themselves or to their families.10 In a telephone
results of our survey are unknown. Finally, while we survey of 489 American citizens identified by random
identified knowledge of research methods as a predictor digit dialing, Trauth et al. found that prior research par-
of willingness to participate, we also found that certain ticipation, being middle aged, espousing a favourable
misconceptions (impoverished individuals always or attitude towards the use of humans in medical research,
sometimes participate in trials and that once completed a and having a friend or relative who was ill positively
clinical trial should never have to be repeated) reflecting influenced willingness to participate.5 We found that
deficiencies in knowledge were also predictors of willing- 58.7% of respondents, as compared to 46.0% in the
ness to participate. study by Trauth et al., were willing to participate in a
Positive attitudes towards research participation study focusing on a new treatment for a disease that
appear to be surpassed by concerns regarding self- was of concern to them.5 Moreover, we found that
participation. In a survey of 225 visitors to the fewer respondents (52.7%) were willing to participate
Heinrich-Heine University, Ohmann et al. found that in a trial focusing on a new treatment for a disease
while 89.5% judged clinical trials to be important, only affecting someone close to them, with more respond-
25% would take part.9 These authors found that will- ents expressing uncertainty regarding research partici-
ingness to participate was significantly higher among pation for illnesses experienced by others (35.3%)
individuals who considered trials to be important, pos- versus themselves (26.1%). Robinson and colleagues
sessed general knowledge about clinical trials, and had found that being terminally ill, having a desire to
participated previously in a clinical trial.9 In a qualita- prolong life, physician recommendation, and a belief in
tive study involving 14 members of the general public, the competency of healthcare providers are incentives
Asai and colleagues noted greater willingness to partici- to participate in clinical research.3 Similar to our results,
pate in research if individuals perceived direct benefits Cassileth et al. noted that while most respondents
(71%) believed that individuals should serve as 950 Italian citizens, Apolone and colleagues demon-
research subjects, responses regarding their research strated unfavourable attitudes towards participation in
participation reflected greater self-concern and less clinical studies and limited knowledge about clinical
altruism.4 research, which varied according to socio-demographic
The perceived risks and benefits associated with clini- and geographic variables.14 Others have highlighted that
cal circumstances influence decisions regarding research a poor understanding of randomisation, treatment allo-
participation and may vary with healthcare experiences. cation procedures and expectations by trial participants
Coppolino and colleagues conducted interviews of 100 represent important barriers to research participation.1 In
elective cardiac surgery patients and their SDM to assess our survey, nearly 30% of respondents felt that they
agreement among patients and their SDM regarding would never or only sometimes be informed of their
research participation in minimum risk and greater- participation in a trial and of the possible risks and ben-
than-minimal risk scenarios. Patients (72% and 73%) efits associated with their participation.
and SDM (65% and 74%) expressed a comparable Several important observations can be made from our
degree of willingness to participate in low and greater- survey. First, comprehension of the principles underly-
than-minimal risk cardiac surgery scenarios respec- ing clinical trials and consent issues differed between
tively.11 On the other hand, Ciroldi and colleagues members of the general public and patients; with
noted that patients, SDM and physicians were more patients in different clinical settings also expressing dif-
likely to participate in a low-risk critical care study.12 ferent levels of knowledge regarding trial implementa-
Our study did not evaluate the perceived risks associ- tion. Based on these findings, we hypothesise that
ated with particular interventions, but rather the per- strategies for research participation decision-making
ceived risks associated with specific clinical may be influenced by experiences with the healthcare
circumstances. The majority of respondents in all four system. Second, individuals who expressed a sense of
groups would participate in a trial under circumstances ‘uncertainty’ as to whether patients in clinical trials
where they would likely benefit (if they had either a received the best care were less likely to be willing trial
fatal or non-fatal ongoing illness with no known cure participants. Third, we found only modest comprehen-
or were critically ill with a low chance of survival). sion of clinical research methods and research ethics
Unlike family members of critically ill patients and among our survey respondents, nearly half of whom
dialysis patients who favoured participation under high- had a post-secondary education. Finally, we found that
risk/low-benefit circumstances (critical illness with a respondents who demonstrated a greater understanding
high chance of survival), oncology respondents and of the objectives of trails (trials determine how well a
members of the general public did not favour participa- treatment works) and who had a sense of the chal-
tion under low-risk/low-benefit (healthy state) or high- lenges associated with trial implementation (it takes
risk/low-benefit circumstances (critically illness with a several years to conduct a clinical trial), were more
slim or a high chance of survival). Strategies for weigh- likely to be willing trial participants. Similarly, we found
ing the risks and benefits of research participation may that certain misconceptions (impoverished individuals
be influenced by prior healthcare experiences. always or sometimes participate in trials and that com-
Previous studies suggest that substantial scepticism pleted trials should never have to be repeated) reflect-
exists regarding whether trial participants receive the best ing a lack of knowledge were also predictors of
care possible and highlight this as an important factor willingness to participate. These findings suggest that
limiting research recruitment.13 Casseileth observed that better education of the public on the principles of clini-
while 52% of research participants stated that their main cal trials may enhance research participation.
reason for participating was to receive the best medical
care, only 13% believed that research participants actu-
Conclusion
ally receive better treatment.4 Similarly, while 53% of
our respondents felt that clinical trial participants always In order to ensure successful recruitment into clinical
or almost always receive the best care possible, 36% trials, stakeholders in clinical research must engage the
believed that they would never, almost never, or only public in a dialogue to dispel myths and misconceptions
sometimes receive the best care possible. regarding research methods and ethics. Potential research
Apart from most respondents identified in oncology participants must understand that the overall care that
clinics, our respondents’ understanding of clinical trials they receive will not be compromised by trial participa-
were similar to those of Trauth et al.5 in that they were tion and that the standard of care will always be met
beleaguered by misconceptions, suspicions, and insuffi- regardless of the study arm to which they are ran-
cient information. Using a questionnaire administered to domised. If clinical trials are to prevail in answering
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