Appendix 9c - Kost Clinical Research Experience

Article
Assessing Research Participants’ Perceptions of their Clinical Research
Experiences
Rhonda G. Kost, M.D.1, Laura M. Lee, R.N., B.S.N.3, Jennifer Yessis, Ph.D.2, Barry S. Coller, M.D.1, and David K. Henderson, M.D.3,
and The Research Participant Perception Survey Focus Group Subcommittee4
Abstract
Introduction: Participants’ perceptions of their research experiences provide valuable measures of ethical treatment, yet no validated
instruments exist to measure these experiences. We conducted focus groups of research participants and professionals as the initial
step in developing a validated instrument.
Methods: Research participants enrolled in 12 focus groups, consisting of: (1) individuals with disorders undergoing interventions;
(2) in natural history studies; or (3) healthy volunteers. Research professionals participated in six separate groups of: (1) institutional
review board members, ethicists, and Research Subject Advocates; (2) research nurses/coordinators; or (3) investigators. Focus groups
used standard methodologies.
Results: Eighty-five participants and 29 professionals enrolled at eight academic centers. Altruism and personal relevance of the research
were commonly identified motivators; financial compensation was less commonly mentioned. Participants were satisfied with informed
consent processes but disappointed if not provided test results, or study outcomes. Positive relationships with research teams were
valued highly. Research professionals were concerned about risks, undue influence, and informed consent.
Conclusions: Participants join studies for varied, complex reasons, notably altruism and personal relevance. They value staff relationships,
health gains, new knowledge, and compensation, and expect professionalism and good organization. On the basis of these insights, we
propose specific actions to enhance participant recruitment, retention, and satisfaction. Clin Trans Sci 2011; Volume 4: 403–413

Keywords: human subjects protection, research ethics, participant perceptions, motivation, research participants.
Introduction

The conduct of high quality clinical research relies on enrolling
and retaining subjects who are invested in, understand, and
have confidence in clinical research processes. In addition,
regulatory and ethical imperatives are designed to protect
research participants’ rights and safety. Current mechanisms to
assess whether researchers are achieving these goals rely almost
exclusively on review of process completion, (e.g., whether
appropriate consent processes were documented, informed consent
forms were signed, and regulatory guidelines were followed). We
hypothesize that directly assessing participants’ perceptions of
whether accurate transfer of information, voluntariness, and
safety were accomplished in the clinical research process can
provide robust, actionable information about the quality of these
processes. We further hypothesize that improved understanding
of research participants’ experiences with respect to autonomy,
safety, and satisfaction can help researchers: (1) enhance human
subjects protection, including informed consent; (2) enhance
recruitment and retention; (3) improve the quality of clinical
research processes; and (4) increase public trust in the research
enterprise. Thus, a participant-oriented approach would place
evaluation of clinical research at par with the current standard of
robust evaluation of the clinical performance of hospitals.1
Several studies have evaluated participants’ comprehension
of the informed consent process,2–6 and their motivation to
participate in clinical research.7–10 How participants perceive
their clinical research experiences has the potential to inform the
ethical, clinical, and scientific components of clinical research, and
the Association for Accreditation of Human Research Protection

Programs requires organizations to have established processes for
assessing and responding to participant concerns for the purposes
of performance improvement.11 However, to our knowledge, no
validated tools exist for the comprehensive assessment of human
research participants’ research experiences.
In contrast, the healthcare industry has used standard patient
surveys for accountability and improvements to patient care for
decades.1 In the 1990s, the Picker Institute conducted focus
groups and interviews with patients, family members, friends, and
healthcare professionals to determine which aspects of medical
care are most important to patients and families, captured in eight
general themes or dimensions of patient-centered care (Table
1).12–17 They used this information to develop survey questions to
assess patients’ perceptions of hospital care and then established
the validity of the results across geographic, racial, and ethnic
groups (Z. Griffin, NRC Picker, Inc., personal communication,
June 9, 2011). The data generated from these hospital patient
surveys has proved to be extremely valuable, leading various
accrediting and regulatory bodies (e.g., The Joint Commission
[JC] and the Center for Medicare and Medicaid Services [CMS])
to mandate that hospitals collect such data.18, 19
We sought to build on this experience and apply similar
methodology in assessing the perceptions of research participants,
with the goal of assessing and improving the quality of clinical
research. Thus, in 1995, the NIH Clinical Center leadership
and two of the authors (D.H. and L.L.) collaborated with the
Picker Institute (later NRC Picker, Incorporated) to modify their
general hospital survey to acquire information about clinical

The Rockefeller University, New York, New York, USA; 2Propel Centre for Population Health Impact, The University of Waterloo, Ontario, Canada; and 3National Institutes of Health,
Clinical Center, Bethesda, Maryland, USA , 4The Research Participant Perception Survey Focus Group Subcommittee: Nancy Needler, R.N., and Ann Dozier, R.N., Ph.D., The University of
Rochester, Rochester, New York, USA; Jean Larson, R.N., Shelley Britt, R.N., M.S.N., Sandra Alfano, Pharm.D., and Gina D’Agostino, M.B.A., Yale University, New Haven, Connecticut,
USA; Cynthia Hahn and Kevin Tracey, M.D., The Feinstein Institute for Medical Research at North Shore-LIJ Health System, Manhasset, New York, USA; Andrea Saltzman, R.N., and
Enrico Cagliero, M.D., Massachusetts General Hospital (Catalyst), Boston, Massachusetts, USA; Mollie Jenckes, M.HSc., and Dan Ford, M.D., Johns Hopkins University, Baltimore,
Maryland, USA; Susan Margatic, M.S., Wake Forest University, Winston-Salem, North Carolina, USA.
1

Correspondence: RG Kost ( [email protected])
DOI: 10.1111/j.1752-8062.2011.00349.x

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research participants’ experiences. New questions were developed
specifically addressing clinical research processes, including:
(1) informed consent; (2) study access; (3) participant safety;
and (4) the right to withdraw from a study. The pilot survey
questions were drafted using expert opinion, rather than by
obtaining data from participants. In 2002, the leadership of the
Rockefeller University Hospital and General Clinical Research
Center (GCRC) learned of the survey and proposed to collaborate
with the Clinical Center to adapt the survey for use at Rockefeller
University. A protocol describing the implementation of the
initial survey, including the methods used to obtain informed
consent and insure participant anonymity, was approved by the
Rockefeller University Institutional Review Board (IRB) in 2004.
Since inception of the pilot survey, data from 2,200 participants
at NIH, and 450 participants at Rockefeller University Hospital
have been collected and reviewed. Data from these initial surveys
provided valuable information that helped focus local educational
initiatives for investigators and research nurses concerning human
subject protections.
Although these initial steps were valuable, we recognized that
the surveys were limited because they had not been rigorously
derived from focus group information that would insure their
concordance with participant concerns and priorities. As a result,
we conducted focus groups of research participants to understand
important dimensions of the research experience from participants’
perspectives and to obtain data that would help in formulating
individual survey questions. In parallel, we conducted focus groups
of research professionals to obtain their perspectives of what they
believe participants consider important, and to learn of their greatest
concerns regarding the protection of human subjects. We drew
broadly from the expertise, creativity, and experiences of collaborators
at multiple institutions in a transparent and participatory process.
This report describes the key themes and implications that emerged
from the focus groups, including those related to participant
autonomy, recruitment, and education; informed consent; subjects’
rights; and provision of research-related clinical care.
On the basis of these data, we identified a number of
opportunities to improve participants’ research experiences and
offer potential interventions for consideration. In addition, we
used the data to develop a survey instrument. The assessment
of its validity constitutes the second phase of the project that is
currently ongoing.
Methods

Protocol development
An Executive Committee consisting of representatives from The
Rockefeller University, NIH Clinical Center, and NRC Picker, Inc.
developed the project’s specific aims and outcome targets. The
Executive Committee refined the study design with the benefit of
expert input from professionals in human subject research from
multiple academic institutions. Letters of invitation describing
the project were sent both to the Principal Investigators of the
12 Clinical and Translational Science Award sites (CTSAs) in
existence at the time, and 5 GCRCs that expressed interest in
participating. A Focus Group Subcommittee (representatives
from eight CTSAs and five GCRCs) was created to: (1) develop
two Moderator’s Guides for conducting the focus groups; (2)
refine protocol procedures; and (3) operationalize recruitment
at the self-selected academic centers that became participating
centers (five CTSAs and five GCRCs).
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The project’s specific aims were to: (1) conduct 12–16 focus
groups with research subjects to determine the most important
aspects of their research experiences; (2) conduct six focus
groups of research professionals to understand what factors they
think are most important to participants, and what factors the
professionals believe are critical in the safe and ethical conduct
of clinical research; and (3) collect detailed information on the
operational issues and obstacles to the review and conduct of such
a multiinstitutional protocol (to be reported separately).
The Advisory Committee and Focus Group Subcommittee
developed inclusion and exclusion criteria, and policies and
procedures for participation, including: (1) the requirement
that research participants’ experiences must have occurred
within the prior 2 years; (2) the stratification of participants by
protocol type; (3) the stratification of focus groups by protocol
type (participants) and research role (professionals); (4) rules for
sensitive protocols, such as those involving HIV or behavioral
illnesses; (5) how best to make initial contact with participants;
and (6) recruitment methodologies.
Because an initial informal survey of participating institutions
indicated that only a small percentage of research participants
were non-English speaking, the Focus Group Subcommittee
decided that the focus groups should be conducted in English.
Participants were subdivided into three groups: (1)
participants who were affected by the disorder under study and
received a therapeutic intervention as part of the study (Affected/
Interventional; AI); (2) those who were affected by disorders under
study and enrolled in natural history studies (Affected/Natural
History; AN); and (3) those who were healthy volunteers enrolled
in any study type (Healthy Volunteer; HV). The membership of
the focus groups was similarly subdivided. Research participants
were given $50 gift cards as compensation before the start of the
focus group.
Focus groups of research professionals were also subdivided
into three categories to avoid potential self-censoring because of
professional deference across perceived hierarchical levels. The
three groups were: (1) IRB members or chairs, ethicists, and
Research Subject Advocates; (2) research nurses and research
coordinators; and (3) investigators. Research professionals were
eligible to participate if they had active roles in the conduct
or oversight of clinical research, including having served as
principal investigator or coinvestigator, research coordinator,
research nurse, IRB chair or member, research ethicist, or
Research Subject Advocate. Research professionals were not
compensated.
Recruitment
Recruitment selection was guided by research coordinators who
identified participants whom they judged likely to contribute
actively to focus groups. We recognize that this selection process
may introduce bias, but we judged it very important that focus group
participants be willing to speak openly about their experiences.
The Executive Committee reviewed the coded eligibility for all
participants and professionals before the conduct of the focus
groups. Once selected, prospective focus group members provided
demographic, educational, and research experience information
in advance of the focus group, with research professionals and
participants completing different forms geared to their roles.
Personal identifiers were removed from the questionnaires, but
the questionnaires remained linked to the focus group number
and type for analytic purposes.
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1. Coordination and integration of care and services

Research participants’ groups

2. Respect for patients preferences, values, and expressed needs

1. Reasons participants join research studies

3. Emotional support

2. Informed consent

4. Involvement of family and close others

3. Positive and negative aspects of the research experience

5. Physical comfort

4. Reasons participants remain in research studies

6. Information, education, and communication

5. Reasons participants drop out of research studies

7. Continuity and transition from hospital to home

6. Family involvement and familial reaction to participation

8. Access to care and services

7. Comparison of expectations versus experiences in research

Table 1. The dimensions of patient-centered care.

12–17

8. Enrollment recommendations
9. Suggestions for making research participation easier
10. Experiences around recruitment

To provide consistency in the conduct of the study across
centers, one experienced focus group moderator who was also a
research social worker facilitated the focus groups for participants
at all but one of the centers. One center requested permission to
have a local moderator conduct the research participant focus
groups. A second experienced moderator conducted all of the
research professional focus groups via conference calls. The two
main study moderators were independent of the protocol design
team. An Executive Committee member served as an observer
in each focus group.
Informed consent
The collaborating institutions differed in local IRB requirements
for informed consent for focus groups. Seven IRBs required
written informed consent, whereas one ruled the protocol exempt
from review, obviating the need for written informed consent.

11. The role of incentives
12. Misconceptions about research
Research professionals’ groups
1. Concerns on behalf of research participants
2. Perceived participants’ concerns
3. Informed consent
4. Participant expectations
5. Reasons participants stay in research studies
6. Reasons participants leave research studies
7. Retention by study type
8. Barriers for participants
9. Resources to overcome barriers
10. Comments about the participant survey

Focus groups
Focus groups followed a semistructured interview process
according to the formats described in the two Moderator’s Guides,
including an initial introduction and a 90-minute moderatorfacilitated discussion. The moderator validated the main themes
heard during the focus groups by restating them at the end of the
session and requesting participants to confirm or modify them.
Focus groups were audiotaped and the Executive Committee
observer took written notes. The moderator and observer held an
audiotaped debriefing session immediately after each focus group,
during which they identified and discussed the main themes of
the focus group.
Research participant focus groups
Ten to 12 eligible research participants were invited to attend each
participant focus group, with the goal of having eight participants.
The first eight subjects arriving were included in the group;
participants arriving after the first eight were thanked for their
willingness to participate, given the compensation, and released
without participating. Focus groups accruing fewer than eight
members were conducted if at least five research participants were
available. The research participant Moderator’s Guide included
open-ended questions designed to facilitate discussion about
several specific aspects of research participation (Table 2).
Research professional focus groups
Research professional focus groups were comprised of professionals
who had at least 2 years of clinical research experience immediately
before the study. Six to eight research professionals were invited to
each focus group conference call; the focus groups were conducted
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11. Community involvement
Table 2. Specific issues discussed in focus groups.

if at least four research professionals participated. The research
professionals’ Moderator’s Guide was designed to elicit discussion
about the themes enumerated in Table 2.
Audiotapes and transcripts
Permission for audiotaping was included in the informed
consent process, and the moderator’s opening comments
reminded participants about the taping. Audiotapes were kept
in a secure location by the moderator until delivered to NRC
Picker staff for transcription. Names, institutions, and other
identifiers were redacted from all transcripts, observer notes,
and debriefing notes before analysis. Focus group transcripts
were analyzed systematically by coding the data into emerging
themes. Specifically, the analysis team imported transcripts into
the analysis software, NVivo (QSR International, Cambridge,
MA, USA), which allows the analyst to code qualitative data into
an index system to facilitate text searching and/or determine
patterns in the responses. Coding involved careful reading of all
text and documenting passages that related to the main ideas/
themes that emerged.20–22
The Moderator’s Guides were used as a framework for
data analysis. Transcripts were analyzed using the “cross-case”
technique.23 Participants’ discussion points were grouped according
to topics defined in the Moderator’s Guide. Unique perspectives
on key issues were also included in the findings. Direct quotes
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Total Research Participants N = 85 (mean age 50 years, range 19-86)
Ethnicity

Race

Language

Affected/Intervention
(AI) 27

Groups, N

male 45%

Gender

not Hispanic
93%

White 58%

English 92%

high school 13%

Education

full time 35%

Employment

Affected/Natural
History (AN) 28

female 54%

not reported
7%

African-American
28%

not reported
8%

some college
28%

part time 19%

Healthy Volunteer
(HV) 30

not reported
1%

Asian 2%

4 year college
31%

not in labor force
23%

American Indian
2%

graduate school
26%

unemployed 9%

not reported 9%

not reported 2%

seasonal 2%
not reported 12%

Total Research Professionals N = 29 (mean age 50 years, range 31-76)
Groups, N

Gender

Ethnicity

Race

Investigators 7

male 24%

not Hispanic
97%

White 97%

Coordinators 11

female 76%

not reported
3%

Asian 3%

Language
English 100%

Education
2 year college 7%
4 year college
10%

Ethicists 11

Graduate 38%
PhD 17%
MD 21%
MD/PhD 3%
Not reported 4%

Table 3. Demographics of participants and research professionals participating in focus groups.

from participants were referenced where useful to illustrate and
support the findings. Themes were identified to represent ideas
that emerged. Members of the Executive Committee and the Focus
Group Subcommittee, as content experts, reviewed examples of the
thematic analysis to align and validate the coding strategy.
Text from each focus group was analyzed separately, first by
identifying individual issues that emerged, then organizing related
concepts into categories or themes. A final index system was
developed, consisting of the main concepts, themes, subthemes,
and corresponding quotes. Both themes and main ideas were
identified using inductive analysis.

Research participants had a wide range of experience with
clinical research: some were participating in their first study,
whereas others had completed 20 or more studies. Some
participants had experiences at more than one research center
and others at just one. Some participants relied heavily on
participation in studies for income. Medical illnesses of affected
participants included HIV infection, hepatitis, cancer, diabetes,
epilepsy, rheumatoid arthritis, and cardiovascular diseases among
others. Research professionals came from varied clinical and
scientific backgrounds, and, overall, were very experienced in
clinical investigation (Table 4).

Results

Research participants’ focus groups

Eighteen focus groups were conducted from May to November
2008 across eight centers. Twelve focus groups conducted at seven
centers involved only research participants. Four focus groups
were conducted in each of the three categories of AI, AN, and
HV. Nine focus groups at six centers were moderated by a single
moderator, and three focus groups conducted at a single center
were moderated by a second, local moderator. Six focus groups
of research professionals were conducted by teleconference,
moderated by a third moderator and included an observer.
Two focus groups were conducted for each of the three types of
research professionals.
Demographics
Participants in the 18 focus groups included 85 research
participants and 29 research professionals. The demographic
characteristics of those participating are delineated in Table 3.
The relevant research experiences of participating professionals
are summarized in Table 4.
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Themes and motivation for participation
Themes identified in the focus groups fell into two general
categories: (1) those discussed by both research participants
and research professionals, and (2) those unique to one or the
other group. Table 5 contains a list of participants’ reasons for
participating in clinical research from participant perspectives,
categorized into 10 main themes. Participants most often
identified that multiple factors motivated individuals to join
research studies. Across all participant groups, altruism was the
most cited reason for participation but was often combined with
other reasons, such as interest in, or benefit to, the health of the
participant or a family member.
Financial compensation emerged as a theme for motivation
to participate in clinical research as a result of discussion with
research participants from all the three groups, but was most
commonly noted by healthy volunteers. Financial motivation
was not, however, often cited as the primary motivation for
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Number of studies
conducted as an
investigator

Source of majority of
funding

Focus of clinical
research (multiple
answers permitted)

How often do you conduct
the informed consent discussion?

Number of years
in clinical research

Mean = 4.32

NIH grants 18 (66%)

Observational 8 (28%)

Never 38%

<5 years, 3%

Range = 0 to 20

Institutional 3 (10%)

Prevention 3 (10%)

Sometimes 24%

5–10 years, 35%

Private sources 3 (10%)

Mechanics of disease 8 (28%)

Usually 17%

>10 years, 62%

Industry 1 (3%)

Therapeutic/drug 11 (38%)

Always 21%

Other 3 (10%)

Behavioral 6 (21%)
Procedural 1 (3%)
Other 4 (14%)
Missing 1 (3%)

Table 4. Self-reported relevant experience of research professionals in focus groups.

1. Altruism

Participants’ themes

2. Study topic relevant to the individual’s health or the health of
family/friends

1. Extent of satisfaction with the process
2. Time spent reading information

3. Anticipated learning about science, research, or health topics
from participation

3. Adequacy, or clarity of information, or signing process

4. Access to new therapies

4. Individual approach to obtaining consent (style)

5. Financial compensation

5. Extent to which characterization of risks is clear

6. Free healthcare

6. Length of the process and repetition of content

7. Researchers enrolled as research participants

7. Indifference to content of informed consent document

8. Family influence

8. Instilling fear of study participation

9. Commitment to volunteerism

9. Undue pressure to enroll

10. Previous positive experience with investigator

10. Adaptation of information to the individual

Table 5. Reasons identified by participants for participating in clinical research.

11. Use of video media
12. Degree to which process was engaging

participation. Affected participants cared most about access
to new therapies, and, in several instances, participation in the
research study was the only mechanism available to obtain access
to experimental treatment for rare or advanced disorders. Access
to free healthcare motivated many participants, but the reasons
varied. Individuals in all the groups who did not have, or who
had lost, healthcare insurance coverage stated that research
participation was a means to gain access to free diagnostic
testing and treatment, as well as to free prescriptions or over-thecounter medications. In addition, some healthy volunteers had
the perception that if their screening tests and focused physical
exams for study entry allowed them to participate, then they
must be in good health.
Informed consent
Twelve themes emerged around the informed consent process
in participants’ focus groups (Table 6). In general, research
participants were satisfied with the informed consent process,
though their expectations varied widely. Some healthy
volunteers explicitly stated that they joined studies to receive
financial compensation, and stated flatly that they did not
listen to the study explanation or attend to the content of the
informed consent form. Other participants, including other
healthy volunteers, stated that they cared about study risks and
wanted detailed explanations during the consent process. Still,
other healthy volunteers stated that they did not attend to risk
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Research professionals’ views of aspects of the informed
consent process likely to be important to participants*
1. Individual approach to obtaining consent (style)
2. Appropriate pace for the process (i.e., not rushed)
3. Length of the consent form
4. Clarity of the description of the risks
5. Use of techniques that confirm participant understanding
6. Level and clarity of language
7. Adequate time allowed between the consent discussion and
start of the protocol
8. Absence of undue pressure
9. Trust
10. Clarity about freedom for participants to withdraw at any time
*Listed in order of the frequency with which each issue was identified.

Table 6. Themes identified relevant to the informed consent process.

explanations because they trusted the institution to protect their
safety. Many participants appreciated having sufficient time to
read the informed consent form and even suggested that forms
be mailed to participants in advance. Some participants stated
that the forms they read were too long and complex. Some study
participants said they appreciated having detailed interactions
with individuals obtaining informed consent. Most participants
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Factors associated with positive experiences
1. Close relationships with research staff
2. Study involved learning and was interesting
3. Free health monitoring or treatment
4. Access to study results and publications
5. Feeling valued
6. Treated better (i.e., with more respect and attention) in research
7. Health improved
8. Being tended to (individualized attention)
9. Conquering fear, aversion
Factors associated with negative experiences
1. Pain, extended discomfort
2. Disorganized or unprofessional staff
3. Negative interactions with staff
4. Not receiving clinical test results during the study
5. Risks, side effects (fears or actual)
6. Cancellations, waiting
7. Payment problems
8. Unanticipated aspects of the study (i.e., “surprises”)
9. Protocol too demanding

Concerns about consent form length were raised in all the
research professionals groups, but were more common among
ethicists and nurses than among investigators. Professionals
mentioned this issue more often than did participants. In
describing their consent processes, ethicists and investigators
emphasized the importance of ensuring that risks are clearly
described. Ethicists were very concerned that participants
receiving remuneration may be so eager to enroll that they do
not carefully assess risks. Although participants also expressed a
desire to have risks clearly defined, this issue was not ranked near
the top of participants’ concerns. All professionals underscored
the importance of confirming participants’ full understanding
of the study and cited a variety of methods, such as pen and paper
quizzes or verbal quizzes, to accomplish this task.
Factors associated with participants viewing the research
experience positively
Factors associated with participants’ viewing their clinical research
experiences positively are listed in Table 7. Overwhelmingly, the
factor most frequently identified as contributing to a positive
experience was developing a close relationship with the research
team. Many stated that the care and attention focused on them in
the research process far exceeded what they experience during
routine medical care. Many participants also enjoyed learning
about health and disease, and some stated that this new knowledge
improved their ability to care for themselves.

10. Lack of privacy
11. Undue pressure to stay in the study
Note: Listed in order of the frequency with which each issue was identified.

Table 7. Factors contributing to participants’ perceiving the research experience
positively or negatively.

appreciated clear basic language and repeated explanations in
consent forms; only one participant felt that the low reading
level language used in the consent form was insulting. In
describing interactions with research investigators, some
participants complained either about not having enough time
to read or consider long consent forms, or about having the
form read to them. Affected/Intervention protocol participants,
in particular, often were not aware of, or did not recall receiving
information from either the investigators or the consent forms
that adequately described the full extent of the procedures or
visits required. Participants commonly complained about not
fully understanding how much of their time would be required
to participate in the protocol.
Research professionals identified 10 themes relevant to the
informed consent process as likely to be important to research
participants (Table 6). Research professionals across all the
three groups most often identified the research team members’
individual personal approach to obtaining consent as important
to a successful interaction. They also placed priority on not
rushing the consent process, noting that providing sufficient time
for the consent process demonstrates respect for participants and
helps build trust for future study participation. Investigators also
appreciated the importance of having an extended period of time
for the informed consent process. Nurse coordinators indicated,
however, that despite the recognized benefits of having time
to obtain informed consent, occasionally the consent process
is rushed.
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Factors associated with participants viewing the research
experience negatively
The factor most frequently identified as contributing to negative
participant experiences was pain or discomfort, often associated
with procedures, such as intravenous line placement, phlebotomies,
or lumbar punctures, especially when these procedures did not
proceed smoothly. Cumulatively, issues related to study logistics,
such as appointment or procedure delays perceived by the
participant as because of poor organization or planning were
also frequently cited as having a negative impact. Dismissive or
unprofessional conduct or comments by research or medical staff
was also perceived negatively and mentioned by all the groups at
all the centers (Table 7).
Factors associated with participants’ continued participation
Reasons participants identified for remaining in research studies
included: staff responsiveness to requests, financial compensation,
commitment to the research project, and investment by staff in
individual participants. Positive relationships with research staff
were the strongest reasons participants remained in studies. The
most common reasons participants left research studies were: (1)
studies were more demanding than expected; (2) unpleasant side
effects, often associated with interventions; and (3) participant
inconvenience (e.g., limited clinic hours, difficulty parking, and
requirement for numerous visits).
Participants’ comments regarding “expectations versus
experiences” in research
Participants volunteered far-ranging comments about how
their expectations for study participation compared with their
actual experiences of being in research studies. The most
common response was positive, in that participants noted that
the experience met or exceeded their expectations. The next
most common response was that they sometimes did not really
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understand what was going to happen because, in the words of
one participant, “you can’t understand it until you experience it.”
For example, in one cancer study, the participant was unprepared
for the profound fatigue related to cytokine infusions despite both
the consent document and the individuals obtaining consent
emphasizing this point. Participants also said some experiences
were worse than they had been prepared to expect. Some Affected/
Intervention protocol participants expressed disappointment in
the limited clinical benefits of their studies.
Research professionals’ focus groups
Themes and motivation for participation
In sharp contrast to the research participants’ results, very few
professionals identified altruism as a motivation for participants
to join research studies. Professionals emphasized the high
quality of healthcare in studies and health monitoring that is
integral to many studies as important factors in participants’
decisions to join studies. Professionals viewed financial
compensation as a necessary incentive for many studies,
especially those involving procedures. Opinions of professionals
differed considerably in their perceptions as to whether the
provision of “free healthcare” played a role in participants’
decisions to join studies.
Concerns of professionals
Research professionals from all the groups identified participant
safety as their greatest concern. Some investigators expressed
uncertainty about whether the risks involved in some studies
were worth the benefit. Nurses and ethicists expressed concern
that risks associated with participation may be poorly understood
by participants, and that without a clear understanding of the
risks, participants are not able to provide truly informed consent.
Furthermore, they worried that participants did not appreciate
the concept of unforeseen risks. Nurse coordinators stressed
the importance of ensuring that participants are aware of the
availability of research staff to answer questions or address
concerns.
The ethicists were also primarily concerned about participant
safety, but their focus was on other aspects of safety. They worried
about whether the science behind the studies was sound, whether
true equipoise was present, and whether adequate safety nets
were available to participants, especially those in placebo
arms. They also expressed concern about whether study plans
were implemented and monitored as proposed. Ethicists and
investigators both voiced serious concern about protecting and
assuring the rights of vulnerable populations, especially children.
They were concerned about ensuring that children understood
that participation is completely voluntary, noting that children
may be more vulnerable to pressure to enroll, especially if pressure
comes from one or both parents.
Investigators and nurses expressed concern about whether
participant consent is free from undue pressure. Some professionals
voiced concerns that participants may agree to take part in clinical
studies partly because their trusted physicians suggested the study.
Participants did, in fact, stress the important role of interaction
with the research team or with their own doctors in recruitment.
Professionals also expressed concerns about: remuneration being
used to purchase illegal drugs; confidentiality; patients taking
medications incorrectly; difficulties in scheduling; and clarity of
communication.
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Professionals’ comments regarding expectations versus
experiences
Many research professionals stated that participants’ research
experiences exceeded their expectations. Research professionals
of all types expressed the conviction that participants’
expectations were determined during the informed consent
process. Ethicists, in particular, emphasized that the informed
consent process was the appropriate time to align participants’
expectations with research realities. Despite the prevailing view
among most research professionals that participants’ research
experiences exceed expectations, ethicists and nurses agreed that
participants’ expectations are likely to vary with the study type,
with participants who enter therapeutic trials are more likely to
be disappointed than healthy volunteers.
Discussion

In the 45 years since Beecher’s landmark publication and
the subsequent revelations about the details of the Tuskegee
study,24–26 we have learned remarkably little about whether
research participants perceive that their experiences have
included informed consent, fair treatment, and protection from
harm.27–29 The paucity of insight into participants’ perceptions is
particularly disconcerting in view of the enormous interest and
concern about the ethical and practical aspects of conducting
clinical investigation in the intervening years, and the growth of
an entirely new and extensive infrastructure to insure the integrity,
safety, and transparency of clinical research. Instead of obtaining
outcome measures by assessing the views of participants, almost
all of the effort has been focused on the use of process indicators
selected by expert opinion (e.g., a duly authorized, appropriately
dated, and signed informed consent form) as surrogates for the
ethical quality of the research.
Hospitals have obtained valuable outcome information about
medical care and patient satisfaction using validated surveys30–33
and so we have endeavored to emulate this methodology to obtain
outcome data on the clinical research experience, including, but not
limited to: the voluntary nature of research participation; the need
to distinguish research participation from receipt of routine care;
the recruitment and retention processes; the initial and ongoing
informed consent process; the scientific and medical expertise and
skills of the staff conducting the protocol; the emotional, cognitive,
and sensory experiences that accompany research procedures; and
the quality of the facilities and environment. To our knowledge,
no prior studies have evaluated research participants’ perceptions
of these features.
However, one of the biggest surprises to emerge from the
hospital data was that some of the factors that physicians and
nurses consistently identified as likely to be important to patients
were not identified as important by the patients themselves,34–36
we also wanted to compare the perceptions and priorities of
individuals who have participated in clinical research projects
with those of clinical research professionals.
We choose the focus group methodology because: (1) this
approach has been used successfully in the development of high
quality clinical patient surveys; (2) the precise language used by
participants in focus groups to describe their experiences can
be used to develop questions for a formal survey instrument for
clinical research participants; (3) opportunities for face-to-face
exchange of thoughts and experiences, both among participants
and between the moderator and participants, provides a depth
of response not available in surveys; and (4) it provides detailed
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Identified opportunity

Potential intervention

Motivation
• Altruism as motivation for participation
• Compensation as second order motivation
for participation
• Free healthcare as motivation

• Consider role of altruism in planning recruitment, retention, and conduct
• Moderate the emphasis on compensation in recruitment
• Guard against undue influence; facilitate access to available alternatives

Informed consent
• Some participants under estimate risk
• Participants do not understand the research
study plan
• “Diagnostic Misconception” that screening
tests equal a clean bill of health

• Develop means to test and enhance understanding of study risks and
requirements of participating
• Reconstruct informed consent to address the limitations of studyrelated testing

Study conduct and retention
• Participants desire, but do not receive their
clinical results

• Implement standardized procedures to share clinical results
with participants

• Participants desire, but are not informed of
the results of the research study in which
they participated

• Evaluate ethical issues relative to sharing overall research results
• Where appropriate, develop and test standard procedures for sharing
overall research results with participants

• Positive impact of professional and organized conduct by staff
• Negative impact of unprofessional or
disorganized conduct by staff

• Educate research teams on the impact of professionalism on
participants’ experiences and willingness to continue in studies.
• Develop metrics for quality review and improvements on key items
such as courtesy, respect, timeliness, and organizational workflow

• Under-appreciated value of “research
partnership” to participants

• Explicitly acknowledge and respect role of participant as essential
partner in research process

Table 8. Opportunities for improvement and possible interventions to address them in clinical research processes.

insights into subtle aspects of human motivation that may not
be obvious even to experienced research professionals in the
day-to-day conduct of research. We recognize, however, that this
methodology has limitations, including the qualitative nature of
the data, the limited number of participants, the potential bias
inherent in purposeful recruitment of focus group participants,
and the subjective nature of the interpretation of the data. For
these reasons, focus groups are only the first step in our project
to develop a comprehensive survey of research participants’
perceptions of the research process. The next step will be to
assess the concordance of the results of that survey in a large
cohort of research participants with data from the focus groups.
We anticipate that these two datasets will be complementary,
providing information that neither could provide alone.
Several themes emerged from the focus groups that are
worthy of further consideration (Table 8). Remarkably, although
many factors contributed to participants’ decisions to join studies,
altruism emerged as the most common reason. Whereas it may
seem counterintuitive that altruism, rather than perceived
benefits connected to immediate self-interest, is highest on the
list, a growing literature supports altruism as a major motivation
for participation in research. Altruism tempered by other
considerations, including personal benefit, has been reported to
play an important role in participation in several cancer-related
studies and has recently been termed “conditional altruism.”7,9
Surveys conducted by the NIH Clinical Center on a broad sample
of volunteers participating in clinical research are in accord with
the focus group results, because they have consistently identified
altruism as among the top reasons for participation (Lee, LM,
Henderson, DK, unpublished data). In addition, recent studies
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investigating the neurologic basis and evolutionary advantages
of altruism have identified strong positive rewards experienced
by individuals who participate in altruistic behavior.8,37,38 Thus, a
complex picture is emerging about the role of altruism in human
motivation.
The role of financial compensation remains an enigma.10
Whereas financial compensation was one of several factors
motivating participation, it was almost never the primary factor.
Nonetheless, all participant groups identified remuneration as
motivational. Research professionals, on balance, seemed to
overestimate the role of compensation as a motivator.
The motivation to enter a research study to receive healthcare
may reflect the problems in access to care that exist in the United
States healthcare system. In addition to the economic benefits
of receiving free healthcare, participants cited the personalized
attention and increased amount of professional time committed to
their care as powerful motivators. The issue of undue inducement
to participate may be important to consider for those who have
little or no health insurance and may have accepted risks associated
with research participation that they otherwise would not have
accepted, to gain access to medical care. Providing access to social
services to explore nonresearch sources of healthcare may be an
important part of assuring participant autonomy.
Participants expressed overall satisfaction with the informed
consent process and they understood that they had the right
to withdraw from studies at will. However, some participants,
including both healthy volunteers and patients with serious
disorders seeking novel treatment options, explicitly stated that
once they were intent on participating, they did not care what
the investigator or the informed consent form said about the
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study risks. Similarly, despite undergoing extensive informed
consent processes, participants still did not realize the full
extent of their commitments with regard to research visits
and procedures.
Research professionals place much more emphasis on
participant safety than research participants themselves do, and
remarkably, this finding holds up even in instances in which
participants have suffered adverse events. Given the amount of
time that investigators, IRBs, and clinical research coordinators
devote to explaining risks of participation, the fact that participants
do not voice safety concerns more prominently is surprising.
Future studies should focus on how to communicate risks to
participants to align their perceptions of those risks better with
those of the research professionals.
Given participants’ satisfaction with the informed consent
process, a surprising area of poor communication identified in
the focus groups is participants’ lack of understanding of what
will happen to them in a study. The frequency of inaccurate
expectations expressed by participants reinforces the need for
measures of participants’ experiences, rather than just processbased assessments. Future research needs to explore in depth the
barriers to participant comprehension, including the “therapeutic
misconception,”39,40 excessive participant trust in clinical research
staff, and research subject denial.
The motivation to participate in research to obtain a general
healthcare checkup is a serious concern that emerged from our
study, and raises the possibility of research participants being
vulnerable to a “diagnostic misconception” to complement the
well-established “therapeutic misconception.”39,40 The mistaken
belief that having a protocol-directed medical history and physical
exam and a protocol-specified set of diagnostic tests that do not
identify significant medical findings is the equivalent of being
given a clean bill of health, poses serious medical and ethical
issues. Future studies should be directed to creating new consent
language that ensures that participants understand the limitations
of the diagnostic procedures and tests performed in the study
they are considering joining.
One strong theme that emerged from the focus groups
was that participants want to share in the scientific discovery
process. Participants consistently expressed disappointment
if they did not receive test results during or after a study. This
desire extended beyond the results of their routine medical
tests, to include research results. They also wanted to know the
outcomes of the studies in which they participated, irrespective
of the lag time in data analysis or the ultimate medical relevance
for their care. This view was expressed not only by participants
for whom group/placebo assignment could have therapeutic
implications, but also very broadly by participants in all types
of studies who linked this information to their feelings of being
valued. Thus, participants want to share broadly in the new
knowledge that comes both from their participation in the
study as well as from the overall study. This theme has received
relatively little attention in the literature on protection of human
subjects, though recently some authors have advocated for the
routine return of aggregate results to participants in cancer
trials.41 Future studies should be targeted to address the issue
of whether to develop uniform policies about providing study
outcomes to participants in lay language as an integral part of
research design.
Participants’ personal relationships with their research teams
are of paramount importance to satisfaction with their clinical
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research experiences. This theme, which has been suggested
previously,27 stands out as among the strongest in the entire study.
Participants most appreciated a team that was caring, respectful,
and responsive. This relationship was also a major factor in
participants’ decisions to remain in studies. Some participants
expressed feelings of personal abandonment and loss when
research staff were transferred or when studies ended without
opportunities for future contact. Of note, research professionals
did not identify the importance of these relationships as key
contributors to participant satisfaction. Participants expressed
the importance of this relationship in both positive and negative
ways—as part of the motivation to continue in, or return to
participate in subsequent studies, and, when kindness was absent,
as a specific reason to leave a study. The depth and importance
of these relationships highlights the importance of the training,
skills, and sensitivity of each research team member. On the
other hand, such close relationships might raise the potential for
undue influence, with the possibility of the loss of the relationship
even being viewed as subtle coercion to continue in a study. If
future studies confirm our findings, focused attention should be
directed to training research staff members in developing positive
relationships, however safeguarding against using the relationship
in a way that exerts undue influence.
Conclusion

Our study underscores four major points: (1) we have an
extraordinarily limited understanding of what motivates
individuals to participate in research; (2) we have only a
rudimentary understanding of how clinical research participants
perceive their experiences; (3) existing quality control processes
provide virtually no insight into whether research participants
understand the information provided to them as part of the
informed consent process; and (4) if our findings are confirmed
in subsequent studies, clinical researchers have extraordinary
opportunities to improve these processes. In many instances, we
believe that modest changes in policy can successfully address
participants’ concerns. We believe that findings from this study
underscore the need to incorporate participants’ perceptions into
clinical research processes and provide compelling evidence for
the need for continuous performance improvement activities in
clinical research.
Conflict of Interest

Jennifer Yessis, Ph.D. was a survey scientist employed by NRC
Picker, Inc., a commercial developer and vendor of healthcare
surveys during part of the conduct of this study. NRC Picker plans
to develop a commercial research participant survey based, in
part, on the results of the focus groups. Dr. Yessis has no financial
interest in NRC Picker, Inc. or any future commercial survey.
Acknowledgments

The project described was supported by Grant Award Number
UL1RR024143 from the National Center for Research Resources
(NCRR), a component of the National Institutes of Health (NIH)
and NIH Roadmap for Medical Research, and its contents are
solely the responsibility of the authors and do not necessarily
represent the official view of NCRR or NIH. The project was also
supported by grant from the NCRR S07 RR18141 in response
to RFA-OD-03–007, Human Subjects Research Enhancement
Program and support provided by NRC Picker, Inc.
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Acknowledgments

Special acknowledgments to moderators and transcript analyst:
(a) Deborah J. Snyder, MSW, LCSW-C, The National Institute of
Mental Health, National Institutes of Health, Bethesda, Maryland,
Moderator for nine of the Participant Focus Groups. (b) Gina
Riggins Ford, RN, Clinical Center National Institutes of Health,
Bethesda, Maryland, Moderator for six of the Professionals Focus

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Groups. (c) Christine Frank, PhD; contractor; qualitative analyst;
conducted NVivo analysis of transcripts. Individuals who provided
valuable input regarding study design. Laurie Shaker-Irwin, PhD,
University of California, Los Angeles, California; Wajeeh Bajwa,
PhD, University of Florida, Gainesville, Florida; Laurel Yasko,
RN, BSN, Jane Alexander, RN, Mary Fisher and Shannon Valenti,
University of Pittsburgh, Pittsburgh, Pennsylvania.

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