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2
What Is Participant-Centered Clinical Research?
INTRODUCTION
The Clinical Research Enterprise depends upon and ul-
timately serves the interest of the public, yet members of the
public often have been seen as passive recipients of research
results rather than as active partners in the Clinical Research
Enterprise.
Participatory research actively involves the public in the
research process by incorporating public views and repre-
sentation into the prioritization, review, conduct, and trans-
lation and dissemination of scientific research. This fosters
trust in the Clinical Research Enterprise, increases research
participation, addresses issues of the most importance to
communities, and aids the translation of research results into
practice.
According to participants of a National Institute of En-
vironmental Health Sciences (NIEHS) meeting about com-
munity-based participatory research (CBPR) held in 2000,
CBPR can benefit schools of public health, state and local
health departments, and public and private funding institu-
tions, as well as the general public. The overall benefits of
CBPR identified by meeting participants were enhancement
of data quality and quantity by establishing trust; moving
beyond categorical approaches; improving research defini-
tions and direction; enhancing translation and sustainability
of research findings; and improving the community's health,
education, and economics by sharing knowledge obtained
from projects (Fallon et al., 2000~.
The participants in this section of the workshop focused
on the basics of participatory research and models for its
application. Because participatory research is loosely defined
and exists in multiple forms, workshop participants used the
terms community-based participatory research, participatory
research, community-based research, and participant-cen-
tered research to describe similar concepts. Similarly, the
ticipatory research and outlined some of its benefits.
Marshall Chin described factors that facilitate participatory
research. Zelda Tetenbaum discussed the Council of Public
Representatives and research participant issues. Kenneth
Olden described participatory research at the NIEHS. Fran
Visco discussed the National Breast Cancer Coalition and its
role as an advocacy organization, Kenneth Bertram spoke
about the Congressionally Directed Medical Research Pro-
grams, and Jennifer Bryson described the partnership be-
tween Genentech and breast cancer advocates for the
Herceptin trial. Jerome Yates discussed the stakeholder pro-
gram of the American Cancer Society. Leslie Ford concluded
this portion of the workshop by describing the Community
Clinical Oncology Program of the National Cancer Institute.
DEFINING PARTICIPATORY RESEARCH
Lawrence W. Green, Dr.P.H., Director, Office of Sci-
ence and extramural research at the Centers for Disease Con-
trol and Prevention (CDC), began the discussion about par-
ticipant-centered research by citing the two translational
blocks to applying science to improve human health from
basic science to clinical research and from new knowledge
to practice (see Figure 2.1~. Engaging participants more ac-
tively in clinical research primarily addresses the second
block by aiding the application of studies carried out in re-
search settings to situations in which they can serve the most
people most effectively.
Participatory research has been in existence in various
forms for decades, and there is a body of literature about the
topic and some experience from which to draw, particularly
from research in developing nations.) However, the term
~ Israel BA, et al., 1998 provides an overview of community-based re-
search and has 200 references to the work of others. In addition, the recently
term "community" Is used In multiple contexts to describe . .
published Community Based Participatory Research for Health offers ~n-
communities consisting of various individuals and locations formation about the history and origins of CBPR, as well as theoretical and
and of various sizes. Larry Green offered a definition of par- methodological issues (Minkler and Wallerstein., 2002).
9
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10
ENGAGING THE PUBLIC IN THE CLINICAL RESEARCH ENTERPRISE
BASIC
BIOMEDICAL
RESEARCH
~ CLINICAL / ~
BLOCK 1: \ SCIENCE AND / BLOCK 2:
Translation KNOWLEDG E Translation
from in vitro
and animal
to human
studies
of new
knowledge
into clinical
practice
FIGURE 2.1 The Translational Blocks
participatory research is difficult to define in practice, com-
mented Dr. Green.
To address this lack of definition, the CDC, in collabo-
ration with the University of British Columbia, is develop-
ing a set of guidelines and criteria for participatory research
that define it as a "systematic inquiry, with the collaboration
of those affected by the issue being studied, for purposes of
education and taking action or effecting change" (Green et
al., 1996; see Box 2. 1~.2
According to Dr. Green, participatory research has three
defining elements: science, co-learning, and action. Each
criterion for classifying participatory research can be placed
on a continuum from most participatory to least, and each
alternative emphasizes one of the three objectives, generally
at some cost to the other goals.
While a definition of participatory research is impor-
tant, Dr. Green emphasized that understanding what partici-
patory research is not also is essential. It is not, for example,
just involving people more intensively as subjects in con-
ventional research. It also is not an alternative research meth-
odology. Rather, it is an approach that can be applied to any
methodology survey, epidemiological, experimental,
qualitative, or others appropriate to the research questions
that people want answered.
"Participatory research is not the academic researcher
merely going out to the community for a perfunctory meet-
ing to explain the laudable purpose and methods of the re-
search," he commented. These meetings should take place in
the interest of informed consent, but alone they do not con-
stitute participatory research, he added.
Dr. Green listed multiple benefits of participatory re-
search, including:
2 An Institute of Medicine report, The Future of the Public's Health in
the 21st Century, was released on the day of the workshop. That report
defines community-based participatory research as "involving all stake-
holders in each aspect of a study designed to evaluate the application and
impact of new discoveries aimed at improving the health of a defined popu-
lation, frequently involving the evaluation of interventions designed to pro-
mote health in community settings" (IOM, 2003a, p.382).
\ / GOAL:
Enhanced
public health;
safer, cheaper,
more effective
new treatments
.
results are relevant to interests, circumstances, and
needs of those who would apply them;
· results are more immediately actionable in local
situations for patients and/or practitioners; and
generalizable findings are more credible to practi-
tioners and policymakers elsewhere, because they were gen-
erated in partnership with people like themselves.
.
Flexibility and adaptation to local circumstances are
important factors for getting the most from applied scientific
`~[Participatory research] represents an innovative and valuable
corrective to the tendency of conventional clinical research to pack-
age intervention methods and programs into one-size-fits-all, off-
the-shelf approaches based on a notion of universal best prac-
tices."
Lawrence Green
research. Dr. Green said, "[Participatory research] represents
an innovative and valuable corrective to the tendency of con-
ventional clinical research to package intervention methods
and programs into one-size-fits-all, off-the-shelf approaches
based on a notion of universal best practices."
The local, contextual considerations also offer an alter-
native to centralized regulations for protecting research par-
ticipants by building trust. According to Dr. Green, there has
been a "push" from government agencies and foundations
for researchers to move their research into the community.
This push needs to be coupled with a "pull" from clinical
practitioners and community-based organizations, he said.3
3 See also Green LW and Mercer SL. 2001. Can Public Health Research-
ers and Agencies Reconcile the Push from Funding Bodies and the Pull
from Communities? American Journal of Public Health 91 ( 12): 1 926-1 929.
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WHAT IS PARTICIPANT-CENTERED CLINICAL RESEARCH?
11
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12
"Despite skepticism, participatory research is Doable without sac-
rificing goon science in the name of community participation."
Lawrence Green
He noted, "Despite skepticism, participatory research
is doable without sacrificing good science in the name of
community participation." Academia may be the slowest to
change to accommodate participatory research, because the
promotion and tenure systems are mired deeply in a tradi-
tion of autonomous research, said Dr. Green. He believes
that the next generation of public health scientists can
change this with the help of tenured professors who can sup-
port some of the necessary academic reforms and clinical or
community initiatives to facilitate participatory research.
FACTORS TO FACILITATE THE USE OF
PARTICIPATORY RESEARCH BY RESEARCHERS
As a general internist, a primary care physician, and a
health services researcher, Marshall H. Chin, M.D., M.P.H.,
Associate Professor of Medicine at the University of Chi-
cago, has had some experience with participatory research.
He commented, "The current system that we have set up is
not conducive to either patient participatory research or
community-based participatory research."
"The current system that we have set up is not conducive to either
patient participatory research or community-basec participatory
research."
Marshall Chin
.~=
According to Dr. Chin, the community-based participa-
tory research (CBPR) system would be improved by devel-
oping the following:
pilot developmental grants;
incentives for players to work together;
· grant review study sections that understand and
value CBPR; and
.
appropriate grant review criteria for CBPR.
In addition, successful CBPR must have community-
focus, including an effort to involve vulnerable or particu-
larly hard-to-reach populations; provide collaboration be-
tween community and academic partners in equal
partnerships; and should ultimately benefit the community,
with an emphasis upon reducing disparities.
ENGAGING THE PUBLIC IN THE CLINICAL RESEARCH ENTERPRISE
"Participatory research requires time to establish trusted
relationships, to develop the research infrastructure, and to
develop a track record to be competitive for larger grants,"
noted Dr. Chin. Therefore, pilot programs are essential and
require adequate funding. The Centers for Disease Control,
the Agency for Health Care Research and Quality, the Robert
Wood Johnson Foundation, and the W.K. Kellogg Founda-
tion all have notable pilot programs.4
According to Dr. Chin, funders also need to provide in-
centives to ensure that the many players funders, research-
ers, the public, and agencies are working together and not
allowing the needs of any one player to overcome the greater
need for the public good. This partnership reduces conflicts
of interest, but is riskier and more ambitious than traditional
models, he commented.
``Participatory research requires time to establish trusted relation-
ships, to Develop the research infrastructure, and to Develop aback
record to be competitive for larger grants,"
Marshall Chin
Dr. Chin' s third recommendation, creating grant review
mechanisms that understand CBPR, is perhaps the most im-
portant issue currently, in his view. He pointed out that even
if there was universal agreement that CBPR is a positive de-
velopment, projects utilizing it will not be funded if grant
reviewers do not understand its methods and importance.
To help people understand CBPR, grant review criteria
that are appropriate for CBPR must be created, said Dr. Chin.
He noted that study sections see the randomized controlled
trial as the "gold standard," but that the study question is
crucial to deciding the most appropriate method of research.
While the randomized controlled trial is the most rigorous
study design in terms of internal validity, the results may not
be applicable to real world populations. Dr. Chin concluded
that achieving these goals to facilitate the conduct of CBPR
will require a culture change.5
Encouraging CBPR at Academic Institutions
Lewis Sandy, M.D., Executive Vice President of the
Robert Wood Johnson Foundation (RWJ), commented that
4 In October 2002, the CDC announced awards for community-based
research totaling $~.4 million (CDC, 2002). The Robert Wood Johnson
Foundation is revising its Clinical Scholars Program to emphasize CBPR.
The W.K. Kellogg Foundation's Community Health Scholars Program in-
crease the number of faculty at health professional schools who are capable
of performing CBPR (University of Michigan, Undated).
5 Dr. Chin also noted that in 2003, the Journal of General Internal Medi-
cine will have a special issue on CBPR. In that issue, the journal will high-
light outstanding examples of CBPR and will include editorials and papers
that discuss key issues involved in advancing CBPR.
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WHAT IS PARTICIPANT-CENTERED CLINICAL RESEARCH?
RWJ has been trying to promote CBPR, and is revamping its
Clinical Scholars Program to emphasize such research. He
then asked what institutional mechanisms could help to pro-
mote CBPR, particularly at academic health centers.
Dr. Green responded that while traditional researchers
have not generally been enthusiastic about participatory re-
search, the next generation of professors has been more ac-
cepting and could have a strong influence by encouraging
the participatory research model.
The Association of Academic Health Centers and
schools of public health are addressing the shift toward par-
ticipatory research, and a recent Institute of Medicine report
encourages the implementation of CBPR (IOM, 2003a). The
Kellogg Foundation, which has a program of postdoctoral
fellowships and community scholarship, also has been a
leader in promoting CBPR.
Dr. Chin offered two specific suggestions to encourage
participatory research at academic health centers. The first
was to create centers and resources to help investigators
make contacts in the community. His second suggestion was
to change how CBPR is viewed within academic health cen-
ters, particularly for promotion decisions. In order to do this,
there have to be criteria set up that make it so that academic
health centers truly value community service and rigorous
community-based participatory research, and then, similarly
with the study sections, there must be people on these pro-
motion committees who understand and value this type of
work, said Dr. Chin.
PARTICIPANT INVOLVEMENT
Members of the public are involved in the research pro-
cess as advocates, tax payers, research consumers, research
participants, and as family and friends of patients. They serve
on ethical review and other oversight bodies and support
research through public funds, as well as participate in trials
themselves. Their concerns often include issues such as in-
formed consent, conflicts of interest, and access to new thera-
pies. As a long-time health educator, Zelda Tetenbaum of
the Council of Public Representatives at the National Insti-
tutes of Health (NIH) has found that it is difficult to involve
people in health studies before they actually have a disease
and see a trial as their last hope. Until you get down to that
real crunch time, many patients are in denial of their situa-
tion, she said.
Literacy Volunteers of America, a recognized group of
trained volunteers who work on a one-to-one basis with indi-
viduals who want to learn how to read, is one model for
engaging the public in clinical research, Ms. Tetenbaum
said.6 Under this model, an independent advocate/interpreter
would advise each participant throughout the course of a re-
6 See www.literacyvolunteers.org for more information about Literacy
Volunteers of America.
13
search project, providing clear and direct access to informa-
tion at a level appropriate to individual research participants'
needs. The volunteer would provide ongoing information
about the results of the trial, including any possible adverse
outcomes.
Similar programs already exist within many patient ad-
vocacy groups. One example is the American Cancer
Society's "Reach to Recovery" program, in which trained
volunteers offer support and comfort to patients before, dur-
ing, and after breast cancer treatment.7 In the clinical trial
setting, the role of the volunteer would be to interpret and
explain, but not to expand upon, the directions and orders
given by the physician or the nurse to the participant, ac-
cording to Ms. Tetenbaum.
The National Center for Research Resources of the NIH
has instituted a Research Subject Advocacy Program in each
of its General Clinical Research Centers (GCRCs).8 Each
GCRC funds a full-time employee to help research partici-
pants gain access to resources and to help them understand
issues concerning participation in clinical trials.
``One of the things that we have to do is try to educate the public
better about clinical research trials' why they are important' and
what kinds of questions they should ask so that when they are
facing their diagnosis'they at least have some background.,
Jerome Yates
.~=
Informed Consent
Elaine Larson9 R.N.9 Ph.D.9 FAAN9 Professor at Colum-
bia University School of Medicine9 expressed concern that
the informed consent process can be intimidating to a newly
diagnosed patient9 particularly because written forms often
contain difficult languages including legalese. While the pub-
lic seems to be fairly well informed about individual research
studies and findings9 very few know and understand the mea-
sures in place to protect them as research participants. She
cited a survey of 900 patients in a large academic health
center9 the majority of whom had been in a research study9
that showed that only 45 percent knew there were protective
measures for their own rights or that there was9 for example9
an Institutional Review Board. However9 they still volun-
teered for studies (Larson and McGuire9 1990~.
Jerome Yates of the American Cancer Society noted that
from a patient perspective it is extremely difficult to assimi-
7 For more information, see www.cancer.org/docroot/ESN/content/
ESN_3_Ix_Reach_to_Recovery_5.asp?sitearea=ESN.
~ See www.ncrr.nih.gov/clinical/cr_gcrc.asp for more information about
the GCRCs and the Research Subject Advocate program.
OCR for page 14
14
late information after being told about a new diagnosis, es-
pecially a diagnosis of cancer. "One of the things that we
have to do is try to educate the public better about clinical
research trials, why they are important, and what kinds of
questions they should ask so that when they are facing their
diagnosis, they at least have some background," he said.
Conversations with the patient during the consent pro-
cedure and throughout the trials are more important than the
contents of a written document, said Dr. Yates. Ms.
Tetenbaum noted that the informed consent process should
be regarded as ongoing and significant, not a quick, one-
time conversation.
While consent forms may be made more intelligible,
their interpretation by a patient population remains prob-
lematic, she commented. A recent study found that the text
of many informed consent forms fails to meet the readabil-
ity standards set by the IRBs that provided the consent lan-
guage (Paasche-Orlow et al., 2003~.
The average time for obtaining informed consent is es-
timated to be no greater than 10 minutes, and that is a gen-
erous estimation. Because of this, one may question
whether the information is appropriately conveyed and
fully understood, and whether the patient is sufficiently
competent and literate to provide informed consent, said
Ms. Tetenbaum. She noted that patients have demonstrated
a better understanding when their own physician has de-
scribed the trial fully, reviewed the consent form in detail,
and discussed all the implications in a patient-centered en-
vironment. Sufficient time should be provided for the pa-
tient to seek additional help deciding whether or not to par-
ticipate, and informed consent should work toward
empowering the patient, she added.
"Patients who choose to enroll in a clinical trial should enter a
system that envisions them as equal participants in the research
effort."
Zelda Tetenbaum
"Patients who choose to enroll in a clinical trial should
enter a system that envisions them as equal participants in
the research effort," commented Ms. Tetenbaum.
Veronica Catanese, M.D., Senior Associate Dean of
the New York University School of Medicine, wanted to
know how an informed consent patient participation sup-
port group could be formed, given that clinical research
takes place in a variety of venues. She asked if there was a
role for voluntary health organizations in organizing such
groups, and if the groups should be disease-specific or have
a more broad, cross-disciplinary focus.
Ms. Tetenbaum replied that there appear to be many
disease-specific programs in place, and that as a volunteer
ENGAGING THE PUBLIC IN THE CLINICAL RESEARCH ENTERPRISE
effort, a broader and more inclusive focus might work
equally well. She suggested taking advantage of the NIH
presence already established in many of the research institu-
tions and research centers around the country to establish a
generic core of people to act as informed consent advisers.
Conflicts of Interest
Ms. Tetenbaum commented that a key focus of NIH-
sponsored clinical trials is the assurance of the highest ethi-
cal standard for the conduct of research and the protection of
the human subject, and that individuals who support the con-
cept of patient-based clinical trials must endorse this effort
in order to retain public trust.
She added that conflicts of interest on the part of re-
searchers and/or institutions administering clinical trials are
becoming a very serious issue in the eye of the public. The
American Association of Medical Colleges and the Associa-
tion of American Universities recently published reports
dealing with investigator and institutional conflicts of inter-
est (AAMC, 2001 a,b; AAU, 2001~. In addition, the Institute
of Medicine report about protecting research participants,
the former National Bioethics Advisory Commission, and
the former National Human Research Protections Advisory
Committee have made recommendations regarding the man-
agement of conflicts of interest (IOM, 2003b; NBAC, 2001;
NHRPAC, 2001~. The Department of Health and Human
Services has drafted guidance on the topic (DHHS, 2001~.
ENCOURAGING PARTICIPANT ENROLLMENT AND
PHYSICIAN AWARENESS
In order to encourage relatively healthy, early stage dis-
ease patients to participate in clinical research, there is a need
to reach out to the specialists and the general practitioners
who are seeing these patients. Various mechanisms under
consideration to do this are: creating celebrity public service
announcements, working through chapters and local support
groups, encouraging counselors at specialized centers to pro-
mote patient participation, and providing doctors greater ac-
cess to information about trials and how to enroll patients in
those trials.
Leslie Ford of the National Cancer Institute (NCI) com-
mented that there are little organized data that would indi-
cate the most influential factor in promoting participation in
clinical trials. The success of celebrity endorsements is hard
to determine; the public is made aware of the availability of
trials through spokespersons, but this awareness does not
necessarily encourage enrollment. Doctor's recommenda-
tions, awareness in the community, and association with
people who have participated in other research are all impor-
tant factors to encourage participation in trials.
Dr. Yates agreed that physician awareness is critical to
encourage participant enrollment in clinical trials. While
patient awareness is also important, trust and confidence in
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WHAT IS PARTICIPANT-CENTERED CLINICAL RESEARCH?
the physician appear to be the most significant factors. Gen-
erally speaking, physicians will participate only if they think
there is patient benefit, according to Dr. Yates.9 Cost, incon-
venience, and discomfort that may result from the experi-
ment are patient issues that may block participation.
He pointed out that a study of English physicians noted
that trusting relationships that have been nurtured over time,
often found between primary care physicians and their pa-
tients, are especially critical in encouraging participant en-
rollment (Fallowfield et al., 1998~. The survey also found
that initially only about 44 percent of respondents said they
would participate in a randomized clinical trial. Given addi-
tional information and time with a knowledgeable person,
though, that proportion increased to 83 percent.
Despite the importance of physician awareness of clini-
cal trials, an NCI survey of primary care physicians recently
found that 37 percent said they were not aware of pertinent
clinical trials, and 40 percent said they leave the discussion
of clinical trials to the patient's oncologist and generally do
not continue to follow patients (Crosson et al., 2001~.
CHALLENGES TO COMMUNITY INVOLVEMENT
The needs of researchers and communities can differ,
and researchers who are moving into the community must be
prepared to meet community needs and to address potential
distrust of scientists and research. Forming partnerships be-
tween the scientific community and the public could aid this
process, but as Dr. Chin noted, in some situations there may
be an imbalance in which one partner has more expertise
than the other. To address this difference in expertise, it is
important to establish equal partnerships that acknowledge
the strengths and weaknesses of all parties involved, accord-
ing to Dr. Chin.
The multidisciplinary nature of CBPR presents a simi-
lar challenge. The issues that affect health in the community
are multifactorial clinical, economic, social making in-
put from various disciplines essential. Dr. Kenneth Olden of
the National Institute of Environmental Health Sciences
(NIEHS) commented that behavior has an important impact
on health and noted that it is necessary to involve a broad
spectrum of disciplines in the research process, especially
representatives with social science expertise.
Engaging and educating the public are other challenges
for clinical research. Dr. Yates noted that while primary care
physicians are often the conduits to patient enrollment, only
a few of them are actually involved in the majority of patient
enrollments. He noted that for physicians, understanding the
clinical information is not the problem. Rather, the lack of
accessibility to trial information is a hindrance to enrolling
9 In a related development, survey results published subsequent to the
workshop indicated that many oncologists view patient benefit rather than
the creation of generalizable future knowledge as the main societal purpose
of clinical trials (Joffe S and Weeks JC, 2002).
15
"But the bottom line," he commented, "is that the patients trust
very much in what their physicians tell them."
Jerome Yates
..........................................................................................................................................................................................................................................................
patients. Availability of information on the Internet and train-
ing other staff in the office are critical in order to make phy-
sicians the best resource for patients. While not easy, it is
important to involve the primary care physicians through
educational efforts. "But the bottom line," he commented,
"is that the patients trust very much in what their physicians
tell them."
E. Albert Reece, M.D., Ph.D., M.B.A., Vice Chancellor
and Dean of the University of Arkansas College of Medi-
cine, expressed concern that activist subsections of the pub-
lic could overtake CBPR projects, and wanted to know how
to ensure that a cross-section of the public is represented
rather than a small faction.
Dr. Olden replied that NIEHS has a multi-prong ap-
proach for outreach and communication that employs town
meetings and brainstorming sessions on a national level with
CBPR partnerships and collaborations developed by the 40
NIEHS centers in their own communities. (See NIEHS sec-
tion).
RELEVANCE OF COMMUNITY STUDIES
Hugh Tilson, M.D., Dr.P.H., Senior Advisor to the
Dean, University of North Carolina School of Public Health,
wanted to know how to ensure that research is addressing
fundamental unanswered questions, particularly in commu-
nity health, while also being locally relevant. There is a need
for a better framework to discuss the tradeoff or balance be-
tween specificity and generalizability, he commented.
Dr. Green replied that the scientific community has not
yet fully determined how to maximize both generalizeability
and local relevance. Primarily clinical, biological questions
are being replaced by community- and population-based in-
terventions in different settings. The biological questions
deal with the human organism, which is fairly homogeneous
within the species, while community- and population-based
interventions deal with human behaviors, cultures, laws, and
societies, which are heterogeneous across settings, jurisdic-
tions, states, and countries.
When findings are applied in settings other than re-
search, there is a need to apply them with some modifica-
tion, Dr. Green noted. The findings need to be subjected to a
process similar to continuous quality improvement ap-
plied, tested, fit to the local population and practitioner's
situation, and piloted in those situations to be effective in
varied settings. The findings would not necessarily have to
be tested in each setting, but would not be blindly applied
either (Green, 2001~.
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16
MODEL PARTICIPATORY RESEARCH
COLLABORATIONS
National Institute of Environmental Health Sciences
Kenneth Olden, Ph.D., Director of NIEHS, commented
that his number one priority is to make the Institute respon-
sive to the needs of the American people, who pay for the
research. Community involvement is essential to accomplish
this goal, and openness is critical to successful communica-
tion with the public, said Dr. Olden. Therefore, the scientific
community must ensure that processes are open, accessible,
and understandable to the public. This openness would al-
low stakeholders to form partnerships based on credibility.
The NIEHS was the first institute within NIH to make a
serious effort to support CBPR, establishing several key ac-
tivities to ensure community involvement and community
participation. The Institute funds CBPR projects,~° and re-
cently created the Federal Interagency Working Group for
Community-based Participatory Research to strengthen
communication between federal agencies interested in sup-
porting CBPR methodologies for biomedical research, edu-
cation, health care delivery, or policy (NIEHS, 2002~.
To support what Dr. Olden terms "citizen-based prior-
ity-setting," the Institute hosts town meetings throughout the
country, primarily with the lay public but also including
some scientists in the region. Audience members are asked
to express their expectations and concerns about the involve-
ment of various agencies in community health and the envi-
ronment. This information is then used to set NIEHS priori-
ties for clinical research, epidemiolo~ical studies,
community outreach, and basic sciences research.
NIEHS also holds brainstorming sessions in which sci-
entists and public interest groups meet to discuss research
strategies in the specific areas of research that affect them. In
addition, a 30-member Public Interest Liaison Group made
up of senior leadership of major advocacy groups meets
twice a year to talk about the investments of the NIEHS and
the relevance of these investments to the concerns of the
advocacy groups and their constituents.
By involving all the stakeholders from the beginning of
the research process, NIEHS addresses concerns, reserva-
tions, and questions throughout the process, rather than only
after results are announced, Dr. Olden noted. This aids the
conduct of the research as well as its translation into practice
in the community. The major challenge to implementing this
principle at the NIEHS has been changing the culture of the
agencies and of the research community and ensuring that
they create mechanisms and vehicles to communicate with
the public, said Dr. Olden.
Dr. Olden also commented that there is a direct correla-
tion between the outreach activities of the NIEHS and the
· · ~ , , ~ _ OTTO T T ~ ~ ~ ~ -
-
i° See http://www.niehs.nih.gov/translat/cbpr/grantees.htm for a list of
grant recipients.
ENGAGING THE PUBLIC IN THE CLINICAL RESEARCH ENTERPRISE
projects that the Institute ultimately funds. When NIEHS
hosts town meetings and outreach activities, participants lis-
ten to the public concerns and then talk with experts in the
field to address the scientific opportunities and gaps dealing
with those issues. For example, in response to town meet-
ings in places like Marin, California where breast cancer
rates are seemingly inexplicably higher than in the rest of the
nation and with the help of brainstorming sessions with
breast cancer advocacy groups and scientists, NIEHS has
decided to create three Breast Cancer and Environment Cen-
ters around the country.
"The objective of clinical research is to improve the health of the
American people, and the American people ought to have an im-
portant role in the Development of the research agenda."
Jerome Yates
In addition, based on discussions with Parkinson's dis-
ease advocacy groups over a number of years, NIEHS re-
cently created a consortium center of three institutions to
address the environmental aspects of Parkinson's disease.
"The objective of clinical research is to improve the health
of the American people, and the American people ought to
have an important role in the development of the research
agenda," commented Dr. Olden.
The Congressionally Directed Meclical Research Programs
Kenneth A. Bertram, Colonel, U.S. Army Medical
Corps, Director, Congressionally Directed Medical Research
Programs (CDMRP), began his presentation by noting that
the creation of CDMRP is a result of consumer advocates
telling Congress that there was a need to better meet research
goals. The Program was assigned to the Army's Medical
Research and Materiel Command in 1993 and involves con-
sumers, the Department of Defense (DOD), and scientists
and clinicians from both academia and industry.
The CDMRP cycle begins with advocates going to Con-
gress and requesting money to address unmet research needs.
Congress then appropriates funds to the Program (see Figure
2.2~. The Office of the CDMRP then brings together a se-
lected group of the nation's leading advocates, consumers,
scientists, clinicians, and representatives from other govern-
ment agencies to advise them on how to best invest each
year's appropriations. Responding to Program Announce-
ments, scientists, clinicians, and consumers write proposals
that are peer reviewed. Recommended proposals receive
funding grants and the CDMRP continues to monitor them
for the life of the awards.
Each group involved in the collaboration process has
responsibilities, outlined in Box 2.2.
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WHAT IS PARTICIPANT-CENTERED CLINICAL RESEARCH?
Vision- - ~
/ Setting Release of Program
Congressional ~ Receipt of +/ Announcement
Appropr~abon Funds ! ~
Proposal
Receipt
Candidate Approval of \
Award List ~ Commanding \ /
General ~ \ In/
Programmatic Peer
Review 4- Review
FIGURE 2.2 The CDMRP Cycle
Car. Bertram presented this figure during the workshop.
Consumers have helped to define the DOD's award
mechanisms. For example, consumers were instrumental in
making innovation a critical underlying theme for the
awards. The Exploration Award supports the initial evalua-
tion of an imaginative concept for which no preliminary da-
tum is available and the Innovator Award encourages cre-
ative and visionary breast cancer research. The HBCU/MI
(Historically Black Colleges and Universities/Minority In-
stitutions) Partnership Awards are designed to address health
disparities.
Part of the programmatic criteria for the Breast Cancer
Center of Excellence Award is that breast cancer consumers
and survivor groups must be active participants at all levels,
from the beginning. The Collaborative Clinical Transitional
Research Award supports cooperation among academic cen-
ters, community-based oncology clinics, consumers, and the
17
private sector. These two award mechanisms are essentially
CBPR programs, commented Dr. Bertram.
The DOD also has a Consumer Working Group to main-
tain and increase participation of consumers in peer review
and all programmatic review decisions and to continue to
raise awareness about the research that they are funding in
the community. (See Box 2.3~. "The Office of CDMRP con-
tinues to embrace the partnership philosophy and has used
``The Office of CDMRP continues to embrace the partnership phi-
losophy and has used that to manage their programs and to do
ongoing evaluations of their programs.,
Kenneth Bertram
that to manage their programs and to do ongoing evaluations
of their programs," concluded Dr. Bertram.
Dr. David Rimoin, M.D., Ph.D., Chairman of Pediat-
rics and Director of Medical Genetics-Birth Defects at Cen-
ters Cedars-Sinai Medical Center, asked how the DOD be-
came involved in such a broad array of projects including
breast cancer, prostate cancer, neurofibromatosis, and tu-
berous sclerosis research and how disease-specific advo-
cates could take advantage of this funding mechanism.
Colonel Bertram responded that specific projects at the
DOD have been directed and funded through Congressional
mandates.
The breast cancer program, which was largely the result
of lobbying by breast cancer advocates, was the first DOD
program funded and has become the model for subsequent
disease programs at the DOD. Breast cancer advocates con-
tinue to work to make certain that Congress recognizes the
importance of that model, regardless of the constituency,
noted Dr. Bertram.
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18
The National Breast Cancer Coalition
The National Breast Cancer Coalition (NBCC) is made
up of more than 600 organizations and tens of thousands of
individuals from across the country who work together in
pursuit of three goals increasing access to quality care and
clinical trials for women with breast cancer and all women
who are at risk of breast cancer; increasing the influence of
breast cancer advocates in all decision making about the dis-
ease, including funding decisions for breast cancer research;
and increasing collaboration in the design of new strategies
to prioritize research.
To meet these goals, the NBCC has developed advo-
cate-training programs. ~ ~ Project LEAD (Leadership, Edu-
cation and Advocacy Development), for example, is a sci-
ence-training course for breast cancer advocates. The NBCC
provides the four-and-a-half day course at no charge to nomi-
nated individuals. During the training, participants learn
about the scientific process and gain other tools that enable
them to contribute to research review discussions. Project
LEAD has trained about 1,000 advocates to date. The NBCC
also has a clinical trials project that educates constituents
about the importance of clinical trials through a number of
programs and outreach materials.
In addition, the NBCC developed a pilot program with
Genentech for trials of Herceptin (see the next section for
more information). Genentech initially asked NBCC for help
with a compassionate use policy; NBCC agreed on the con-
dition that Genentech pilot-test the Coalition's clinical trials
~ ~ See www.natlbcc.org/bin/index.asp?strid=554&depid=7&btnid=0 for
more information about the NBCC's education arid training opportunities.
ENGAGING THE PUBLIC IN THE CLINICAL RESEARCH ENTERPRISE
project. This required that NBCC representatives participate
on the steering committee for the trial and on the Data and
Safety Monitoring Committee, help with outreach materials
for the trial, and attend all of the investigator meetings. In-
vestigators also were partnered with trained advocates for
community outreach and to accrue trial participants.
The NBCC has developed similar relationships with a
number of other companies, including the Breast Cancer In-
ternational Research Group, but the Coalition reserves the
right to be selective, Ms. Visco emphasized. The NBCC has
developed a set of criteria against which it judges clinical
trials to see if they warrant participation of members and to
prioritize these trials.
Genentech
Before 1995, Genentech rarely worked with the patient
advocacy community, according to Jennifer Bryson, Direc-
tor of Corporate Affairs for the company. Breast cancer ad-
vocates originally approached Genentech regarding an ex-
panded access program, but they now have input to trial
design and implementation issues. Advocates also help with
outreach and communications to recruit participants and
raise awareness about the research.
Initially, the corporation was concerned that the advo-
cates' request for access could distract from the primary mis-
sion of the trial, that they could not appreciate the complex-
ity of drug development, that they would not accept what the
company said, that they would remain vocal critics despite
the company's responsiveness, and that they would not have
much to contribute to the larger goal of trial completion and
approval, commented Ms. Bryson.
Corporate employees soon realized, though, that they
shared with advocates a desire to find answers and that ad-
vocates brought a unique and relevant perspective to the pro-
cess. Advocates gave fundamental feedback about the trial
design and the protocol, helping to widen the eligibility cri-
teria and look at some of the standard exclusion criteria that
were not necessarily relevant to the trial. In addition, advo-
cates convinced Genentech to remove the placebo arm of the
study so that more people could have access to potential
therapies.
Once they felt the trial was acceptable, advocacy groups
helped to recruit participants to the study. Prior to the forma-
tion of the Clinical Trial Network, Genentech was recruiting
an average of 16 patients per month for its Herceptin trial;
after the partnership was established, the company recruited
about 40 patients per month, largely due to changes in proto-
col design and outreach activities made possible by partner
input, according to Ms. Bryson.
Advocates became involved in investigator meetings,
the Steering Committee, and the Data and Safety Monitoring
Committee. In addition, they assisted investigators in per-
forming community outreach a clinical trial network sys-
tem partnered local, trained advocates with trial sites to com-
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WHAT IS PARTICIPANT-CENTERED CLINICAL RESEARCH?
municate in a culturally relevant way about the trial and its
availability. To counteract patients' fears about clinical tri-
als in general, advocates discussed why the Herceptin trial
was important and then talked about the eligibility criteria
and the specifics of the trial.
The advocates were able to reach out using their net-
works, and Genentech provided additional technical assis-
tance, including educational tools such as posters, commu-
nication kits that included fact sheets, local press releases,
and advertisements. The company also created a newsletter
specifically for advocates, HER2 News. Genentech has
learned much from their collaboration with breast cancer
advocates on the Herceptin trial (See Box 2.4~. "Advocates
can provide meaningful and unique insights that can increase
the relevance of the scientific question, the enrollment of
clinical research, and the speed of scientific progress," com-
mented Ms. Bryson.
"Advocates can provide meaningful and unique insights that can
increase the relevance of the scientific question, the enrollment of
clinical research, and the speed of scientific progress,"
Jennifer Bryson
American Cancer Society
Jerome Yates, M.D., National Vice President for Re-
search at the American Cancer Society (ACS), discussed the
stakeholder program of the ACS, which involves consumers
or patient advocates in the research proposal review process.
The ACS recruits individuals who have either had cancer or
have had family members with cancer and have a strong
interest in cancer control. They bring the patient/caregiver
19
perspective to the discussion, provide a perspective on prac-
tical and financial issues that those involved in clinical re-
search do not always recognize, assure a full discussion of
the relevance of the research proposed, and become a critical
resource to the research committee, according to Dr. Yates.
The American Cancer Society holds training sessions to
educate these stakeholders about the basic concepts of can-
cer biology and research, how the peer review process works,
and how to review a grant application. The one-and-a-half
day sessions with research department staff also provide a
review of the American Cancer Society Research and Train-
ing Program. In addition, candidates attend peer review
meetings for a year as ad hoc members to observe stakehold-
ers in action and to interact with peer-review panel mem-
bers, scientists, and nonscientists. They are then appointed
to two-year terms.
The stakeholders play an important role in cancer pre-
vention programs, ensuring that there is a full discussion of
cancer relevance at peer review committee meetings and also
becoming better-informed resources and research advocates
for their home communities about the role of cancer research
and training in the battle against cancer, said Dr. Yates.
The advantages of public participation listed by Dr.
Yates include:
the sharing of community opinions;
increased research awareness;
recruitment of research advocates; and
the provision of objective risk assessment.
Disadvantages include:
· program costs for training efforts and committee
discussion time; and
· participation costs such as time for learning and
ensuring that participant members can stand behind their
views when questioned by scientists and others.
"We have to do a better job at educating the public and
getting physicians committed to the importance of clinical
trials," he said.
National Cancer Institute
Leslie Ford, M.D., Associate Director for Clinical Re-
search, Division of Cancer Prevention at the National Can-
cer Institute spoke about community collaborations at two
levels the physician/researcher community level and the
participant community level.
The NCI philosophy has been that if community physi-
cians participate in clinical trials, they will upgrade the qual-
ity of care provided in communities. In keeping with this
philosophy, the NCI created the Community Oncology Pro-
gram and then the Community Hospital Oncology Program,
predecessors of the Community Clinical Oncology Program
(CCOP), which was established in 1983. The CCOP is a
consortium of community hospitals and practicing physi-
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20
clans funded through peer-reviewed cooperative agreements
who participate in NCI-approved cancer treatment, preven-
tion, and control clinical trials. The basic mission of the
CCOP is to bring state-of-the-art cancer research to indi-
viduals in their own communities by involving community
physicians and patients in NCI-approved clinical trials and
involving primary health care providers in the research pro-
cess.
Currently, there are 50 CCOPs in 30 States; 11 minor-
ity-based CCOPs in 8 States, the District of Columbia, and
Puerto Rico; and 12 research bases, or coordinating centers,
across the country. The minority-based CCOPs were started
in the late 1980s specifically to target the problem of accrual
of minority populations to cancer clinical trials.
In the CCOP model, the research bases develop proto-
cols with the input of the CCOP practicing physicians and
consumer advocates. They are responsible for data manage-
ment and analysis and quality assurance of the data. Mem-
bers and affiliates assist in the recruitment of participants.
Over the last 20 years, the CCOP has accrued over
90,000 patients into treatment clinical trials. Over 50,000
patients and individuals at risk for cancer have been accrued
to prevention and control clinical trials. Currently, more than
4,000 physicians and over 400 hospitals are involved in the
program. Dr. Ford noted that advocates are involved with
NCI through concept evaluation panels in state of the sci-
ence meetings, in cooperative groups, on Data and Safety
and Monitoring Committees, on scientific disease commit-
tees in which the protocols are developed, and on participant
advisory boards.
The NCI study of tamoxifen and raloxifene, known as
STAR, is one example of successful community collabora-
tion. This study has a projected sample size of 19,000 women
and, at the time of the workshop, had accrued almost 15,000
post-menopausal women at increased risk for breast cancer.
The participant advisory board, a group of 16 women who
have been randomized to the trial and nominated by their
local centers to participate on the board, provide feedback to
NCI about aspects of trial design, communication strategies,
and recruitment and adherence.
EFFECTIVENESS OF PUBLIC INVOLVEMENT
Answering a query from Adrian Dobs, M.D., Professor
at the Johns Hopkins School of Medicine, about how best to
measure whether initiatives to involve participants and com-
munities are working, Dr. Olden stated that the most impor-
tant measure of the success of CBPR is the short- and long-
term impact on public health and health policy of research
using the CBPR process. Two outcomes that could be used
to measure the success of CBPR are involvement of more
members of the public in the research process and improve-
ment of the overall health of the public. The latter is more
difficult to determine and measure.
Recently, the CDC awarded $11.4 million to fund 25
ENGAGING THE PUBLIC IN THE CLINICAL RESEARCH ENTERPRISE
CBPR projects (CDC, 2002; DHHS CDC, 2002~. One is an
actual trial to compare groups who have engaged more ac-
tively in the community with groups who have not, and how
they achieve various benchmarks in the program process.
These projects will likely provide basic concrete data about
the efficacy and benefits of participatory research.
The CCOP provides an example of successful commu-
nity participation. There was much skepticism about the pro-
gram at its initiation, but it has had much impact on commu-
nity participation, according to Dr. Yates. Currently, 80
percent of participants in NCI clinical trials are coming from
communities around the CCOPs, he said. Dr. Olden men-
tioned that CBPR programs are not just about "feeling good;"
there is a need for established benchmarks to measure re-
sults.
ADVOCACY AND PUBLIC INVOLVEMENT
Myron Genel, M.D., Associate Dean of the Office of
Government and Community Affairs at the Yale University
School of Medicine, wanted to know how successful models
of disease-focused advocacy could be used to engage advo-
cates to deal with overarching health issues, such as the epi-
demic of obesity, that are not disease-specific. He noted that
translating active advocacy into true partnership at the local
levels is a challenge to successful advocacy.
Ms. Visco commented that the NBCC is a good model
of how to bring advocacy to a community level, because it is
a coalition of organizations, as opposed to a chapter organi-
zation; the Coalition members are existing groups in their
communities. Most of them are local support groups, and
they are not all specific to breast cancer; many of them deal
with women's issues and health generally. The Coalition
members take back to their communities what they learn
through NBCC programs and are encouraged to make con-
nections with clinical researchers and institutions in their
own communities. As trained advocates, they develop rela-
tionships and programs on a local level similar to those that
the NBCC develops on a national level.
She pointed out that the breast cancer advocacy move-
ment built on the experiences of AIDS groups and that while
these two movements are focused on specific diseases, their
experiences can serve to inform future advocacy activities.
More collaboration at the community level would help to
spread models and experiences to other diseases and areas of
health. Dr. Ford added that the AIDS community success-
fully used the CCOP as a model. Instead of cooperative
groups and cancer centers, the AIDS contingent has its own
Research Council made up of consumers, patients, and re-
searchers to develop clinical trials that they then disseminate
nationally.
Regarding the role of researchers as advocates either
on their own behalf or on behalf of research in general Ms.
Visco said that while there are widely varied perspectives
about this role for researchers, the agendas of patient advo-
OCR for page 21
WHAT IS PARTICIPANT-CENTERED CLINICAL RESEARCH?
cates and researchers do sometimes overlap. From the pa-
tient advocacy community, the scientific community learned
how to advocate and how to lobby, abilities which have led
efforts such as the doubling of the NIH budget, she com-
mented.
Colonel Bertram added that CDMRP scientists are not
required to garner funds through advocacy and that many
science organizations have designated advocacy groups that
lobby Congress for additional money.
ROLE OF INDUSTRY
Eighty percent of all funding and activity for clinical
trials of medical therapies and medical device intervention
comes from industry, and two-thirds of all patients who par-
ticipate in clinical trials are in industry-sponsored programs
(Top AHCs, 2002~. Ken Getz, M.B.A., president of
CenterWatch, wanted to know what industry can do to play
a part in engaging and educating the public without appear-
ing to be self-serving.
Ms. Bryson noted that Genentech enjoys a reputation of
credibility among oncology advocacy groups, because of its
decision to work with advocacy groups around substantive
issues. They have kept their discussions very science-based,
and because of that, they always tend to be related to a spe-
cific product, but the conversation is always about the sci-
ence, she said.
Ms. Visco has approached the pharmaceutical industry
to form partnerships that could create a new model of doing
clinical research, making certain that trials that the NBCC
believes to be important will move forward as quickly as
possible and ensuring that Coalition constituents and mem-
bers are educated to understand the process and its impor-
tance. The NBCC is careful when determining which trials
to recommend to its members, and its participation with com-
panies around clinical trials is one of many coalition activi-
ties, said Ms. Visco. The partnership between NBCC and
Genentech for the Herceptin trials mentioned earlier is a no-
table example of such cooperation.
21
In addition, NBCC has developed relationships and col-
laborations with industry in which the Coalition periodically
brings a group of trained advocates to industry to learn how
industry members make decisions and about what trials are
being planned.
Dr. Ford commented that the scientific community
should want to involve advocates and consumers on disease
committees and on protocol design committees, not just to
recruit participants but also to ensure that studies are rel-
evant to the public.
An audience member commented on the importance of
having unbiased "watchdogs" like The National Academies
to ensure that clinical research and scientific information
remains unbiased and stays true to scientific principle. He
suggested that the government continue to promote research
such as comparative studies of efficacy of different kinds of
drugs and treatment modalities. Private companies are un-
likely to promote research about other drugs, making
overarching, unbiased evaluations by others essential.
SUMMARY
Participatory research offers benefits including results
that are relevant to interests, circumstances, and needs of
those who would apply them; results that are more immedi-
ately actionable in local situations for patients and/or practi-
tioners; and generalizable findings that are more credible to
practitioners and policy makers elsewhere, because they
were generated in partnership with people like themselves.
However, there are still several obstacles to implement-
ing this type of research. Four elements to improve the sys-
tem of CBPR include pilot developmental grants, incentives
for players to work together, grant review study sections that
understand and value CBPR, and appropriate grant review
criteria for CBPR. Also, there is a need to explore how to
engage the public in the CRE. The programs of the NIEHS,
NBCC, CDMRP, Genentech, the American Cancer Society,
and the NCI can inform future efforts to facilitate participa-
tory research.
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22
ENGAGING THE PUBLIC IN THE CLINICAL RESEARCH ENTERPRISE
REFERENCES
CDC (Centers for Disease Control and Prevention). 2002, October 2. HHS
awards $11.4 million for community research into effective disease pre-
vention and health promotion. CDC Press Release. [Online]. Available:
www.phppo.cdc.gov/eprp/pr-cdclO2.asp [accessed January 8, 2003].
Crosson K, et al. 2001. Primary care physicians' attitudes, knowledge, and
practice related to cancer clinical trials. Journal of Cancer Education
16(4): 188-192.
DHHS CDC (U.S. Department of Health and Human Services, Centers for
Disease Control and Prevention).2002. Program Announcement 02003:
Community-Based Participatory Prevention Research. [Online]. Avail-
able: www.phppo.cdc.gov/eprp/docs/PA02003Final.pdf [accessed Janu-
ary 8, 2003].
Fallon LR, Tyson FL, and Dearry A, eds. 2000. Successful Models of Commu-
nity-Based Participatory Research: Final Report. [Online]. Available: http:/
/www.niehs.nih.gov/translatlcbr-final.pdf [accessed March 19, 2003].
OCR for page 23
WHAT IS PARTICIPANT-CENTERED CLINICAL RESEARCH?
Fallowfield LJ, et al. 1998. Attitudes of patients to randomized clinical
trials of cancer therapy. European Journal of Cancer 34(10): 1554-1559.
Green LW, et al. 1996. Study of Participatory Research in Health Promo-
tion. Ottawa, Canada: Royal Society of Canada. See also: www.ubc.ca/
guidelines.html.
Green LW. 2001. From research to "best practices" in other settings and
populations. American Journal of Health Behavior 25:165-178.
IOM (Institute of Medicine). 2003a. The Future of the Public's Health in
the 21st Century. Washington, DC: National Academies Press.
Prepublication copy.
IOM. 2003b. Responsible Research: A Systems Approach to Protecting
Research Participants. Washington, DC: National Academies Press.
Israel BA, et al. 1998. Review of Community-Based Research: Assessing
Partnership Approaches to Improve Public Health. Annual Review of
Public Health 19:173-202.
Joffe S. Weeks JC. 2002. Views of American oncologists about the pur-
poses of clinical trials. Journal of the National Cancer Institute
94(24): 1847-1853.
Larson E, McGuire DB. 1990. Patient experience with research in a tertiary
care setting. Nursing Research 39:168-171.
Minkler M, Wallerstein N. eds. 2002. Community Based Participatory Re-
search for Health. San Francisco: Jossey-Bass.
NBAC (National Bioethics Advisory Commission). 2001. Ethical and
Policy Issues in Research Involving Human Participants. Volume 1.
Rockville, MD: NBAC.
23
NHRPAC (National Human Research Protections Advisory Committee).
2001. NHRPAC's Recommendations on HHS's Draft Interim Guidance
on Financial Relationships in Clinical Research. [Online]. Available:
ohrp.osophs.&hs.gov/nhrpac/documents/augO1 a.pdf [accessed January
9, 2003].
NIEHS (National Institute of Environmental Health Sciences). 2002. Inter-
agency Working Group for Community-Based Participatory Research.
[Online]. Available: www.niehs.nih.gov/translat/IWG/iwghome.htm
[accessed March 5, 2003].
Paasche-Orlow M, Taylor HA, Brancati FL. 2003. Readability standards
for informed-consent forms as compared with actual readability. New
England Journal of Medicine 348:721-726.
Top AHCs turning away from industry-sponsored clinical trials. 2002.
CenterWatch 9(3):1-7.
UBC IHPR (University of British Columbia Institute of Health Promotion
Research). Undated. Guidelines and Categories for Classifying Partici-
patory Research Projects in Health Promotion. [Online]. Available:
www.ihpr.ubc.ca/guidelines.html. [accessed January 8, 2003].
University of Michigan School of Public Health. Undated. Community
Health Scholars Program: Goals and Competencies. [Online]. Avail-
able: www.sph.umich.edu/chsp/program/index.shtml [accessed March
5, 2003].
Representative terms from entire chapter:
clinical trials
