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Workshop Summary
The Clinical Research Enterprise depends upon practi-
tioners, policy makers, and others for participation in trials,
ethical review of research, and continued support of research
funding. However, the role of the public has expanded be-
yond this traditional model as consumers have begun to de-
mand a role in the formulation of the research agenda and in
the design, review, and pursuit of research. In addition, con-
sumers are taking a greater role in accessing health informa-
tion and pushing for better translation of research into prac-
tice.
Exploring the role of the public in the Clinical Research
Enterprise was the focus of this workshop. Mary Woolley of
Research!America opened the workshop by noting that sup-
port for research is strong, but the public lacks much basic
knowledge about the Clinical Research Enterprise.
NIH Director Dr. Elias Zerhouni added that engaging
the public in the Clinical Research Enterprise is a strategic
imperative for several reasons the public can aid the trans-
lation of research findings into practice, help to speed up the
clinical research process, and help to make the research pro-
cess more efficient. He also noted that translation from clini-
cal findings into practice is often the weak link in the Enter-
prise and that there is a need for improved infrastructure to
support the National Clinical Research Enterprise. The three
major priorities for engaging the public in the Clinical Re-
search Enterprise listed by Dr. Zerhouni are trust, ongoing
bi-directional communication between the research commu-
nity and the public, and education.
WHAT IS PARTICIPANT-CENTERED RESEARCH?
Defining Participatory Research
Dr. Larry Green stated that members of the public tradi-
tionally have been seen as passive recipients of research re-
sults rather than as active partners in the Clinical Research
Enterprise. Participatory research extends the role of the pub-
1
kc in clinical research beyond participation in trials. It ac-
tively involves members of the public in the research pro-
cess by incorporating public views in the prioritization, re-
view, and translation and dissemination of research. This
fosters trust in the Clinical Research Enterprise, increases
research participation, addresses issues of the most impor-
tance to communities, and aids the translation of research
results into practice.
Participatory research has been in existence in various
forms for decades, but is difficult to define in practice. The
CDC, in collaboration with the University of British Colum-
bia, has defined it as a "systematic inquiry, with the collabo-
ration of those affected by the issue being studied, for pur-
poses of education and taking action or effecting change"
(Green et al., 1996~. Workshop participants used the terms
community-based participatory research, participatory re-
search, community-based research, and participant-centered
research to describe similar concepts.
Benefits of participatory research listed by Dr. Green
and others include:
· enhanced data quality and quantity;
· results are more immediately actionable in local
situations;
· results are relevant to the interests, circumstances,
and needs of those who would apply them;
· findings are more credible to practitioners and
policymakers;
· translation and sustainability of research findings
are enhanced;
· research awareness is increased;
· trust between the research community and the pub-
lic is enhanced;
· research definitions and directions are improved;
· translation and sustainability of research findings is
enhanced; and
· the community's health, education, and economic
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2
situation are improved as a result of involvement in partici-
patory research programs.
Disadvantages of greater participant involvement, out-
lined by Dr. Jerome Yates, 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.
Factors to Facilitate the Use of Participatory Research
Successful community-based participatory research
(CBPR) should include community focus and equal collabo-
ration between community and academic partners, and
should ultimately benefit the community, according to Dr.
Marshall Chin. Creating centers and other resources to help
investigators make contacts in the community and changing
how CBPR is viewed within academic health centers could
encourage CBPR at academic institutions.
According to Dr. Chin, the community-based participa-
tory research system would be improved by developing:
pilot developmental grants;
incentives for community members and research-
ers to work together;
· grant review study sections that understand and
value CBPR; and
· appropriate grant review criteria for CBPR.
To encourage CBPR at academic institutions:
· the next generation of professors who are more ac-
cepting of participatory research could influence others;
· foundations and others could create programs to
support postdoctoral fellowships in CBPR;
· institutions could create centers and resources to
help investigators make contacts in the community; and
· institutions could change how CBPR is viewed in
academic health centers, particularly for tenure and promo-
tion decisions.
Participant Involvement
Zelda Tetenbaum noted that engaging the public in clini-
cal research is difficult until people actually have a disease
and see a trial as a potential last hope. Literacy Volunteers of
America, American Cancer Society's "Reach to Recovery"
program, and the Research Subject Advocacy Programs at
General Clinical Research Centers provide some models for
engaging the public in the clinical research enterprise and
enabling potential participants to better understand research.
ENGAGING THE PUBLIC IN THE CLINICAL RESEARCH ENTERPRISE
Informed consent and conflicts of interest are major
concerns for patients, families, and patient advocates, said
Ms. Tetenbaum. Informed consent should be an ongoing
and significant process. The Association of American
Medical Colleges, Association of American University,
Institute of Medicine, National Bioethics Advisory Com-
mission, and the National Human Research Protections
Advisory Committee have recently offered recommenda-
tions to address the issue of conflicts of interest, and the
U.S. Department of Health and Human Services has drafted
guidance on the topic.
Encouraging Participant Enrollment and Physician
Awareness
Doctors' recommendations, awareness in the commu-
nity, and association with people who have participated
in research were identified by workshop participants as
important factors that promote participant enrollment in
clinical research. However, Dr. Leslie Ford noted that
there is little organized data that would indicate the most
influential factor for encouraging participation in clinical
research.
Dr. Jerome Yates noted that awareness on the part of
trusted physicians is critical to encourage participant enroll-
ment in clinical trials. However, many physicians are un-
aware of available clinical trials.
Challenges to Community Involvement
Challenges to community-based participatory research
and potential solutions offered by workshop participants in-
clude:
· public's distrust of scientists and research re-
searchers must be prepared to meet community needs;
· power imbalance establish equal partnerships that
acknowledge strengths and weaknesses of all parties;
· multidisciplinary needs involve a broad spectrum
of disciplines in the research process;
· the need to educate and engage the public, includ-
ing doctors make trial information more accessible and
train staff.
Effectiveness of Public Involvement
Dr. Kenneth Olden stated that the most important mea-
sure of the success of CBPR is the short- and long-term im-
pact 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 improvement of the
overall health of the public. The latter is more difficult to
determine and measure.
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WORKSHOP SUMMARY
Moclel Participatory Research Collaborations
Models for collaboration include the approach of the
National Institute of Environmental Health Sciences, the
Congressionally Directed Medical Research Programs, the
National Breast Cancer Coalition, Genentech's collabora-
tion with breast cancer advocates, the American Cancer
Society's Stakeholder Program, and the National Cancer
Institute's Community Clinical Oncology Program.
INCREASING THE ROLE OF THE PUBLIC IN
RESEARCH OVERSIGHT
IOM Report
The review of research involving human participants is
essential to the conduct of ethical research. Members of the
public are not only affected by the results of such reviews,
they also play an important role in the review process. As
outlined by the IOM report, Responsible Research: A Sys-
tems Approach to Protecting Research Participants, trans-
parency of this process also is crucial to maintaining the
public's confidence in research (IOM, 2003~.
Dr. Daniel Federman, chair of the Committee on As-
sessing the System for Protecting Human Research Partici-
pants, discussed the recommendations of the committee re-
garding participant involvement in the oversight and review
of research. The report also addresses the importance of
quality improvement activities in the process of human pro-
tections. The committee's recommendations discussed by
Dr. Federman during the workshop include the following:
· All research involving human participants should
take place within the framework of a human research par-
ticipant protection program (HRPPP) that fosters a culture
of ethical research conduct and integrity and is supported by
the highest authorities within organizations and given the
resources to function effectively;
· A three-pronged process of review that includes
complementary assessments of science, financial conflicts
of interest, and a comprehensive review focused on ethics
should be utilized to review research. It is essential that these
review mechanisms be properly staffed and able to share
information effectively with each other;
At least 25 percent of the Research ERB member-
ship should be unaffiliated and nonscientific;
· Obtaining informed consent should be an ongoing
process rather than a discrete moment;
.
.
All studies that have more than minimal risk should
be monitored, with prompt reporting of adverse events to
investigators and Research ERBs, as well as sponsors; and
· People nonnegligently injured in the course of re-
search should be compensated for at least medical care and
rehabilitation expenses, without regard to fault.
3
The government should assume responsibility for collecting
baseline data on the protection system. Currently, no one
knows either the number of people injured in research or the
number of people participating in research (the "numerator"
and "denominator".
Issues Regarcling Inclepenclent Members of IRBs
Nancy Dubler noted that some IRB chairs have wel-
comed the prospect of more public members, but others have
expressed concerns, as have unaffiliated, nonscientist IRB
members. Her certification program aims to address the con-
cerns of both of these groups by educating and recruiting
unaffiliated, nonscientist IRB members as well as providing
guidelines for them.
Angela Bowen discussed Western IRB, an independent
review board that could serve as a model for others. WIRB
panels are generally composed of three physicians, three
other scientists, and three nonscientists, and use alternates
and consultants as necessary. They meet weekly, and mem-
bers are paid for their service. The Board offers nonfinancial
support to its members as well, including training, indemni-
fication, and adequate staff support. Service on IRBs by un-
affiliated and faculty members could be encouraged by rais-
ing the profile of IRBs, compensating for time away from
other work, and including IRB service in tenure and promo-
tion decisions, according to Dr. Bowen.
Public Involvement in the Accreclitation Process
Marjorie Speers emphasized the importance of public
involvement in oversight, including a human research pro-
tection program accreditation process. This is one way of
fostering public trust and increasing public support. The
board of directors of the Association for the Accreditation
of Human Research Protection Programs (AAHRPP) in-
eludes five public members, and the Association incorpo-
rated participant concerns into its standards. Potential re-
search participants can use the accreditation status of
institutions as an aid to decision-making when choosing
whether to participate in research at a particular site.
AAHRPP will make public the accreditation status of insti-
tutions.
New Moclels of Ethical Review
Dr. Greg Koski stated that in the current system, there is
an overreliance on IRBs to ensure that research participants
are protected. The ethical conduct of research requires the
support of an entire program, which includes an effective
administrative staff, an information system, and a communi-
cation system, as well as quality assurance, management, and
compliance functions. He further emphasized that the goal of
the protection system should be prevention of harm and ex-
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4
cellence in the conduct of research rather than simple com-
pliance with the regulations.
Alternatives to the current system of ethical review in-
clude the distributed network consortium, centralized con-
sortium, tandem, and practice-based network models. These
models will function only to the degree that institutions are
willing to trust their review partners.
Currently, interpretation of ethical review regulations is
extremely variable. OHRP offers guidance for interpretation
and hopes that its developing quality assurance process will
provide a "gold standard reference" of best practices to share
through OHRP. The first phase, quality assurance, has be-
gun and the tools are available from OHRP.
STEPS TO IMPROVE THE TRANSLATION AND
DISSEMINATION OF THE RESULTS OF CLINICAL
RESEARCH
The Internet and Health Communication
The lnternet is now the primary way that most people in
the United States get health information, according to Dr.
Barry Wolcott of WebMD. The Internet can be used to con-
duct research, facilitate connections between researchers and
potential participants, and promote behavioral change. He
emphasized that the Internet should be a major component
of any marketing campaign to recruit for clinical trials and
IRBs. However, there are concerns about privacy, confiden-
tiality, validity, and credibility on the Internet that must be
addressed.
The Role of VHAs
Voluntary Health Associations (VHAs) inform patients
about the availability of clinical trials, recruit patients to tri-
als, sometimes conduct or fund trials, and provide informa-
tion about research results. John Walsh noted that several
VHAs have expressed frustration about the difficulties of
getting, sharing, digesting, and translating existing informa-
tion; the lack of basic information collected about their dis-
ease; and the lack of information about indirect costs to soci-
ety of particular diseases.
The Alpha- 1 Foundation is a model of community-cen-
tered collaboration that includes consumers, clinical re-
searchers, government, and industry, all of which are part of
the research infrastructure employed by the group. Commu-
nity-centered research coordination includes stakeholder li-
aison meetings; expert advisory committees; FDA participa-
tion; consideration of ethical, legal, and social implications;
and outcome studies.
Translation and Dissemination of Research Results at NIH
NIH has employed consensus development conferences
for 25 years in order to consolidate and communicate infor-
ENGAGING THE PUBLIC IN THE CLINICAL RESEARCH ENTERPRISE
mation of public health importance. The public aids in iden-
tifying issues of importance and in interpreting some infor-
mation. The results of the conferences are distributed to tar-
geted audiences. However, there is still a need for evidence
about how to translate this knowledge into behavioral
change.ClinicalTrials.gov was launched in early 2000 to pro-
vide a single point of access for reliable trial-related infor-
mation. The site is easily searchable and contains approxi-
mately 7,100 trial listings. The entries include the purpose,
eligibility criteria, location, contact information, number of
patients required, and the study status of the trials.
According to Steve Katz, challenges to translating and
disseminating information include:
· translating knowledge into behavior change of
health care providers and the public;
· making information available to all Americans (this
includes disseminating information at an understandable lit-
eracy level, and sensitivity to culture and vulnerable popula-
tions);
· making information available in many forms;
· knowing when and how to communicate the infor-
mation; and
· providing enough valid information.
Targeting Messages
There is a need for more research about how to engage
health care practitioners in lifetime learning. Dr. Wolcott
commented that restating research findings, such as those
presented in NIH Consensus Reports, in the form of specific
questions for patients to ask their physicians would encour-
age practical use of the research. Personal interest stories,
such as those pairing a patient and doctor to talk to the me-
dia, also can aid in the dissemination of information.
Funcling for Research Translation
Dr. Hugh Tilson noted that there is a lack of funding for
research to determine the most effective mechanisms for
translating and disseminating research results. Dr. Wolcott
noted that companies build these costs into their expenses
for research and development, but other sectors have not
marketed discoveries with the same vigor.
CONCLUSION
During the workshop, speakers identified obstacles to
the application of community-based participatory research
and also potential ways to counter those obstacles. The Clini-
cal Research Roundtable will continue to address similar is-
sues that affect the Clinical Research Enterprise to ensure
that it is functioning optimally producing and sharing the
results of research that are necessary to improve human
health.
Representative terms from entire chapter:
human research
