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Appendix C
Background for CRR Workshop: Exploring New
Models for Engaging the Public in the Clinical
Research Enterprise
PARTICIPANT-CENTERED CLINICAL RESEARCH:
MODEL COLLABORATIONS AMONG COMMUNITY/
DISEASE ADVOCATES, RESEARCHERS, AND
SPONSORS
The ultimate goal of clinical research is to positively
affect the health of people, and those who participate in hu-
man studies are the cornerstone of the clinical research en-
terprise. However, the perspectives of participants have not
generally been incorporated into formulating the research
agenda and carrying it out; the public, including research
participants, have often been seen as passive recipients of
research results. This approach has led to problems in the
application of research findings in the general public.
However, research participants have begun to take a
greater part in the research process, from formulation of re-
search priorities to the ethical review of research proposals
to the dissemination of research results. These developments
are nascent and the inclusion of participants in the traditional
research model is not without problems, but if the clinical
research enterprise stakeholders wish to gain the trust of
skeptical populations, retain participants, address the issues
of most importance to particular communities, and dissemi-
nate their results among the populations affected by the re-
search, they must engage participants at many stages of the
research process.
The Department of Defense Congressionally Directed
Medical Research Programs were among the first to involve
consumers in the evaluation of funding decisions for re-
search. Since 1995, these DoD programs have included the
perspective of consumers who are survivors of the particular
cancer being studied (e.g., breast cancer) or their family
members. Consumer reviewers are expected to represent the
perspective of those affected by the disease and to ensure
that the projects reflect the needs and concerns of the af-
fected community. They are full voting members of the re-
view panel; they can comment on the technical merits of
proposals, but are not required to fulfill a scientific role.
54
According to DoD assessments, the program has been suc-
cessful consumer reviewers feel that they have made
valuable contributions to the reviews and that scientists on
their panels have shown them respect and acceptance; sci-
entists have indicated that the community presence on the
panels has served as a reminder of the human aspect of
disease and has enhanced communication to gain a mutual
understanding.
It is important to note that the definition of participants
is not limited to those directly taking part in research re-
searchers must also engage academic and practice commu-
nities, research advocacy groups, public health officials, and
similar groups in order to ensure that their research is rel-
evant and its results are useful. For example, clinicians must
be engaged in the application of "best practices" developed
through research.
Other terms for Participant Centered Clinical Research
include "Community Based Participatory Clinical Re-
search," "Community Based Research," "Participatory Re-
search," "Participatory Action Research," "Action Re-
search," "Empowerment Evaluation."
Selected Moclel Programs of Participant-Centerecl Clinical
Research:
Department of Defense Congressionally Directed Medical
Research Programs
http: //cdmrp . army . mil/CWG/default. him
Project LEAD (National Breast Cancer Coalition this is a
training program to aid public participation in the research
process)
http://www.natlbcc.org/bin/index.htm
The Detroit Community-Academic Urban Research Center
http: llwww . spin. umi ch. edu/urc/
Prevention Research Centers (Centers for Disease Control
and Prevention)
http: llwww . cdc . gov/nccdphp/aag/aag_prc . him
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APPENDIX C
Community Programs for Clinical Research on AIDS (NIH)
h t t p : I I w w w . c p c r a . o r g /
HIV Vaccine Trials Network (NIH)
http://www.hvtn.org/
Women's Interagency HIV Study (NIH)
https://statepiaps jhsph.edu/wihs/
Community Advisory Boards (various components of NIH,
no single website)
Selected References
Andejeski Y. et al. 2002. Benefits and Drawbacks of
Including Consumer Reviewers in the Scientific Merit Re-
view of Breast Cancer Research. Journal of Women's Health
and Gender-Based Medicine 1 1 (2~: 1 1 9-1 36.
Bastian H. 1994. The Power of Sharing Knowledge:
Consumer Participation in the Cochrane Collaboration.
http :llwww. cochraneconsumer. com/p_Involve. asp.
Department of Defense. Department of Defense Con-
gressionally Directed Medical Research Programs: Con-
sumer Involvement. http://cdmrp.army.mil/CWG/
default.htm.
Dresser R. 2001. When Science Offers Salvation: Pa-
tient Advocacy and Research Ethics. New York, NY: Ox-
ford University Press.
Israel BA, et al. 2001. The Detroit Community-Aca-
demic Urban Research Center: Development, Implementa-
tion, and Evaluation. Journal of Public Health Management
and Practice 7~5~:1-19.
Green LW and Mercer SL. 2001. Can Public Health
Researchers and Agencies Reconcile the Push from Funding
Bodies and the Pull from Communities? American Journal
of Public Health 91:1926-1929.
Rich IM, et al. 1998. Perspectives from the Department
of Defense Breast Cancer Research Program. Breast Dis-
ease 10~5-6~:33-45.
Wakefield S. et al.2002. Models of Community Partici-
pation in NIH-Funded HIV-Research Networks. Presenta-
tion at the September 19, 2002 U.S. Conference on AIDS.
INCREASING THE ROLE OF THE PUBLIC IN
RESEARCH OVERSIGHT
As outlined above, research participants are essential to
carry out clinical research and also have a role in promulgat-
ing research results. In addition, they have a role to play in
reviewing research to ensure that it is ethical by the stan-
dards of potential participants, to offer a view from outside
the traditional scientific mold.
The regulations governing human research in the United
States require that Institutional Review Boards (IRBs) have
at least one "non-scientific" member and at least one mem-
ber not affiliated with the institution; their role as public
members is to ensure that the ethical review of research pro-
posals is not dominated solely by scientific professionals.
55
Their participation in research review is essential to foster
transparency to promote public trust, ensure that research is
consistent with participant community values, and make sure
the protection system is accountable.
However, recruiting and training participant representa-
tives for IRBs is not always easy. While public members and
consumer representatives that serve on health care licensing
and similar boards are trained and supported by the Citizen
Advocacy Center, there is no similar non-disease-specific
group to serve this role for IRBs. Among advocacy groups,
the National Alliance for the Mentally Ill offers a training
guide for consumers to serve on IRBs, but this guide is the
exception rather than the rule.
When public members can be identified, trained, and
recruited, there is still potential that they may have difficulty
in fully participating. The needs of public members may
differ from those of other members, for example, meeting
after normal work hours, assistance in translation and under-
standing of scientific issues, and other issues.
Selected References
Bastian H. 1994. The Power of Sharing Knowledge:
Consumer Participation in the Cochrane Collaboration.
http :llwww. cochraneconsumer. com/p_Involve. asp.
Citizen Advocacy Center. 2002. About CAC. http://
www. cacenter. org/about. him.
Dresser R. 2001. When Science Offers Salvation: Pa-
tient Advocacy and Research Ethics. New York, NY: Ox-
ford University Press.
IOM.2003. Responsible Research: A Systems Approach
to Protecting Research Participants. Washington, DC: The
National Academies Press.
National Alliance for the Mentally Ill. 2001. Serving on
a Research Review Board. http://www.nami.org/research/
reviewboard.html.
STEPS TO IMPROVE THE TRANSLATION AND
DISSEMINATION OF THE RESULTS OF CLINICAL
RESEARCH
One of the major issues blocking the application of ba-
sic scientific discoveries and the results of clinical trials to
improve human health is the lack of planned dissemination
and translation of clinical research results. If the results of
clinical research are not shared and translated, people will
not benefit from the new knowledge produced by that re-
search and vetted clinical results will not be applied in prac-
tice.
While "best practices" and similar research are often
targeted at practicing doctors and similar professionals, com-
munication with the general public is also important to im-
prove the nation's health. If a person has arthritis, for ex-
ample, she will want to know what her options are for
treatment. Perhaps she has heard that glucosamine works to
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56
alleviate symptoms. How can she check this information ~r
accuracy? Will she be able to understand tn~ results the me
not communicated in nonscientific language? If she Onds
contradictory information' how can she determine which
treatment options may be right for her? With the growing
poput~ty of the Intemet, how does she know which i-~for-
mation is vabd? If the research reHects `'real world'?: consid-
eratior~s, its Innings He more likely to have an impact on the
health of the public.
A website developed by the Department of Health
and Human Services and other federal agencies (www.
healthOnder.govy, has a search engine =d other Adores that
kink the user to reputable websites for more intimation.
Additionally, other privately operated websites such as
webmd.com provide health ~nfo~atior~ =d tools for users.
The Negation is Resented in nonscientific language and
the sites are relatively easy to use. Queens however, ~ndi-
viduals rely on press accounts that can be contradictory (i.e.,
the plethora Qua Fiches about what malt makes people fat,
whether mammography is effective, whether hormone re-
placement therapy is harmful or helpful) and are omen too
short to provide the -~l portent of findings and their impli-
cations in relation to ether mats.
ENGAGING THE PUBLIC IN THE CLIN;:ICAL RESEARCH ~T^PR~E
Clinical research FOSUitS dD~ their meanings in the
context of current knowledge must be communicated in
order to be elective. For this to occur, the scientists who
generated the results should be more involved in the trans-
Iat~on and inte~ret~or~ of those results for ~ broad audi-
ence. Likewise, members of the public should contribute
to the transition and dissemination of research results, as
well as the interpretation of the implications of new find-
ings. It is important to note that this will require time and
resources for the activities that aid translation and dis-
semination.
selected RelerenGes
Majumdar SR, Chang Vow, Armstrong PW. 2OQ2. Do
the investigative sites that the pan in a positive clinical tnal
translate the evidence into practiced Arr£er~can Journal of
Medicine 113~29. 140-145.
:Lau ~ Ad Herbert M. 20~31. The realities of synthesiz-
~g and ~sse~nating beseech evidence. Healthc£'re ~OM-
agement Forum 14~:35-43.
Wilkes MS. 1997. The public disse~nat~on of meccas
research: problems and solutions. Journal of Heals Com-
mun~cation. 2~1).3-15' discussion 61-62.
Representative terms from entire chapter:
breast cancer
