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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 Arrer~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.