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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.