Director's Council of Public Representatives
Fall 2004 Meeting MinutesOctober 27, 2004NIH Participants:
COPR Members Attending:
COPR Members Not Present:
NIH DIRECTOR’S WELCOMEDr. Elias A. Zerhouni Dr. Elias Zerhouni welcomed the public to the 12th meeting of the NIH Director’s Council of Public Representatives (COPR). He noted the importance of the previous day’s workshop, Inviting Public Participation in Clinical Research: Building Trust through Partnerships, an event designed to solicit input from the various communities that have a role in conducting clinical trials in this country. Dr. Zerhouni thanked COPR members Dr. Debra Hall and Dr. Rafael Gonzalez-Amezcua for serving as co-chairs for the workshop. Dr. Zerhouni also thanked Dr. Raynard Kington, Deputy Director, NIH, for presiding over the workshop and all of the COPR members for their support of this event. He then announced the passing of two former COPR members, Ms. Barbara Lackritz and Ms. Rosemary Quigley. Dr. Zerhouni acknowledged their passion and cited them as examples of the remarkable people who come to NIH because they want to give something to the larger medical community. He asked for a moment of silence in honor of Ms. Lackritz and Ms. Quigley. Following this moment of silence, Dr. Zerhouni suggested that their passion for advancing the mission of NIH must continue and that public discussion in the context of scientific investigation is essential to accomplishing that mission. Returning to the topic of the workshop, Dr. Zerhouni recognized the more than 80 workshop participants, who had come from various regions in the country and represented diverse groups. He provided a brief history of the workshop, the planning of which began more than a year ago with COPR deliberations and a series of discussions about the NIH Roadmap for Medical Research vis-à-vis potential input from the public. Early in Dr. Zerhouni’s tenure, he had directed the COPR to review opportunities for gathering the public’s perspective, and subsequent discussions converged into the workshop and today’s meeting. Dr. Zerhouni also recognized the NIH Public Trust Initiative (PTI) as an important contributor to the workshop. He thanked the co-chairs of the NIH PTI, Dr. Patricia Grady, Director, National Institute of Nursing Research, and Dr. Yvonne Maddox, Deputy Director, National Institute of Child Health and Human Development. He introduced Dr. Dushanka Kleinman, Associate Director for Roadmap Coordination. Dr. Zerhouni then explained that both the Public Trust Initiative and the NIH Roadmap for Medical Research focus on improving public health. The NIH leadership understands that there is no perfect solution to today’s public trust issues. The public is diverse, and thus “public trust” does not have a single definition. The previous day’s workshop regarding public trust and clinical research helped to identify common factors that NIH leadership should consider, he noted. Dr. Zerhouni reminded attendees that the COPR meeting was open to the public and that time would be set aside for comments and questions after the presentation by COPR members about the workshop. Dr. Zerhouni then recognized seven outgoing COPR members— Kimberley Hinton, Nancye Buelow, Debra Hall, Ted Mala, Larry Sadwin, John Shlofrock, and Don Tykeson—for whom this would be the last COPR meeting. He thanked the departing members and recognized them as an extraordinary class. He also acknowledged Mr. Tykeson’s role in discussions of ways to improve the NIH’s ability to communicate its agenda to the public and the Congress. Dr. Zerhouni noted that recently developed NIH materials, such as brochures, carry the following tagline about NIH: “the nation’s medical research agency.” Mr. Tykeson had suggested this tagline to help raise awareness of NIH outside the Washington, D.C., area. Dr. Zerhouni thanked Mr. Tykeson and called the tagline his legacy to NIH. COPR PRESENTATION OF PRELIMINARY FINDINGS OF THE WORKSHOP INVITING PUBLIC PARTICIPATION IN CLINICAL RESEARCH: BUILDING TRUST THROUGH PARTNERSHIPSDr. Debra Hall and Dr. Rafael Gonzalez-Amezcua Dr. Rafael Gonzalez-Amezcua stated that, on behalf of the entire COPR, he and Dr. Hall would present the preliminary recommendations arising from Tuesday’s workshop. He reported that the workshop had been successful and had yielded interesting results. He stated that COPR had embarked on this project a year earlier, with strong interest from COPR members, based on Dr. Zerhouni’s request for public input on ways the NIH could enhance trust in clinical research. The workshop planning began as COPR learned about the NIH Roadmap for Medical Research initiative of reengineering the clinical research enterprise. This portion of the NIH Roadmap for Medical Research involves engaging the public in clinical research and building alliances to encourage public participation in clinical trials. This Roadmap initiative consists of three priorities: to build trust among members of the public, to promote communication between researchers and the public, and to educate the public about the value of clinical research. Dr. Gonzalez-Amezcua acknowledged the contribution of the NIH PTI staff in planning the workshop. PTI staff represent a number of NIH Institutes and Centers (ICs). Dr. Gonzalez-Amezcua specifically thanked Dr. Grady, Dr. Maddox, and Dr. Kleinman for working closely with COPR to develop the foundations for the workshop. Dr. Hall noted that COPR had prepared for this workshop over a period of several months, conducting literature searches, interviewing experts in clinical research, and working with NIH staff, and had identified three purposes for the workshop:
Dr. Hall elaborated that the goals of the workshop were also (1) to identify guiding principles that all involved communities could use to build participation and trust in medical research and (2) to develop initial recommendations for the Director, NIH, and partnering organizations. The workshop included participants who represented various backgrounds, geographical areas, races and ethnicities, conditions and diseases, patient populations, and the health and medical media. Dr. Hall reported that the day after the workshop, COPR members had reviewed what they’d heard during the workshop, spent some time identifying key themes and concepts, and converted them into a preliminary set of recommendations. These preliminary recommendations will be refined in the coming weeks. Dr. Hall also reported that the workshop had generated tremendous energy and that the participants reflected the world in which we live. Based on their experience, they had provided specific ideas that could be translated into action, and had called for broad changes in the research culture. Most notably, many participants had identified the powerful link between community health care and public trust in clinical research, and asserted that the link could not be ignored. At the same time, COPR recognized that the NIH does not deliver community health care. With this preamble, Drs. Hall and Gonzalez-Amezcua presented the following preliminary recommendations: Clear Communication of Intent Leads to Trust
Building Capacity for Community Partnerships
Fostering Public Trust and Communication Is Everyone’s Job
Following this presentation, Dr. Zerhouni repeated a question that had arisen during the Spring 2004 COPR meeting: Why should the public trust us? He concluded that the NIH had to answer this question first, and reiterated that COPR had worked hard to bring together individuals with unique perspectives in the hope of generating ideas to overcome distrust. He expressed his hope that the workshop would spark a continuing dialogue leading to increased participation and greater trust in clinical research. Question, Answer, and Discussion SessionDr. Hall opened this session by asking attendees to consider:
Dr. Gonzalez-Amezcua introduced workshop facilitator Dr. Rob Williams and noted his instrumental role in ensuring that ideas and opinions generated by the workshop had moved forward. Drs. Hall and Gonzalez-Amezcua then opened the forum for discussion. One audience member remarked that the tagline for the NIH, “the nation’s medical research agency,” would help to establish and reinforce the identity of the NIH. At present, not many people made this connection, and the tagline might serve as a good starting point for other recommendations by providing a clear vision of what the NIH represents to the nation’s health. Dr. Steve Katz, Director, National Institute of Arthritis and Musculoskeletal Diseases (NIAMS), requested more elaboration on what COPR was recommending related to community involvement in research. NIAMS has gained a tremendous amount of experience through a health center in the District of Columbia that serves Hispanic and African-American communities. This center has facilitated interaction between community health care and the NIH, and has provided a forum for District patients to take advantage of the intramural research program at NIH. However, this center is highly labor intensive and expensive. Dr. Katz asked COPR to elaborate on this issue. Dr. Hall suggested that workshop participants were seeking ideas for community-involvement in research and efforts that involve stimulating partnerships between local communities and research institutions. What the participants expressed was a need to take steps toward building links with individuals in the community and providing resources for community members to participate in research. Dr. Katz reminded everyone that outreach was part of the NIH Roadmap for Medical Research, particularly the Clinical Research Associates program, and he asked whether people knew about this aspect of the initiative. Another audience member asked about the full disclosure of clinical trial outcomes and noted that during the past few weeks, there had been some discussion at NIH of open access to applications. The audience member asked if in the preliminary recommendation, disclosure was limited to clinical trials or whether it would be expanded to other NIH-funded activity. Dr. Hall responded to the need to review information carefully but said that this recommendation was considered fairly broad. Ms. Suzanne Pattee, of the Cystic Fibrosis Foundation, called for more specificity in the definition of clinical research and communities. She said that a disconnect existed between what researchers wanted to accomplish and what patients want. Ms. Pattee cautioned that the Centers for Disease Control and Prevention and the NIH have separate missions, and that NIH should not duplicate the CDC model. Instead, NIH should focus on basic and clinical research. Dr. Dawna Torres Mughal informed audience members that the recommendations had been organized under broad themes, which should also be presented. She suggested that these broad themes would aid the discussion. Ms. Jennifer Gorman Vetter listed the themes. Dr. Torres Mughal also commented that several terms—medical research, clinical trial, and clinical research—were used interchangeably and that one term should be used for consistency. Ms. Barbara Butler responded that discussion should focus on the topic of the workshop: clinical research. Dr. Mala commented that research involves everyone. Everything that NIH does, every dollar it sends out, and every life it touches should be involved in the effort to increase public trust. Dr. Hall added that one problem with perception is that the public does not differentiate between NIH, NIH-funded researchers, and the medical community. Dr. Zerhouni acknowledged that defining a community is a complicated task, because one person often belongs to many communities. Depending on the context, these preliminary recommendations could be implemented differently. For example, if the focus was on a geographical community, then a new infrastructure might need to be established. Dr. Gonzalez-Amezcua suggested that defining “community” should serve as a starting point. He noted that when COPR members started to compress the notes from the workshop, they listed education and communication as priorities. Dr. Hall also noted that at the workshop, a presentation by Dr. Robert Beall, President and CEO of the Cystic Fibrosis Foundation, focused on patients and geographic communities. Dr. Zerhouni congratulated COPR for pulling together a preliminary report based on the workshop. He noted that with more than 80 participants, it was not easy to crystallize the diverse comments. With so many people putting forth ideas, any summary sentence that COPR generated would most likely have several different interpretations. Dr. Zerhouni noted that COPR had focused on communication between the research world and the patient and public world, and that once this issue was addressed, the resulting changes should be institutionalized. He noted the need for a clear communication strategy and the adoption of best practices. Dr. Gonzalez-Amezcua noted that prior to the workshop, some COPR members had been trained as “weavers,” who listened to breakout discussions and identified themes. He noted that communication and education were dominant themes and that there was a call for all of the NIH to understand that the community, however it was defined, needed education. The public couldn’t trust what it didn’t know. Dr. Hall also cited a tremendous hunger among the public for information related to health and research. Dr. Mala stated that public trust belongs to all involved in research and noted that a shift in culture that includes the grantee community would represent a new way of doing business at the NIH. Part of the evaluation for anyone who receives money from NIH should include a question about how the investigators have communicated trust to the public and how they have helped the goal of transparency. Dr. Sally Anderson, of the National Institute on Alcohol Abuse and Alcoholism, also cautioned that the work of developing public trust involves many communities of various sizes and that all participants want more of a say in how research is done. However, one missing element is an understanding that the researcher-participant relationship differs from the doctor-patient relationship. Dr. Zerhouni agreed, and observed that community surveys about academic centers typically yield negative responses, but that research participants and others feel positively toward academic centers. The same is true for medicine. The overall trust factor for medicine is similarly low, but people feel good about their specific doctors. Dr. Zerhouni noted that the recommendation about better researcher training should focus on the researcher-participant relationship. For example, the recommendation of saying “thank you” to research participants is amazingly simple and the kind of best practice the NIH can readily implement. CLOSING REMARKSDr. Zerhouni noted that, with the issue of public trust, people do not separate researchers from health care providers, which complicates the ability to address the issue. He stated that COPR had identified some preliminary recommendations that the NIH could work on and take under advisement. He noted that NIH is very interested in building public trust and that Institute and Center directors support the Public Trust Initiative. The identification of a common language and the implementation of changes in the way NIH does business could be a great outcome of the final recommendations. In both this set of recommendations and the NIH Roadmap for Medical Research, there is a clear message to train researchers to communicate with participants. Dr. Zerhouni spoke of a meeting he had attended in Kansas City, where members of the public posed questions to a representative of the Susan G. Komen Breast Cancer Foundation. He learned that 78 percent of women with breast cancer had never been asked to participate in clinical research, but that a great many did so when asked. He noted that the research community has a duty to provide transparency and that sometimes, even when a clinical trial is completely transparent, it can still be perceived as opaque. Anything that is not clear is often interpreted in the worst way. Mr. Mike Hill noted that this need for transparency prompted the recommendation to establish two advocates/ombudsmen, one for patients and one for providers. Such liaisons could increase participant interactions with researchers. He added that although there is a database available to provide information on all active clinical trials, most physicians do not have time to go online and research clinical trials to recommend to patients. Dr. Raynard Kington acknowledged the workshop as a valuable enterprise and noted that COPR members had devoted many hours over the past months to assembling the mix of diverse participants. He pointed out that the preliminary recommendations are just a first step in the process, and outlined the following next steps: Develop a thorough synthesis of the notes from the workshop breakout sessions, including the full range of comments, who participated, and information from the speakers. Make this Workshop Proceedings available to the public online on the COPR web site at www.copr.nih.gov and on the www.getinvolved.nih.gov web site.
Dr. Zerhouni reminded everyone that the COPR recommendations presented were a first draft and a further review by COPR would result in a more refined set that would be circulated to COPR members and participants as well as being posted on the COPR web site at: www.copr.nih.gov. Dr. Hall thanked the NIH leadership, the NIH Offices of Public Liaison, and Ms. Gorman Vetter for their help in coordinating the workshop. The April 2005 meeting is scheduled for April 28–29. Dr. Zerhouni thanked Dr. Hall and Dr. Gonzalez-Amezcua for co-facilitating the meeting. The meeting adjourned at 4:30 p.m.
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