Director's Council of Public Representatives
Spring 2004 Meeting MinutesApril 29, 2004NIH Participants:
COPR Members Attending:
COPR Alumni:
COPR Members Not Present:
NIH DIRECTOR'S REPORTElias A. Zerhouni, M.D. Dr. Zerhouni welcomed participants to the 11th meeting of the Director’s Council of Public Representatives (COPR). He noted the progress shown at each COPR meeting. He then introduced four new COPR appointees in attendance as ad hoc participants: Mr. Craig T. Beam, Regional Partner, Hammes Company, and former Chairman, American Heart Association; Ms. Wendy Chaite, Esq., President, Lymphatic Research Foundation; Mr. R. Mike Hill, Executive Director, Northwest Florida and Big Bend Health Councils, and President, Florida Association of Health Planning Agencies; and Mr. James Kearns, President, River Falls Productions, Ltd. Dr. Zerhouni extended a special welcome to Dr. Thomas Ansfield, a member of the Advisory Committee to the Director (ACD) who serves as the ACD liaison to the COPR. COPR member Mr. Larry Sadwin serves as the COPR liaison to the ACD. Dr. Zerhouni thanked Dr. Ansfield and Mr. Sadwin for their time and commitment to the liaison effort. Two COPR members were unable to attend the meeting: Mr. Bill Novelli and Ms. Nancye Buelow. Dr. Ruth Browne joined the meeting via teleconference. Two COPR alumni also attended the meeting: Dr. Len Tamura and Ms. Zelda Tetenbaum. UPDATE FROM THE DIRECTORMeetings and Events Dr. Zerhouni highlighted noteworthy meetings and events. The third meeting of the NIH Blue Ribbon Panel on Conflict of Interest Policies was held April 5–6, 2004. After review, the Panel made recommendations for improving existing rules and procedures governing real and apparent conflicts of interest for the NIH staff. It also made recommendations regarding requirements and policies for reporting NIH staff financial interests. The panel is a working group of the ACD and will provide recommendations to the ACD at the May 6, 2004, meeting. The ACD will deliberate and approve final recommendations to go to the NIH Director. Bruce Alberts, Ph.D., President of the National Academy of Sciences, and Norman R. Augustine, Chairman of the Executive Committee of the Lockheed Martin Corporation, co-chair this panel. Mr. Sadwin also serves on the panel. COPR members were invited to attend the May 6 meeting. In addition to Mr. Sadwin, Ms. Barbara Butler, Dr. Dawna Torres Mughal, and Ms. Wendy Chaite will attend. Dr. Zerhouni, Dr. Alberts, and Mr. Augustine will testify before the House Energy and Commerce Subcommittee on Oversight and Investigations at a May 12, 2004, hearing on conflict of interest issues. Congressional Hearings Dr. Zerhouni testified before the Senate and House Labor, Health and Human Services, and Education Appropriations Subcommittees on April 1, 21, and 22, respectively, regarding the Fiscal Year (FY) 2005 Budget. He also presented the NIH Roadmap and Management Initiatives at the hearings. The Director testified on clinical research before the House Energy and Commerce Subcommittee on Health on March 25 and briefed congressional staff on the Biosecurity Initiative on March 4. More information on these issues is available in the NIH Director’s Update. NIH Budget Dr. Zerhouni commented on the budgetary environment. Congress is aware that the NIH is under pressure and must make difficult choices. At the appropriations hearings in early April, he presented the President’s FY 2005 Budget for the NIH of $28.8 billion, an increase over FY 2004 of 2.6 percent. In addition to the request for the NIH, the HHS budget includes $47 million for nuclear/radiological countermeasures research at the NIH, which brings the total increase in the NIH budget to $764 million, or a 2.7 percent increase. COPR Member Activities Dr. Zerhouni noted recent activities of COPR members at the NIH. Many COPR members have served on NIH Institute and Center (IC) Director Review Panels and Work Groups. Eight members have served on these review panels since COPR formed in 1999. Twelve members recently served as ad hoc members of the NIH Plain Language Evaluation Subcommittee. They were charged with judging consumer-oriented products entered in the NIH Plain Language Program. The Director thanked the following COPR members and alumni for their time and commitment to this effort: Mr. James Armstrong, Dr. Ruth Browne, Ms. Barbara Butler, Dr. Frances Dunston, Dr. Rafael Gonzalez-Amezcua, Dr. Ellen Grant, Dr. Debra Hall, Dr. Ted Mala, Dr. Rodrigo Munoz, Dr. Leonard Tamura, Ms. Zelda Tetenbaum, and Mr. Donald Tykeson. Mr. Sadwin has also given of his time and talent in service to the NIH through his participation on numerous work groups and in his capacity as the COPR liaison to the ACD. Update on the NIH Roadmap The Director reviewed key Roadmap activities. These activities are also described in the NIH Director’s Update:
Gene Transfer Research Dr. Zerhouni updated participants on a program launched by the NIH and the Food and Drug Administration (FDA) for a new Human Gene Transfer Research Data System on March 26, 2004. It is called Genetic Modification Clinical Research Information System (GeMCRIS) and is a unique public information resource. NIH and FDA staff have worked for two years to ensure that adverse events in this program can be reported quickly. GeMCRIS allows users to access an array of information about human gene transfer trials registered with the NIH, including medical conditions under study, institutions where trials are being conducted, investigators carrying out these trials, gene products being used, route of gene product delivery, and summaries of study protocols. The pilot Web site for the project is http://www.gemcris.od.nih.gov . Selected NIH Research Advances for 2003-2004 Dr. Zerhouni highlighted recent NIH scientific advances, including the following:
Meeting Theme—Public Trust Dr. Zerhouni returned to the meeting theme—public trust. Public trust has emerged as an important issue for the clinical research enterprise and also for the NIH. In the process of developing the Roadmap, Dr. Zerhouni involved NIH staff, scientists, the public, and more than 300 outside scientists. The group found that preserving and enhancing public trust in research is a strategic need. This theme also emerged in the context of increasing discoveries that require public participation. Translating research from animal to human models has worked well in the past. Today, however, chronic diseases are an important focus of research. Such conditions do not have one cause; they evolve due to complex interactions between genes and environment, diet, and other components that are not fully understood. It is difficult to develop a comprehensive model for a complex disease. It is unlikely that scientists will make progress against these diseases without a vibrant clinical research enterprise to investigate these conditions. At the core of such an enterprise is public trust. Dr. Zerhouni recently announced the creation of the NIH Public Trust Initiative (PTI) to improve public health by promoting activities and attitudes that instill confidence in the NIH’s work as the premier biomedical and behavioral research enterprise. He asked Dr. Patricia Grady, Director of the National Institute of Nursing Research, and Dr. Yvonne Thompson Maddox, Deputy Director of the National Institute of Child Health and Human Development (NICHD), to co-chair the initiative. He said there is no better topic on which to receive input from COPR than ways to further the PTI. This is a critical time in the NIH’s history to look at the issue of public trust. The PTI is important to the Roadmap but extends beyond that effort. Dr. Zerhouni asked Mr. Sadwin to act as COPR meeting manager for the morning session, then introduced NIH staff attendees: Drs. Grady and Maddox; Duane Alexander, M.D., Director, NICHD; Lawrence Tabak, D.D.S., Ph.D., Director, National Institute of Dental and Craniofacial Research; Judy Vaitukaitis, M.D., Director, National Center for Research Resources; Roderic Pettigrew, Ph.D., M.D., Director, National Institute of Biomedical Imaging and Bioengineering; Francis Collins, M.D., Ph.D., Director, National Human Genome Research Institute; James Battey, M.D., Ph.D., Director, National Institute on Deafness and Other Communication Disorders, and Chair, NIH Stem Cell Task Force; Sharon Hrynkow, Ph.D., Acting Director, Fogarty International Center; Ruth Kirschstein, M.D., Senior Advisor to the NIH Director; Michael Gottesman, M.D., Deputy Director for Intramural Research, NIH; Dushanka Kleinman, D.D.S., M.Sc.D., Associate Director for NIH Roadmap Coordination; and Alan Rabson, M.D., Deputy Director, National Cancer Institute. OVERVIEW OF COPR PUBLIC TRUST EFFORTSDebra Hall, Ph.D. and Lawrence Sadwin, COPR Members Mr. Sadwin and Dr. Debra Hall co-facilitated the meeting. Mr. Sadwin noted the COPR Public Trust Steering Work Group began planning for the April COPR meeting in November 2003. Their aims were to coordinate a workshop on public trust and write a white paper/report on the subject. Mr. Sadwin introduced Dr. Hall, who provided an update on COPR efforts. Dr. Hall told attendees that the COPR had agreed the first priority was to enhance public trust in clinical research, so they focused on devising strategies for exploring trust and its effect on clinical research. The COPR used a literature review to find key concepts related to trust, including the following:
The review also revealed that some minority groups reported feeling like guinea pigs with regard to research, and this feeling led to a lack of trust. Lack of trust is manifested, Dr. Hall said, by the following:
There is a lack of public understanding about research, she added. Members of the public do not always recognize that a research protocol may differ from standard treatment. Some participants, however, view research as their only opportunity to receive medical treatment. The public thinks the Government is responsible for protecting people in research, but they also want to be personally empowered. They scrutinize health-related research more than other types of research. Dr. Hall detailed COPR’s findings, which were based on their literature review of research and trust. With regard to the public, the COPR’s findings were as follows:
With regard to the NIH Roadmap, COPR recommended the following:
Dr. Zerhouni thanked Dr. Hall for an excellent analysis and summary of the literature findings. He then introduced Drs. Grady and Maddox, co-chairs of the NIH Public Trust Initiative. The NIH leadership thought it important to have this initiative involving the scientific perspective to complement COPR’s work on trust from the public perspective. NIH Public Trust InitiativePatricia A. Grady, Ph.D., R.N., FAAN, Director, NINR Dr. Grady expressed gratitude to Dr. Zerhouni and COPR, and opened her presentation with the PTI goal: “To improve the public’s health by promoting public trust in biomedical and behavioral research.” She defined the public as “individuals, patients, families, and communities,” and trust as “confidence placed by the people in an institution or process.” The NIH can improve communication and its interactions with the public. The PTI is critical to the NIH Roadmap, Dr. Grady said. The PTI fits into the broader framework of why people should care about the NIH and how it does its work. It is very important that the NIH translates research knowledge into practice and disseminates findings through the Internet and other vehicles. Dr. Grady described the COPR-planned workshop as an important complement to the PTI. She mentioned areas in which public participation could be improved, such as the use of interdisciplinary teams, public-private partnerships, and new paths to discovery. Some new, exciting Roadmap paths such as Nanomedicine also entail addressing new legal and ethical issues. Dr. Grady closed by emphasizing that the audience included leaders of the NIH and important members of the PTI Steering Committee who were listening keenly to COPR recommendations and were eager to work with COPR. Yvonne Thompson Maddox, Ph.D., Deputy Director, NICHD Dr. Maddox outlined current PTI activities. Those involved with the PTI learned from the COPR report on enhancing public trust that an inventory is needed of current public outreach and education activities among the various NIH Institutes and Centers. The PTI has asked the Institutes and Centers to send information on current programs, and PTI staff members are working on a national survey to ascertain the issues involved in public trust. Suggested survey questions include: Does the public trust their investment in research? Do they understand research? What are their expectations and concerns with regard to research? The PTI will work with COPR to develop additional survey questions. Dr. Maddox noted the PTI Steering Committee is in place and that many members were in attendance. Dr. Maddox also noted that the research enterprise should be viewed as a continuum, from discovery to translation to dissemination. The PTI will review models and may also find gaps. Survey results may lead to action items and possible initiatives to create programs that engage the public to a greater extent in biomedical research. The NIH cannot solve all problems, but some solutions may be translated to other research organizations. One idea is to send scientists to work in communities. Another idea is to establish an NIH Biomedical Research 101 course to teach science and present research positives and negatives. Dr. Maddox pointed out that the PTI has a wide array of participants from the NIH community. The Steering Committee will review inventory results and develop guidelines, criteria, and new programs to be used in the Initiative. Dr. Maddox closed by saying that the ultimate goal for the PTI is a tall one: To establish for the NIH a trusted reputation. Discussion Dr. Zerhouni thanked Drs. Grady and Maddox and opened the meeting for questions. Dr. Mala asked how the NIH is publicizing its public trust efforts. Dr. Grady said that the PTI is starting with the inventory of current activities in this area to see what is already being done. NIH Officers of Public Liaison are the PTI voice for taking the message to the many constituencies of the Institutes and Centers. They are the intermediaries. The PTI also will use every opportunity to publicize the NIH through societies and organizations that represent each institute’s mission. Ms. Chaite asked if other COPR members could participate in the PTI Steering Committee. Dr. Grady responded that Ms. Jennifer Gorman Vetter, COPR Executive Secretary, is the COPR representative to the PTI. As projects are identified, the PTI will form subgroups and working groups that will fit more closely into COPR’s work. Such developments will offer opportunities for participation. Dr. Maddox noted PTI is a far-reaching, long-term initiative that will need many ambassadors to the public. Dr. Zerhouni added that the PTI is a large initiative whose boundaries are at the outer edge of the NIH interface with the public, including campaigns to educate the public about research, public health goals, and achievements. A key question voiced by a Steering Committee member was: “Why should the public trust us?” NIH must be able to answer that question first. The PTI eventually will develop best practices for public trust. The Director reiterated that the PTI would receive input from public members of Institute and Center advisory councils. He asserted the NIH would consider how to better educate the public about the conduct of research. There is an important disconnect in the communication and education process. Dr. Raynard Kington, Deputy Director, NIH, agreed and suggested that the NIH might develop a Biomedical Research 101 course to help the public understand the research process. That could lead to communities of research. Mr. James Kearns offered to use his writing skills to help in the effort to get information to the public. Dr. Zerhouni suggested that a comment from Ms. Barbara Butler about partnering with public members of other advisory councils should be investigated on a council-to-council basis. The Trust Perception: Building a Reputation that Communities Really Know and TrustDavidShore, Ph.D., Associate Dean and Director of the Trust Initiative at HarvardUniversitySchool of Public Health Mr. Sadwin introduced Dr. David Shore, Associate Dean and Director of the Trust Initiative at Harvard University School of Public Health. Dr. Shore opened his presentation with a comment made by Harvey Feinberg, M.D., President of the Institute of Medicine (IOM). When asked what is necessary to have better treatment options five years in the future, Dr. Feinberg answered, “Research.” The consensus of opinion among those in Dr. Feinberg’s audience, however, was that there is little trust in research. Dr. Shore commended the NIH, COPR, and the PTI for their work on trust. Trust is good business, good leadership, and good medicine. It is one thing to build capacity around trust, however, and another to have a perception of trustworthiness among the public. He suggested that researchers think of patients and the public as customers. Health seekers are essentially customers; they want to be cured and be well cared for in the process. Health care is consumer driven, Dr. Shore contended. If the patient is a consumer, the NIH should treat the patient as a partner. The challenge is that people think like consumers when they are well but like patients when they are sick. There is mistrust among minority groups but there are also significant trust issues with other groups based on socioeconomic status, geography, and health status. Dr. Shore contended that a better question is: Why do minorities participate at all in clinical research? He suggested not asking why patients don’t trust researchers, an approach that blames the victim. Focusing on distrust puts the onus for change on health seekers rather than on health providers. It is essential to build trustworthiness. Biomedical research is intangible to most of the public, and trust is intangible. Dr. Shore advised that if the NIH wants to be known in the community, it needs something that is proprietary in the public mindset. The public is now mistrustful of many things related to health, such as health insurance companies. They also hear news reports of increasing medical errors in hospitals. The movie, John Q, did not inspire trust in the system. Although there are regulatory safeguards, most of the public does not believe the safeguards will ensure safety. The public does not trust the regulators. Dr. Shore suggested that the phrase, “Trust me. I am from the NIH and I am here to help you,” has no meaning. People do not recognize the NIH as a trustworthy enterprise. Medicine has a strange language, strange customs, and a strange culture. Doctors hold all the power and patients feel at their mercy. People trust their own personal doctor but not doctors in general. It is too painful to say that they don’t trust their own personal physician. Dr. Shore emphasized that there is very little trust among the public. There is even less trust for things related to health and medicine, which extrapolates to a lack of trust in clinical research. Trust is a proxy for competence and confidence. He recommended that NIH learn how to think differently. Dr. Shore stated that trust is not an end in itself but is needed to achieve the ends of a profession or of an organization. The NIH needs public trust to successfully conduct clinical research and improve public health. Trust is built. Because much clinical research is conducted without high visibility, investigators must be of good conscience. Deep personal trust, according to Dr. Shore, is one part perceived competence and two parts conscience. The word science is contained in the word conscience. A reputation is an intangible that is connected to acting competently with good conscience. Integrity is another key component of trust, as is performance. Doing the right thing, Dr. Shore asserted, is as important as doing things right. People also want consistency and predictability. Dr. Shore used Coca Cola as an example. Among other comments, he said people can trust that the brown liquid in the container will taste the same every time. It is not the same in a health care system in which patients experience the system anew each time they encounter it. Dr. Shore quoted Warren Buffet on trust: “Trust is like the air we breathe. When it’s present, nobody really notices. But when it’s absent, everybody notices.” A good reputation is a proxy for belief in an organization and is critical to an organization’s success. Buffet went on, “If you lose dollars for the firm, I will be understanding, but if you lose reputation for the firm, I will be ruthless.” Reputation is almost more important than the product. In polls, General Electric ranks in categories for which they have no products. People think of the company as having a reputation for good products. Princeton University ranked among the top 10 business schools in the United States, even though it has no business school. Princeton is synonymous with quality. Success, Dr. Shore contends, is more an issue of who you are—that is, reputation—than what you know. Why would someone trust you if they don’t know you? Dr. Shore ended with a quote from Alice in Wonderland: “The keys are on the table. All you have to do is pick them up.” Discussion Mr. Sadwin thanked Dr. Shore for his presentation and opened the floor for discussion. Senator Jim Jensen asked where the Health Insurance Portability and Accountability Act of 1996 (HIPAA) fit into Dr. Shore’s accounting of trust. Dr. Shore said that HIPAA is a manifestation of a lack of trust that the Government (and those involved with an individual’s health care) will keep medical information private. Privacy guidelines were not needed in the past. HIPAA shows that people now think external oversights are needed for providers and organizations. HIPAA is more about confidentiality than about privacy. Mr. Kearns commented on Dr. Shore’s references to Coca Cola. He noted that the public did not like reformulated Coke; the new formulation failed. Americans find failure to be antithetical. “Are we now reality averse?” he asked. Dr. Shore responded that the issue of risk is an important one. Trust is necessary for people to take a risk. Trust is important in the clinical research enterprise because people won’t reveal important information if they don’t trust. They also won’t participate unless they trust. Dr. Shore also mentioned the related issue of trust in the “health care family.” Nurses and doctors generally don’t trust each other. This leads to a disruptive organization. An organization cannot convey a public persona of trust without having trust internally. What Does the Public Think? A Review of Current DataMs. Mary Woolley, President, Research! America Dr. Zerhouni introduced Ms. Mary Woolley and complimented her work as important. Ms. Woolley characterized herself as an advocate for research, for the NIH, and for maximum public participation in all aspects of research. Ms. Woolley wants researchers to engage with the public whose interest they serve. She wants researchers to convey that they work for the public. She anticipates helping to make the NIH Roadmap and the COPR goals a reality. Ms. Woolley provided information about her organization and its research in public perceptions. She presented the survey methodology and described the population sampled. She gave detailed research results on factors that impact the public’s perception of research, including trust of research and researchers. The findings were as follows: Research
Factors affecting research participation (in order of importance)
Factors impacting research participation
Other research-related factors important to Americans
Ms. Woolley summarized that people in America want positive research results more quickly and they do not want to see waste or fraud in research. These issues, she asserted, would be good starting points for the public trust efforts because medical research helps deal with them both. Controlling health care costs and making sure that all have access to care are also of concern to Americans. Americans want more information about medical research. Research needs to have a public face, Ms. Woolley emphasized. Ms. Woolley concluded that she and her organization “stand ready” to help increase public outreach. Mobilizing Communities of ResearchNeil S. Calman, M.D., Co-Founder and President, Institute for Urban Family Health For 25 years, Dr. Calman had a family practice in the Bronx and Manhattan, New York. He has a long history of public health service and has received three national awards for his work. Dr. Calman’s Institute is a nonprofit organization that provides community health services, health services research, and health professional education in New York. He directs the Bronx Health REACH project, which is funded by the CDC. The project is designed to eliminate disparities in health outcomes among minorities. According to Dr. Calman, it is important to look at how people view the health care system when thinking about public trust in medical research. People think of medical research as part of the health care system, which they distrust. People generally distrust the medical system for many reasons, among them ever-changing recommendations about treatment. People read that doctors are more likely to kill them than guns in the home. These issues, coupled with disparities in access and treatment, further exacerbate mistrust. The data show that among minorities, African Americans have the worst health care outcomes. Dr. Calman then detailed the Bronx REACH consortium and its activities. The project involves and employs the community in its research. Residents are trained to conduct research-related activities. The principal investigators have established relationships with health agencies, community organizations, and faith organizations. The project conducted focus groups to help understand the gaps in health outcomes and how best to involve the community in the research project. Findings were as follows:
Implications for Community-Based Research Key points learned from this research that affect public trust are as follows:
Dr. Calman said the work of building trust in the NIH and in clinical research nationally is linked to building a health care system that people trust, and to which there is nondiscriminatory access. Panel Discussion—Questions and Answers Dr. Hall reminded attendees of the meeting mission statement:
Dr. Hall suggested that the themes emerging from the morning presentations were:
Dr. Calman emphasized access to health care, but Dr. Hall reminded attendees of the need to keep the NIH mission in mind. Dr. Kington explained the Tuskegee experience and its impact on minority trust in research was well publicized but he was bothered that only one side of the issue is discussed. The flip side of the negative argument is accountability. Is the research community addressing the community’s problems? Ms. Woolley agreed with Dr. Kington. The advocacy community, she said, wants change. They want research and regulatory environments that address issues of concern to the community. The research community is eager to learn how it can use its skills to help with problems defined by the community. This is the difference between a missionary and a Peace Corps approach. The Peace Corps goes into the community and says, “How can we help you?” Dr. Calman seconded this approach, citing his research experience. His project partnered with well-established health care researchers. They went to the community and asked community members what types of health-related research they felt needed to be done. He advised attendees that the model to follow is to let the community-based research agenda be driven by community-based organizations. Dr. Grady addressed the issue of bringing trust back into the health care system. She said if the NIH could inspire trust in the research enterprise, it might translate into trust in the health care system. She added that Dr. Calman had given the audience clues about how to do that. Dr. Maddox added that the NICHD has examples of when it partnered with community members to design an agenda and identify problems. NICHD trained the trainers: those trained in methods to reduce infant mortality due to Sudden Infant Death Syndrome went into the community to teach community members to help themselves. Once involved, the community feels they have to help find solutions. Dr. Ruth Browne suggested that dialogue is needed on changing the research-funding paradigm. The dialogue needs to center on community readiness to participate in research, which requires capacity building. Capacity building involves a shift toward sharing resources with the community. Dr. Grady identified as a recurring issue the need to translate research to underserved populations; i.e., geographically or socially isolated populations, minorities, and rural residents, among others. Partnering with researchers like Dr. Calman could help the NIH develop strategies for reaching such groups. Potential partners include groups who implement research and health care agendas. The effort could capitalize on the positive public attitude toward nurses. Nursing research is at times translational. The NIH needs to find groups to move research ideas and results forward. Dr. Calman suggested the following potential partners:
He described these groups as bright and interested in local communities. They have credibility in the communities. He said they are not like the advocacy groups with whom the NIH generally interacts and are trusted and established in the communities. Ms. Woolley added that institutions do not presently encourage researchers to become involved in the community. That mindset needs to change. Leadership should recognize researchers for public outreach services to the community and show that they value outreach. Mr. Kearns asked why the NIH did not fund Dr. Calman’s work. Dr. Zerhouni responded that there are differences in the mission statements of different government agencies. The CDC is the appropriate funding agency for Dr. Calman’s work, but his work highlights an important disconnect between the evolution of the health care system and its impact on discovery science. This is a fundamental structural defect and the NIH may have to find interventions to change the fact that academic research centers receive most of the medical research funds. Those institutions train people, leading to the “ivory tower” mystique. Community research using community intermediaries is an undeveloped area. Dr. Zerhouni suggested that Dr. Calman’s identification is revealing about the evolution of the health care system vis-à-vis the pressures that academic health care systems experience and how that process affects the NIH’s ability to be recognized by public constituencies. Dr. Zerhouni said this issue may require further study. Dr. Zerhouni closed the session, referring to the NIH Roadmap that addresses transforming clinical research via better contacts with the community. He remarked that diseases have been reduced from the acute challenge they presented 40–50 years ago. Today, people deal with chronic conditions like heart disease rather than acute diseases. Life expectancy has increased. Therefore, the role of the academic health center is not as critical in the area of chronic disease as the role of the community health care center. Most cancer patients, for example, are treated in outpatient settings. This is a system issue. Dr. Zerhouni suggested this system issue could be tackled with interventions, such as having academic centers relate to communities in the way Dr. Calman describes. This is a large problem, he said, and it needs to be addressed. ACD AND COPR LIAISON UPDATEDr. Zerhouni introduced Thomas J. Ansfield, M.D., member of the Advisory Council to the Director (ACD) and liaison to COPR. Dr. Ansfield thanked Dr. Zerhouni for the opportunity to attend COPR meetings and for instituting open communication between the ACD and COPR. He said he trusts that cross-fertilization of ideas between the two groups will provide sound advice and direction to the Institutes and Centers and their leadership. Dr. Ansfield gave a brief history of the ACD. It began in 1965 when President Johnson appointed a committee under Dr. Dean Wooldridge to study NIH operations. The Wooldridge Committee recommended establishing an advisory group to help the NIH Office of the Director make “major plans and policies pertinent to the NIH mission in the conduct and support of biomedical research, medical science, and biomedical communications.” The committee may make recommendations on program development, resource allocation, administrative regulation, and policy. The Secretary of the Department of Health and Human Services appoints members of the general public and the academic and private sectors in overlapping terms of four years. At the January 2004 meeting, the ACD reviewed the Blue Ribbon Panel Report on the Future of Intramural Clinical Research. Recommendations included the following:
The ACD also recommended creating a single, high-level oversight committee and strengthening the roles of the Office of the Director and the Institute and Center leadership in clinical research. Ed Benz, M.D., and Joseph Goldstein, M.D., will co-chair the NIH Director’s Blue Ribbon Panel on the Future of Intramural Clinical Research to recommend how best to use the Mark O. Hatfield Clinical Research Center, due to open in 2004. Dr. Ansfield detailed other ACD work group activities. Linda Waite, Ph.D., is serving as chair of the Basic Behavioral and Social Sciences Research Working Group, which is examining areas of opportunity in basic behavioral and social science, consistent with the NIH mission. They are also examining barriers to the submission and peer review of grant applications in the basic behavioral and social sciences. The working group will complete its work by fall 2004. Ruth Kirschstein, M.D., Senior Advisor to the NIH Director, and David Burgess, Ph.D., of the ACD are co-chairing the working group on Postdocs: Training and Career Opportunities in the 21st Century. Dr. Ansfield explained the ACD will hear and consider recommendations of the Blue Ribbon Panel on Conflict of Interest Policies at its meeting on May 6, 2004. Panel co-chairs Dr. Alberts, and Mr. Augustine will present an overview of the panel’s work. They also will facilitate discussion of the panel’s findings with ACD members. Dr. Ansfield closed his presentation with comments concerning its ties to COPR. ACD embraces principles that Mr. Sadwin presented at the last ACD meeting—that “public input into the NIH process of research choices is critical and that it is essential to consider the interests of the public in the decision-making process. To ensure this happens, the public must be able to understand and access the NIH decision-making process. The process must be transparent to the public.” Dr. Ansfield said that, together, the COPR and the ACD provide a critical ear and serve as complementary sounding boards for scientific and public review in support of the Director and the Institutes and Centers and staff. He said he looked forward to providing counsel to ensure the development of science and research that enhance health issues most relevant to all Americans. Mr. Sadwin next thanked COPR members who commented on the recommendations of the Blue Ribbon Panel on Conflict of Interest. Their views were expressed to the Panel. Dr. Zerhouni noted the ACD, like COPR, is working hard, as evidenced by the number of working groups and reports. They are addressing important issues. The issue of postdoctoral training and the development of young scientists will receive more attention in the future. The ACD will keep COPR updated. Enhancing Public Input and Transparency in the Research Priority Setting Process at the NIH (COPR report)Leonard J. Tamura, Ph.D., and Zelda D. Tetenbaum, M.Sc., Immediate past Co-Chairs, Public Input and Participation Work Group, COPR, COPR Alumni Members Mr. Sadwin introduced Dr. Leonard J. Tamura and Ms. Zelda D. Tetenbaum, immediate past co-chairs of the COPR Public Input and Participation Work Group (PIPWG). They are COPR alumni members who then presented the COPR report on “Enhancing Public Input and Transparency in the Research Priority Setting Process at the NIH.” Dr. Tamura explained the PIPWG spent many hours on the report. He quoted Dr. Zerhouni—”Engaging the public is a major priority, it is a national priority, it is not an option”—and said that the COPR agrees with Dr. Zerhouni on the importance of this issue. Dr. Tamura acknowledged many who helped develop the report, including the Public Liaison Officers of many Institutes and Centers, Palladian Partners staff, and PIPWG members. Dr. Tamura reminded attendees that the 1998 IOM Scientific Opportunities and Public Needs Report noted research priority setting and public input as areas that needed attention at the NIH. COPR itself evolved from a recommendation in that report. The PIPWG focused in its report on public input and transparency in the research priority-setting process at the NIH. Core assumptions behind the report are:
The public is everyone outside the NIH, including patients, family members, advocates, and health care providers, among others. The NIH, PIPWG commented, should realize that it has many publics and tailor activities as appropriate for each one. The report reflects a sampling of many best practices that are ongoing among the NIH Institutes and Centers. Its 11 recommendations were categorized in terms of public input, transparency, and funding, as follows:
Ms. Tetenbaum, PIPWG co-chair, presented recommendations 8 through 11. She said that public trust is at the core of the research enterprise. Making adjustments to enhance transparency and public input will require funding and NIH must find the resources to show that it is committed to involving the public in its priority-setting process. Ms. Tetenbaum closed by thanking Dr. Ruth Kirschtein and Dr. Zerhouni for their support in developing the report. She also gratefully acknowledged the work of Ms. Jennifer Gorman Vetter, Ms. Shelly Pollard, Institute and Center Public Liaison Officers and Communication Directors, and COPR members. Discussion Dr. Frances Dunston asked for information regarding the extent to which the Institutes and Centers are practicing the positive outreach efforts cited in the report. Actual figures are not yet known. The intent of the report is to encourage those who are not engaged in such activities to become more active in public outreach. Dr. Dunston remarked that establishing some baseline knowledge about existing Institute and Center activities would later allow COPR to measure the impact of its recommendations on the NIH. Dr. Ellen Sigal applauded the recommendation that the NIH leadership and researchers spend time beyond the NIH campus. She cited the many opportunities to attend town hall meetings and partner with community organizations. She mentioned the Director’s e-mailed Weekly Update, which can be found on the NIH Web site. The communication is well done and reaches a broad audience of lay people and academics. She wondered if the NIH had measured the effectiveness of this communication. Dr. Tamura asserted that Dr. Sigal’s comment highlights a difficulty in measuring NIH outreach activities—so much is being done. He advocates a bidirectional form of communication to solicit input from the targeted audiences. Dr. Sigal noted the National Cancer Institute (NCI) includes a component at large national cancer meetings called NCI Listens. This is an opportunity for the community to give feedback. Dr. Ted Mala expressed hope that this COPR report would be woven into NIH Roadmap activities and act as a benchmark for the effectiveness of Institute and Center outreach programs. He said he hoped the NIH would move these recommendations forward and recognize positive public outreach efforts. Elliot R. Siegel, Ph.D., of the National Library of Medicine (NLM) commented that the NLM has been doing outreach since 1989 and has found it important for NLM staff and leadership to go on the road. Getting out among the public has helped the NLM learn which programs matter to the public. This is important in tailoring effective programs. Dr. Zerhouni called for a vote on formally accepting the COPR report. Dr. Sigal moved to approve the report and Dr. Dunston seconded the motion. The report received unanimous approval. Next Steps and Action Items for COPR Efforts on Public TrustDr. Zerhouni applauded the PIPWG’s trans-NIH research to find best practices across Institutes and Centers. He suggested cross-fertilization improves the process. He then asked COPR for the next step in implementing the recommendations. Ms. Butler answered that COPR will work on distribution methods for the report to different publics, then measure what has been done a year from now. This measurement will help ascertain the report’s effectiveness. COPR also will develop a presentation to be given to advocacy groups. The goal is broad dissemination of the report. Dr. Zerhouni suggested presenting the report to the Institute and Center Directors at their monthly meeting on May 27. COPR could describe current positive activities at NIH and recommend improvements. He especially liked the recommendation to include public representatives on Institute and Center advisory councils. It is important for COPR to engage the Directors in this work. Dr. Zerhouni also recommended sending the report to each Institute and Center communications staff. The NIH has many publics, which vary by Institute and Center. Even strategic planning does not cut across Institutes and Centers. The Roadmap is one exception. It is therefore important to define and reach the various publics. According to Dr. Zerhouni, the report evaluation should be done in the context of a feedback loop. To judge whether or not an action is effective, the action should be seen in the context of reaction and input. Some Institutes and Centers are very active in their outreach programs but they are not necessarily receiving public input. The requirements vary. The NCI is most involved with the public, probably due to its Cancer Control and Prevention Program, which requires much public input. The Director concluded that COPR should talk to the Institute and Center Directors and then develop operational strategies that may require meeting with a group of advisory council public members to share ideas. In addition, Dr. Zerhouni remarked that the COPR has provided leadership in contributing to the National Research Council/Institute of Medicine of the National Academies report to study the NIH organizational structure and determine whether the current organization and structure of NIH are optimally configured for the scientific needs of the twenty-first century. Dr. Zerhouni thanked Dr. Tamura and Ms. Tetenbaum. He reiterated that he was pleased with the report, which is a proactive, thoughtful analysis with a strategy for change. He added that he is impressed with how much COPR has accomplished since he first attended a COPR meeting two years ago. According to the Director, the COPR work is in line with his best expectations for the Council. Dr. Zerhouni asked if there were a sense of where to go next. Should COPR look at a broad spectrum of issues related to health care restructuring—the issue raised in Dr. Calman’s presentation—or should it look at a smaller set of issues? Dr. Mala answered that he heard a call for more community involvement in the research process. There is a need to engage the public in the idea that research will improve their health. Ms. Wendy Chaite thought that perhaps the vision could be expanded within the Department of Health and Human Services. There is a need to create a mechanism for dialogue because all the agencies are interconnected in their public health work. Dr. Dunston added that NIH grantees are mediators of public trust for the NIH. Their public interactions determine whether or not there is public trust. The NIH could facilitate their ability to engender public trust. Ms. Kimberly Hinton agreed, saying the public could make the connection between the investigator and the NIH. The NIH has an image problem, however. People do not think of the NIH when they are treated at Johns Hopkins University, for example. The NIH should be the “Good Housekeeping” seal of quality in research. Those who receive money from the NIH should have information on their letterhead crediting the NIH for the funding. Ms. Hinton suggested sending them NIH logos to put on their correspondence. Dr. Hall agreed that this suggestion is a good idea and would promote transparency. Dr. Zerhouni proposed that the planned COPR workshop (October 2004) should include grantees for an interactive discussion. The NIH has 2,800 grantees. Mr. John Burklow suggested adding to the COPR workshop agenda ways to improve NIH visibility with NIH grantees and their communities; perhaps this could be accomplished in the longer-range plan. Dr. Zerhouni agreed. The recommendation could be translated into an analysis of how to better link the NIH grantees and their communities. The Roadmap mentions facilitation of translational research, such as in diseases that have gone from acute to chronic. There is a strong scientific rationale for reinventing the system. The pending October COPR discussion is synergistic but requires some thought. The topic is provocative but good to attempt as part of both the workshop and the NIH Public Trust Initiative (PTI). This means the PTI should look externally, not just internally, and involve intramural and extramural components to see where the NIH may be putting up obstacles. Dr. Dunston expressed that, in working with grantees, there is a need to improve the quality of their engagement with the public. The workshop could facilitate that capacity in the grantees. It should also include community members to facilitate dialogue in a manner similar to Dr. Calman’s model. The workshop’s intent, she explained, would be to have grantees and community members develop a set of strategies together that would allow the dissemination of best approaches to engender public trust throughout the clinical research enterprise. An outcome could be the development of a set of strategies. Dr. Zerhouni suggested starting on a small scale with pilots and components. COPR could take what is successful in the pilots and replicate those components, using several approaches rather than top-down research that dictates a single path. Scientific meetings could subsequently be organized to use the successes to move the effort forward. The task is possible but cannot be accomplished overnight. Dr. Sigal commented that the NIH has a rich network in its local area to begin the effort. Dr. Zerhouni ended this discussion by noting that the NIH already promotes partnerships with academic centers and others nearby. NIH Plain Language InitiativeMs. Ann Brewer from the Office of the Director presented awards to several COPR members for their work on the NIH Plain Language Evaluation and Awards Subcommittee evaluating products and entries. The following members were honored with a token of appreciation: Dr. Hall, Dr. Dunston, Dr. Mala, Dr. Browne, Dr. Tamura, Ms. Butler, Ms. Tetenbaum, Dr. Rafael Gonzalez-Amezcua, and Mr. Donald Tykeson. Alumni members Drs. Ellen Grant and Rod Munoz were not present to receive their awards. Wrap-up and Final CommentsDr. Zerhouni asked if any COPR members wished to provide input independent of the day’s issues. Dr. Mala wondered about the implementation of COPR’s ideas as presented in the PIPWG Report. He was particularly interested in the discussion about favorably weighting criteria for evaluating grant applications if the grantees included in their research plans strategies for mentoring community members as part of the research process. Dr. Mala emphasized the importance of this strategy among racial/ethnic populations in which health disparities exist. Dr. Zerhouni explained measuring the effectiveness of implementing change is a constant issue. He asserted the Office of Science Policy could address Dr. Mala’s particular suggestion regarding applications. More broadly, COPR has been effective, such as in its comments to the IOM. The issue of measuring the effectiveness of implementation of COPR’s work can be broken into two components—how effective COPR is in getting its recommendations implemented, and evaluating the effectiveness of those recommendations. Mr. Sadwin noted that the COPR recommendations would first be presented to the ACD. Dr. Zerhouni suggested that the COPR could discuss with ACD members the response to the report and how to implement it. The ACD may have suggestions and recommendations for the COPR to consider prior to making the report final. COPR members were invited to attend the ACD meeting on May 6 and the congressional hearing on May 12. Dr. Zerhouni asked if there were other comments. Ms. Gorman Vetter noted the COPR Workshop on Trust and the next COPR meeting would be scheduled for the end of October 2004. The workshop and meeting date will be confirmed via email. The April 2005 meeting is scheduled for April 28–29. Dr. Zerhouni thanked Mr. Sadwin for co-chairing the meeting. The meeting was adjourned at 4:30 p.m.
This page was last reviewed on May 19, 2008. |
