Director's Council of Public Representatives
Spring 2005 Meeting MinutesApril 28, 2005NIH Participants:
COPR Members Attending:
COPR Members Not Present:
Speakers:
EXECUTIVE SUMMARYThe 13th meeting of the National Institutes of Health (NIH) Director’s Council of Public Representatives was held on April 28, 2005. NIH Director Elias A. Zerhouni, M.D., introduced the following new members of the Council: Ms. Nicole Johnson Baker, Ms. Christina Clark, Ms. Valda Boyd Ford, Ms. Cynthia Lindquist, Dr. Nicolas Linares-Orama, Mr. Michael Manganiello, and Dr. Marjorie Mau. Dr. Zerhouni described NIH highlights over the past six months, including the opening of the Mark O. Hatfield Clinical Research Center, the awarding of Nobel Prizes to four NIH grantees, the announcement of the new NIH conflict-of-interest regulations, and continuing work in the development of a new NIH Office of Portfolio Analysis and Strategic Initiatives (OPASI). He related his discussions of NIH issues in recent Congressional hearings and expressed satisfaction with progress in the new Director’s Pioneer Award Program for innovative research. Mr. John T. Burklow reviewed ongoing efforts by the NIH to disseminate research-based information to the public, emphasizing the expansion of media efforts. Dr. Bruce A. Fuchs described a program of the NIH’s Office of Science Education to develop school curricula and promote science careers through use of the Internet. Dr. Timothy C. Hays reported progress in the development of a Congressionally mandated archive of all peer-reviewed articles for NIH-sponsored research. The primary purpose of the archive is to increase the public’s access to NIH research results. The first manuscripts were to arrive beginning May 2, 2005. Dr. Thomas Ansfield reported on current activities of the Advisory Committee to the Director (ACD). Drs. Patricia Grady and Yvonne Thompson Maddox, Co-Chairs of the NIH Public Trust Initiative, reported on the program’s progress, including development of an inventory of NIH activities relating to public trust. Dr. Beverly Laird and Ms. Cary Zahrbock described the Consumer Advocates in Research and Related Activities (CARRA) program, of the National Cancer Institute (NCI). The program now includes about 200 consumer members (comprising cancer survivors, caregivers, family members of survivors, and professionals), who review NCI communication and educational materials, review Web sites, and help plan public workshops. Trained CARRA members are also recruited to serve as public members in the NCI grant review process for clinical trials. Dr. Sally Rockey addressed the complexities of the process in which clinical researchers interact with communities. She stressed the potential effectiveness of clinical research networks and efforts by the new NIH National Clinical Research Associates Initiative, which is currently in the planning and feasibility stages. NIH DIRECTOR’S UPDATEElias A. Zerhouni, M.D., Director, NIH The 13th meeting of the National Institutes of Health (NIH) Director’s Council of Public Representatives was held on April 28, 2005. NIH Director Elias A. Zerhouni, M.D., welcomed the COPR members and presenters. He thanked those who had participated in the previous day’s awards ceremony of the use of plain language and he thanked those COPR members who participated in the evaluation and selection process for the plain language awards. He introduced the following new members of the Council: Ms. Nicole Johnson Baker, Ms. Christina Clark, Ms. Valda Boyd Ford, Ms. Cynthia Lindquist, Dr. Nicolas Linares-Orama, Mr. Michael Manganiello, and Dr. Marjorie Mau. Dr. Thomas Ansfield attended the meeting as the liaison from the Advisory Committee to the Director (ACD). COPR member Ms. Wendy Chaite is now serving as the COPR’s liaison to the ACD, replacing former member Mr. Larry Sadwin in that role. Dr. Zerhouni welcomed National Cancer Institute (NCI) advocates Mr. Douglas Ulman, Ms. Vernal Branch, Ms. Cary Zahrbock, and Dr. Beverly Laird, stating that the NCI has been an active program in the area of improving public participation and outreach. Finally, Ms. Rosemary Barber was welcomed to the meeting. Ms. Barber attended the meeting as a representative of the United Kingdom Medical Research Council’s Advisory Group on Public Involvement. In his updates, Dr. Zerhouni announced that the Mark O. Hatfield Clinical Research Center opened in September 2004. At a time when state-sponsored clinical research facilities are experiencing fiscal pressures, this new state-of-the-art research center on the NIH campus can take the lead in supporting bold, large-impact clinical research. Dr. Zerhouni also announced four NIH grantees became Nobel Laureates in October 2004. They are Dr. Richard Axel, of Howard Hughes Medical Institute, Dr. Linda Buck, of the Fred Hutchinson Cancer Research Center, Dr. Irwin Rose, of the University of California, Irvine, and Dr. Avram Hershko, of the Technion-Israel Institute of Technology in Haifa, Israel. In addition, since the last COPR meeting, Dr. Zerhouni stated that the NIH has moved forward with its initiative on conflicts of interest, developing new ethics rules for NIH staff. These interim regulations, unveiled in February 2005, will serve the goal of making the NIH the most trusted source of scientific information in the United States. They will ensure that NIH information is accurate and allow healthy exchanges and interactions among all persons involved. The process will adapt over time. Recognizing that research is not a linear process and much overlap exists among agencies and institutes, Dr. Zerhouni described the new Office of Portfolio Analysis and Strategic Initiatives (OPASI) that NIH is creating to assess and plan its work. The OPASI will address issues such as coordinating trans-NIH initiatives, setting cross-cutting priorities, reducing redundancy, and analyzing the NIH research portfolio. Dr. Zerhouni expressed his intention for OPASI to support a transparent process and to foster better decision-support tools. Dr. Zerhouni discussed the NIH Roadmap for Medical Research, the NIH Strategic Plan for Obesity Research, the NIH Neuroscience Blueprint, and OPASI at the Appropriations Overview Hearing, House Appropriations Subcommittee on Labor, HHS, and Education on March 9, 2005. He participated in a discussion of the NIH research portfolio and reauthorization at a hearing of the House Committee on Energy and Commerce, Subcommittee on Health, on March 17, 2005. Dr. Zerhouni and several NIH Directors attended a Senate Appropriations Subcommittee Hearing on the FY 2006 Budget on April 6, 2005. Dr. Zerhouni announced that Dr. David A. Schwartz will be the new Director of the National Institute of Environmental Health Sciences (NIEHS), replacing Dr. Kenneth Olden. Dr. Elizabeth G. Nabel will become the new Director of the National Heart, Lung, and Blood Institute (NHLBI), and Dr. Antonio Scarpa will become the new Director of the Center for Scientific Review. Dr. Judith L. Vaitukaitis stepped down as Director of the National Center for Research Resources (NCRR) and now serves as Senior Advisor on Scientific Infrastructures and Resources in the Office of the Director. Dr. Barbara Alving is currently Acting Director of the NCRR. Dr. Zerhouni described the NIH, with its incorporation of new directors in leadership roles, many from outside the NIH, as a vibrant agency. He celebrated the proactive strategic coordination that is occurring. The NIH’s new Director’s Pioneer Award Program, which supports scientists who exhibit exceptional creativity and innovative approaches, has completed its first year and will present approximately 5 to 10 new awards in September 2005. MOVING SCIENTIFIC DISCOVERY TO THE PUBLIC: HOW SCIENCE INFORMATION GETS FROM THE LAB TO THE PUBLICMr. John T. Burklow, Associate Director for Communications and Public Liaison, NIH Reminding the meeting participants that science is the basis of health education, Mr. John Burklow provided examples of ways in which the NIH disseminates scientific information to the public, including underserved populations. For years, the NIH has worked to increase its accessibility to reporters and to be known as the place from which reporters can obtain research-based information from scientists. The NIH has a large-scale communications plan and publishes and disseminates a wide spectrum of science-based health education documents, many in Spanish and other languages. Mr. Burklow gave examples of recent large campaigns to translate scientific findings into public action in areas such as eye health, heart disease, and diabetes. Partnerships play an increasing role in these efforts. The COPR members suggested that clearly highlighting the NIH’s role in these efforts could help to advance the understanding and progress of the NIH is this area. It was also suggested that the NIH might expand on strategic initiatives to emphasize its contribution to some scientific results. All agreed that working on the grassroots level is most effective. HOW THE NIH TAKES BASIC SCIENCE AND TURNS IT INTO TOOLS THE PUBLIC CAN USE: A CASE STUDYBruce A. Fuchs, Ph.D., Director, Office of Science Education, Office of the Director, NIH Dr. Bruce Fuchs described how the NIH develops educational products based on scientific research. Decisions by young people to focus on fields of science are often made in middle-school years. On a percentage basis, U.S. schools are lagging behind those of many other countries in fostering scientific careers. The NIH Office of Science Education (OSE) features a Web site [www.science.education.nih.gov] that offers educational resources. Traffic for the site has been growing rapidly. The site features a popular component called “LifeWorks” for the benefit of young students, which describes scientific careers and profiles scientists. In the NIH Curriculum Supplements Program, individual institutes produce curricula that focus on specific areas of scientific expertise. For example, the National Human Genome Research Institute (NHGRI) created a curriculum on the human genome project. The NIH employs strategies to make such tools applicable to hard-to-reach audiences, and it markets them to teachers rather than schools. The OSE has been increasing the sophistication of the presentations of these products that are distributed to teachers. Dr. Fuchs noted that the topic of science would be added to the No Child Left Behind Program in a few years, but would be considered an optional subject. In response to a question regarding partnering with commercial agents such as the Disney Channel, Dr. Fuchs responded that it is often very difficult because of such issues as rights to the materials developed. Parents are also eligible to receive NIH educational materials if they homeschool their children. UPDATE ON PUBLIC ACCESSTimothy C. Hays, Ph.D., Public Access Policy Project Manager, Office of Policy for Extramural Research Administration, Office of Extramural Research, Office of the Director, NIH Dr. Timothy Hays reviewed the progress of the new policy for public access to archives of publications funded by the NIH, which is to go into effect on May 2, 2005. NIH-funded researchers are asked to submit a copy of their final manuscripts upon acceptance for publication to the National Library of Medicine’s PubMed Central (PMC) at http://nihms.nih.gov. The authors specify when the articles should be made available publicly on PMC after the final date of journal publication. After receiving thousands of public comments, the NIH set a policy for the timing of submission ranging from immediately upon journal publication to 12 months afterwards. The longer 12 month delay was implemented to accommodate the needs of smaller specialized journals of learned societies. The policy applies to all publications of research from currently funded NIH research (grants, cooperative agreements, contracts, and other mechanisms) or from previously funded research if the paper is accepted after May 2, 2005. The articles submitted for the archive are final versions, as accepted for publication, and containing all changes resulting from the journal’s peer review process. NIH will also accommodate corrections from authors that occur during copyediting or post publication. The policy does not apply to book chapters, editorials, reviews, conference proceedings, and publications resulting from non-NIH-funded research. NIH hopes to add about 60,000 articles to the archive each year. This new program addresses current general trends such as the new developments in information technology tools, the public’s increasing use of the Internet to obtain medical information, and the interest of the U.S. Congress. The system should ensure the preservation of NIH-funded publications, allow scientists, NIH, and the public to mine publications for information, and help the NIH monitor scientific productivity and establish priorities. The NIH Policy should not affect copyright since it explicitly recognizes and upholds the principles of copyright. Authors and journals can continue to assert copyright in NIH-funded scientific publications, in accordance with current practice. Dr. Hays also discussed the benefits to principal investigators (PIs) for participating in the Policy. First, PIs and institutions can use the manuscript submission as an alternative means to fulfill the existing requirement to provide publications as part of progress reports. Second, by adding their manuscripts to PMC, which is a comprehensive, integrated, biomedical information technology system, authors will benefit from the modern information technology tools already available in PMC (e.g., PubMed, GenBank, Molecular Database, MedlinePlus, Clinical Trials, Small Molecules (PubChem), etc.). Lastly, authors will have the ability to ensure timely public access to their research manuscripts. Once their manuscripts are electronically available through PMC, authors will benefit from higher visibility of their research and the potential for increased citations. ADVISORY COMMITTEE TO THE DIRECTOR (ACD) LIAISON REPORTThomas J. Ansfield, M.D., Member, ACD, and Liaison to the Council of Public Representatives On behalf of the ACD, Dr. Thomas Ansfield expressed his appreciation for the window into the work of the Council of Public Representatives. He welcomed Ms. Wendy Chaite as the new liaison from the COPR. The ACD recognizes the importance of both ensuring that the public is part of the decision-making process and of making the work of the NIH transparent. At its December 2004 meeting, ACD members received reports on the NIH Roadmap for Medical Research, COPR activities, behavioral and social science research, the process for approving outside awards for NIH employees, issues pertaining to postdoctoral fellows, conflict of interest, the NIH Director’s Pioneer Award Program, and the National Institute on Alcohol Abuse and Alcoholism (NIAAA). Dr. Ansfield stressed that the ACD and COPR can act as complementary sounding boards for issues of importance to NIH. UPDATE ON THE NIH PUBLIC TRUST INITIATIVEPatricia A. Grady, Ph.D., R.N., F.A.A.N., Co-Chair, NIH Public Trust Initiative, and Director, National Institute of Nursing Research Yvonne Thompson Maddox, Ph.D., Co-Chair, NIH Public Trust Initiative, and Deputy Director, National Institute of Child Health and Human Development Drs. Patricia Grady and Yvonne Thompson Maddox, co-chairs of the NIH Public Trust Initiative, reviewed the program’s ongoing philosophy, goals, and plans. The initiative encourages activities within the Institutes and Centers (ICs) and across the NIH in the following areas: involving and protecting human participants in clinical research, including the public in IC business, promoting the visibility of NIH information for the public, teaching and developing curriculum materials for various levels of science education, and educational and outreach programs for clinical and basic research communities funded by NIH. Participants in the initiative have been creating an inventory of NIH activities relating to the issue of trust and have been in contact with all ICs. This will eventually result in a formal document for public reference. One activity of note was a unique outreach effort by NIH Public Liaison Officers (OPLs), who traveled to Anchorage, Alaska, to participate in a health fair and learned about special health and research issues in geographically isolated villages. This produced a better understanding of Alaskan health care delivery—including traditional methods—and the building of bridges to support clinical research activities. A MODEL FOR PUBLIC INPUT AND PARTICIPATION INTO RESEARCH AND RELATED ACTIVITIES: THE NCI CARRA PROGRAMBeverly Laird, Ph.D., Member, NCI Director’s Consumer Liaison Group (DCLG), and Member, NCI Consumer Advocates in Research and Related Activities (CARRA) The National Cancer Institute (NCI) created the Consumer Advocates in Research and Related Activities (CARRA) program in 2001, to draw upon the experience of people affected by cancer to represent the views of cancer survivors and family members in NCI’s daily work. Approximately 200 highly qualified, pre-screened individuals from many different cancer types, age groups, and ethnic groups across the nation comprise the CARRA membership. NCI staff request their service as members of peer review groups for clinical and translational proposals, work group participants for initiatives such as caBIG (cancer Biomedical Informatics Grid), reviewers for NCI communication and educational materials in development, and roles in many other activities in research and the communication of research. Dr. Laird described the program’s rationale and operation, including the role of the NCI Director’s Consumer Liaison Group (DCLG) in the initiation of CARRA. She also illustrated connections between CARRA’s goals and the goals of COPR recommendations, as well as relevance to the Public Trust Initiative and the NIH Roadmap. The CARRA Web site is located at http://la.cancer.gov/carra. Dr. Zerhouni described the CARRA program as very important, one which could perhaps serve as a consumer-involvement model for the NIH as a whole. PUBLIC PARTICIPATION IN THE PEER REVIEW PROCESS: THE NCI CARRA PROGRAMMs. Cary Zahrbock, Member, NCI Consumer Advocates in Research and Related Activities (CARRA) Ms. Cary Zahrbock highlighted the training and involvement of CARRA members in the peer review process for clinical and translational research at NCI. The patient advocate role focuses on reviewing patient recruitment, procedures (protocols), and human subjects protection. In collaboration with the NCI Division of Extramural Activities (DEA), the CARRA program has developed a Peer Review Training Workshop, conducted jointly by NCI staff, CARRA members, outside scientists, and a facilitator. CARRA members then participate in peer review meetings as full voting members—including extensive preparation prior to the meeting, submitting a critique online, and participating in the discussion and scoring. The CARRA members are equally accountable for all policies, including confidentiality and conflict of interest policies. Ms. Zahrbock listed several benefits of involving CARRA members in peer review, including the increased likelihood that research studies eventually funded by NCI would be able to recruit and retain study participants, reach diverse populations, incorporate sound human subjects protections, and be adaptable to healthcare provider practices. She also emphasized how CARRA members carry back to their communities an increased understanding of and confidence in the research prioritization process, and positive perceptions of and support for clinical research. HOW DOES THE NIH WORK WITH THE SCIENTIFIC COMMUNITY TO BUILD TRUST WITH PATIENTS?Sally Rockey, Ph.D., Deputy Director, Office of Extramural Research, Office of the Director, NIH Dr. Sally Rockey reviewed the issue of trust in light of the recent COPR report and recommendations on public trust in clinical research. The report stressed building relationships, partnerships, patient communities, and networks. Yet, she noted, we must address complexities. Clinical researchers need different and expanded expertise to assume a role that interacts with communities. Training and the new NIH National Clinical Research Associates initiative, a component of the NIH Roadmap, could address this need. The NIH ICs have robust relationships with advocacy groups. We need processes of harmonization that streamline and optimize by knowing what does and does not work in communities, and that can foster actions that strengthen the process. One strategy is the use of clinical research networks, which employ informatics and other technologies to broaden the scope of research and reduce duplications. A problematic issue is the desire of researchers to pursue and define their own careers, at the same time that the research program requires substantial collaboration. Dr. Raynard Kington noted that his office has contracted with the RAND Corporation to study the feasibility of the NIH National Clinical Research Associates Program. A representative from that effort could be asked to report on progress at the next COPR meeting. PUBLIC COMMENTSThree public visitors offered comments to the COPR. Mr. Rogelio Lopez, a Senior Public Health Programs Administrator from Southern California, praised the goals presented in the COPR report on trust and cautioned that many consumers are not familiar with issues such as confidentiality and privacy. Dr. Trevor Marshall, of the Autoimmunity Research Foundation, described that group’s efforts to increase the visibility of a therapy for the idiopathic disease sarcoidosis, relating the effort in terms of public trust. Ms. Rosemary Barber, of the United Kingdom Medical Research Council Advisory Group on Public Involvement, expressed her desire to engage COPR members to discuss issues of public trust. FINAL THOUGHTS AND FUTURE MEETING DATESThe meeting resulted in the recognition of a need to improve the interactions of researchers and communities and to seek greater rigor in the tools used to integrate information. One key is to institutionalize new processes. Based on the COPR recommendations, an accountability process has begun. The COPR should identify a method for increasing NIH recognition in a substantial way. The fall meeting of the COPR is scheduled for October 24–25, 2005. The next spring meeting is scheduled for April 19–21, 2006, with a new-member orientation on April 19, 2006. In 2006, the fall meeting is scheduled for October 23–24. ADJOURNMENTDr. Kington thanked the participants and adjourned the meeting at 4:45 p.m. LIST OF ABBREVIATIONS AND ACRONYMS
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