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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
National Institutes of Health
John E. Fogarty International Center
for Advanced Study in the Health Sciences
Minutes of the Advisory Board
Fifty-first Meeting
Table of Contents
Attendance
- Call to Order
- Consideration of Minutes of Previous Meeting
- Review of Requirements for Confidentiality and Conflict
of Interest Procedures
- Future Meeting Dates
- Report of the Director
- Challenges and Opportunities in the Global AIDS Response
- Update on FIC International AIDS Programs
- Discussion
- Closed Portion of the Meeting
- Review of Application
- Adjournment
The John E. Fogarty International Center for Advanced Study in the Health Sciences (FIC) convened the fifty-first meeting of its Advisory Board on Tuesday, May 21, 2002, at 8:35 a.m., in the Conference Room of the Lawton Chiles International House, National Institutes of Health (NIH), Bethesda, Maryland. The meeting was open to the public from 8:35 a.m. to 12:00 p.m., followed by the closed session, from 1:00 p.m. to adjournment at 2:45 p.m., as provided in Sections 552b(c) (4) and 552b(c) (6), Title 5, U.S. Code, and Section 10 (d) of Public Law 92-463, for the review, discussion, and evaluation of grant applications and related information.[1] Dr. Gerald T. Keusch, Director, FIC, presided as chair.
Board Members Present:
Dr. Cutberto Garza
Dr. Cora B. Marrett
Dr. Patricia A. Marshall
Dr. Jane Menken (ad hoc)
Dr. Theodore Reich
Dr. Catherine M. Wilfert
Board Members Absent:
Dr. Mary Claire King
Dr. Robert E. Shope
Members of the Public Present:
Dr. Rupert Ambrose, MasiMax, Inc., Rockville, MD
Dr. Catherine Hankins, Associate Director, Social Mobilization and Information Department, UNAIDS, Geneva, Switzerland
Dr. Rose Maria Li, ASI, Inc., Bethesda, MD
Mr. Bertil Lindblad, Deputy Director, UNAIDS, New York, New York
Mr. Dikembe Mutombo, President, Dikembe Mutombo Foundation, Atlanta, GA
Dr. Peter Piot, Executive Director, UNAIDS, and Assistant Secretary-General, United Nations, Geneva, Switzerland
Dr. Jaime Sepulveda, Director General, Instituto Nacional de Salud Pública, Cuernavaca, Mexico
Dr. Paul Wilson, Department of Cell Biology, Cornell University Medical College, Ithaca, New York
Federal Employees Present:
Mr. Ray Atri, FIC/NIH
Dr. Richard Krause, FIC/NIH
Ms. Danielle Bielenstein, FIC/NIH
Ms. Judith Levin, FIC/NIH
Dr. Joel Breman, FIC/NIH
Dr. Jeanne McDermott, FIC/NIH
Dr. Kenneth Bridbord, FIC/NIH
Mr. Michael McDowell, FIC/NIH
Mr. Bruce Butrum, FIC/NIH
Dr. Kathleen Michels, FIC/NIH
Ms. Jennifer Cabe, FIC/NIH
Mr. Richard Miller, FIC/NIH
Ms. Bonnie Costley, FIC/NIH
Ms. Fil Naldo-Fontelo, FIC/NIH
Dr. Lois K. Cohen, NIDCR/NIH
Dr. Rachel Nugent, FIC/NIH
Dr. Tony Demsey, OER/OD/NIH
Ms. Sherri Park, NICHD/NIH
Ms. Hilda Dixon, EEO/OD/NIH
Mr. Mark Pineda, FIC/NIH
Ms. Irene Edwards, FIC/NIH
Ms. Amanda Porter, FIC/NIH
Ms. Mollie Fletcher, FIC/NIH
Dr. Aron Primack, FIC/NIH
Dr. Pierce Gardner, FIC/NIH
Ms. Charlotte Quinn, FIC/NIH
Dr. Kevin Hardwick, NIDCR/NIH
Dr. Joshua Rosenthal, FIC/NIH
Ms. Mildred Hatton, FIC/NIH
Ms. Melanie Rouse, FIC/NIH
Dr. Ruth J. Hegyeli, NHLBI/NIH
Dr. Luis A. Salicrup, FIC/NIH
Dr. Karen Hofman, FIC/NIH
Ms. Janice Solomon, FIC/NIH
Ms. Cherice Holloway, FIC/NIH
Ms. Rachel Sturke, FIC/NIH
Dr. Allen Holt, FIC/NIH
Ms. Natalie Tomitch, FIC/NIH
Dr. Sharon Hrynkow, FIC/NIH
Dr. Ed Tramont, NIAID/NIH
Dr. Dean Jamison, FIC/NIH
Dr. Wendy Wertheimer, OAR/NIH
Mr. Andrew Jones, FIC/NIH
Dr. Jack Whitescarver, OAR/NIH
Dr. Flora Katz, FIC/NIH
Mr. Randolph Williams, FIC/NIH
Dr. Gerald T. Keusch, FIC/NIH
OPEN PORTION OF THE MEETING
I. CALL TO ORDER
Dr. Gerald T. Keusch called the meeting to order and welcomed everyone. He noted that the Board presently consists of seven members and that the nominations forwarded to the Secretary, Department of Health and Human Services (DHHS), have not yet been approved. The FIC has requested an increase in the number of Board members from 12 to 13 to strengthen the Board's scientific expertise in human immunodeficiency virus (HIV) infection and AIDS. Two new ex officio members are Dr. Stephen Straus, Director, National Center for Complementary and Alternative Medicine, NIH, and Dr. Yvonne Maddox, Deputy Director, National Institute of Child Health and Human Development, and Acting Deputy Director, NIH.
Dr. Keusch welcomed several special guests. Dr. Jaime Sepulveda, Director General, Instituto Nacional de Salud Pública, Cuernavaca, Mexico, a previous member of the Board, was attending as a representative of FIC's International Advisory Group (IAG). Other members of the IAG are Dr. William Makgoba, President, South African Medical Research Council, who attended the Board's meeting in February 2002, and Dr. N. K. Ganguly, Director, Indian Council on Medical Research, who will attend the Board's meeting in September 2002.
In welcoming Mr. Dikembe Mutombo, President, Dikembe Mutombo Foundation, Dr. Keusch noted that Mr. Mutombo is promoting health and improved quality of life in his country, Democratic Republic of the Congo (formerly Zaire), and has received many awards for his humanitarian charitable activities, including the U.S. President's Service Award.
Dr. Keusch welcomed Dr. Peter Piot, Executive Director, UNAIDS, and his colleagues Dr. Catherine Hankins and Mr. Bertil Lindblad. He also welcomed Dr. Jack Whitescarver, Director, Office of AIDS Research (OAR), NIH, and his colleague Dr. Wendy Wertheimer, and Dr. Ed Tramont, Director, Division of AIDS, National Institute of Allergy and Infectious Diseases (NIAID).
Dr. Keusch acknowledged several additional staff members from other NIH institutes and centers (ICs): Dr. Lois K. Cohen, National Institute of Dental and Craniofacial Research (NIDCR); Ms. Hilda Dixon, Equal Employment Office, Office of the Director; Dr. Ruth J. Hegyeli, National Heart, Lung, and Blood Institute; and Dr. Rose Maria Li, formerly of the National Institute on Aging, and currently with ASI, Inc., Bethesda, MD.
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II. CONSIDERATION OF MINUTES OF PREVIOUS MEETING
The minutes of the Advisory Board meeting of February 5, 2002, were considered and accepted unanimously.
III. REVIEW OF REQUIREMENTS FOR CONFIDENTIALITY AND CONFLICT OF INTEREST PROCEDURES
The rules and regulations pertaining to conflict of interest were maintained.
IV. FUTURE MEETING DATES
The following meeting dates were confirmed:
Tuesday, September 10, 2002
Tuesday, February 11, 2003
Tuesday, May 20, 2003
Tuesday, September 16, 2003
In conjunction with the Board's May 20, 2003, meeting, the FIC will celebrate its 35th anniversary. As part of this celebration, the FIC will host a 1.5-day symposium on global health issues following the Board meeting. Dr. Keusch asked the Board members to plan to participate in this symposium on May 20-21. Also, as with all meetings, subcommittees of the Board will meet on the Monday preceding the Board meeting.
Dr. Keusch asked the Board members to inform Ms. Irene Edwards, Executive Secretary, of any scheduling conflicts they may have with the future dates.
V. REPORT OF THE DIRECTOR
Dr. Keusch reported on personnel changes, the budget, and new and ongoing programs. He invited staff to elaborate on programmatic activities. The Report of the Director, which was mailed to Board members, is appended to these minutes as Attachment 2, Written Report of the Director.
Personnel Changes
Dr. Elias Zerhouni is the new Director, NIH, effective May 15. Dr. Jeffrey P. Koplan, Director, Centers of Disease Control and Prevention (CDC), resigned effective March 31 and is now Vice President for Academic Health Affairs at Emory University. Dr. David Fleming, Deputy Director for Science and Public Health, CDC, is serving as the CDC Acting Director as part of an interim management team. Dr. Marvin Cassman, Director, National Institute of General Medical Sciences (NIGMS), left the NIH on May 3 to head a new Institute for Quantitative Biomedical Research at the University of California at San Francisco's Mission Bay campus. Dr. Roderic I. Pettigrew has been named the first director of NIH's new National Institute of Biomedical Imaging and Bioengineering (NIBIB) and is expected to begin in late August or early September.
At the FIC, Dr. Dean Jamison joined the Division of Advanced Studies and Policy Analysis (DASPA) to lead the team that is revisiting the important study, Disease Control Priorities in the Developing World. The study is being supported by the World Health Organization (WHO) and the World Bank, as before, and the Bill and Melinda Gates Foundation. As the secretariat for the study, FIC can help with the new effort to address resource allocations in science over the next 10-20 years. Dr. Jamison is taking an extended leave of absence from the University of California at Los Angeles to direct this study.
Additional new staff members at the FIC include Dr. Linda Kupfer, Evaluation Officer, DASPA; Ms. Lauren Sikes, Senior Administrative Officer, Office of Administrative Management; and Mr. Mark Pineda, Program Officer for South Asia and Western Europe, Division of International Relations.
FIC Budget
Mr. Richard Miller, Executive Officer, FIC, summarized the status of the Fiscal Year (FY) 2003 budget for the NIH and FIC. The President's Budget, which was presented to Congress in February, provides approximately $27.3 billion for the NIH, an increase of 15.7 percent over the FY 2002 budget. Areas of emphasis include research on cancer, biodefense, and minority health and construction of buildings and facilities at the NIH. Mr. Miller noted that the FY 2003 budget completes the commitment to double the NIH budget within 5 years.
For FIC, the President's Budget for FY 2003 proposes approximately $63.8 million, or an overall increase of 11.3 percent over FY 2002. Mr. Miller noted that the increase for AIDS-related efforts is 17.4 percent, which is substantially higher than that for the NIH overall (10.1 percent) and reflects the importance of FIC's training and capacity-building programs. Since FY 1998, the base year for the doubling of the NIH budget, the FIC budget has grown from approximately $30 million to approximately $64 million.
In FY 2003, FIC plans to highlight two initiatives: the International Clinical, Operational, and Health Services Research Training Award focused on HIV/AIDS and Tuberculosis (ICOHRTA-AIDS/TB) and the Global Health Research Initiative Program (GRIP) for New Foreign Investigators (re-entry grants). FIC also will emphasize three program areas: brain disorders; health, environment, and economic development; and stigma research.
Mr. Miller noted that the House Appropriations Subcommittee hearings for the NIH focused on four themes: collaborations in biomedical research, bench to bedside and beyond, fundamental research - biomedical science in the future, and disease prevention and health promotions. FIC participated with five other ICs in the hearing on collaborations in biomedical research. In his opening remarks at this hearing, Dr. Keusch emphasized FIC's role in the seeding of third-world science, the extent of FIC's scientific collaborations in the interest of global health, and three FIC program areas (AIDS, environment, and tobacco). Mr. Miller noted that the first item is well communicated in an article by Bob Calandra, entitled "The Seeding of Third World Science," which appeared in The Scientist (vol. 16, no. 7, page 50, April 1, 2002).
During the hearing, Congress asked FIC about the correlation between health and economic development, how the FIC tracks and reports global health threats, collaboration with WHO, FIC/NIH programs with Russia, capabilities and research endeavors in the developing world, and knowledge gained from research in other countries. Currently, the FIC has research and training efforts in 90 countries. Mr. Miller said that the hearings went well and that further congressional action on the budget will take place in June and July.
In discussion, Dr. Keusch highlighted the extent of FIC co-funding with other ICs, which has increased steadily since FY 1992. He noted that this level of co-funding reflects the spirit of close collaboration across the NIH. In response to a question from the Board about the need for increased funding to support FIC's significant role in global health, he commented that a consortium of professional organizations has called for a doubling of FIC's budget from FY 2002 to FY 2003. This external support for increased funding of the FIC, and of the NIAID and CDC, was communicated in the May 2002 newsletter of the Infectious Diseases Society of America, and the newsletter has been circulated broadly, including to the Director, NIH, and the Secretary, DHHS. Dr. Keusch indicated that, if FIC received additional monies, they would be targeted to the building of capacity for treatment and prevention of HIV/AIDS. He commented that the FIC, NIAID, and OAR are communicating a consistent message about the need to include capacity building in developing countries as an essential component of global HIV/AIDS activities.
Dr. Keusch suggested that the recent advocacy for FIC reflects increased recognition of the striking disparities in health across the globe, the need for increased investments in global health, and FIC's significant contributions to capacity building. He referred to another recent article, written by Brian Vastag and entitled "World Health Focus of Fogarty International Center," which appeared in the Journal of the American Medical Association (JAMA) (vol. 287, no. 16, April 24, 2002). This article suggests that FIC is the "glue in global health research, holding together an array of resources." Dr. Keusch emphasized that FIC's role as "the glue" reflects the vision of the Board, the rich resources of the NIH, and FIC's interaction with other ICs.
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New and Ongoing Programs
Dr. Keusch noted that since the previous Board meeting, the FIC has issued and received a strong response to several Requests for Applications (RFAs), for the Tobacco Use and Control Research Training Program, the GRIP, Phase I of the ICOHRTA-AIDS/TB, and the International Bioethics Education and Career Development Award. He said that the tobacco RFA attracted a large number of proposals and that, during the closed session of the meeting, the Board will be considering a funding plan to support awards. FIC expects a vigorous competition for GRIP awards based on the number of letters of intent received and favorable reviews of this program in the press. Dr. Keusch noted that the Phase I ICOHRTA-AIDS/TB also is receiving great interest and that FIC will soon be issuing an RFA for Phase II awards to support implementation activities. FIC also will soon issue awards for training and research in bioethics in developing countries.
Bioethics in Research. Dr. James Lavery, DASPA, reported on the Third Global Forum on Bioethics in Research, held in Cape Town, South Africa, February 21-23. The two previous forums were held in Bethesda, Maryland, in 2000, and in Bangkok, Thailand, in 2001. The fourth forum will be held in Brasilia, Brazil, in October 2002, and will focus on genetics research. The goal of the Global Forum is to provide a venue for representatives from developing countries to participate in discussions and debates about the ethics of international research that involves human subjects.
The Cape Town meeting was organized by the Medical Research Council, United Kingdom, and was attended by 110 delegates from 40 countries, including 20 African countries. The broad theme was research bioethics and public health. Three specific themes and issues were (a) whether current ethical guidelines constrain or promote access to drugs, devices, or vaccines subsequent to a trial; (b) challenges in developing ethical guidelines and review processes in developing countries; and (c) the standard of care to be provided during trials. Case studies presented during the meeting prompted discussion of the use and role of traditional medicine, genomics and global health, and the influence of culture on the ethics of research, particularly informed consent. Dr. Lavery noted that a number of current FIC fellows and former fellows served as rapporteurs and gave presentations. Suggestions for future forums included refinement of the case study approach used at the forums and increased opportunities for continued discussion and collaboration after the forums.
Immediately after the Cape Town meeting, many of the delegates attended the annual meeting of the Pan African Bioethics Initiative. Dr. Lavery noted that this initiative is making progress in facilitating the sharing of understanding of good ethical practices between African experts and international organizations involved in research in Africa and the development and implementation of research ethics activities.
In discussion, Dr. Lavery commented that participation and leadership of FIC fellows in the Global Forum are helping to enhance articulation of the perspectives of developing countries. He also suggested that a drive to achieve consensus on guidelines for research ethics may be unrealistic. He said that the case studies presented at the forum are available and that he is collaborating with colleagues at the Clinical Center's Department of Clinical Bioethics to develop a book of case studies in international research ethics.
The Board commented on the paucity of attention given to bioethical issues in research involving children. The Board encouraged FIC to foster discussion of these issues, address the issues in the casebook being developed, and include the bioethics of research in children in future training initiatives in bioethics. Dr. Keusch suggested that the sixth Global Forum, which will be held in North America, could perhaps focus on these issues. Dr. Lavery noted that, whereas the United States has legislated specific guidelines for research involving children, the international community has not done so, and international guidelines such as the Declaration of Helsinki do not include special provisions for bioethics of research involving children. The Board commented that the regulatory environment in the United States also does not always ensure protection of children. Dr. Keusch indicated that he would communicate the Board's concerns about this issue to the new Director of NIH.
Dr. Lavery reported next on a meeting of the Council of International Organizations of Medical Science (CIOMS), held in Geneva, Switzerland, February 27 - March 1. The purpose of the meeting was to review and endorse draft international ethical guidelines for biomedical research involving human subjects; consider and propose means for resolving difficult ethical issues; and consider mechanisms for ongoing review and revision of the guidelines. The draft, developed over the past 1.5 years, is a revision of the 1993 guidelines issued by CIOMS to elaborate on the general principles contained in the Declaration of Helsinki. FIC has taken a proactive role in this activity and provides financial support for the drafting process, particularly to help assure that the guidelines include the perspectives and interests of the developing world. Dr. Lavery commented that use of placebos in research is a key issue still to be resolved. He noted that at least five members of the CIOMS drafting committee are current or previous FIC grantees. The final guidelines are expected in 2003.
Dr. Keusch presented a brief update on FIC's interactions with the Wellcome Trust, to generate additional support for building capacity in bioethics in the developing world. He noted that the Wellcome Trust has determined that FIC's efforts in this area are already significant and has recently announced a program of support for research on bioethical issues in research in developing countries, to complement FIC's activities.
Stigma Research. On September 5-7, 2001, the FIC cosponsored with other ICs, the CDC, and other organizations an international conference on "Stigma and Global Health: Developing a Research Agenda." Dr. Keusch noted that FIC's interest in developing this initiative stemmed from UNAIDS documents that highlighted stigma as a critical barrier to organizing HIV/AIDS vaccine trials. The attendees included approximately 100 individuals from the developing world. The conference was oriented to development of a research initiative, and FIC, in collaboration with other ICs, will soon issue an RFA for research on stigma. Dr. Keusch mentioned that FIC expects to facilitate networking among investigators working on stigma and with investigators in bioethics.
Mathematical Modeling of Infectious Diseases. Dr. Mark Miller, Associate Director for Research, FIC, reported on an FIC consultation, held May 2-3, to examine nine models of the transmission dynamics of smallpox and to demonstrate the utility of these types of models when presented for discussion in a scientific format. Representatives from eight government departments attended the meeting, which followed a previous consultation, held December 13-14, on emerging infectious disease and bioterrorism. Dr. Miller noted that the participants vetted the models and assumptions from the perspective of various disciplines and that FIC was successful in demonstrating the utility of this approach. Based on discussions at the previous Board meeting, FIC has developed and submitted a proposal to NIAID for funding to expand these efforts. FIC continues to focus on mathematical modeling of influenza, malaria, and vector-borne diseases.
Brain Initiative. Dr. Keusch reported that FIC has organized a small working group of colleagues from other ICs to generate a research and capacity-building program in brain research targeted to surveillance, risk factors, and, ultimately, intervention. Dr. Torsten Wiesel, former president of Rockefeller University, chairs the group. In June, FIC will convene an international consultation, with representation from the developing world, to consider a research and training program on cognitive function in children and older adults. Dr. Keusch commented that development of cognitive function in children and premature dementia and senility in older adults are two issues entirely ignored in the developing world.
International Studies on Health, Environment, and Economic Development. Dr. Keusch noted that FIC is developing a companion program to FIC's successful International Studies on Health and Economic Development (ISHED) program. The new program goes beyond the connection between health and economic development to examine the role of the environment simultaneously on health and economic development. The program will provide information for decision-making about health and sustainable development policies and programs. The FIC is participating in trans-U.S. Government agency dialogue on this topic and is contributing to international discussions on sustainable development. A global summit will be held in Johannesburg, South Africa, on August 26 - September 5, 2002, to point the way to achieving more sustainable development.
Injury. Dr. Keusch noted that unintentional and intentional injuries constitute a huge burden of morbidity and disability in the developing world. The FIC has had productive discussions with others ICs [NIGMS, NIBIB, National Institute of Mental Health (NIMH)] concerning a possible research agenda in this arena. The goals for FY 2003 are to expand FIC's thinking and understanding of the topic, define key issues that FIC and other ICs could effectively address together, and convene an international gathering to obtain broad input.
Intellectual Property Rights (IPR). Dr. Keusch said that FIC continues to address issues of intellectual property and its impact on access to, and availability of, products of biomedical research in developing countries. FIC is collaborating with the Rockefeller Foundation to develop a new effort to promote more effective use of IPR law to capture the global goods of inventions developed by scientists in low- and middle-income countries. The foundation and other organizations are establishing a Center for the Management of Intellectual Property and Health Research (MIHR) for this purpose. The NIH is participating in discussions about the founding of the center and will be represented on a liaison committee. To foster expertise in managing IPR in developing countries, FIC is considering development of fellowships in appropriate technology transfer.
Social Science Research. By invitation, Dr. Keusch and Dr. Sharon Hrynkow, Deputy Director, FIC, participated in a meeting of the Social Science Research Council (SSRC) working group on Integrated Doctoral Programs in Health and the Social Sciences, held May 16 in New York City. Dr. Keusch noted that FIC can contribute an international dimension to the potential development of doctoral programs that link education in the social sciences with health research in general and biomedical research specifically. In discussion, the Board encouraged FIC to continue discussions with the SSRC to foster linkages across disciplines and to promote interdisciplinary research in the international arena.
For additional details on personnel changes, the FIC budget, and FIC activities, see the written Report of the Director (Attachment 2).
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VI. CHALLENGES AND OPPORTUNITIES IN THE GLOBAL AIDS RESPONSE
Dr. Peter Piot, Executive Director, UNAIDS, and Assistant Secretary-General of the United Nations (U.N.), Geneva, Switzerland, summarized the status of the global response, and particularly the U.N. response, to HIV/AIDS internationally. Dr. Piot noted that FIC and the U.N. share many similarities in their agendas for HIV/AIDS. He anticipated that the presentations and discussions at the Board meeting would lead to identification of one or two specific issues that FIC and UNAIDS could pursue collaboratively.
Dr. Piot noted that 2001 was a turning point in the 20-year history of the AIDS epidemic and that the context of HIV/AIDS activities has changed dramatically in the past three years. He suggested three reasons for this different environment: political engagement and commitment, empirical evidence, and resources. At the United Nations General Assembly Special Session on AIDS, held in June 2001, governments, for the first time, unanimously endorsed a plan of action with concrete goals, and they are now integrating AIDS into the agenda of mainstream politics and giving priority to AIDS. These actions coincide with evidence that strategies of prevention on a large scale can be effective in reducing the number of new HIV infections in resource-poor settings. Dr. Piot noted that the international resources available to support prevention and treatment of HIV/AIDS have finally transitioned from millions to billions of dollars and, during the past 2 years, have tripled for programs in the developing world. Domestic resources also have increased within national budgets. The rapid creation and implementation of the Global Fund to Fight AIDS, Tuberculosis and Malaria will provide approximately $800 million in 2002, an increase of about 40-45 percent in the resources available for AIDS in low- and middle-income countries. Dr. Piot suggested that this financial investment mechanism is a challenge that forces all "players" to make commitments and to be accountable.
Dr. Piot commented that the NIH has a major role in supporting the global response to HIV/AIDS. While some progress has been made in the fight against HIV/AIDS, many issues continue to be controversial and some new developments are worrisome. Dr. Piot noted the need for governments to translate commitments into appropriate and effective actions, to raise awareness and launch programs in areas where HIV/AIDS is exploding (e.g., China, India, Indonesia, Russia, Asia, Central America, Eastern Europe), and to allocate the resources promised. Cambodia and Haiti are two examples of the success that can be achieved against HIV/AIDS when governments are committed and take deliberate action.
Dr. Piot summarized the roles and activities of UNAIDS, a coalition of eight multilateral agencies, which include the World Bank, WHO, and the United Nations Children's Fund (UNICEF). The UNAIDS headquarters in Geneva, Switzerland, serves as secretariat for the multi-agency coalition and has four major roles: coordination of the global response to HIV/AIDS (similar to the OAR's function at the NIH); political advocacy at the highest governmental levels; documentation of effective policies and strategies and provision of technical support and guidance; and tracking, monitoring, and evaluation of the status of the epidemic. UNAIDS fulfills these roles with a small annual budget of approximately $90 million and 400 staff, most of whom work in developing countries.
Dr. Piot noted two current challenges for UNAIDS: (a) to help countries scale up effective interventions nationwide from small research or community projects, and (b) to ensure continued resources, including monies, personnel, institutions, and infrastructure (e.g., delivery) systems. Presenting a "snapshot" of activities, he highlighted UNAIDS' analytical and programmatic efforts. Each UNAIDS cosponsoring agency contributes its expertise and facilities to support these efforts.
The four main analytical activities for UNAIDS are: the epidemiology reference group (which will issue new country and global estimates on July 2); the monitoring and evaluation reference group, which focuses on geographic indicators; the economics reference group, which estimates resource needs and flows and monitors expenditures; and the country response information system, which is being developed as a fully accessible electronic database containing epidemiological information on HIV/AIDS from all countries. Dr. Piot provided sample UNAIDS materials to the Board, including a CD-ROM containing the UNAIDS library of current documents through December 31, 2001.
He noted that UNAIDS programs are focused on "going to scale." Key efforts relate to prevention (e.g., drug use, mother-to-child transmission); treatment and access to care (e.g., financial and infrastructural programs, technical guidance); impact of HIV/AIDS (e.g., on orphans, human resources); non health-sector activities (e.g., education, rural development, business/employment, conflict and humanitarian issues); stigma, human rights, legal issues (e.g., research ethics); and capacity building (similar to FIC).
In conclusion, Dr. Piot highlighted four areas for potential collaboration between UNAIDS and FIC: stigma, the link between prevention and treatment, ethics and resource allocation issues, and human resources capacity related to HIV/AIDS.
Discussion
The Board asked about UNAIDS's interest in the intersection between nutrition and HIV/AIDS (e.g., malnutrition, response to drug treatment) and in HIV/AIDS in the Caribbean. Dr. Piot responded that UNAIDS supports little activity in nutrition, but that this topic could become part of WHO's strengthened clinical program. He noted that UNAIDS has attempted to generate resources in the Caribbean for HIV/AIDS. For the first time, in February 2001, AIDS was included on the agenda of a CARACOM meeting, and a pan-Caribbean partnership against AIDS has been established and has led to collective negotiations to reduce the price of antiretroviral (ARV) drugs. Also, the World Bank has launched a multi-country program of loans, which amounts to $140 million and includes support for the provision of ARV therapy, to combat AIDS in the Caribbean. Dr. Piot expressed greater concern about Central America, saying that denial of HIV/AIDS in this region is enormous.
The Board commented that UNAIDS and FIC have a "golden opportunity" currently to forge interactions between NIH research and UNAIDS activities and to combine each organization's strengths in the fight against HIV/AIDS. Dr. Piot agreed that working together and in a triangular arrangement with the Global Fund, FIC and UNAIDS could achieve a positive, science-based synergism of effective action.
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VII. UPDATE ON FIC INTERNATIONAL AIDS PROGRAMS
Dr. Kenneth Bridbord, Director, Division of International Training and Research, FIC, presented an update on FIC international AIDS programs. FIC's AIDS programs are conducted in collaboration with OAR, NIAID, and other ICs. They reflect the FIC mission, which is to promote and support scientific research and training internationally to reduce disparities in global health. FIC fulfills its mission by advancing research and training that prepares current and future health scientists to meet global health challenges. Principally, FIC aims to strengthen research capacity and support public health and interventions.
FIC supports a broad array of NIH and international efforts in HIV/AIDS and contributes unique expertise in the development of human resources through its AIDS International Training and Research Program (AITRP) and other programs. Dr. Bridbord noted that virtually all of NIH's major research investments in HIV/AIDS have benefited from FIC's "pre-investment" in research training and capacity building. He highlighted linkages between research training supported at U.S. universities participating in AITRP and country sites participating in the NIAID-supported HIV Vaccine Trials Network (HVTN) and HIV Prevention Trials Network (HPTN) and the NIMH-supported Popular Opinion Leaders (POL) program, a peer education effort. Other NIH programs which the AITRP effort facilitates and supports include the Comprehensive International Program of Research on AIDS (CIPRA), Centers for AIDS Research (CFARs), International Centers for Excellence in Research (ICER), Partnerships for HIV/AIDS Research in Africa, and numerous (more than 50) investigator-initiated (R01) awards.
FIC initiated AITRP in 1988 and has held four competitions for awards, resulting in new or competing renewal funding of 61institutional awards. FIC is supporting 23 AITRP programs currently and will hold the fifth competition for awards in FY 2003. For this competition, FIC will continue to focus on building research capacity and will allow for expansion of programs to integrate prevention with therapy and care, as part of FIC's broader efforts in clinical and operational research. FIC also plans to convert the competition from an RFA to a Program Announcement so that applicants can compete for awards and supplements in open competition annually.
Dr. Bridbord noted that, through AITRP, FIC provides research training support for master's and doctoral degrees, postdoctoral fellowships, short courses in the United States or other countries, in-country and advanced in-country research training, and limited salary and administrative support for participating U.S. institutions. Key characteristics of AITRP that have been adapted for subsequent FIC programs are: a systematic approach to training, stability and long-term commitment, response to local needs and priorities, mutual reinforcement in-country of investments in training and research, leverage to interface with other organizations, individual and institutional partnerships, long-term mentoring, empowerment and mutual respect, networking among programs, and flexibility.
Dr. Bridbord noted that FIC trainees emphasize flexibility as the most important aspect of AITRP and, accordingly, FIC has been aggressive about ensuring that AITRP is flexible to accommodate different needs and interests. He also highlighted, as principles of FIC's capacity building, the importance of sustaining a long-term (decades) effort and commitment to training; in-country coordination with local and community leaders; promotion of "south-to-south" collaboration; training, networking, and mentoring; and inclusion of a wide range of health professionals in training programs.
AITRP is a highly successful program. Dr. Bridbord commented on the rewards for FIC of seeing trainees and scientists associated with the program become scientific, administrative, and government leaders in their countries and recognized, published scientists internationally. He noted, for example, that former AITRP trainees constitute one-third or more of the senior leadership in the Ugandan Health Ministry, most of the leaders in the Malawi AIDS Program, current and past directors of the Brazilian AIDS Program, as well as health ministers and program and institute directors around the world. Many of these individuals have received international awards. In addition, at the 13th International AIDS Conference, held in Durban, South Africa, current or former AITRP trainees authored or co-authored 25 percent of the presentations. For the World TB Conference, to be held in Washington, D.C., in June, FIC-supported trainees will have authored or coauthored 10 percent of the presentations, an indicator of the positive short-term effects that even smaller, more recent FIC programs can have.
Besides AITRP, 11 other FIC programs underpin NIH's international AIDS research efforts. These include, for example, the AIDS Fogarty International Research Collaboration Award (AIDS-FIRCA), International Research Scientist Development Award (IRSDA), International Training and Research in Emerging Infectious Diseases (ITREID), and International Cooperative Biodiversity Groups (ICBG) Program.
The ICOHRTA-AIDS/TB, recently launched, is an example of FIC's "next-generation" program to build on AITRP's success. This program follows on the previous ICOHRTA in Mental Health. Cosponsored by 10 NIH components and the CDC, this program differs from AITRP by increasing the investment in research training at foreign sites and by emphasizing the integration of therapy and care with prevention. The program consists of two phases: Phase I, for the award of planning grants to foreign sites; and Phase II, for comprehensive, linked awards to foreign and U.S. collaborators. Dr. Bridbord noted that the timing of the two phases is critical, the awards will be funded as cooperative agreements, and grantees will interface with the NIH extramural and intramural programs. Importantly, the ICOHRTA-AIDS/TB shifts the "center of gravity" for training to developing countries, while maintaining collaborations with U.S. or other partners.
In closing, Dr. Bridbord emphasized that FIC-supported people are a large part of the "global glue" in health research and that many of the individuals trained in FIC's programs now work in governments and research organizations around the world. By investing in the complementary efforts of AITRP and ICOHRTA-AIDS/TB, FIC hopes to help build centers of research excellence in the developing world that can successfully compete in the global scientific marketplace and advance critical research areas in AIDS, TB, and other global health problems.
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VIII. DISCUSSION
The Board commended FIC for expanding its programs to include operational research and partnerships with private and not-for-profit organizations. Dr. Keusch noted the input of the Board in helping FIC move to link clinical research, operational issues, and health services. He agreed with Dr. Piot that integration of prevention with clinical care and treatment is extremely important, and he thanked OAR for supporting this concept. Dr. Jack Whitescarver, Director, OAR, commented that international research has historically not been a high priority for NIH and that impetus from the Congress has led NIH to recently endorse the importance of international research. He said that the NIH looks to FIC to help fill the void in research capacity internationally and that the OAR applauds FIC's vision and new programs and will help FIC "grow" its budget within the limits of NIH's resources.
The Board noted the importance of FIC and NIH collaboration in regional workshops and activities (e.g., in the Caribbean) to identify research priorities and cross-cutting issues, such as training, grantsmanship, research management.
The Board raised the question of how to attract students into international research opportunities. Dr. Keusch noted that FIC staff have had ongoing discussions about this issue over the past several months and are considering developing a program to acquaint students in the health sciences (beginning with medical students and, perhaps, students in other health professions), in both the United States and developing countries, with international research.
Reflecting on the presentations by Dr. Piot and Dr. Bridbord, the Board asked, "What's next on FIC's agenda?" Dr. Keusch noted two areas that FIC has targeted for attention: international training in behavioral and social science research, and continued outreach to other ICs, agencies, and international organizations. FIC has taken initial steps in the first area, by developing and supporting the ICOHRTA in Mental Health and collaborating with OAR to support several grants for behavioral research in HIV/AIDS. The Board expressed particular concern that FIC's limited resources (funding and personnel) may impede its ability to contribute effectively to moving the international agenda for HIV/AIDS forward.
Dr. Jamison emphasized that multilateral agencies such as the World Bank, regional banks, and WHO will not be able to be fully effective partners with UNAIDS or FIC unless they modify their administrative structures (e.g., allocation of staff and staff time, administrative budgets) to support an increased capacity for implementation (e.g., dispersal of funds to effective programs). He noted that the current administrative budgets for most of these agencies do not "match" the rhetoric. The Board cited one example, the great disparity in the pricing of drugs for HIV/AIDS in Latin America and the Caribbean, and a proposal that the Pan American Health Organization and the Inter-American Development Bank jointly develop a revolving fund to ensure that all individuals in the region have equal access to subsidized drugs.
Dr. Jamison suggested that UNAIDS and FIC could have a role in building capacity for science and implementation within multilateral agencies. Dr. Piot agreed that the capacity of multilateral sponsors of international HIV/AIDS activities must be increased in order to have a major, long-term, and sustainable impact on HIV/AIDS. He emphasized several approaches: external pressure (e.g., from the scientific community) to encourage the agencies to make HIV/AIDS a "core business" and to modify their structures and behaviors to accommodate this change; identification and use of incentives for making these organizational changes; and specification of each agency's areas of strength in the HIV/AIDS effort.
Dr. Piot noted that some progress is being made and that the UNAIDS board will be discussing the core resources of each of the UNAIDS cosponsoring agencies at its next meeting. He strongly encouraged the scientific community to help push the multilateral agencies develop the administrative and technical capacity needed to ensure effective utilization of the billions of dollars that are becoming available for HIV/AIDS programs in developing countries. Dr. Piot noted that 2002-03 will be "the defining year" for this effort and that FIC and OAR could be catalysts for these critical organizational changes.
Dr. Keusch concluded by noting that the "business" of NIH is knowledge generation and the hope is that research guides policies and interventions. He commented that the presentations by Dr. Piot and Dr. Bridbord highlight the need for mutually reinforcing connections between science (and scientists) and the intervention community and populations served, and he agreed that responding to the HIV/AIDS epidemic demands "action above words." Dr. Keusch highlighted two additional critical issues raised by Mr. Mutombo during discussion: connecting with and engaging the political leadership within countries, and communicating information to the population through local media. In closing, Dr. Keusch suggested that there is some reason for optimism in the fight against HIV/AIDS and, in basketball terms, "you don't want to drop the ball, you want to slam dunk."
IX. CLOSED PORTION OF THE MEETING
This portion of the meeting was closed to the public in accordance with the determination that it was concerned with matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2).
There was a discussion of procedures and policies regarding voting and confidentiality of application materials, committee discussions, and recommendations. Members absented themselves from the meeting during discussion of and voting on applications from their own institutions or other applications in which there was a potential conflict of interest, real or apparent. Members were asked to sign a statement to this effect.
X. REVIEW OF APPLICATION
Dr. Sharon Hrynkow chaired the remainder of the meeting during which the Research Awards Subcommittee reported on its activities. A total of 87 scored competing applications were reviewed by the FIC Advisory Board at the February 5 meeting.[2] The applications were in the following programs:
12 applications for the International Bioethics Education and Career Development Award, out of a total of 21 applications;
34 applications for the Fogarty International Research Collaboration Award (FIRCA) program, out of a total of 62 applications;
4 applications for the HIV/AIDS Fogarty International Reserch Collaboration Award (AIDS-FIRCA) program, out of a total of 5 applications;
20 applications for the Tobacco Use and Control Research Training Award, out a total of 64 applications;
2 applications for the International Research Scientist Development Award (IRSDA), out of a total of 4 applications.
The Board concurred with the initial review group recommendations for the 72 applications.
XI. ADJOURNMENT
There being no further business, the meeting was adjourned at 2:45 p.m. on May 21, 2002.
[1] Members absent themselves from the meeting when the Board discusses applications from their own institutions or when a conflict of interest might occur. The procedure applies only to individual applications discussed, not to en bloc actions.
[2] Applications that were noncompetitive or unscored or were not recommended for further consideration by initial review groups were not considered by the Council.
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