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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
Forty-fifth 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
- FIC In-House Research
- Placing Mental Health on the International Health Agenda
- Multidisciplinary Centers of Research Excellence - Concept and Discussion
- Report on Conference - Challenges in Health Disparity in the New Millennium
- Closed Portion of the Meeting
- Review of Application
- Adjournment
The meeting of the Advisory Board of the John E. Fogarty International Center for Advanced Study in the Health Sciences (FIC) was convened on Tuesday, May 16, 2000, at 8:37 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 8:37 a.m. to 12:30 p.m., followed by the closed session for consideration of grant applications until adjournment at 3:00 p.m. Dr. Gerald T. Keusch presided as Chair.
Board Members Present:
Dr. Margaret A. Chesney
Dr. Ezekiel J. Emanuel
Dr. Cutberto Garza
Dr. Mary Claire King
Dr. Cora B. Marrett
Dr. Patricia Marshall
Mr. Thomas J. McAndrew
Dr. Donald O. Nutter
Dr. Theodore Reich
Dr. Catherine M. Wilfert
Board Members Absent:
Dr. Barry R. Bloom
Dr. Thomas W. Cole, Jr.
Dr. Steven E. Hyman
Members of the Public Present:
Dr. Arthur Kleinman, Harvard Medical School, Cambridge, Massachusetts
Ms. Pamela Moore, Capitol Publications
Ms. Georgia Persinos, Washington Insight
Ms. Angela Sharpe, Consortium of Social Science Associations, Washington, D.C.
Ms. Haimi Shiferaw, The Blue Sheet
Federal Employees Present:
Ms. Susan Bettendorf, FIC/NIH
Ms. Judith Levin, FIC/NIH
Mr. Amar Bhat, FIC/NIH
Dr. Jeanne McDermott, FIC/NIH
Dr. Joel Breman, FIC/NIH
Ms. Silvia Mandes, FIC/NIH
Dr. Kenneth Bridbord, FIC/NIH
Dr. Mark Miller, FIC/NIH
Ambassador Kenneth Brill, DOS
Mr. Richard Miller, FIC/NIH
Ms. Kathryn Chantry, FIC/NIH
Dr. Richard Mowery, NCI/NIH
Dr. Lois K. Cohen, NIDCR/NIH
Dr. Richard Nakamura, NIMH/NIH
Ms. Irene Edwards, FIC/NIH
Ms. Sharon Nieberding, FIC/NIH
Ms. Lee Ann Gschwind, FIC/NIH
Ms. Ruth Orenstein, FIC/NIH
Dr. Gray Handley, NICHD/NIH
Ms. Mary Plummer, NICHD/NIH
Dr. Kevin Hardwick, NIDCR/NIH
Dr. Juan Ramos, NIMH/NIH
Dr. Ruth J. Hegyeli, NHLBI/NIH
Dr. Joshua Rosenthal, FIC/NIH
Ms. Anne Hill, FIC/NIH
Dr. Luis A. Salicrup, FIC/NIH
Dr. Karen Hofman, FIC/NIH
Ms. Rita Singer, FIC/NIH
Dr. Sharon Hrynkow, FIC/NIH
Ms. Janice Solomon, FIC/NIH
Dr. Gerald T. Keusch, FIC/NIH
Dr. Sudha Srinivasan, FIC/NIH
Ms. Sylvia B. Kniel, FIC/NIH
Dr. Sandy Warren, CSR/NIH
OPEN PORTION OF THE MEETING
I. CALL TO ORDER
Dr. Gerald T. Keusch, Director, FIC, called the open session of the Advisory Board meeting to order at 8:37 a.m. on Tuesday, May 16, 2000. He introduced several guests: Dr. Richard Nakamura, Deputy Director, National Institute of Mental Health (NIMH), NIH; Dr. Arthur Kleinman, Chair, Department of Social Medicine, Harvard Medical School; and Ambassador Kenneth Brill, Principal Deputy Assistant Secretary of State, Bureau of Oceans and Environmental and Scientific Affairs, U.S. Department of State. Dr. Keusch extended a special welcome to Ambassador Brill and noted that the FIC is working closely with the Ambassador and his office on critical international health issues.
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II. CONSIDERATION OF MINUTES OF PREVIOUS MEETING
The minutes of the Advisory Board meeting of February 8, 2000, were considered and accepted unanimously.
III. REVIEW OF REQUIREMENTS FOR CONFIDENTIALITY AND CONFLICT OF INTEREST PROCEDURES
Dr. Keusch thanked the Board members for providing their updated Confidential Financial Disclosure Reports to the FIC.
IV. FUTURE MEETING DATES
The following meeting dates were confirmed:
Tuesday, September 19, 2000
Tuesday, February 6, 2001
Tuesday, May 22, 2001
Tuesday, September 11, 2001
All subcommittees of the Board will meet on the Monday preceding each Board meeting.
V. REPORT OF THE DIRECTOR
Dr. Keusch presented an update on FIC and NIH activities and reported on FIC's progress and plans. Mr. Richard Miller, Executive Officer, FIC, reviewed the status of the appropriations for the NIH and FIC budgets for Fiscal Year (FY) 2001. The written Report of the Director was distributed previously to Board members, was available at the meeting, and is appended to these minutes as Written Report of the Director.
FIC Budget
Mr. Miller reported that the House Appropriations Subcommittee and the Senate Full Appropriations Committee have met on the FY 2001 budget for the NIH. He noted that Dr. Keusch had an opportunity during the House Subcommittee hearings to discuss FIC's initiatives for the future and the availability of funds to support these efforts. For FY 2001, both the House and Senate have proposed to increase the President's Budget for the NIH to $20.5 billion, which is a 15.2 percent increase and approximately $2.7 billion more than in FY 2000. For the FIC, the House markup is almost $50.3 million, or about a 16.1 percent increase, whereas the Senate markup is approximately $61.3 million, or about a 41.4 percent increase. Mr. Miller noted that these increases are evidence of Congress's recognition of FIC's future initiatives (e.g., in-house epidemiology research, mental health, centers of excellence). The FY 2000 President's Budget for the FIC reflected an increase of 10.8 percent, or about twice the overall increase in the NIH budget (5.6 percent).
The next steps in the FY 2001 appropriations process for the NIH include consideration of the proposed budget by the full House Appropriations Committee on May 24, floor action by the House in early June, floor action by the Senate (to be scheduled), and conference by the House and Senate Committees to resolve the differences in the two bills.
In discussion, the Board noted that the percentage increases proposed for the FIC were dramatically higher than those proposed for most of the other NIH components and that they would enable the FIC to support its initiatives and, through collaboration, add value to the programs of the other institutes and centers. The Board was hopeful that the NIH would be supportive of these increases and that the House was fully aware of the substance of FIC's programs. Dr. Keusch commented that the Senate markup would provide a sufficient, although still not optimal, base of support for FIC's planned initiatives and that the increased funds would have a major effect at the NIH through enhanced collaboration with other institutes and centers.
Personnel Changes
Dr. Keusch highlighted two personnel items: (a) the soon-to-be-announced appointment at the FIC of a senior staff person with a major interest in international clinical trials and clinical research, and (b) the departure of Dr. Neal Nathanson, director, Office of AIDS Research, NIH. Dr. Nathanson will be leaving the NIH on September 1, 2000, to return to the University of Pennsylvania; a search for his successor is under way.
FIC Activities
Dr. Keusch reported on three recent initiatives, as follows.
Bioethics of Clinical Research Internationally. On March 20, the FIC sponsored a meeting at the NIH to discuss new international guidelines for assuring ethical research. The purpose of the meeting was twofold: to obtain comments on a draft document developed by the NIH Office of Protection from Research Risks (OPRR) to guide ethical review of publicly funded research conducted abroad, and to discuss plans for the Second Global Forum on Bioethics in Research and subsequent forums. Dr. Keusch noted that approximately 25 persons, from eight developing countries and funding agencies, participated in the meeting. Dr. Patricia A. Marshall represented the Board.
Dr. Keusch commented that the discussion of the OPRR document was useful and that the OPRR is revising the guidelines based on this input. Dr. Marshall noted that participants expressed concern about several structural and substantive issues and agreed on the importance of capacity building, education of institutional review board members, and increased awareness of the ethics of research in international settings.
With respect to the Second Global Forum on Bioethics in Research, which will be held in Bangkok, Thailand, on October 14-15, 2000, Dr. Keusch noted that the FIC is funding a 6-month staff position to help the World Health Organization (WHO) organize the meeting. The first Global Forum on Bioethics in Research was held at the NIH in November 1999. Subsequent forums are being planned for The Gambia in November 2001, to be hosted by the Medical Research Council (MRC), United Kingdom; Latin America in 2002, in coordination with the 100th anniversary of the Pan American Health Organization; and Europe in 2003, with the support of the Wellcome Trust.
To stimulate training in the bioethics of research, the FIC issued a Request for Applications (RFA) for a new FIC program in International Bioethics Education and Career Development. The program was announced in the "NIH Guide to Grants and Contracts" on March 13 and is being funded jointly, at a level of $2 million initially, with several other NIH components. It will support curriculum development and training in international bioethics related to performing research in low- and middle-income countries and the establishment of a network among grantees. Approximately 14 applications have been received, including several from international sites. Dr. Keusch noted that FIC's initiative has stimulated other organizations (e.g., the Wellcome Trust, the MRC) to support training in this area and that the FIC is maintaining discussions with these organizations to encourage international networking.
In response to a question from the Board, Dr. Keusch said that the FIC has communicated with the National Bioethics Advisory Committee (NBAC) to express concern about the need for broad international input on international issues addressed by the committee. The NBAC International Report is expected to be available for public comment in September. The FIC is attending NBAC meetings and has been asked to provide comments on the issues to be addressed in the report.
International Studies on Health and Economic Development. In May, the FIC will issue an RFA for this new FIC program, which is being co-funded with several other NIH components and, for the first time for the FIC, in collaboration with the World Bank. For this initial foray into health and economic growth issues, the FIC has constructed a broad program to support research on a range of issues relating health status to economic productivity. The FIC anticipates supporting four or five research projects. Dr. Keusch noted that the FIC is collaborating with the World Bank's Global Development Network, which is providing Bank funds for the program, to plan a meeting of the researchers within the next 2 years at an annual meeting of the network focused on health and economic issues. Also in collaboration with the Global Development Network, the FIC is discussing the possibility of organizing and participating in concurrent sessions on health and economics at the meetings of the World Bank and the International Monetary Fund in Prague, Czech Republic, in September 2000.
Consultation on Medicine and the Media. On June 7, the FIC will convene a small planning meeting to discuss the ethics and responsibility of the media in reporting science. Editors of medical journals and members of the press, including correspondents from developing countries, are being invited to attend. Dr. Catherine Wilfert will represent the Board. The overall aim is to identify and clarify issues that need to be addressed and to consider the role of the NIH and the FIC in addressing them. Two specific goals are to consider ways to strengthen the reporting capacity of medical journals in developing countries and to provide educational opportunities (e.g., fellowships) for the press from these countries. Dr. Keusch encouraged the Board members to notify Dr. Karen Hofman, FIC, of potential invitees.
Additional details on personnel changes and FIC activities are provided in the Written
Report of the Director.
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VI. FIC IN-HOUSE RESEARCH
Dr. Mark Miller, Associate Director for Research, FIC, presented the FIC's thinking on the development of an in-house research program at the FIC. He outlined the steps in creating this program, the interaction of the program with other FIC and NIH activities, and issues and questions for the FIC to address. Dr. Keusch welcomed the Board's comments and input on these plans.
The steps to creating an FIC research program include establishment of a Board of Scientific Counselors (possibly as a subcommittee of the Board) to review the research agenda, identification of research goals, development and implementation of strategies to recruit staff, and specification of budget requirements. Dr. Miller noted that the FIC envisages initially a 2- to 4-year plan to develop three research components: demographics and human ecology studies, translational research, and a policy service.
In the first area, the FIC proposes to conduct value-added research on questions that are not otherwise being addressed systematically at the NIH or could be addressed from a different perspective. The emphasis would be on human epidemiology studies with an international health focus. The program would target the communicable and non-communicable disease burden and assessment of social and behavioral, including anthropological and economic, risk factors affecting these diseases. New technologies, such as remote sensing satellite imaging and ecological and environmental approaches to disease transmission, would be utilized. Emphasis would be given to identifying the determinants of health internationally and trends over time in relation to public health practices (e.g., the effect of injection practices and vaccination programs). Dr. Miller noted that this program would complement and add value to several other extramural and intramural programs in epidemiology at the NIH.
In the translational research component, the FIC plans to focus on the translation of knowledge into operational capacity. Emphasis would be given to systematic analysis of determinants affecting the transfer of technology and the adaptation of health interventions. Issues such as social barriers, trade barriers, or legal constraints may be determining factors in the acceptance and use of proven public health measures (e.g., vaccines).
The policy service component would focus on country-specific burdens of disease (social and economic), costs of health interventions, and the risks and benefits associated with these interventions. Decision or policy analysis could help policymakers, for example, clarify the relative utility of rotavirus vaccine for their populations.
Issues and questions that the FIC is exploring further in the development of the program include the following: How well could the FIC integrate this program with its extramural activities? How can the FIC add value, and avoid unnecessary duplication, with other NIH intramural activities? Dr. Miller noted that the FIC anticipates contracting out much of the research, at least initially. Program staff would interact with other FIC and NIH components and would link with other Federal and international agencies and organizations. The FIC has initiated internal and external consultations with many of these groups. The portion of the FIC budget expended on direct research would be expected to grow over time to be on par with that of other NIH institutes' and centers' intramural and in-house efforts, perhaps eventually to approximate 10 percent of the FIC's research budget. Funds could be obtained from various sources, including appropriated funds and gift funds.
Discussion
Dr. Keusch noted that the NIH needs in-depth and reliable information on global health issues, beyond the current assessments of disease burden, in order to effectively address global health issues. Through the proposed research program, the FIC could significantly help to generate this information and thus enable the FIC to assess the health effects of NIH's international programs, inform other institutes and centers about cross-cutting issues, act as a lever for international research activities, and build capacity within the FIC to more effectively perform its international roles.
Dr. Keusch also noted that the FIC's recent reorganization, now completed, sets in place a structure for the research program. As mentioned at the previous Board meeting, a new Division of Advanced Studies and Policy Analysis (DASPA) replaces the former Office of International Science Policy and Analysis and the Division of International Advanced Studies. The new division is housed in a newly created "think-tank" setting in the Lawton Chiles International House, which will include DASPA on the second floor and the in-house research program on the third floor. Dr. Keusch said that the FIC is recruiting a bioethicist and an economist for the division and that Dr. Roy Anderson, Oxford University, has agreed to come to the FIC as a new Fogarty scholar to apply his expertise in modeling to global health issues.
The Board noted the progress made at the FIC during the past 2 years and favored development of the in-house research program. The members noted that such a program would amplify areas of importance in international health and strengthen FIC's capacity for leadership on global health issues. The Board commented on the need to fit the program within FIC's strategic plan, to define indicators of success for the program, to recruit the best talent into the program, to identify specific activities on which to focus (e.g., improved methodologies and tools for international epidemiology, bioethical issues, international health and economic development), and to balance FIC's intramural and extramural activities.
Dr. Margaret A. Chesney highlighted the importance of involving social and behavioral scientists in the international health research agenda. As an example of the contributions they can make, she noted the recent revised publication of "Discovering Global Success: Future Directions for HIV Prevention in the Developing World," by SF Morin, MA Chesney, and TJ Coates (University of California, San Francisco, AIDS Research Institute, Policy Monograph #1, revised April 2000). This publication was prepared in collaboration with participants at The Fogarty Workshop on International HIV/AIDS Prevention Research Opportunities, held in San Francisco, California, on April 18-20, 1998. More than 170 biomedical, social, and behavioral scientists from 37 countries participated in the workshop to identify research priorities and achieve consensus on multidisciplinary prevention strategies. For FIC's in-house research program, Dr. Chesney encouraged stronger emphasis on behavioral studies (e.g., of chronic illness, risk factors of disease) and linkage with other NIH components (e.g., the Office of Behavioral and Social Science Research).
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VII. PLACING MENTAL HEALTH ON THE INTERNATIONAL HEALTH AGENDA
Dr. Arthur Kleinman presented a broad perspective of the burden of mental diseases, indications of the effectiveness of mental and social health programs internationally, examples of policy-relevant factors, and recommendations for specific initiatives for an international mental health agenda. He noted that the past 15 years of laissez-faire capitalism has led to increased wealth globally, but also to a worsening of social and mental health problems such as substance abuse, violence, sexually transmitted diseases, suicide, depression, breakdown of the family, disintegration of communities, and diseases of poverty. Inequality and poverty are deepening for many individuals, and health care and public health resources are more unfairly distributed.
These observations are supported by international data. Estimates of the burden of disease in terms of disability-adjusted life years (DALYs), in 1998, indicate that neuro- psychiatric disorders accounted for 11.5 percent of the global burden of disease (23.5 percent in high-income countries and 10.5 percent in low- and middle-income countries); that unipolar major depression alone accounted for 4.2 percent of this burden; and that inclusion of suicide increased the burden of depression by 40 percent. Dr. Kleinman noted that these estimates are believed to be extremely conservative, do not account for the profound effects of mental health problems on families and interpersonal relations, and do not convey the physical pain and symptoms associated with severe depression, which eventually leads to suicide in 15 percent of the individuals affected. In 1990, unipolar major depression ranked 5th among the 10 leading causes of DALYs worldwide, mental illness (including suicide) was the 2nd leading category of illness (following cardiovascular conditions) in established market economies, and, among persons aged 15 to 45 years old, five mental health problems were among the 10 leading causes of disability worldwide (calculated as years lived with disability, or YLDs). These problems were unipolar major depression, alcohol use, bipolar disorder, schizophrenia, and obsessive-compulsive disorders. Most of these problems affect individuals during their most productive years. The estimated economic costs of mental disorders, based on 1994 U.S. data, total more than $204 billion.
Dr. Kleinman noted that accurate data on the costs of mental disorders in developing countries are lacking. However, data indicate that the governments of these countries expend less than 1 percent of their health budgets for mental health problems, which account for 10.5 percent of the burden of disease in these countries. Data from China are informative. With 21 percent of the world's population, China has 42 percent of all suicides worldwide (approximately 330,000 deaths each year) and 7.8 million schizophrenic patients, but only 100,000 hospital beds dedicated to psychiatric patients, only 13,000 physicians working in mental health (of whom approximately 1,000 are fully trained psychiatrists), and virtually no psychiatric care in more than three-quarters of its rural areas, where 70 percent of the population resides.
Yet, major advances have been made in psychiatric treatment, and interventions for depression compare favorably, in terms of cost effectiveness, to interventions for hypertension, for example. Still, most cases of depression are not diagnosed or adequately treated, even in the developed world. Among the mental and social health programs that have been shown to be effective, Dr. Kleinman highlighted a program of psychiatric rehabilitation services in Shanghai, China, as a cost-effective, world-class model that could be generalized throughout the country. However, as with the dozens of other effective programs in developing countries, this translation does not happen. No single effective program for a mental health condition has ever been generalized throughout a developing nation. For many countries, the policy-relevant concerns include the shortage of therapeutic resources (medications, personnel); overuse of relatively cheap, inappropriate therapies (e.g., electroconvulsive therapy); lack of treatment for somatic comorbidities (e.g., infections); inadequate evaluation of patients; and unregulated, impoverished, and unhealthy hospital conditions. Dr. Kleinman emphasized that these concerns are evidence of an ethical crisis in the care of mental health patients who continue to be subjected worldwide to systematic stigma and neglect.
He recommended a number of specific initiatives to confront this crisis. Focusing on research, Dr. Kleinman emphasized the critical need for an international mental health policy center that includes both training and policy-relevant research activities. No such center currently exists. Support for training would help create a critical mass of international mental health policy research experts in developing countries, programs that would constitute nodes in a research network, and in-country websites to assure access to international medical literature. Dr. Kleinman suggested that establishment of a postdoctoral fellowship in international mental health policy research would attract fellows from developing countries who could be trained at key centers in the developed world. The fellows would focus on policy and service issues in the developing world and receive funding support for mental health research on their return to their home countries. Importantly, this research could be focused on development of demonstration projects, rigorous evaluation of these projects, and generalization of cost-effective programs to regional or national levels.
Dr. Kleinman noted that rigorous evaluation research to measure the cost effectiveness, treatment outcomes, and community benefits of interventions is the single highest research priority currently. Research also is needed to better understand and combat the stigma associated with mental health problems. Interdisciplinary studies combining epidemiology, ethnography, and economic approaches are particularly valuable for non-Western cultural settings.
Other recommended initiatives include the following: upgrade the quality of mental health services in low- and middle-income countries; upgrade the amount and quality of mental health training of health workers at all levels; implement policies to interdict violence against women and to improve women's economic status; improve mental health services for children and adolescents; develop effective treatment and prevention programs for substance abuse; develop broad initiatives to attend to the causes and consequences of collective and interpersonal violence; and designate primary prevention of mental, neurological, behavioral, and psychosocial disorders as a major focus for health. Commenting on the importance of primary prevention, Dr. Kleinman said that mental retardation rates are three to five times higher in developing countries than in the developed world because of birth trauma, infection, and other factors.
In closing, Dr. Freire highlighted the following points, or quandaries, for the FIC and Board's consideration: (a) how to ensure both efficient development of, and widespread access to, drugs (e.g., by awarding "placeholder" licenses); (b) whether the U.S. Government's "march-in" rights to ensure that developed technologies meet public health needs, as required in the United States, could be extended to other countries; (c) how to accommodate the rights and rules of other nations in the development and distribution of pharmaceuticals and other biomedical technologies; and (d) ways of coordinating international trade and intellectual property concerns internationally. Dr. Freire noted that NIH and DHHS staff hope to address some of these issues with the U.S. Trade Representative's office and the WHO.
Discussion
Dr. Keusch thanked Dr. Kleinman for his remarks. He noted that the FIC and the NIMH continue to have ongoing and productive discussions about potential collaborations and linkages in an international agenda for research and research training in mental health. Dr. Keusch agreed that mental health is "undeniably important" in the global burden of disease, and he suggested that the FIC can be most effective by collaborating with other NIH institutes and centers.
The Board asked about the status of prevention of mental health problems. Dr. Kleinman noted that much is known about primary, secondary, and tertiary prevention of some problems (e.g., mental retardation, depression, schizophrenia, other psychiatric diseases), but this knowledge is not being applied. Research is needed to understand the realities and possibilities for prevention in developing countries and to develop an agenda for prevention that includes generalization of effective demonstration projects. Dr. Kleinman emphasized that external funding will be needed to support this research and that training is essential. Most of the educational curricula for physicians, nurses, and health professionals in developing countries do not include mental health; education of mental health professionals is virtually nonexistent; and specialized mental health services are lacking.
The Board suggested that the FIC could play a role in facilitating the development and availability of curricula that are relevant to local needs, assuring access to medical journals, and strengthening the research infrastructure in developing countries. Specialized research training in mental health is needed for medical school faculty and to develop mental health policy researchers who can address in-country needs. The Board also suggested that cross-cultural research on stigma would be useful and applicable to other diseases besides mental health problems and that sociology, anthropology, and policy science could contribute to this research. Dr. Keusch noted that the FIC has included research on stigma as one of five proposed initiatives for FY 2002.
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VIII. MULTIDISCIPLINARY CENTERS OF RESEARCH EXCELLENCE - CONCEPT AND DISCUSSION
Dr. Kenneth Bridbord, Director, Division of International Training and Research, FIC, presented an update on FIC's concept of International Centers of Research Excellence (ICORE), which was introduced at the previous Board meeting. Dr. Bridbord reviewed the impetus for this idea and described the aims and activities of the centers.
The factors leading to the development of this concept include the continued evolution of FIC's strategic plan, NIH's growing investment in international research in developing countries, FIC's expanded interests in training and capacity building, international discussions of the global burden of disease, and internal FIC discussions. Dr. Bridbord summarized the concept of ICORE as "partnerships in preparing the world to meet the health challenges of the 21st century." The goal is to build sustainable health research capability at selected developing country institutions by sustained support and collaborations (measured in decades). "Sustainability" is defined as the stage when institutions can independently and successfully compete for, and administer, research awards. The FIC expects that some developing country institutions could reach this stage within 10 years, but that, for the majority, the overall development period will span several decades, requiring long-term partnerships and support.
Dr. Bridbord noted that, with ICORE, the focus shifts, subtly but importantly, to the initiation of center applications by foreign, not U.S., partners. Eligibility for foreign institutions would be defined in terms of a minimum annual research and training funding base from the NIH or significant external sources of funding, in addition to demonstrated scientific accomplishments and management structure. In response to a request from the Board, the FIC is identifying institutions within developing countries that already receive significant NIH or other support which could provide the base for additional ICORE funding; a preliminary list of institutions was provided to the Board.
The proposed ICORE structure includes four components: a central administrative core, which would be funded at the foreign institution; a clinical science core, which would include biomedical and behavioral interventions; a developmental science core, which would focus on the training and career development of young scientists; and a technology transfer science core, which would support demonstration projects, operational research, and continuing education. Dr. Bridbord noted that the central administrative core is critical for achieving sustainability which the FIC could facilitate through training in grantsmanship. Centers could focus on various research areas, but would be expected to have strong competence in infectious diseases and to build competence in one or more areas of chronic diseases (e.g., mental health disorders, cardiovascular disease, cancer) as decided by the foreign institution. More than one U.S. collaboration could be established to promote these research programs.
The FIC envisages long-term, multidisciplinary awards to foreign and collaborating U.S. institutions to support training and research capacity building. Dr. Bridbord estimated that total funding for each center and associated research training awards could amount to up to $1 million per year.
In closing, he noted several advantages of the ICORE approach. An ICORE program would help develop sustainability, give institutions the needed glue and leverage to integrate many other activities funded by the NIH and other organizations, have a ripple effect in attracting other partners and resources, and enable the FIC to efficiently manage its own program growth.
Discussion
Dr. Keusch highlighted four key themes in the ICORE concept: the bringing together of multiple disciplines to focus on core international research and ethics issues, the development of a critical mass of multidisciplinary researchers to "think outside the box," the extension of responsibility to recipient institutions in developing countries, and the creation of sustainable regional capacity and resources. He anticipated that many NIH institutes and centers will elect to become partners in the program.
The Board was very supportive of the ICORE concept, noting that the FIC will use a relatively small amount of additional funds to build on a decade of international investment in research training for positive effect. Members commented on a similar effort in India where the Government of India successfully combined in-country resources to support centers of excellence in neuropsychiatric genetics. U.S. institutions, including the NIMH, collaborated in this effort. Key factors in the success of this effort included emphasis on high-quality science, participation of in-country investigators, and enthusiastic acceptance by local scientists. It was noted that such efforts nevertheless may involve significant hurdles (e.g., potential corruption and graft) which must be acknowledged and addressed by the collaborating partners. The Board also noted that study of successful country-wide public health efforts (e.g., in Costa Rica) may illuminate other, non-disease, models for achieving positive health outcomes which could be a focus of research in the centers.
The Board encouraged the FIC to consider further the potential contribution of the ICORE program to the goal of reducing health disparities, evaluation criteria for assessing the effects of the program, and ways to avoid duplication of research efforts. It was noted that research conducted in the centers should be mutually beneficial to the host country and the United States and that "sustainability" does not connote assured, continued funding from the FIC or NIH.
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IX. REPORT ON CONFERENCE -- CHALLENGES IN HEALTH DISPARITY IN THE NEW MILLENNIUM
Dr. Cutberto Garza reported briefly on a conference convened by the Office of Research on Minority Health (ORMH), NIH, entitled "Challenges in Health Disparity in the New Millennium: A Call to Action. Held in Washington, D.C., on April 16-19, 2000, the conference attracted approximately 2,000 participants. The three objectives were to recommend a framework for the ORMH to address U.S. and international health disparities; highlight the role of ORMH in addressing these issues through basic and clinical biomedical and behavioral research; and promote partnerships with congressional leaders, industry, and other Federal agencies. Dr. Garza noted that the participants' principal recommendation was that the ORMH should be elevated to center or institute status at the NIH. Other issues that were addressed related to inadequate access to health care and bias in receiving health care, both of which compromise health outcomes.
Dr. Garza noted that, for some health outcomes, minority groups appear to be advantaged. Some Hispanic Americans have lower-than-expected infant mortality and cardiovascular disease rates, compared to other minority groups and the majority population. He also alluded briefly to other population groups, such as Pima Indians, that are not migrating and, yet, are undergoing changes in disease patterns as their dietary and behavioral patterns change. Dr. Garza suggested that the FIC could play a role in facilitating international collaborative research on biological, environmental, and behavioral factors and changes that may be contribute to such differences.
X. 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.
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XI. REVIEW OF APPLICATION
A total of 73 applications requesting $5,899,563 in FY 2000 funds were reviewed by the FIC Advisory Board as follows:
9 applications for Senior International Fellowship (SIF) awards requesting $369,000;
39 applications for Fogarty International Research Collaboration Awards (FIRCAs) requesting $1,522,380;
2 applications for AIDS-FIRCA awards requesting $80,640;
22 applications Minority International Training Awards (MIRT) awards requesting $3,907,543; and
1 application for a conference award requesting $20,000.
The Board concurred with the initial review group recommendations for 73 proposals, recommending $5,899,563.
XII. ADJOURNMENT
The meeting was adjourned at 3:00 p.m. on May 16, 2000.
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