Home > About Fogarty > Advisory Board > Meeting Minutes Archives > 09-15-1998

September 15, 1998 Meeting Minutes

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
Fortieth Meeting

 

Table of Contents

Attendance
1. Call to Order
2. Consideration of Minutes of Previous Meeting
3. Review of Requirements for Confidentiality and Conflict of Interest Procedures
4. Future Meeting Dates
5. Report of the Director
6. Board's Presentatio to Mr.Schambra
7. Fogarty International Research Collaboration Award (FIRCA): Introductory Comments
8. FIRCA Life: A View From the "Hood"
9. FIRCA in Russia: The Large Impact of a Small Investment
10. FIRCA: The Peer Review Prespective
11. Discussion
12. Closed Portion of the Meeting
13. Review of Application
14. 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, September 15, 1998, 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 12:55 p.m., followed by the closed session for consideration of grant applications until adjournment at 3:00 p.m. Dr. Philip E. Schambra presided as Chair.

Board Members Present:

Dr. Francisco J. Ayala
Dr. Marvin Cassman
Dr. Margaret A. Chesney
Dr. Rita R. Colwell
Dr. Philip C. Hanawalt
Dr. Samuel L. Katz
Dr. Adel A. F. Mahmoud
Dr. Thomas E. Malone
Dr. Cora B. Marrett
Dr. Donald O. Nutter

Board Members Absent:

Dr. Thomas W. Cole, Jr.
Dr. Carl Kupfer
Mr. Thomas J. McAndrew

Members of the Public Present:

Ms. Fil Fontelo, FIC Volunteer
Dr. Mary-Claire King, University of Washington, Seattle

Federal Employees Present:

Ms. Frances Anderson, FIC/NIH
Ms. Susan Bettendorf, FIC/NIH
Mr. Amar Bhat, FIC/NIH
Dr. Joel Breman, FIC/NIH
Dr. Kenneth Bridbord, FIC/NIH
Ms. Stephanie Bursenos, FIC/NIH
Ms. Paula Cohen, FIC/NIH
Ms. Irene Edwards, FIC/NIH
Mr. Robert Eiss, FIC/NIH
Mr. Gray Handley, NICHD/NIH
Ms. Susan Harrison, FIC/NIH
Ms. Mildred Hatton, FIC/NIH
Dr. Kevin Hardwick, NIDR/NIH
Dr. Ruth J. Hegyeli, NHLBI/NIH
Dr. Allen Holt, FIC/NIH
Dr. Sharon Hrynkow, FIC/NIH
Dr. Josefa Ippolito-Shephard, FIC/NIH
Ms. Julie Kaneshiro, OD/NIH
Ms. Silvia Mandes, FIC/NIH
Dr. Leonid Margolis, NICHD/NIH
Ms. Christina McLauchlan, FIC/NIH
Dr. Kathleen Michels, FIC/NIH
Mr. Richard Miller, FIC/NIH
Ms. Sharon Nieberding, FIC/NIH
Dr. Joshua Rosenthal, FIC/NIH
Dr. Philip E. Schambra, FIC/NIH
Ms. Rita Singer, FIC/NIH
Ms. Jahna Stanton, FIC/NIH
Ms. Natalie Tomitch, FIC/NIH
Dr. Sandy Warren, CSR/NIH

OPEN PORTION OF THE MEETING

I. CALL TO ORDER

Dr. Philip E. Schambra, Director, FIC, called the open session of the Advisory Board meeting to order at 8:35 a.m. on Tuesday, September 15, 1998. He welcomed all attendees and introduced a new Board member, Dr. Margaret A. Chesney, who had been unable to attend the previous meeting. Dr. Schambra noted that the terms of three Board members will expire in January 1999, before the next Board meeting. These members are: Dr. Philip C. Hanawalt, Dr. Adel A.F. Mahmoud, and Dr. Thomas E. Malone. Dr. Schambra presented each with a certificate of appreciation and thanked them individually for their contributions to the Board and FIC.

On a sadder note, Dr. Schambra commented on the unfortunate deaths of Dr. Jonathan Mann and his wife, Dr. Mary Lou Clements-Mann, in the Swissair crash. Dr. Mann was very influential in the development and implementation of FIC's AIDS nternational Training and Research Program and was a member of the Expert Advisory Panel to Review NIH/FIC International Activities, convened by Dr. Harold Varmus.

Dr. Schambra informed the Board that, after a nationwide search, Dr. Gerald Keusch has been selected to serve as FIC Director and, simultaneously, NIH Associate Director for International Research. Dr. Schambra will step down as FIC Director on September 30 and plans to retire from Federal service by the end of 1998. He thanked the Board for its commitment to the FIC and said that his tenure as director had been a rich and rewarding experience

Dr. Keusch is Professor of Medicine and Chief, Division of Geographic Medicine and Infectious Diseases, at Tufts University School of Medicine and New England Medical Center. He also serves as Scientific Director of the Health Group at the Harvard Institute for International Development. Dr. Keusch is an internationally recognized expert in infectious diseases who has conducted NIH-supported and other studies in various regions of the world. He serves on a number of committees and boards related to international programs and activities. Dr. Schambra noted that Dr. Keusch has met with him and FIC staff over the past several months and that the FIC is extremely pleased and impressed by the personal and professional qualities that Dr. Keusch will bring to the FIC and NIH. His appointment is expected to begin officially on October 1, pending approval by the Secretary of the Department of Health and Human Services (DHHS).

II. CONSIDERATION OF MINUTES OF PREVIOUS MEETING

The minutes of the Advisory Board meeting of May 19, 1998, were considered and accepted unanimously.

III. REVIEW OF REQUIREMENTS FOR CONFIDENTIALITY AND CONFLICT OF INTEREST PROCEDURES

Dr. Schambra 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, February 9, 1999
Tuesday, May 18, 1999
Tuesday, September 28, 1999

Tuesday, February 8, 2000
Tuesday, May 16, 2000
Tuesday, September 19, 2000

Dr. Schambra asked Board members to inform Ms. Irene Edwards, Executive Secretary, of any scheduling conflicts they may have with the future dates. All subcommittees of the Board will meet on the Monday preceding each Board meeting.

V. REPORT OF THE DIRECTOR

The written Report of the Director was distributed previously to Board members, was available at the meeting, and is appended to these minutes as Attachment 2. Dr. Schambra highlighted several items and reported on additional activities. Mr. Richard Miller, Executive Officer, FIC, presented an update on FIC's budget for Fiscal Year (FY) 1999

FIC Personnel

Four changes have occurred among FIC personnel, as described in Dr. Schambra's written report. Ms. Linda Staheli, Acting Director, Division of International Research, left FIC in August to pursue an independent consulting practice. Dr. Sharon Hrynkow is serving as Acting Director of this division concurrently with her position as Special Assistant in the Office of the Director, FIC. Dr. Charles Gardner, FIC's Program Officer for Africa and the Middle East, has left the FIC to become Science Attaché at the U.S. Embassy in India, a position held by Dr. Schambra from 1984 to 1988. Dr. Gardner succeeds Mr. Gray Handley, who held the position for the past 5.5 years and has now returned to the NIH.

Ms. Linda Reck, a Health Science Policy Analyst in the FIC Office of International Science Policy and Analysis, left the FIC on September 11 to return to a position in the NIH Office of AIDS Research (OAR). Within OAR, she will be responsible for planning and evaluation of NIH AIDS activities and for coordination of NIH international AIDS activities. Dr. Schambra noted that all of these individuals will be deeply missed at the FIC and reflect the high quality and superior service of the personnel recruited to the FIC in recent years. For additional details regarding FIC, NIH, and DHHS personnel changes, see the written report.

FIC Budget

Mr. Miller reported that the congressional appropriations committees have taken action on the NIH FY 1999 budget, but that neither the full House nor Senate have voted on the appropriations bill. The President's Budget for the NIH is about $14.8 billion, or an 8.4 percent increase over FY 1998, one of the larger increases by the Administration in recent years. The House Appropriations Committee proposes to increase this budget by $99 million to $14.9 billion, for a 9.1 percent increase, while the Senate Appropriations Committee has proposed $15.6 billion, or a 14 percent increase. Because a number of issues need to be resolved, the NIH expects to be operating under a continuing resolution for the first several weeks of FY 1999, which begins on October 1, 1998.

For the FIC, the President's Budget is about $30.3 million, or a 7.4 percent increase over the budget for FY 1998. The House Appropriations Committee proposes basically to support the President's Budget, increasing it only about $50,000, while the Senate Appropriations Committee has proposed a significant increase, to $35.4 million, or about 25.5 percent higher than in FY 1998. The committee's report highlights five areas for FY 1999: expansion of FIC's program on emerging infectious diseases, expansion of international training efforts to combat biological warfare agents, increased efforts against tuberculosis, expansion of FIC's initiative in medical informatics in sub-Saharan Africa and extension to other world regions, and increased opportunities for U.S. and foreign women scientists.

Dr. Schambra noted the difficulty of developing firm plans for FIC's programs when funds have not yet been appropriated. As in any given year, staff currently are dealing with three different budgets: closing out FY 1998, anticipating action on FY 1999, and developing plans for FY 2000. Dr. Schambra commented that FY 1998 has been one of FIC's most favorable budget years during the 10 years he has served as FIC Director and that the FIC is well positioned programmatically and financially for future advancement.

Program Developments

AIDS International Training and Research Program (AITRP). Dr. Schambra reported that the FIC received 24 applications in the recompetition for this program, 16 of which were from new applicants. All applications were reviewed for scientific merit by a Special Emphasis Panel convened by the National Institute of Allergy and Infectious Diseases (NIAID) in June. Second-level review will be conducted by the FIC Advisory Board during the present meeting. Several NIH components (the OAR, the National Institute of Dental Research, the National Institute of Mental Health, and the National Institute on Drug Abuse) have contributed a total of $2 million to support meritorious proposals under this program in FY 1998, which will be in addition to the $7 million allocated by the FIC.

Tuberculosis International Training and Research Program. Nine proposals were received for the limited competition for tuberculosis-related supplements to the AITRP and/or FIC's International Training and Research Program in Emerging Infectious Diseases. These proposals will be reviewed for scientific merit in mid-September by an NIAID Special Emphasis Panel, and the FIC Advisory Board will conduct its second-level by mail shortly after the present meeting. The total support available for this program in FY 1998 is expected to be more than $1 million, contributed by the FIC ($625,000), the U.S. Agency for International Development (about $375,000), and, recently, NIAID ($125,000).

International Cooperative Biodiversity Groups (ICBGs). Six ICBGs have been chosen for new 5-year awards from a total of 22 proposals. The awards include three competing renewals and three new starts, including one for projects in Vietnam and Laos. The awards are expected to be made at the end of September. Additional details on these and other FIC activities are presented in the written Report of the Director.

NIH Leadership Forum

Dr. Schambra reported on the 5th annual NIH Leadership Forum which was held September 8-9 at Airlie House in Virginia. International health research was one of three items for discussion at this meeting of the NIH leadership. The other two topics were: ethical issues in medical research, and health disparities among racial, ethnic, and economic groups. Representing the FIC at the meeting were Dr. Schambra and Dr. Keusch; participating as well were Board members Dr. Marvin Cassman, Dr. Carl Kupfer, and Dr. Barry Bloom (who has recently accepted Secretary Shalala's invitation to be a member of the Board).

In introductory and concluding remarks at the forum, Dr. Varmus outlined his views on the importance of international health. He commented on the following points: the enhanced role of the FIC as a result of combining the FIC directorship with the new position of NIH Associate Director for International Research; the need and opportunity for more financial resources for international health; new challenges in global health (e.g., bioterrorism, biological warfare); the potential for NIH to play a larger role globally; and the evolution of thinking concerning ethical issues in international medical research. With regard to resources, Dr. Schambra noted that the FIC budget is only about two-tenths of 1 percent (0.002 percent) of the total NIH budget, but accounts for about one-seventh or one-eighth of NIH's total expenditures for international health activities.

The session on international health included presentations from three NIH institute directors who gave examples of the types of activities possible and the ways of accomplishing them. Dr. Anthony Fauci, Director, NIAID, described the recently developed multilateral initiative on malaria as a type of "bottom-up" development. Dr. Richard Klausner, Director, National Cancer Institute, described the Middle East Cancer Consortium, which can be characterized as a "top-down" effort. Dr. Carl Kupfer described the broad and major impact that the National Eye Institute has had on prevention of blindness and cataract in India. The session ended with a presentation by Dr. Bloom on ethical issues associated with international research. Dr. Varmus offered concluding remarks about the importance of hearing from other NIH components about their international programs, the usefulness of establishing an interagency group to identify pertinent policy issues to be addressed, and the need for additional resources.

Adding to Dr. Schambra's report, Dr. Cassman commented on the complexity of ethical issues in medical research involving human subjects, particularly when these subjects are "vulnerable" populations, a term that can be defined in many different ways. He noted that the issues, which include concerns about informed consent and privacy, are not going to be resolved immediately. Rather, the discussions about them will evolve over time and will necessarily include different perspectives and participants, including the scientific community.

Back to top ^

VI. BOARD'S PRESENTATION TO DR. SCHAMBRA

On behalf of the Board, Dr. Thomas E. Malone honored Dr. Schambra for his accomplishments as FIC Director. The Board presented him a Tiffany globe as a gift and wished him well in his retirement. On the evening preceding the Board's meeting, the members also honored Dr. Schambra at a dinner organized by Dr. Adel A.F. Mahmoud.

In presenting the Board's gift, Dr. Malone noted that, with Dr. Schambra's vision and leadership, the FIC has been transformed from an isolated operation with three or four programs and little interaction with other NIH components, Federal agencies, or the international community to a completely different organization that initiates innovative collaborative research and training programs focused on major global issues. To achieve this transformation, Dr. Schambra masterminded FIC's first program plan, recruited excellent staff, developed intensive collaborations with other NIH components, and achieved co-funding and co-programming with other Federal agencies, international organizations, and even foreign countries. The Board applauded Dr. Schambra.

Dr. Schambra thanked the Board and the staff, saying that his accomplishments would not have been possible without their support and leadership. For this, he said, he is deeply grateful.

VII. FOGARTY INTERNATIONAL RESEARCH COLLABORATION AWARD (FIRCA): INTRODUCTORY COMMENTS

Dr. Schambra introduced the main agenda topic for the meeting: an updated perspective on the FIRCA. Five speakers addressed the topic. FIC staff described the current program and the changes that are being proposed in the program; a former and a current grantee presented their impressions of the program and its value to their research and their collaborating scientists; and an NIH Scientific Review Administrator provided a peer review perspective.

Background on the Current Program

Mr. Robert Eiss, Director, Office of International Science Policy and Analysis, FIC, reviewed the purpose, evolution, and benefits of the FIRCA program. The FIRCA is a small grant awarded to an NIH-supported grantee to foster research collaboration between the NIH grantee and investigators in developing nations and former Socialist economies. The award provides $20,000 in direct costs each year for 3 years to purchase materials and support travel. As noted by Dr. Varmus, the FIRCA is a useful lubricant for these types of collaborations.

During a formative period (FY 1990-92), the FIC, in response to congressional and other encouragement, sought to increase collaboration with investigators in South and Central America, regions that then accounted for only 4 percent of all international grants awarded by the NIH. Small awards were made initially to NIH intramural scientists. After the first year, this effort was expanded to include collaboration with investigators in Central and Eastern Europe, which were undergoing major democratic reforms. By FY 1992, the FIC had gained sufficient funding to support a full-fledged program of 42 awards, now known as FIRCAs, which were made available to extramural scientists. Over the next several years, the FIRCA program was expanded to developing nations in Asia, Africa, and the Middle East.

Between FY 1992 and FY 1997, the FIC supported 245 FIRCAs. Of these, the greatest number of FIRCAs (74) supported collaborations with Russian investigators; the greatest number (53) were made to U.S. grantees of the National Institute of General Medical Sciences; and a large percentage (43.9 percent) were awarded to scientists at 14 leading U.S. universities, many of which have extensive NIH-supported international portfolios. In all, 17 NIH institutes and centers and 78 U.S. universities participated in the program. Since FY 1992, more than 660 new FIRCA applications have been reviewed, and award rates have generally been 30 percent or higher.

Mr. Eiss noted that the FIRCA program has been viewed as a model for similar efforts offered by other institutions. The benefits may far outweigh the modest sum of each award. They include not only the research materials that can be bought, but also the sustenance and facilitation of science and intellectual capability in resource-poor areas of the world. In FY 1992, FIC's expectations for the program were threefold: it would introduce peer review and investigator-initiated research in areas of Soviet influence, collapse the geographic isolation of researchers around the world, and enable NIH-supported scientists to gain access to new research tools and populations to enhance or redirect their research. Mr. Eiss noted that these expectations often have been met.

A sampling of the research projects supported by FIRCAs shows that, at its most productive, this award mechanism has enabled U.S. scientists to reconceptualize their studies and thereby obtain important new insights, and to access research expertise in other countries. Research results made possible by FIRCAs have sometimes been the basis for investigators' recompeting applications for NIH grants. In closing, Mr. Eiss noted that the FIRCA was Dr. Schambra's "brainchild" and that, using this award, the FIC has been able to meld NIH's scientific objectives with broader developmental and diplomatic needs.

Proposed FIRCA Program Changes

Dr. Kathleen Michels, Program Officer, Division of International Training and Research, FIC, reviewed the reasons for changing the FIRCA program and the proposed changes. She noted that Dr. Varmus's External Advisory Panel to Review NIH/FIC International Activities endorsed the FIRCA program and that the program has been successful in fostering scientific development in foreign countries and in encouraging U.S. scientists to participate in international health research.

Recently, however, the number of applications for FIRCAs has declined. To ascertain the reasons for this decline, FIC staff spoke informally with applicants, potential applicants, and grantees. The reasons cited include (a) the small amount and declining monetary value of the award, (b) ineligibility because of insufficient time remaining on the parent grant, and (c) inadequate salaries and meager funding of foreign collaborators in their home countries.

FIC followed up these informal consultations with a formal survey of grantees who did not reapply for a FIRCA. This survey indicated a high level of satisfaction with the program, as well as the need for changes. The 64 grantees who responded to the survey offered the following reasons for not reapplying: not enough time remained on their parent grant (30 percent of respondents), their project was completed (38 percent), the collaboration would continue without FIRCA funding (14 percent), and FIRCA funding was insufficient to accomplish project goals or was not worth the time and effort of reapplying (14 percent). The other reasons cited (by 38 percent) included: not realizing they could reapply, did reapply but was not funded, renewal of parent grant was in progress, and emphasis of collaboration changed from that of the parent grant.

To accommodate these difficulties and to maintain the excellence of the program, the FIC proposes to make several changes in the program. These proposed changes were provided to the Board prior to the meeting. They are: (1) Increase the maximum allowable direct cost of the FIRCA from $20,000 to $32,000 per year, which includes a 40 percent adjustment for inflation, $2,000 for the foreign investigator to attend a related scientific conference, and a stipend up to $5,000 for the foreign investigator when justified; (2) drop the time that must remain on the parent grant from 19 months (18 months for the AIDS-FIRCA) to 12 months for both FIRCA programs; and (3) increase the scientific flexibility of the award to support a broader range of research activities in the same general area as the parent grant if justified.

The proposed changes have been incorporated into a revised draft of FIC's Program Announcement for the FIRCA. Dr. Michels noted that the FIC already has received NIH approval to increase the amount of the award to $32,000. She welcomed the Board's comments and suggestions on the proposed changes.

Back to top ^

VIII. FIRCA LIFE: A VIEW FROM THE "HOOD"

Dr. Mary-Claire King, American Cancer Society Professor of Medicine and Genetics, Division of Medical Genetics, Department of Medicine, University of Washington, Seattle, described her experience as a new FIRCA grantee. She is completing the first year of two FIRCAs, which are supporting collaboration on breast cancer research with investigators in Chile and in Hungary. Drawing on her expertise in medical genetics, Dr. King also spoke on the potential niche for FIRCAs in supporting collaborations in human genetics. In conclusion, she commented on the proposed changes for the FIRCA program.

Two Collaborations: Chile and Hungary

One of Dr. King's FIRCAs is supporting collaboration with investigators at the University of Chile, Santiago. This research is directed toward identification of families in Chile who have multiple cases of cancer. Because genes that predict breast cancer have been identified (BRCA-1, BRCA-2), the researchers are first targeting breast cancer, which is rare in Chile and therefore likely to be genetic in origin. The ultimate aim is to clarify the genetic component of breast cancer and of other cancers (e.g., stomach, gall bladder) that are more common among Americans of Hispanic ancestry. With FIRCA support, Dr. King's team is able to transfer genetic epidemiology techniques to Chilean investigators and to gain access to population data that would be difficult to obtain in the United States. The collaborators are working toward submitting an R01 application to support this project when the FIRCA ends.

Dr. King is also transferring human genetics technology to Hungary where she is collaborating with an investigator who has previously had a successful FIRCA with another U.S. investigator. In the current study, the collaborators are tracking the expression of ancient mutations in BRCA-1 and BRCA-2, which are found in families of Hungarian ancestry, through generations to define specific rates of cancer, and the nongenetic risk factors that influence these rates, as these families have moved to different parts of the world, including the United States. Dr. King is using the FIRCA support to "springboard" the Hungarian team to another funding source (e.g., the Soros Foundation, World Health Organization, Howard Hughes Medical Institute).

Dr. King suggested that, for international collaborations, FIRCAs offer the essence of the NIH ideal. They support investigator-initiated, peer-reviewed, hypothesis-driven projects whose budgets support essential material costs, whose review and administration are not bureaucratized, and whose work is focused on the science. Administering the FIRCAs, she noted, is an FIC staff that is exceptional for its experience in the science and in international fieldwork and for its flexibility and helpfulness to grantees. She emphasized that the international experience of FIC staff is enormously valuable for such collaborations and is generally not available among other NIH staff

A Niche for FIRCAs: Human Genetics

Dr. King suggested that the revolutionarily rapid development of genomics will offer an expanding niche for international research supported by FIRCAs in the next few years. As work is completed on the human genome project, research to identify and characterize critical genes responsible for complex traits (e.g., cardiovascular disease, inherited forms of cancer, diabetes, mental illness, autoimmune diseases) will accelerate. Population studies will be essential to "reduce" the biological heterogeneity of any of these traits and to identify common environmental triggers. Emphasis will be given to research on large family groups, individuals of the same ancestry or sharing the same environment, isolated populations, and groups in which a trait is extremely common. The ability to work with populations in other and various parts of the world will be essential for comparative studies (e.g., of schizophrenia, systemic lupus erythematosus).

Dr. King noted that this type of research already is raising concerns about privacy, confidentiality, and informed consent. She emphasized that these concerns must be addressed and that the interests of the public and scientific community, worldwide, must be incorporated into the research. Investigators who have recently made claims about "owning the DNA" of China or being able to "sell Iceland" are two examples of the possibilities that can develop if proper scientific and public scrutiny is not maintained.

Dr. King suggested that FIRCAs "offer a way" through these ethical and scientific "mine fields" by directly engaging U.S. and foreign investigators in mutually designed projects that are valuable scientifically but may be difficult to carry out because of cultural differences, concerns about ethical and informed consent issues, and the participation of vulnerable populations. To highlight the value and use of FIRCAs, she described two potential human genetics studies that could be conducted in Israel (on inherited deafness) and in Holland and China (on the relation between famine and schizophrenia). In each instance, the FIRCA would build on existing research to clarify genetic influences of the trait in an historically important population. By using the FIRCA mechanism, the NIH can allocate a small amount of funds for a "high-risk" project that could have enormous payoff.

Comment: The Proposed FIRCA Changes

Dr. King commented on four characteristics of the FIRCA: the timeframe, the funding amount, the expectations for FIRCA grantees, and renewal awards. She favored the 3-year timeframe as "just right": it allowed sufficient time and flexibility to assess the feasibility of the study, to resolve major crises, to identify additional collaborative personnel, and to adjust budgets and goals. She agreed that increasing the funding amount to $32,000 and including a small salary supplement for foreign investigators was appropriate. Regarding expectations, she felt that it was unrealistic to expect all FIRCAs to lead to NIH-supported R01s but that it is realistic to expect that they will lead to additional training for foreign investigators and U.S. postdoctoral investigators. Finally, Dr. King suggested that FIRCAs should be viewed as one-time, small grants that are useful to "lubricate the system," rather than grants that can be renewed continually.

Discussion

Responding to a question about the availability of FIRCAs to support behavioral or social science research, FIC staff noted that the awards are, by design, an extension of NIH-supported parent grants and reflect the applications received from the extramural community. FIRCAs are available for hypothesis-driven research in any research area and for any grantee supported by the NIH. The Board suggested that the availability of FIRCAs for behavioral and social science research should be advertised more widely and could help bridge the gap between biomedical and behavioral research. It was proposed, and staff agreed, that the revised Program Announcement should include examples of behavioral and social science research, as well as basic biomedical studies.

The Board also suggested that staff give serious thought to placing more emphasis on limiting the FIRCAs to projects that require international collaboration (e.g., because of foreign expertise, facilities, populations, or environmental circumstances) and could not otherwise be accomplished in the United States.

See section XI below for the Board's continued discussion of these suggestions during the "Open Discussion" part of the agenda.

Back to top ^

IX. FIRCA IN RUSSIA: THE LARGE IMPACT OF A SMALL INVESTMENT

Dr. Leonid Margolis, Head, Unit on Intercellular Interaction, Laboratory of Cellular and Molecular Biophysics, National Institute of Child Health and Human Development (NICHD), NIH, presented a brief historical perspective on science in Russia, reasons for supporting FIRCAs for Russian and Eastern European scientists, and suggested changes for the FIRCA. In 1994-95, Dr. Margolis was a Fogarty Scholar in Residence, during which time he reported to the Board on the state of Russian science. Previously, as a scientist educated and working in Russia, he received support from a FIRCA for research on liposomes, conducted in collaboration with investigators at The Johns Hopkins University. Dr. Margolis is currently conducting his research at NICHD.

Science in Russia

Dr. Margolis noted that Russian science has a magnificent past, having been at the "cutting edge" of physics in the 18th and 19th century and of mathematics and biomedicine since the 19th century. The Russian scientists Mechnikov and Pavlov were awarded Nobel Prizes for their discoveries, and, because of its many wars, the country developed the world's best military medicine. With the arrival of communism in 1917, everything changed. The Communists were ignorant about science and thwarted any scientists or ideas that contradicted the writings of Marx and Engels. The most vulnerable fields were physics and, particularly, biology and biomedicine, where outdated notions and theories were prescribed and political connections assured a scientist's position and funding.

Despite these impediments, a few true scientists remained and were able to sustain their careers. Paradoxically, gifted Russian thinkers found that science offered them a venue for maintaining their intellectual freedom and Russia's strong intellectual traditions. With the collapse of communism in 1991, funds to support science and scientists' salaries disappeared. Fortunately, at this critical moment of "to be or not to be," international grants became available, from the Soros Foundation and from the FIC, through its FIRCA.

Investing in Russian Science

Dr. Margolis suggested the following reasons for supporting Russian or any other foreign science: Science is international, although good scientists will emigrate to practice their science and will always be welcomed by other countries; preserving research teams is critical to modern science; some scientists will quit science rather than move to other countries; and the emigration of established scientists threatens future generations of scientists who will not benefit from their teaching and supervision.

Dr. Margolis asserted that international grants, such as the FIRCA, are an investment in international science from which the entire world benefits. Even with the FIRCA's small amount of funds, which is a significant sum for foreign scientists, good science can be accomplished, important face-to-face interactions can be achieved, and necessary laboratory materials can be purchased. Three important characteristics of the FIRCA for Russian scientists are its availability to talented young scientists, its award based on peer review, and the distribution of funds directly to investigators. For Russia, the FIRCA is a substantial award and has had a tremendous impact on Russian science over the past 7 years. Dr. Margolis noted that probably the most important impact of the program has been its availability to young scientists, who still have difficulty obtaining research funds within the corrupted Russian system.

Suggested Changes for the FIRCA

Dr. Margolis suggested several ways to modernize the FIRCA to accommodate changes in the world. These included provision of a small salary for foreign collaborators; allowing for the transfer of equipment to a foreign laboratory for the duration of the grant; making surplus equipment available to foreign collaborators; reinstating the intramural FIRCA program; and broadening the eligibility for FIRCAs to foreign scientists who do not have prior connections with an NIH grantee and who could submit applications for FIRCAs directly to NIH grantees through the World Wide Web.

Dr. Margolis noted that provision of a small salary (e.g., $200 per month for 2 years) would be especially helpful to young Russian scientists at this time, for both their support and their morale. He also noted that his intramural colleagues at the NIH have expressed a desire to apply for FIRCAs to support collaborations with scientists in Eastern Europe and other regions. Elaborating on his last suggestion, Dr. Margolis proposed that U.S. investigators could screen the FIRCA applications they receive and select ones to submit for NIH peer review. The broadened eligibility and application process, which could be advertised in scientific journals of Eastern Europe, could result in an influx of fresh, new ideas into science and would even further enhance the funding options for young Russian scientists.

Discussion

The Board thought that the suggestion to broaden the eligibility for FIRCAs to all scientists is worth exploring. Major considerations would be the number and type of communications (e.g., abstracts, proposals, or applications) that potentially could be forwarded to NIH grantees and the amount of time they would have to review them. Members noted that prior connections can be advantageous for assuring that a research collaboration can be accomplished. Staff suggested that the FIC could serve as a "middleman" to introduce potential collaborators. (See section XI below for the Board's continued discussion of this topic during the "Open Discussion" part of the agenda.)

The Board considered further the possibility of FIRCA renewals, suggesting that the initial award continue to be for 3 years and that 2-year extensions be allowed if needed. To facilitate submission of FIRCA applications, which can be delayed when scientists have to rely on foreign postal systems, the Board encouraged the FIC to promote electronic-mail submission at the NIH, a capability that is already available at the National Science Foundation (NSF). Electronic-mail communications are essential for international research collaborations.

The Board suggested modifying the draft Program Announcement for FIRCAs to state that requests for computers would be considered. It also was suggested that the FIC and NIH could be aggressive about obtaining donated computer equipment from industry for this type of international collaboration. (See section XI below for the Board's continued discussion of this topic during the "Open Discussion" part of the agenda.)

Commenting on potential areas of collaboration with Russian scientists, the Board noted that there are tremendous opportunities for biomedical and behavioral research on diet and hypertension, as well as other critical disease issues.

Back to top ^

X. FIRCA: THE PEER REVIEW PERSPECTIVE

Dr. Sandy Warren, Scientific Review Administrator, Center for Scientific Review (CSR), NIH, presented a CSR perspective of the FIRCA program and outlined the peer review process for FIRCA applications. He reviewed the objectives, purpose, and characteristics of the program. He noted that the objective is to facilitate collaborative research efforts between U.S. and foreign scientists. The purpose is to expand and enhance U.S. scientists' research programs for the benefit, extension, enhancement, and new direction of these scientists, while benefiting the foreign collaborators' scientific interests. In contrast to a typical R01, a FIRCA involves a minimum of two scientists (the U.S. and foreign investigators) and two performance sites. The award of $20,000, which is considered small by U.S. standards, is substantial for foreign scientists.

U.S. applicants for the FIRCA must be principal investigators or program directors on NIH-supported grants. Although the parent grants are primarily R01s, some are P01s (program projects); also eligible are U grants or cooperative agreements. Applications must be submitted by U.S. scientists, but a portion of the application is completed by the foreign scientist. The receipt dates for applications are March 25, July 25, and November 25.

Dr. Warren noted that the FIRCA represents a true collaboration and is a good example of an international outreach program intended to enhance and advance science. FIRCA applications have been reviewed by the NIH International and Cooperative Projects (ICP) Study Section since February 1995. The applications reviewed by the study section cover a broad range of subjects, although most tend to be in the fields of molecular biology, biochemistry, cell biology, and neurobiology. The study section consists of 18 members (including 8 women and 5 minorities) and is very broadly multidisciplinary.

FIRCA applications are evaluated in a different context and with a different mind set than R01 applications. The challenge is to evaluate the science in a collaborative mode and to assess the relationship of two distinct scientific enterprises. High-quality science and logical presentation are as important as in an R01 application, but reviewers must also learn and implement certain nuances in their review (e.g., looking for a good match of expertise, a synergy of effort, and research productivity of the investigators). Dr. Warren said that the ICP reviewers appreciate the diversity and shortness (< 10 pages) of the applications they review; they have been known to characterize their membership in the study section as "citizenship without pain."

Some of the problems noted in FIRCA applications are as follows: a duplication of the specific aims of the parent grant; an unclear benefit to a foreign collaborator (e.g., the research planned is to be conducted only in the United States); lack of collaboration; failure of investigators to read the instructions: and not staying within the page limitations of the application. Dr. Warren noted that he strives to ensure a "level playing field" for all applicants (e.g., by limiting all applications to 10 pages) and to constrain investigators' attempts at gamesmanship.

Frequent mistakes made by FIRCA applicants include: submitting poorly written or vague research proposals, failing to present a hypothesis, and proposing phenomenological versus mechanistic research. Other weaknesses include: lack of preliminary data; limited experience of the principal investigator; the foreign collaborator's lack of publications, limited training, inexperience with the research techniques, lack of unique expertise or knowledge; failure to demonstrate the value of the collaboration; poorly conceived experiments; lack of rationale; failure to show a compelling reason to conduct the research in the foreign country; emphasis on training rather than research; and failure to address data interpretation and statistical analysis.

Dr. Warren reviewed the ABCs of grant writing, as presented in an article entitled "How to Wow a Study Section: A Grantsmanship Lesson," which was published in The Scientist on March 2, 1998. This guidance includes asking someone to critique the completed application before submitting it; presenting research that is hypothesis-driven not technique-driven; focusing on two to four aims; stating the potential impact of the research; presenting preliminary data using readable typefaces and fonts; conveying the excitement of the research; discussing interpretation of the data and alternative hypotheses; organizing the presentation; and contacting program administrators to clarify any questions.

Dr. Warren noted that convincing the study section members of the value of the research and of the particular proposal is critical. In closing, he said that working with the members of the ICP Study Section, who devote much time and effort to the peer review of others, is a distinct joy.

Back to top ^

XI. DISCUSSION

The Board focused on proposed changes for the FIRCA program. The members considered further four suggestions presented earlier (see sections VIII and IX): limiting FIRCAs to research that is uniquely international and cannot otherwise be done in the United States; broadening FIRCA eligibility to scientists who do not have prior connections with NIH grantees; providing equipment to foreign collaborators; and encouraging increased participation of behavioral and social science researchers.

The Board agreed that, although priority could be given to research that is uniquely international or difficult to accomplish in the United States, the FIRCA is a cost-effective and important mechanism for supporting good science and good scientists anywhere in the world. Science is an international endeavor, and the FIRCA can be used to expand and advance science quickly and effectively.

The Board continued to question whether the broadening of eligibility to scientists who do not have prior connections with NIH grantees is feasible. Two particular concerns were: the number and quality of applications likely to be sent to NIH grantees over the Internet, and the importance of face-to-face interaction between scientists prior to establishing a research collaboration.

The Board encouraged FIC staff to explore ways of "moving" equipment to foreign collaborators. Possibilities include the transfer of surplus equipment, the donation of equipment by industry, and the loan of equipment by academia. The Board suggested that the FIC could develop a relationship with U.S. Embassies to handle shipping and customs procedures. It was noted that the MacArthur Foundation has handled similar shipping and customs requirements for years. Dr. Schambra said that FIC would follow up on these suggestions.

To foster the participation of behavioral and social science researchers in the FIRCA program, the Board made two suggestions: add special reviewers to the ICP Study Section, as needed, to review FIRCA applications that include behavioral or social science research; and to provide Dr. Warren's guidance (see section X above) to potential applicants. Dr. Warren indicated that the addition of ad hoc reviewers to the study section is problematic because they may not readily understand the special objectives and nuances of the FIRCA mechanism. The Board suggested that FIC staff address these problems and possible solutions.

The Board also considered three additional suggestions: extending FIRCA eligibility to grantees of non-NIH funding sources (e.g., NSF); interagency collaboration on areas of mutual interest; and using the FIRCA mechanism to support the return of young foreign scientists to their home countries.

The Board strongly encouraged the FIC to pursue the possibility of extending the FIRCA to non-NIH grantees. Discussions between the FIC and NSF's International Division are particularly warranted. Staff indicated interest in this follow-up and noted that the FIC already collaborates with the NSF to support Bioprospecting Awards, a mechanism similar to the FIRCA.

Dr. Schambra noted further that, beyond the FIRCA program, the FIC could explore other opportunities for interagency collaboration in areas where the NIH shares aims, mechanisms, and common agendas with the NSF and other agencies. One possibility would be minority international research and training programs.

The Board encouraged the FIC to consider allowing the FIRCA to support the return of young foreign scientists from the United States to their home countries. Staff noted that the FIRCA was not designed for this purpose, but has been used in this way on occasion. It also was noted that the FIC is entering discussions with NIAID to explore the possibility of establishing a different, K-type mechanism to provide support for foreign scientists, particularly from sub-Saharan Africa, who are returning to their home countries from the NIH intramural program. Staff indicated that a variety of possibilities could be explored for the FIRCA program (e.g., reopening the program to NIH intramural scientists; encouraging three-way partnerships between intramural scientists, NIH grantees, and foreign collaborators).

Asked for his specific comments on the FIRCA program, Dr. Schambra said that one of the main characteristics of the FIRCA has been its broad, encompassing nature, not limited to any geographic region or any science or health problem. He noted that the program was intended to provide general FIC support for the conduct of international science by the NIH components and that the program was structured to assure maximum opportunity and maximum access to the resources available with a minimum of bureaucratic requirements. Key features of the program have been the quality of the science conducted by the NIH grantee, the quality of the science proposed in the FIRCA application, and a strong rationale and good relationship for coupling the original grant and the FIRCA.

Changes to the FIRCA Program Announcement

In discussion, the Board approved the following changes to be made in the revised Program Announcement: (a) add a statement, within the context of allowable expenses, that the FIRCA would support purchase and shipping of new equipment; (b) include a statement about extending eligibility for FIRCAs to non-NIH grantees on a selective basis and subject to discussion and mutual agreement by both agencies.

Two additional changes to the Program Announcement, which were suggested and approved earlier by the Board, were: (c) to add examples of behavioral and social science research (see the "Discussion" under section VIII above), and (d) to note that requests for computers can be included in FIRCA applications (see the "Discussion" under section IX above).

Motions

The Board made and unanimously approved several specific motions. These were to: (1) increase the FIRCA award to $32,000; (2) reduce the eligible time remaining on the parent grant to 12 months; and (3) provide a maximum of $5,000 per year, if well justified, as a stipend to support the salary and travel of foreign collaborators.

In closing, staff said that the FIC will move vigorously to incorporate all the changes into the FIRCA program and, at the same time, maintain the flexibility of the program.

XII. 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.

XIII. REVIEW OF APPLICATION

A total of 46 applications requesting $9,678,934 in FY 1998 funds were reviewed by the FIC Advisory Board as follows:

• 5 applications for the International Training Program in Medical Informatics requesting $820,219;

• 14 applications for the AIDS International Training and Research Program (AITRP) requesting $8,461,215;

• 8 applications for Senior International Fellowship (SIF) awards requesting $292,500;

• 18 applications for FIRCA awards requesting $45,000; and

• 1 application for AIDS-FIRCA awards requesting $60,000.

The Board concurred with the initial review group recommendations for 46 proposals, recommending $9,678,934.

XIV. ADJOURNMENT

The meeting was adjourned at 3:00 p.m. on September 15, 1998.

Back to top ^