Home > About Fogarty > Advisory Board > Meeting Minutes Archives > 02-09-1999
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-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
- New Directors for Fogarty Programs
- Report on Consultative Group Meeting
- FIC Budget
- History of Medical Bioethics
- International Ethical Guidelines for Human Subjects Research
- Discussion
- 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, February 9, 1999, 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 12:32 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. Marvin Cassman
Dr. Margaret A. Chesney
Dr. Thomas W. Cole, Jr.
Dr. Rita R. Colwell
Dr. Samuel L. Katz
Dr. Adel A. F. Mahmoud
Dr. Cora B. Marrett
Mr. Thomas J. McAndrew
Dr. Donald O. Nutter
Board Members Absent:
Dr. Francisco J. Ayala
Dr. Barry R. Bloom
Members of the Public Present:
Dr. Robert J. Levine, Yale University School of Medicine, New Haven, Connecticut
Dr. David J. Rothman, Columbia University, New York, New York
Dr. Angela Sharpe, Consortium of Social Science Associations, Washington, D.C.
Federal Employees Present:
Dr. Sharon Hrynkow, FIC/NIH
Dr. Josefa Ippolito-Shephard, FIC/NIH
Ms. Julie Kaneshiro, OD/NIH
Dr. Richard Krause, FIC/NIH
Dr. Gerald T. Keusch, FIC/NIH
Ms. Silvia Mandes, FIC/NIH
Ms. Christina McLauchlan, FIC/NIH
Ms. Ellie Menser, FIC/NIH
Dr. Kathleen Michels, FIC/NIH
Mr. Richard Miller, FIC/NIH
Ms. Charlotte Quinn, FIC/NIH
Dr. Joshua Rosenthal, FIC/NIH
Dr. Chris Schonwalder, NIEHS/NIH
Ms. Barbara Sina, FIC/NIH
Ms. Rita Singer, FIC/NIH
Dr. Scott Somers, NIGMS/NIH
Ms. Natalie Tomitch, FIC/NIH
Dr. Sandy Warren, CSR/NIH
Dr. Judith Whalen, NICHD/NIH
Ms. Christine Banks, FIC/NIH
Dr. Andrea Baruchin, NIDA/NIH
Dr. Kate Berg, NHGRI/NIH
Ms. Susan Bettendorf, FIC/NIH
Dr. Joel Breman, FIC/NIH
Dr. Kenneth Bridbord, FIC/NIH
Ms. Stephanie Bursenos, FIC/NIH
Dr. Virginia Cain, OBSSR/NIH
Dr. Jeffrey Cohen, OPRR/NIH
Dr. Lois K. Cohen, NIDCR/NIH
Ms. Nancy Coulter, FIC/NIH
Ms. Donna Dean, OD/NIHM
Ms. Irene Edwards, FIC/NIH
Mr. Robert Eiss, FIC/NIH
Dr. Ruth Fischbach, OD/NIH
Dr. Christine Grady, NINR/NIH
Mr. Gray Handley, NICHD/NIH
Dr. Kevin Hardwick, NIDCR/NIH
Dr. Ruth J. Hegyeli, NHLBI/NIH
Dr. Allen Holt, FIC/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 8:35 a.m. on Tuesday, February 9, 1999. This was the first Board meeting chaired by Dr. Keusch who, on October 1, 1998, became Director, FIC, and Associate Director for International Research, NIH. Dr. Keusch said he was pleased to have the opportunity to work with the Board, and he thanked Dr. Adel A. F. Mahmoud for agreeing to extend his participation through the current meeting.
Dr. Keusch commented on the nomination and approval process for new Board members. Areas of emphasis in identifying candidates to fill three vacancies on the Board are international health and nutrition, bioethics, and genetics. Dr. Keusch invited Board members to suggest potential candidates.
Dr. Keusch announced that the FIC will undertake a formal strategic planning process, which will culminate in the production of a formal plan by the end of calendar year 1999. The planning process is being initiated in response to a request from Dr. Harold Varmus, Director, NIH, of all institutes and centers (ICs) at the NIH. Preparatory to this effort and also at the request of Dr. Varmus, the FIC convened an ad hoc Consultative Group Meeting on December 17 to discuss priorities for allocating FIC's budgetary increase for FY 1999 (see section VII below for a report on this meeting).
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II. CONSIDERATION OF MINUTES OF PREVIOUS MEETING
The minutes of the Advisory Board meeting of September 15, 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.
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, May 18, 1999
Tuesday, September 28, 1999
Tuesday, February 8, 2000
Tuesday, May 16, 2000
Tuesday, September 19, 2000
Dr. Keusch 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
Dr. Keusch highlighted several changes in FIC and NIH personnel. 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. Philip E. Schambra stepped down as Director, FIC, on September 30, 1998. On January 1, 1999, he retired from the Federal Government. Dr. Keusch noted that a very warm and well-deserved reception was held at the Lawton Chiles International House to celebrate Dr. Schambra's 30 years of contribution to the Government and to international research. At the reception, Dr. Schambra received a book of congratulatory letters from colleagues around the world and a letter of appreciation from President Clinton.
Dr. William Harlan, Associate Director for Disease Prevention, NIH, was appointed Acting Director, Office of Alternative Medicine, for the transition of this Office to the National Center for Complementary and Alternative Medicine. Dr. Keusch met with Dr. Harlan and discussed the potential for international collaborations.
Within the FIC, Dr. Sharon Hrynkow was named Director, Division of International Research (DITR), FIC; formerly, she was Acting Director of the division. Ms. Cynthia Palmer, who is trained in environmental and occupational health sciences and law, joined the FIC as a Special Expert in the Office of International Science Policy and Analysis. Dr. Sudha Srinivasan, who is trained in genetics and molecular biology, joined the FIC as Program Officer for Africa and the Middle East, DITR.
Additional information on these and other personnel changes are presented in the Director's written report.
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VI. NEW DIRECTIONS FOR FOGARTY PROGRAMS
Dr. Keusch presented his perspective on FIC and NIH's role in international research and a strategic vision for building future programs. He invited the Board and other attendees to comment on the new directions proposed for FIC.
FIC/NIH Role in International Research
Dr. Keusch noted that, with Dr. Varmus' leadership and interest in international health, the FIC and NIH are presented with an extraordinary opportunity to mobilize resources and opportunities in international health research. He emphasized that the NIH is a research institution and that it can most appropriately influence the global health agenda by focusing on research issues and opportunities for interventions (i.e., translational research). He also noted that although interventions per se are the responsibility of other institutions, the research questions addressed by the NIH must be considered within the context of these interventions. Dr. Keusch cited the example of the global vitamin A intervention program. A number of research questions have yet to be addressed in this program (e.g., how to intervene, when to intervene, how to improve intervention) and could be addressed by the NIH in collaboration with the U.S. Agency for International Development (USAID), which already participates in the program.
The FIC is the NIH component that has a mandate to address international issues that bridge the gaps between fundamental and translational research and implementation of interventions. The FIC acts as a catalyst and carries out its mandate in collaboration with other NIH components. Dr. Keusch said that he has begun to meet with the IC directors and the NIH advisory councils to discuss FIC's role and to engage their interest in the global health agenda. As Associate Director for International Research, NIH, he also has an opportunity to convey Dr. Varmus' interest in an enhanced international research agenda and can speak for the NIH when interacting with other organizations such as the World Health Organization (WHO).
Dr. Keusch suggested that, with expanded interest and opportunities, the NIH could reasonably expect to increase its expenditures for international research from 2 percent to 4 percent of the total NIH budget. He cautioned that such an investment would be sizable and must be meaningful for both the United States and its partners abroad. Under
Dr. Schambra's leadership, the FIC and NIH had already begun to address many major global health issues: emerging diseases such as AIDS, re-emerging diseases such as tuberculosis, loss of biodiversity, environmental effects, and population and health.
"Building a House"
Dr. Keusch noted that the charting of FIC's new directions can be viewed much like "building a house." Within this scheme, FIC's platform consists of a twofold mission: to build research capacity in poor and transitional economies, and to create collaborative research networks with U.S. institutions and scientists. The foundation of FIC's "house" consists of four areas fundamental to achieving FIC's mission: molecular genetics, genomics, and other basic sciences; clinical research; bioethics; and medical informatics. Dr. Keusch said, in this regard, that the FIC will pursue opportunities for mutually beneficial basic studies, especially genetics research; design a program to develop a well-trained cadre of clinical investigators; develop a bioethics program that incorporates a forum for continuing, international discussions of culturally relevant bioethical issues and the training of internationally recognized, competent individuals with expertise in bioethics; and continue to promote its new program in medical informatics. Dr. Keusch said that many of FIC and NIH's international programs are built on these four fundamental areas.
FIC's current programs can be grouped into five areas: medical informatics, biodiversity, environmental and occupational health, population and demography, and human immunodeficiency virus (HIV) infection and emerging infectious diseases. In comments on these program areas, Dr. Keusch said that the FIC will expand the medical informatics program, continuing to emphasize both Africa and malaria while also extending the program geographically to other regions (Latin America and the former Soviet Union). He cited FIC's biodiversity program, a very successful and maturing program that is yielding results, as an example of a productive interagency collaboration that addresses a need thoughtfully and well. The environmental and occupational health program, also a maturing and successful collaborative effort, will receive further attention and support, and the FIC will give careful attention to its population and demography program to address the critical demographic and health changes occurring in developing countries. He noted that FIC's strongest program area, HIV infection and emerging infectious disease, has been extremely successful and deserves increased support.
Dr. Keusch highlighted four initiatives included in FIC's congressional budget for FY 2000: bioethics policy and training; environment, ecology, and infectious diseases; maternal and child health; and health and economic development. International bioethics is a new area for the FIC and NIH, which the Board addressed later during the meeting (see sections IX and X below). Dr. Keusch noted that the FIC is discussing a potential collaboration with other NIH components, the National Science Foundation, and other agencies to better understand the relationships between environment, ecology, and infectious diseases. This collaboration would be modeled on FIC's successful collaboration on the International Cooperative Biodiversity Groups; a Request for Applications (RFA) would be issued, with funding to begin in FY 2000. With the National Institute of Child Health and Human Development (NICHD), the FIC is developing a program to provide training opportunities in maternal and child health. This program would complement anticipated NICHD support of U.S. research centers in maternal and child health, which would address both domestic and international issues. The FIC will be issuing an RFA for the training program, with funding to begin in FY 1999. To address the relationship of health and economic development and the role of the NIH in this area, the FIC will convene a consultative group in spring 1999.
FIC's agenda also includes establishment of productive and strategic alliances with other organizations. More cooperative and complementary interactions are needed with other Federal agencies (including USAID), foundations, the World Bank, and WHO and other multilateral organizations. Dr. Keusch noted that discussions are under way with USAID to add an NIH research agenda to USAID interventions in specific areas. Similar discussions will be held with the Centers for Disease Control and Prevention. For its health and economic development initiative, the FIC already has engaged the World Bank in planning for the spring consultative group meeting. And, the FIC has involved the Wellcome Trust in discussions of a bioethics initiative.
Future prospects for international research that need to be addressed specifically include nutrition, vaccine trials and infrastructure development, clinical research training, chronic diseases, and support of international centers of excellence for research in developing countries. In closing, Dr. Keusch noted that FIC's agenda addresses several cross-cutting concerns for the NIH: health and economics, the interface between research results and policy, and research applications to medical care and public health.
Discussion
The Board said it was pleased about FIC's new directions, the effort to build on the strengths of existing programs, and the emphasis on public health. It was suggested that the definition of intervention research that could be supported by the FIC deserves further consideration and discussion. The Board emphasized the need for collaborations across the NIH and suggested that the FIC could play an important liaison role, promoting IC partnerships and cooperation for international health research. Dr. Keusch noted that the FIC recognizes this opportunity and that his NIH colleagues have responded positively to the possibility of enhanced collaborations. He also noted that he hopes to create a "think tank" on international health research at the FIC which would provide an intellectually challenging environment for scientists who could come for short-term visits to identify and discuss major issues.
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VII. REPORT ON CONSULTATIVE GROUP MEETING
Dr. Samuel L. Katz commented on the discussions of the ad hoc Consultative Group that met at the NIH on December 17. The FIC convened this group of five distinguished scientists to discuss priorities for allocating FIC's substantial budgetary increase for FY 1999. This increase amounted to $7.2 million, a 25.7 percent increase over FY 1998. Dr. Katz, who represented the Board at the meeting, noted that Dr. Varmus participated fully in the discussions. The Summary Report of the Consultative Group Meeting was distributed to the Board and was made available to all attendees.
Dr. Katz reported that the Consultative Group discussed the FIC's program and policy priorities for FY 1999 (as described above by Dr. Keusch). The group also addressed expansion of FIC's role in international research and opportunities for collaboration. The group suggested that the FIC could influence policy discussions at other Federal agencies, such as the U.S. Department of State, U.S. Department of Defense, and USAID, by promoting NIH's platform for investment in international research and international programs. Similarly (as noted by Dr. Keusch), the FIC could act on NIH's behalf to discuss and influence the policies of relevant non-Federal sectors (e.g., the pharmaceutical industry, the food and agriculture industry) and multinational bodies (e.g., WHO). The FIC could foster discussions on a wide range of global health issues, such as ways to overcome barriers (e.g., cost of drugs, patenting, intellectual property rights) to the availability of new therapies for developing countries; expanded access to communication and information technology; health and safety of food (i.e., food technology and microbiology); long-term effects of tobacco use in developing countries; and cardiovascular disease.
Dr. Katz remarked that the current climate for international research is more favorable than in the past and that the American public and Congress appreciate that research investments abroad directly benefit the health and the economy of Americans. He reported that the group felt very optimistic about FIC's future directions and Dr. Keusch's new leadership for "a wonderful program" begun by Dr. Schambra. He also noted that the group was "realistically concerned" about the availability of new monies with which to expand FIC's programs. In closing, Dr. Katz commented that the group expressed hope that the FIC would continue with a series of consultative discussions. He encouraged the Board members to read the group's report.
VIII. FIC BUDGET
Mr. Richard Miller, Executive Officer, FIC, presented an update on FIC's budget for FY 1999 and budgetary initiatives for FY 2000. The FIC budgets reflect the new directions charted by Dr. Keusch (see section VI above).
FY 1999. Mr. Miller reported that the NIH budget for FY 1999 is $15.6 billion, a $2.0 billion (14 percent) increase over FY 1998. The FIC budget for FY 1999 is $35.4 million, a $7.2 million (25 percent) increase over FY 1998. FIC's FY 1999 budget includes the following changes: an increase of about $1.9 million for AIDS activities; an increase of about $1.4 million for the International Training and Research Program in Emerging Infectious Diseases, with emphasis on tuberculosis and malaria; small budgetary increases for the International Training and Research Program in Environmental and Occupational Health and for the International Cooperative Biodiversity Groups program; an increase to enhance the Fogarty International Research Collaboration Award (FIRCA), including an increase in allowable direct costs from $20,000 to $32,000; and an increase to expand the International Training Program in Medical Informatics.
New initiatives for FY 1999 include the following: FIC funding of the Minority International Research Training program, in addition to the funds provided by the NIH Office of Research on Minority Health, to enhance training opportunities for minorities and, particularly, women; support for an International Maternal and Child Health Research and Training program in collaboration with NICHD; funding of an International Research Scientist Development Awards program for U.S. postdoctoral biomedical and behavioral scientists in the formative stages of their careers to pursue careers in international health research; and support of workshops to focus on specific areas. Planning is already under way for a workshop on ecology and infectious diseases, to be held in April, and two workshops, on bioethics and on health and economic development, to be held in the summer.
FY 2000. The President's Budget for FY 2000, which was submitted to the Congress on February 1, includes $15.9 billion for the NIH and $36.3 million for the FIC, representing increases of 2.1 percent and 2.4 percent, respectively, over FY 1999. Mr. Miller noted that these increases still reflect the commitment of the President and the Administration to enhance the NIH budget by 50 percent over 5 years.
FIC initiatives in the FY 2000 President's Budget for the NIH include start-up funds to support an Ecology and Infectious Disease program ($450,000), a Bioethics program ($320,000), and a Health and Economic Development program ($252,000). These programs will be supported by a combination of funds from FIC's AIDS and non-AIDS budgets and by funds redirected from FIC's Scholars-in-Residence program.
In closing, Mr. Miller said that the Senate Appropriations Subcommittee hearings for the NIH will be held February 23. For the House Appropriations Subcommittee hearings, Dr. Varmus will testify on February 24 and the FIC is scheduled to testify on February 25.
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IX. HISTORY OF MEDICAL BIOETHICS
Dr. David J. Rothman, B. Schoenberg Professor of Social Medicine, Columbia University, New York, New York, presented a brief, historian's perspective on the evolution of bioethics in the United States and highlighted some of the implications of this history for the FIC and NIH. Complimenting the FIC on adding bioethics to its global research agenda, he emphasized that the integration of bioethics into research programs is vital and makes the programs much more effective and relevant.
Dr. Rothman distinguished medical ethics, which has a long tradition dating back at least to Hippocrates, from bioethics, which arose in the 1960s outside of medicine. He noted that, whereas medical ethics was largely a matter of professional discourse among physicians, bioethics is the substance of public discourse. He said that, since the 1960s, bioethics has transformed medical decision-making in the United States in four ways: by shifting responsibility for medical decisions from health professionals to patients; by collectivizing this decision-making; by formalizing the decision-making and relying on regulations, guidelines, and codes; and by emphasizing, in an unprecedented way, patient autonomy.
Critical Moments
Noting that "beginnings count," Dr. Rothman described three critical moments in the evolution of bioethics in the United States. He said some historians date the beginning of bioethics to the invention of dialysis machines for patients with end-stage renal disease. With this invention, for the first time, the demand for a life-saving technology outnumbered the machines available. Unwilling to assume responsibility for deciding which patients would have access to the machines, physicians turned to lay persons to make these decisions. As a result, for the first time, the public became involved in medical decisions and medical ethics, these issues were covered widely by the popular media, and decisions were made by formal committees following formal procedures.
Dr. Rothman noted that even more dramatic and critical for the emergence of bioethics was the crisis atmosphere that surrounded early efforts in human experimentation. Henry Beecher's 1966 article about this subject in The New England Journal of Medicine (NEJM) provoked strong reactions by the public, which led to critical policy decisions by the NIH regarding support of clinical research. Dr. Rothman noted that congressional pressure and NIH action to define rules and regulations for investigators resulted in a quicker and more effective regulation of this research in the United States than occurred elsewhere. The markers of bioethics in this case were reliance on collective judgment (institutional review boards), formal regulations, elevation of informed consent as the expression of a subject's autonomy, and wholesale involvement of the public in medical decision-making.
The third critical moment that firmly implanted bioethics within medical decision-making occurred in 1976 with the case of Karen Ann Quinlan. The outcomes of this case were collectivized judgment (the ethics committee), formal and prospective intervention by the court as a legal arbiter, assurance of a patient's autonomy even when incompetent, and widespread media coverage and public discourse of medical decision-making.
Implications for the FIC and NIH
Dr. Rothman highlighted four implications of this history for FIC and NIH's discussions of bioethics for international research. First, he emphasized that the evolution of bioethics in the United States has been "home-grown and idiosyncratically American," an internal, insular development in response to particular problems within the United States. He noted, for example, that the Nuremberg Code, developed internationally, had little effect on U.S. regulations of human experimentation and American medicine. The markers of bioethics in the United States (e.g., regulations, informed consent, public and media involvement) are peculiarly American. He noted that, in fostering bioethical sensitivities abroad, U.S. investigators have much to offer (e.g., a long tradition in medical ethics,
35+ years of experience in addressing and resolving bioethical issues), but must understand that their experience is U.S.-focused. A key question for the FIC and NIH will be how to reshape this focus to be relevant to other countries, developed or developing. Dr. Rothman cautioned, "Don't for a moment underestimate the gaps."
Second, Dr. Rothman noted that medical decision-making in the United States has extraordinary public visibility. In Europe and, especially, in developing countries, medical issues are generally not discussed in the public arena. A key question for the FIC and NIH will be how to translate this type of intense public involvement to other countries.
Third, Dr. Rothman cited the importance of beginning to parse the principles that follow from this intense public involvement in medical issues. It will be important to understand the influence of these principles on the ethical behaviors of U.S. investigators conducting international research abroad, where the public may not be as involved as in the United States.
Fourth, Dr. Rothman added that the evolution of bioethics in the United States includes a particular concern for vulnerable populations, the definition of which is broad and expansive in this country. This orientation is important to American bioethics but may not be shared by other countries. A key question for the FIC and NIH is how to encourage investigators from other countries to "see things from the bottom up."
In closing, Dr. Rothman commented that the powerful change that has occurred in medical decision-making is still evolving and is a very important consideration when trying to build research capacity. Citing the historian's ultimate conceit, he said "time will tell" whether the issues are confronted successfully.
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X. INTERNATIONAL ETHICAL GUIDELINES FOR HUMAN SUBJECTS RESEARCH
Dr. Robert J. Levine, Professor of Medicine, Yale University School of Medicine, New Haven, Connecticut, commented on international ethical guidelines for research involving human subjects, the adequacy of U.S. institutional review boards (IRBs) to evaluate multinational research, and FIC's draft proposal to establish a bioethics program.
International Ethical Guidelines
Dr. Levine noted that three major international documents address the ethics of research involving human subjects: the Nuremberg Code, the World Medical Association's (WMA) Declaration of Helsinki, and the Council of International Organizations of Medical Sciences' (CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects. Commenting on these documents, Dr. Levine noted that the Nuremberg Code, written in 1947-49, is a historical landmark, but essentially a "dead" document. Written by U.S. lawyers and doctors, it requires the informed or voluntary consent of human subjects of research (competent, healthy adults), but does not deal with research on other types of persons or research that could be justified because of potential therapeutic benefit to the subject.
In 1953, the WMA repudiated the Nuremberg Code as a document written by jurists and not by physicians. The WMA convened an ethics committee that worked for 11 years to develop the document known as the Declaration of Helsinki. This document recognizes that some risks of research could be justified in terms of the potential benefits to subjects, introduces the concept of proxy consent (e.g., for children and persons with mental disabilities), and "coined" the term "therapeutic research." Dr. Levine noted that "therapeutic research," as defined in the declaration, is research that is called "compassionate use" in the United States (e.g., of an investigational drug). As such, the declaration is ill suited to provide guidance for the conduct of controlled clinical trials. WMA's attempts to revise the declaration to cover randomized clinical trials began with the 1975 revision, and they were manifested as minor changes, such as insertions of phrases in preexisting sentences. The net effect of these minor amendments was to compromise the value of the declaration.
In the late 1970s, CIOMS began development of a new document to provide guidance for interpreting the Helsinki requirements, particularly as they relate to research conducted in developing countries. Dr. Levine noted that the Proposed International Ethical Guidelines, issued by CIOMS in 1982, were well received and widely adopted by many professional societies and by many governments. In 1991, CIOMS began revision of these guidelines and, in 1993, issued the International Ethical Guidelines for Biomedical Research Involving Human Subjects, a comprehensive document that consists of 15 guidelines and commentary on the application of the guidelines in specific contexts.
More recently, the ethics of research conducted internationally has received attention. Dr. Levine cited an article by Wolfe and Lurie, and a companion editorial by Angell (NEJM, 1997), which criticized as unethical the placebo-controlled clinical trials of the short-duration regimen of AZT for the prevention of perinatal transmission of HIV. These trials, carried out in developing countries, were denounced as violating Article II.3 of the Declaration of Helsinki, which requires that all subjects in a clinical trial receive the "best proven diagnostic or therapeutic method." (Article II.3 is one of the logical flaws in the declaration that were created by characterizing all research as either therapeutic or nontherapeutic and by trying to force a fit of controlled clinical trials into the category of "therapeutic research." This error is to be corrected in the next revision of the declaration.)
The NEJM publications reopened international dialogue on the ethics of research involving human subjects that is conducted across national boundaries. Two responses have been generated. One, a report by the Pediatric AIDS Foundation, will be published shortly in The Lancet. The second, a document that is being prepared by the UNAIDS Project, is intended to provide guidance for the conduct of multinational trials of vaccines to prevent HIV infection. Dr. Levine noted two issues that have been difficult to resolve in this guidance and that continue to be topics of discussion and debate: what are the rights of participants in a trial who are exposed to, or develop, infection or disease, and what are the responsibilities of research sponsors to assure that products developed during a trial in a developing country are "reasonably available" to the residents of the country.
Review of Multinational Research by IRBs
Dr. Levine remarked that IRBs in the United States may be able to evaluate the scientific design of multinational research, particularly with the assistance of the NIH, and the risks and benefits of the proposed research. He emphasized that they are not competent, however, to evaluate aspects of the research that are culturally sensitive or specific
(e.g., informed consent protocols and procedures, confidentiality and privacy of information, material inducements to participate).
Draft Proposal for a Bioethics Program
Dr. Levine said he was delighted with FIC's proposal for a bioethics program. He highlighted the following features, included in the proposal, as especially important: the need to find an appropriate balance between ethical universalism and cultural pluralism (e.g., respect for persons may be universal, but personal autonomy is not); the convening of a steering group of representatives from international agencies and all regions; development of an interpretative or conflict-resolving body to assure just distribution of resources in an international context; education of clinical investigators and health care practitioners about culturally relevant ethics; sponsorship of bioethics workshops in developing countries; solicitation of proposals from sponsors in developing countries to partner with the NIH in convening these workshops; and exploration of how to interpret the U.S. Code of Federal Regulations governing human subjects research for applicability to international studies. He commented briefly on each of these features.
In closing, Dr. Levine emphasized that anthropologists who specialize in cross-cultural research should be included in the FIC and NIH discussions of bioethics. He noted that translations from one language to another may obscure meanings or create false assumptions that the parties to a discussion understand one another. Anthropologists can help create true understandings of meanings, many of which are rooted in culture-specific symbols. They can also help others understand how specific cultures form their views of morality as well as the power structures they develop to assure adherence to their moral standards.
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XI. DISCUSSION
Dr. Keusch thanked Drs. Rothman and Levine for presenting thoughtful remarks on the complexity of bioethics in the international arena. He noted that the NIH is probably the largest funder of clinical research and clinical trials internationally and that it has a responsibility to ensure that the investigations it supports meet the ethical guidelines governing the NIH and are appropriate to the context of the research. Inviting the Board and attendees to express their views on international bioethics and research, he said that the FIC will act on this input in developing its bioethics program.
The Board suggested that it would be useful to study how ethical issues (e.g., informed consent) are addressed within other international clinical research programs (e.g., in Egypt). Representatives from these programs could be invited to the NIH to discuss their experiences, for example, in the development of local infrastructure for vaccine trials. In addition, anthropologists and others who are knowledgeable about cultural differences in developing countries would be valuable resources who could provide critical insights on local sociocultural differences that might affect a community's receptivity to, and participation in, clinical trials research. It was noted that nuances between communities are important and that definitions of autonomy, personhood, and informed consent, for example, will reflect particular cultural contexts. In conducting international research, U.S. investigators will find it necessary to refrain from imposing U.S. constructs of bioethics and, instead, engage local communities in developing culturally specific constructs for research involving these communities. When discussing these bioethics issues, caution should be taken to guard against "essentializing" a culture, which can lead to stereotyping, and to balance cultural pluralism and ethical universalism.
The Board encouraged the FIC to reexamine, from a culturally sensitive perspective, the needs involved in bioethics for international research and the ways in which these needs have been, and could be, met. It was suggested that, in developing bioethics guidelines, emphasis is better given to identification of specific needs rather than lofty ideals or prescriptions based on U.S. experience. For example, citing the need for review of research protocols is much more useful and acceptable than announcing that IRBs must be established throughout the world. Similarly, citing the need for informed consent is more applicable than prescribing the specific legal and formal procedures for establishing consent that are used in the United States. It was noted that issues of trust and power are embedded in the negotiation of consent and reflect sociocultural differences.
Dr. Keusch emphasized that a truly collaborative effort must be launched to address the bioethics of international research. He also noted that the FIC and NIH must be cautious about taking ownership, or being accused of taking ownership, in this effort. The Board suggested that the FIC could create an international forum for partnership to facilitate discussions, but would need to be humble about its role in this partnership, allow others to lead in understanding cultural diversity, and be candid about U.S. bioethical issues that have yet to be resolved. It also was noted that, although the United States is a partner, much of the research conducted by U.S. investigators is done by these investigators within a developing country and, hence, the United States is both "the problem and the solution." The FIC was encouraged to convene the international forum in partnership with others and at a "neutral" multinational organization. Dr. Keusch emphasized the need for ongoing dialogue and discussion.
The Board agreed that training is an essential component of FIC's bioethics program, but cautioned that identification of persons to perform the training will be difficult. Few individuals from non-industrialized countries, and especially persons of color, are working on bioethical issues and the supply of potential role models or trainees for the program is limited. It was also noted that, although all institutions that have a research grant from the NIH or the National Science Foundation must have a program in ethics, these programs are variable and generally not of good quality. Further, U.S. medical schools are moving toward the formal teaching of ethics as a specialty.
The Board encouraged the FIC to "think beyond" the notion of a group of experts as sources for the training program and, instead, to seek individuals with varying experiences and from many different arenas that involve bioethics. It was suggested that the training issue for the FIC is not to create future bioethicists, but to create a structure that would foster development of alternatives, or variants, of bioethicists who could serve their own countries.
In closing, Dr. Keusch noted everyone's agreement on the need to initiate broad discussion of bioethics in international research and said that the FIC wishes to take leadership to get the process started.
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 34 applications requesting $977,000 in FY 1999 funds were reviewed by the FIC Advisory Board as follows:
5 applications for Senior International Fellowship (SIF) awards requesting $200,000;
14 applications for FIRCA awards requesting $335,000;
4 applications for AIDS-FIRCA awards requesting $99,000; and
11 applications for International Research Fellowship (IRF) awards requesting $343,000
The Board concurred with the initial review group recommendations for 34 proposals, recommending $977,000.
XIV. ADJOURNMENT
The meeting was adjourned at 3:00 p.m. on February 9, 1999.
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