Justification Narrative - Fogarty FY2011 Congressional Justification

Overall Budget Policy

FIC distributes its resources among many programs and mechanisms and is committed to funding the largest number of meritorious projects possible, while allowing the flexibility needed to support selected program priorities and to respond to emerging scientific opportunities. Funding decisions are based on the number of high-quality applications, the overall number of applications, and the availability of funds. FIC funds a large number of initiatives with collaborating funding partners that include other NIH Institutes/Centers, other government agencies, and non-government organizations. Funding decisions take into account program relevance and overall portfolio consideration, and all future years will be adjusted accordingly.

Funds are included in R&D contracts to support several trans-NIH initiatives, such as the Therapies for Rare and Neglected Diseases program (TRND), the Basic Behavioral and Social Sciences Opportunity Network (OppNet), and support for a new synchrotron at the Brookhaven National Laboratory, as well as increased support for other HHS agencies through the program evaluation set-aside.

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Research Capacity Strengthening

The development of appropriate and effective health interventions that address local needs and priorities requires a sustainable base of research sites and people in developing countries. The establishment of highly capable research institutions in these countries is critical to finding solutions to public health challenges, and to training the research workforce of the future. Over the past few decades, Fogarty investments have greatly enhanced the number of trained foreign investigators working at research institutions abroad. Fogarty is strengthening in-country institutions by investing in cross-cutting areas that help to provide a sustainable research environment. These areas include investment in information and communication technology, informatics training for global health research, training and curriculum development in research ethics, and research management.

Portrait of a Program: Global Research Training in Population Health

FY 2010 Level: $1.142 million
FY 2011 Level: $1.188 million
Change: $ .046 million

The FIC Global Research Training in Population Health (POP) program supports research training for developing country scientists and clinicians with the long-term objective of strengthening overseas research programs and institutions that investigate health and disease characteristics of the local population. Under the POP program, U.S. universities play a key role in building sustainable capacity through the provision of international research and training their foreign counterparts. The POP program enables these trained overseas scientists to contribute to the knowledge and evidence-base for local and global health efforts. Local scientists are critical for the communication and dissemination of scientific evidence that leads to the development of policies appropriate for their home countries and for the establishment of international guidelines.

The POP program has two primary lines of research inquiry: a) demographic processes, including aging, child health, adult health, mortality, morbidity, urbanization, and other social, behavioral, and economic factors that influence population dynamics, and b) reproductive health, including reproductive biology, fertility, contraceptive development and trials, and reproductive health evaluations. In FY 2011, in response to the Administration's commitment to improving global maternal and child health, Fogarty will expand and enhance the POP program to include further training opportunities for reproductive health and family planning. In much of the developing world, the health needs of women have been poorly characterized and understood. Research training in reproductive health is critical to addressing knowledge gaps that lead to high maternal morbidity and mortality rates and building a local cadre of scientists who can develop and implement effective health interventions for women around the world. For example, the POP program supports a partnership between the Virginia Commonwealth University and the University of Chile to provide research training in reproductive biology research, in areas that are critical to the health of the woman, including polycystic ovary syndrome, pre-term birth, and promoting healthy pregnancies.

Sustainable development of human resources for global health research

Throughout history, the U.S. has maintained leadership in scientific research through its commitment to academic exchange and the global sharing of skills and knowledge. Advances in global health are built upon a foundation of well-trained researchers from both the U.S. and overseas who work together to investigate major global health issues. To this end, FIC established the Fogarty International Clinical Research Scholars Program, which provides opportunities for new U.S. investigators seeking hands-on experience working in developing countries and pairs them to early career foreign health scientists who work alongside the U.S. trainee during the clinical research year. Simultaneously, research training of overseas scientists remains a high priority for Fogarty. Over the past 40 years, Fogarty training programs have helped to train over 5,000 investigators around the world. Well-trained researchers in developing countries provide scientific evidence with an understanding of the unique biological, epidemiological, social, and cultural contexts of the local community. In addition, prominent investigators of large population-based research in developing countries are often called upon by their Ministries of Health to help design and implement healthcare delivery programs for local populations, which provides additional opportunities for research on the translation of new scientific information to benefit larger populations.

Portrait of a Program: Strengthening the Research Enterprise

FY 2010 Level: $3.499 million
FY 2011 Level: $3.626 million
Change: $ .127 million

Information and Communication Technology - With increasing globalization, the need to monitor, diagnose and respond to epidemics has increased dramatically. Biological data need to be integrated with information technologies that can rapidly store, manage, and visualize data in order to bring the power of modern biology to development of treatments for disease, and rapidly deliver this information anywhere in the world. These advances in global health are facilitated and strengthened by researchers working together to share data, tools and knowledge. Since 1998, Fogarty has supported partnerships between the U.S. and international research institutions to increase the capacity of biomedical scientists to design, access and use modern information technology in support of health sciences research. These partnerships are training biomedical and behavioral scientists, engineers, clinicians, librarians, and other health professionals to access, manage, analyze, and share biomedical information electronically. They are also training individuals who will be capable of developing new informatics applications. This will increase the ability of local scientists and institutions to conduct multi-site clinical trials and perform international disease surveillance and prevention programs that will serve as regional centers of excellence for medical, genome, and global health informatics. In FY 2009, Fogarty awarded eight grants in the third competition for this innovative training program.

Research Ethics - With the growing volume of biomedical and health research conducted in low- and middle-income countries and the accompanying need for local research ethics capacity, Fogarty developed the International Research Ethics Education and Career Development Award program. This initiative supports U.S. and international research institutions to establish or expand current graduate curricula and training opportunities in bioethics related to performing research in developing countries. Its primary outcome is the advanced training of professionals who can assume the roles and responsibilities of bioethicists involved in ethical review of clinical investigations in their countries. Fogarty currently awards a total of $3 million to support 19 training programs that span four years in geographical areas such as Latin America, sub-Saharan Africa, Asia Pacific, Middle East and North Africa, South Asia, and Central and Eastern Europe. Since 2001, more than 330 trainees from developing countries have participated in this training program.

International Collaborative Research

The burden of chronic, non-communicable diseases is climbing at a rapid rate in the developed and developing world due to an aging worldwide population and economic development. Chronic, non-communicable diseases can rarely be pinpointed to a single cause. They are often complex in origin and in consequences, involve a variety of risk factors, and are usually accompanied by several other illnesses or symptoms. As such, international collaborative research across disease disciplines and across countries becomes more critical to meaningfully understand how to prevent, treat, or cure these illnesses. By studying the variation in the patterns of non-communicable diseases in populations around the world, we can begin to understand the extent to which genetics and the environment affect the risk and severity of disease. Many of these discoveries will have relevance to U.S. populations. Fogarty's research programs support research partnerships between U.S. and developing country scientists in a variety of high priority areas.

Portrait of a Program: Brain disorders and mental health around the globe

FY 2010 Level: $1.398 million
FY 2011 Level: $1.454 million
Change: $ .056 million

According to the World Health Organization, hundreds of millions of people worldwide are affected by mental, behavioral, and neurological disorders. Depression is ranked as the leading cause of disability worldwide. In addition, roughly 20% of the world's children and adolescents are estimated to have mental disorders or problems, with similar types of disorders being reported across cultures. Mental disorders have a heavy economic and social toll in industrial and developing countries alike.

In response to this high burden of brain and mental health disorders, Fogarty established an innovative program, Brain Disorders in the Developing World: Research Across the Lifespan. Under this program, grantees develop collaborative research programs that are helping to build sustainable research capacity in developing countries to study brain and mental health function, as well as design effective interventions. This program, in its eighth year, supports research on a broad spectrum of brain disorders such as learning disabilities, epilepsy, Alzheimer's and Parkinson's disease, schizophrenia and clinical depression. The program is also addressing the intersection between brain disorders and infectious diseases, as well as environmental exposures, e.g., the neuropathology of severe malaria and HIV dementia, and the neurobehavioral effects of mercury exposure.

The first phase of a project under this program consists of a two-year planning grant under which applicants further define the area of research to be developed; conduct pilot studies; and develop relationships between partners in the developed and developing world. The second phase of the program, supported in large part by several NIH Institutes, involves substantial collaboration and both research and capacity-building.

For example, collaboration between U.S. and Zambian scientists has highlighted the social and medical consequences of epilepsy-related stigma in sub-Saharan Africa. From the findings of their study, the researchers are implementing evidence-based interventions aimed at decreasing stigma associated with epilepsy. This improves the socioeconomic status of people with epilepsy and lowers the rate of seizure-related morbidity and mortality in four Zambian Provinces. Other studies examine the genetic origins of brain disorders such as microcephaly (when the brain fails to achieve normal size) and schizophrenia. Not only has this program fostered an understanding of neurological diseases abroad, but it has provided essential clues to treatment and prevention strategies that are applicable to both U.S. and worldwide populations.

Research Management and Support (RMS)

FIC's RMS provides administrative, budgetary, logistical, and scientific support to review, award, and monitor research grants, training awards, and contracts. It encompasses strategic planning, coordination, and evaluation of the Center's programs; regulatory compliance; international coordination; international science policy; and liaisons with other Federal agencies, Congress, and the public. Specific functions include an in-house epidemiology section performing mathematical modeling of infectious diseases; international program officers developing partnerships between U.S. scientists and institutions and their counterparts abroad to advance scientific research and training; identification of collaborative opportunities with foreign science funding agencies; and support for all NIH international travel by issuing and tracking official government passports and international visas; review and approval of Notice of Foreign Travel requests; and the creation and coordination of official travel cables to U.S. Embassies.

Recovery Act Implementation

Recovery Act Funding: $17.370 million

In FY 2009, the Fogarty International Center received $17.370 million under the Recovery Act. Of this amount, $10.297 million was obligated in FY 2009 and $7.073 million will be obligated in FY 2010. Fogarty has used its allocated ARRA funds to invest in strengthening human and institutional capacity to conduct cutting edge global health research. These investments include enhanced integration of information and communication technologies (ICT) into research and research training programs, strengthening multidisciplinary global health activities at U.S. academic research institutions, and increased global health research training opportunities for U.S. medical, graduate and post-doctoral students.

To keep pace with advances in ICT, Fogarty awarded funds to 23 institutions that train personnel to use IT in their research projects, develop innovative methodologies to tackle research challenges and facilitate distance learning. For example, Claremont Graduate University will create a virtual global health classroom to link students from multiple countries in a Pacific Rim research network to collaborate on issues related to tobacco use, obesity, diabetes, and alcoholism. The virtual classroom will incorporate live web conferencing, online course options, and distance-learning opportunities. In addition, ARRA funds will support research on the use of cell phones and PDAs to deliver health information to Chinese youth related to smoking cessation.

Fogarty also used some of its ARRA monies to support two of the NIH Challenge Grant proposals. One project is investigating how cultural beliefs related to diet, lifestyle, and society are acquired and passed on in two different populations, while another project is examining the effects of climate change on cholera dynamics and prediction. Three other successful NIH Challenge Grant proposals (all related to strengthening global health research at U.S. institutions) also received funds. Topics include research on childhood illnesses using hand-held electronic communication devices; developing distance-based learning initiatives to assist international study coordinators; and describing the link between heart disease and diabetes.

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