Congressional Justification for Fiscal Year 2016

Preparing a Diverse and Talented Biomedical Research Workforce

Fogarty's unique niche at NIH has been its support of innovative research training programs to address global health challenges. These programs are built on robust partnerships between U.S. and LMIC research institutions to train the next generation of scientists. For example, over the past 25 years, Fogarty has supported multi-disciplinary biomedical, behavioral, and social science research capacity strengthening for the prevention, care, and treatment of HIV/AIDS and HIV-related conditions. Fogarty trainees have been on the front lines of ground-breaking research on critical interventions including new treatment regimens, prevention of mother-to-child transmission of HIV, circumcision to prevent HIV transmission, and treatment adherence interventions. Fogarty continues to support these efforts with the current Fogarty HIV Research Training Program, which strengthens institutional capacity in LMICs to address emerging priorities in the HIV epidemic and to disseminate evidence to decision makers, health care providers, and the media.

Since 2010, the Medical Education Partnership Initiative (MEPI), led by Fogarty and supported by the U.S. President's Emergency Plan for AIDS Relief, and NIH, has been transforming medical education and research training for medical students, faculty, and other health professionals in Sub-Saharan Africa. MEPI supports training of future scientific leaders to solve their country's most pressing health problems - from HIV/AIDS to non-communicable diseases - and bolsters institutional capacity in African universities to effectively respond to challenges in priority health areas in their countries. Through MEPI, Fogarty will continue to foster the next generation of African faculty researchers by providing research training and mentored research opportunities specifically to junior faculty in MEPI-supported institutions.

Fogarty also supports U.S. postdoctoral scientists to pursue research careers focused on global health. The International Research Scientist Development Award invites these researchers to spend up to five years working in a LMIC under the guidance of U.S.-based and LMIC-based mentors. Among others, current projects include research on cost-effective prevention methods for cardiovascular disease in South Africa and India and the economic impact of community-based integrated health care systems in rural Rwanda.

Translating Discovery into Health

Fogarty's Framework Programs for Global Health Innovation supports interdisciplinary research training programs that focus on translating discovery into effective interventions, processes and policies. To increase the translation of research findings into realized health benefits, projects include implementation considerations appropriate to LMICs, such as affordability, accessibility, ease of use, and scalability. One project based in South Africa engaged experts in microbiology, anthropology, and engineering among other disciplines to develop a sustainable clay and paper filtration system to reduce diarrheal diseases among vulnerable populations.

Through the Multinational Influenza Seasonal Mortality Study (MISMS), and in partnership with HHS, Fogarty is supporting a collaborative effort to analyze national and global disease burden data associated with influenza virus circulation and to promote training in LMICs to enhance analytical capacity and data-driven decision making. MISMS models the epidemiology and evolutionary dynamics of influenza in human, swine, and avian populations, globally. The results of this research have helped target global surveillance efforts and guided seasonal influenza vaccine selection and recommendations on immunization strategies.

Harnessing Data and Technology to Improve Health

Fogarty recognizes the potential for new technologies to revolutionize research and research training, particularly in LMICs. Fogarty's eCapacity Initiative funds innovative research education programs that provide LMIC researchers with the knowledge and skills necessary to effectively incorporate information and communication technologies into global health research and research training activities. For example, a collaboration between researchers in the United States, Argentina, and Peru is developing telediagnostic tools to relay laboratory data through smart phones in high-volume, diagnostics labs and creating an online education program to train staff in multiple locations on its use.

Fogarty is also encouraging innovation in the development and implementation of mobile health technologies to address global health problems. In partnership with other NIH Institutes and Centers, Fogarty's Mobile Health: Technology and Outcomes in Low and Middle Income Countries (mHealth) program is helping to build the evidence base for mobile technology as a tool to improve health outcomes, especially in remote regions with minimal access to quality health care. Researchers in Nigeria, for example, are developing a disposable, cell phone-friendly device to screen for malaria and sickle cell anemia. By decreasing laboratory wait times; this diagnostic tool reduces the risks associated with delayed anti-malaria treatments.

Unraveling Life's Mysteries through Basic Research

Fogarty's International Cooperative Biodiversity Groups program supports research on the discovery of novel compounds and extracts from nature with therapeutic potential. For example, with evidence showing that invasive fungal diseases kill more people annually than either tuberculosis or malaria, scientists in the United States and Brazil are studying the symbiotic bacteria on ants that have evolved to kill microbes that invade the ant's nest. The findings from this research could lead to new antibiotics for drug-resistant microbes, a goal of a recent Presidential Executive Order, as well as new drugs for parasitic diseases and cancer.

As the world becomes more interdependent, Fogarty's unique partnerships and programs will continue to enable scientists in the United States and abroad to work together to tackle the most pressing and complex health problems of our time. Fogarty will continue to invest in future research leaders, who will build on their training experiences to push the frontiers of science and provide the evidence necessary to transform global public health.

Research Capacity Strengthening

Identification of priority health challenges and development of effective health interventions to address those challenges require a critical mass of U.S. and LMIC institutions that can conduct robust research and train the next generation of scientists to solve complex problems. These institutions can stimulate innovative and multidisciplinary research on locally relevant problems, generate effective and implementable solutions, and build a nimble and networked research workforce. Fogarty investments are strengthening U.S. and LMIC research institutions by supporting sustainable research environments and research infrastructure.

Budget Policy: The FY 2016 President's Budget estimate is $34.749 million, an increase of $0.652 million, or 1.9 percent above the FY 2015 Enacted level. Fogarty's Strategic Plan provides the pathway toward developing sustainable global health research and training programs where they are needed most. One goal of the plan is to mobilize the scientific community to address the growing epidemic of chronic, non-communicable diseases related to increased longevity and changing lifestyles in the developing world. To accomplish this, Fogarty continues to invest in this area, while also investing in the critical infectious diseases agenda. With the merging of several Fogarty AIDS programs into one called the HIV Research Training Program, Fogarty plans to increase funding by $1.2 million, supporting grants that focus on building or strengthening HIV-related capacity in a particular scientific or critical research infrastructure area at LMIC institutions.

Program Portrait: International Research Ethics Education and Curriculum Development Award (Bioethics)

FY 2015 Level: $4.1 million
FY 2016 Level: $4.1 million
Change: $0.0 million

If research institutions are to be sustainable platforms for cutting-edge science, they must be equipped to protect human subjects involved in research conducted by their investigators. In light of increased international collaborations and clinical trials abroad, trained individuals and institutional frameworks are needed to ensure that any research conducted is held to high ethical standards and human subjects are adequately protected. The success and credibility of clinical trials and other health research depend on strong, local ethics review boards and appropriate national regulations; therefore, building research ethics capacity in LMICs is critical.

Fogarty's International Research Ethics Education and Curriculum Development Award (Bioethics) program supports the development of culturally relevant bioethics curricula for LMIC scientists, as well as training future leaders who can advise LMIC institutions on formulating and strengthening local bioethics guidelines, building well-informed review bodies capable of evaluating research proposals, and training others in the principles of ethical research conduct. In the last decade, Fogarty has supported training for over 560 LMIC scientists, academics, and health professionals in master's level bioethics curricula.

Through the Bioethics Program, Nigerian grantee Dr. Clement Adebamowo has provided ethics training to over 1,000 West African researchers, drafted the Nigerian National Code for Research Ethics, and established a web-based research protocol tracking system for the country. Notably, the National Health Research Ethics Committee of Nigeria, chaired by Dr. Adebamowo, recently published a statement on the ethics of using innovative interventions in emergency situations, such as the drug ZMapp for victims of Ebola. The Committee concluded that it is ethical to use innovative treatments for Ebola without submitting an application to the Committee. Dr. Adebamowo subsequently published the ethical considerations behind this decision in The Lancet.

International Collaborative Research

Fogarty-supported research collaborations between U.S. and LMIC scientists help to make U.S. academic institutions more globally competitive, extend their reach, and enable U.S. scientists to lead and participate in international research teams that address key global health priorities. The burden of chronic, non-communicable diseases is climbing at a rapid rate in many LMICs due to dramatic gains in life expectancy, urbanization, and global economic development. This has led to a shared research agenda between high-income countries and LMICs, as well as opportunities to share knowledge and lessons learned. As the respective strengths and expertise of local and U.S. scientists are brought to bear on complex challenges, these partnerships also lead to more robust solutions to global health problems.

Budget Policy: The FY 2016 President's Budget estimate is $9.958 million, an increase of $0.775 million, or 7.8 percent above the FY 2015 Enacted level. This area encourages implementation science to address the "know-do" gap, and would expand research training opportunities for U.S. and foreign scientists, foster a sustainable research environment in LMICs, and build strategic partnerships to further global health.

Program Portrait: Mobile Health: Technology and Outcomes in Low and Middle Income Countries (mHealth)

FY 2015 Level: $1.8 million
FY 2016 Level: $2.0 million
Change: +$0.2 million

Fogarty seeks to stimulate innovation in the development and implementation of technologies and other locally relevant solutions to address global health problems. The use of mobile health technologies has expanded exponentially worldwide. Scientists who utilize these tools can enhance the quality of their research and better address certain research priorities. For example, mobile technologies can transform epidemiological and surveillance research and mobile devices can capture, store, analyze, manage, and present data. These devices, which can be used to help create data platforms for new diagnostics, are low-cost and real-time tools for tracking disease progression, movement, behavior, adherence to therapy, and environmental exposures.

The Mobile Health: Technology and Outcomes in Low- and Middle-Income Countries (mHealth) program supports research on the development or adaptation of mHealth technologies specifically suited for LMICs, as well as research on the health-related outcomes associated with implementation of the technology. In particular, the mHealth program encourages multidisciplinary projects that focus on tools or interventions for chronic diseases, disease diagnostics, and crosscutting applications. The program's aims are to use mHealth technologies to improve both clinical and public health outcomes from the, while also building related research capacity in LMICs.

Dr. Peter Winch, for example, leads a program that will develop virtual community health services to ensure health care equity and quality in Mali. Dr. Winch and his team will develop and study an mHealth intervention package that uses mobile phones to deliver important health and reminder messages and helps community health workers tailor their counseling to their client's particular need based on the stage of pregnancy, age of child, or even seasonality. This study builds on proven, community-based approaches that utilize community health workers to reach people in need of care in their homes and to provide the support for behavior change that may be absent in clinic-based care. The results of this research will be used to advocate for more responsive and appropriate community health communication technologies across Mali and in other countries in Sub-Saharan Africa.

Sustainable Development of Human Resources for Global Health Research

Breakthrough scientific advances in global health are built upon a foundation of well-trained researchers from both high-income countries and LMICs who collaborate to solve major global health problems. Investing in the best and brightest minds and catalyzing research and training partnerships between talented U.S. and LMIC scientists continues to be a FIC high priority. Well-trained LMIC researchers bring an understanding of the unique biological, epidemiological, social, and cultural contexts of their communities, thereby contributing this knowledge to research on locally relevant challenges that often have broader, global implications.

Budget Policy: The FY 2016 President's Budget estimate is $9.202 million, an increase of $0.290 million, or 3.1 percent above the FY 2015 Enacted level. FIC's impact has historically been most significant in developing the pipeline of U.S. and foreign research talent. FIC intends to expand the number of overseas research experiences available for young U.S. scientists in order to encourage them to adopt careers in global health. FIC will also continue its research training partnerships between U.S. and foreign institutions and strive to enhance research opportunities for foreign scientists when they return home. In further support, FIC will fund eCapacity training, focusing on the capacity building activities at LMIC institutions.

Program Portrait: Global Health Program for Fellows and Scholars

FY 2015 Level: $3.7 million
FY 2016 Level: $4.2 million
Change: +$0.5 million

Over the last decade, American university campuses have seen a soaring interest in global health among students and faculty from a wide range of fields. Since 2004, Fogarty has met this interest by providing individual support to more than 500 fellows (i.e., postdoctoral students and M.D.s) and scholars (i.e., current Ph.D.s and M.D. students) for hands-on, clinical research training experiences in LMICs. With support from mentors, Fellows and Scholars have conducted studies on a variety of topics including surgical capacity in Rwanda, mental health in Indian slums, sexually transmitted diseases in Peru, and cervical cancer in Zambia. Through these research projects, they have produced scientific discoveries and formed lasting partnerships. Participants have published more than 1,300 articles in peer-reviewed journals, presented research findings at numerous scientific meetings, and used their research training to make practical improvements and advancements in treating disease. Most importantly, many Fellows and Scholars have committed to pursuing careers in global health and have been awarded NIH research grants based on their initial study results.

Fogarty's Global Health Program for Fellows and Scholars provides a year of mentored training and research experience for young investigators at a time when they are still carving out their career plans. Fellows and Scholars come from a wide range of fields, including medicine, public health, nursing, dentistry, pharmacy, veterinary medicine, and other health sciences. With support from 17 NIH ICs and Offices, Fogarty has funded research projects at more than 80 sites in over two dozen countries. Projects initially focused on HIV and other infectious diseases, but have since included non-communicable conditions, such as trauma, mental illness, diabetes, cancer, and cardiovascular disease.

As life expectancy rises around the globe, so do chronic diseases, fueling the need for research into co-morbidities. Understanding that therapies for breast cancer can put women at risk for osteoporosis and fracture, Dr. Evelyn Hsieh chose to use her year-long Fogarty fellowship in China to examine the link between breast cancer and osteoporosis to identify risk factors for bone fractures, such as age and treatment protocols. By conducting this research in China, where women are on average diagnosed with breast cancer at 49 years old (12 years younger than in the U.S.), Dr. Hsieh was able to access a large study population of pre- and post-menopausal women. Dr Hsieh, with additional support from Cancer Institute at the Chinese Academy of Medical Sciences (CICAMS) under the mentorship of Professor You-Lin Qiao (CICAMS), also conducted a pilot study to measure vertebral fracture rates, vitamin D levels, and bone turnover markers in 200 breast cancer survivors in Beijing. The findings from both studies will go a long way towards understanding the risk factors associated with osteoporosis and fracture for women with breast cancer - an issue facing women around the world.

Research Management and Support (RMS)

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 Fogarty'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 program 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; 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.

Budget Policy: The FY 2016 President's Budget estimate is $15.596 million, an increase of $0.154 million, or 1.0 percent above the FY 2015 Enacted level.

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