NIH – Emerging Global Leader Award (K43 Independent Clinical Trial Not Allowed)

The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation’s biomedical, behavioral, and clinical research needs. NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

The objective of the Fogarty Emerging Global Leader Award(K43) is to support research scientists from a low-or middle-income country (LMIC) who hold a junior faculty positions at an academic or research institutions. In many LMIC institutions there is little support for junior faculty with long-term research training to launch an independent research career due to lack of protected time for research activities, inadequate pilot research project funding opportunities, insufficient training in advanced research methodology and data analysis, lack of mentorship ina manuscript and grant writing and meager institutional support for developing, submitting and administering research applications and awards. This intensive, mentored research career development experience under the guidance of experienced LMIC and U.S. mentors is expected to foster an independently funded research career for the most promising LMIC junior research scientist faculty. Overall, it is expected that this program will increase the scientific capacity for health research at LMIC institutions and foster long term research collaborations with U.S. scientists.

The award will provide salary and research project support. Awardees are expected to increase their capabilities in advanced research methodology, analysis and data management, research administrative skills, responsible conduct of research, scientific presentation, and manuscript and grant writing. Applications should propose targeted activities and research projects that will propel awardees to become competitive principal investigators for new research project grant funding by the end of the grant period. This FOA invites applications from eligible LMIC research scientists at LMIC academic or research institutions who propose both critically needed career development activities and a research project that is highly relevant to the health priorities of their country. The research activities should take place primarily in the LMIC.

Interests of Participating NIH Institutes, Centers and Offices

The Fogarty International Center (FIC) is interested in applications from individuals at LMIC institutions seeking to become independent investigators and international research leaders in any therapeutic or scientific area of health priority and scientific importance to the LMIC.  FIC is dedicated to advancing the mission of the NIH by supporting and facilitating global health research conducted by U.S. and international investigators, building partnerships between health research institutions in the U.S. and abroad, and training the next generation of scientists to address global health needs. FIC supports a diversity of research and research training grants that advance basic to implementation science with a particular focus on LMICs. The Fogarty Emerging Global Leader Award is responsive to the FIC Strategic Plan (http://www.fic.nih.gov/about/pages/strategic-plan.aspx) to build research capacity through individuals, institutions and networks by building future research leaders in the U.S. and in LMICs.

The NCI’s Center for Global Health (CGH) will support intensive, mentored research career development for early stage investigators committed to a cancer research career.  CGH is particularly interested in applications that include well-designed epidemiology studies on common risk factors (social, biological, occupational, environmental) for cancer, clinical and translational research, detection and diagnosis, health surveillance including cancer registry development, knowledge sharing, implementation science, informatics, mHealth, or malignancies associated with chronic infection. The research activities should be specifically focused on cancer. The career development plan should include training in advanced scientific skills, research methodology, data management and analysis, grant and manuscript writing, and research administration skills that are appropriate for the LMIC.  The proposed career development and mentoring should be focused on developing independent researchers in the field of cancer in a manner that increases the research capacity at the LMIC institution. Mentors should have a track record of research in cancer.

The National Human Genome Research Institute (NHGRI) is interested in applications from individuals pursuing careers as researchers in the area of the ethical, legal, and social implications (ELSI) of genetics and genomics research or the use of genetics in clinical settings.  Examples of topics appropriate for exploration can be found on the ELSI Research Priorities website at: http://www.genome.gov/27543732. NHGRI may also support applications from individuals who are developing methods and research resources that support, or are conducting basic and translational research in: genomic sciences, informatics, implementation of genomics in clinical care (genomic medicine), and cost-effectiveness of genomic interventions.  The specific research topic proposed should apply across a broad spectrum of diseases and health conditions and should not be specific to just one disease, except to the extent that a particular disease may serve as a model with projects that capitalize on unique opportunities to use, as models, diseases and conditions that are more difficult to study in the U.S. because of prevalence or other factors will be considered.  Examples of such conditions might include, but are not limited to, sickle cell disease and thalassemias, apoA associated kidney disease, and severe adverse drug reactions with higher frequency outside the U.S., such as Stevens Johnson Syndrome (SJS).

The National Institute of Dental and Craniofacial Research (NIDCR) is interested in applications with a research focus on dental, oral, or craniofacial conditions that occur more frequently in the LMIC or are of a high public health burden; research addressing health disparities in dental, oral, or craniofacial conditions; and research to achieve national or regional goals in oral and dental health such as those articulated by the World Health Organization. Examples include, but are not limited to: working with local communities to establish the best means of delivering preventive oral health care; establishing successful approaches to deliver fluoride to a local population, particularly in areas without potable water; studying oral pre-malignant lesions associated with betel nut use; and studying the interplay of genes and environment in dental, oral, or craniofacial health by leveraging environments specific to the country. The program and these topics are responsive to goals 2, 3, and 4 of the NIDCR Strategic Plan (http://www.nidcr.nih.gov/research/ResearchPriorities/StrategicPlan/).

The National Institute of Environmental Health Sciences (NIEHS) is interested in applications that address or seek to understand how exposures to toxic environmental insults alter biologic processes, are linked to disease initiation, progression or morbidity, and activities that lead to the development of prevention and intervention strategies to reduce environmentally induced diseases in LMICs. Examples of environmental exposures relevant to the mission of the NIEHS include industrial chemicals or manufacturing byproducts, e-waste, metals, pesticides, herbicides, and inhaled toxicants including indoor air pollutants from cooking and other sources (https://www.niehs.nih.gov/about/strategicplan/). Topics and disease outcomes of particular interest include airway diseases, CVD and neurological disorders, children’s environmental health and the unique vulnerability of developing children to harmful environmental exposures including outcomes such as low birth weight or premature birth, and research exploring exposures during early life stages or critical windows of susceptibility that may directly or indirectly affect the risk of developing disease.  Career development applications that focus on the effects of alcohol, chemotherapeutic agents, smoking, except when considered as a secondary smoke exposure as a component in the indoor environment (particularly in children), drugs of abuse, pharmaceuticals, dietary nutrients, and infectious or parasitic agents are not of interest to NIEHS.

The National Institute of Mental Health (NIMH) is interested in applications that focus on mental illness and mental disorders in LMICs, specifically conditions and disorders of brain structure and function that affect cognition, social and emotional processing, and behavior and are leading causes of disease burden worldwide, estimated on the basis of disability adjusted life years (DALYs).  For example, disorders of interest include, but are not limited to depression, schizophrenia, bipolar disorder, autism spectrum disorders, and posttraumatic stress disorder. NIMH is particularly interested in research that addresses disparities in access to mental health care in LMICs, care for chronic, non-communicable diseases and/or implementation science in LMIC contexts.  These themes are consistent with goals C, E, and F of the Grand Challenges in Global Mental Health (i.e., improve treatments and expand access to care; build human resource capacity; and transform health system and policy responses;http://www.nature.com/nature/journal/v475/n7354/pdf/475027a.pdf). NIMH is also interested in applications that target HIV/AIDS related topics of interest such as the epidemiology, natural history and pathogenesis of HIV-associated neurocognitive disorders (HAND) and neuropsychiatric disorders before and after treatment initiation in adult and pediatric populations; examination of the neurobehavioral consequences, with respect to in-utero exposure to a dysregulated immune environment and/or antiretroviral medication and consequences of being born to an HIV-positive mother.  NIMH encourages development of common standardized assessment instruments with appropriate norms that can provide reliable and valid measurement of the neurobehavioral consequences of HIV and its treatments throughout the age-span in low and medium resource environments; and development of interventions to improve neurobehavioral functioning compromised by HIV/AIDS and its associated conditions that can be implemented in LMICs.

The National Institute of Neurological Disorders and Stroke (NINDS) is interested in supporting mechanistic, epidemiological, prevention, translational and clinical research across the spectrum of neurological, neuromuscular and neurovascular diseases and disorders in all ages. In addition to prevalent neurological disorders and stroke, NINDS is also interested in supporting research in areas of rare and neglected neurological diseases that are relevant to the Low- or Middle-Income Countries (NINDS Disorder Index http://www.ninds.nih.gov/disorders/disorder_index.htm).

The Office of Research on Women’s Health (ORWH) mission is to improve the health of women, and has made strides in doing so by ensuring that women and diverse populations are included in all clinical studies, sex and gender influences in health and disease are explored, and that women have the opportunity to advance in biomedical careers. ORWH will assess applications for their ability to directly fulfill the goals 4.0 and 6.0 of the NIH Strategic Plan for Women’s Health and Sex Differences Research, which can be found at: http://orwh.od.nih.gov/research/strategicplan/ORWH_StrategicPlan2020_Vol1.pdf.

Additional Information

For applications proposing HIV/AIDS research projects, applicants are encouraged to review the NIH HIV/AIDS Research Priorities, and the NIH Plan for HIV-Related Research for the year they are applying.

Applicants are encouraged to review answers to frequently asked questions about the Fogarty Emerging Global Leader Award program at http://www.fic.nih.gov/Programs/Pages/emerging-global-leader.aspx which will be updated on a regular basis.

Citizens, non-citizen nationals and permanent residents of the United States are not eligible for this K43 award but may apply for the International Research Scientist Development Awards (IRSDA (K01) PAR-18-539 or PAR-18-540 or other similar awards (see https://researchtraining.nih.gov/programs/career-development).

Note: This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial ancillary study to a clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor. Applicants proposing a clinical trial or an ancillary study to an ongoing clinical trial as lead investigator, should apply to the companion FOA (PA-19-051).NIH defines a clinical trial as “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” (NOT-OD-15-015).

NIH not only supports trials of safety and efficacy, it also supports mechanistic exploratory studies that meet the definition of a clinical trial and are designed to explore or understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention.  These studies may focus on basic and/or translational discovery research in healthy human subjects and in human subjects who are affected by the pathophysiology of diseases and disorders.  By addressing basic questions and concepts in biology, behavior, and pathophysiology, these studies may provide insight into understanding human diseases and disorders along with potential treatments or preventive strategies.  NIH also supports biomarker studies that meet the definition of a clinical trial and that may provide information about physiological function, target engagement of novel therapeutics, and/or the impact of therapeutics on treatment response.  NIH thus supports studies that meet the definition of clinical trials (as noted above) but do not seek to establish safety, clinical efficacy, effectiveness, clinical management, and/or implementation of preventive, therapeutic, and services interventions.