NIH – Chronic, Non-Communicable Diseases and Disorders Across the Lifespan: Fogarty International Research Training Award (NCD-LIFESPAN) (D43 Clinical Trial Optional)

August 20, 2018 by School of Medicine Webmaster

Chronic Non-communicable Diseases and Disorders (NCDs) are steadily increasing around the world, including in Low and middle-income countries (LMICs), and will soon account for more than 50% of the expenditures for health care and more than 60% of the disability adjusted life years (DALYs). In 2013, the World Health Organization (WHO) endorsed a global action plan for the prevention and control of NCDs (2013-2020) that included the promotion and support of national capacity for high-quality research and health system development. To address the WHO goals, in-county research expertise is needed to identify research questions, needs and gaps about the burden, causes, prevention, treatment and long-term care of NCDs within regional and local contexts. Advancing research on prevention and control of the dual burden of communicable and non-communicable diseases and disabilities is a key goal of the FIC 2014-2019 Strategic Plan http://www.fic.nih.gov/About/Pages/Strategic-Plan.aspx.

Purpose

The Fogarty International Center (FIC), together with the participating Institutes Centers and Offices: National Institute of Environmental Health Sciences (NIEHS), National Institute of Mental Health (NIMH), National Institute of Neurological Disorders and Stroke (NINDS), National Center for Complementary and Integrative Health (NCCIH), National Institute on Aging (NIA) encourages applications for the Chronic, Non-Communicable Diseases and Disorders Across the Lifespan: Fogarty International Research Training Award (NCD-LIFESPAN) D43 program for institutional research training programs in low- and middle-income countries (LMICs, as defined by the World Bank classification system). The application must propose a collaborative research training program in an LMIC involving either a U.S. institution and institution(s) in an LMIC or applications developed and submitted directly by LMIC institutions with substantial research and research training program experience to work with LMIC institutions with less capacity.

Programs must sustainably strengthen the capacity of LMIC institutions and investigators to conduct research on NCDs. Sustainable NCD research capacity is known to require a critical mass of scientists and health research professionals with in-depth scientific expertise and complementary leadership skills that enable them to conduct independent, internationally-recognized NCD research relevant to the health priorities of their country. This NCD-LIFESPAN program supports institutional research training awards for training programs designed to strengthen the capacity of the LMIC institution(s) to support independent research through the education and career development of individual researchers and key personnel. The trainees are expected to contribute to the research capacity in the LMIC upon completion of their training.

The long-range goal is to provide a solid foundation in LMICs for development and implementation of evidence-based interventions, relevant to NCD’s across the life-span. Sufficient evidence may exist upon which to base research for interventions and implementation strategies. However, often the evidence base is not well developed or not relevant to the given country or culture. Therefore, training across the spectrum of research disciplines is encouraged as needed, from basic biomedical, behavioral and social science to clinical and applied sciences, including translational and implementation science that emphasizes the resources, context and needs of multiple stakeholders in local settings.

New research training programs are expected to focus on collaboration with a single LMIC institution as the major partner.

Previously established collaborative research training programs are expected to expand and network for research training and capacity building with other institutions within the LMIC country and region.

NOTE: LMIC institutions, in collaboration with a U.S. institution, may apply for a one-year D71 planning grant, (PAR-17-097) “Planning Grant for Chronic, Non-Communicable Diseases and Disorders Across the Lifespan: Fogarty International Research Planning Award (NCD-LIFESPAN) (D71)” to support the development and submission of D43 research training program proposals in a subsequent year.

This program does not support HIV/AIDS research training.  Applicants interested in NCD co-morbidities in the context of HIV research training should apply to the Fogarty HIV Research Training Program funding opportunities (see http://www.fic.nih.gov/Programs/Pages/hiv-aids-research-training.aspx).

Special Program Objectives and Considerations

The objectives of the NCD-LIFESPAN research training program are:

  • To strengthen the capacity of LMIC institutions to conduct NCD research and to train a cadre of experts who can assess the magnitude, etiology of, interventions for and other aspects of NCDs. Over time, the goal is for these institutions to become national, regional and international centers of expertise in NCD research;
  • To support multidisciplinary research training in basic through translation and implementation science to address NCDs;
  • To develop a cadre of research experts who are most likely to contribute to science advances and affect clinical practice and public health policy in their country;
  • To support training-related research (degree-related or mentored research projects) that is directly relevant to the health priorities of the LMIC and to global health;
  • To strengthen the research and research training capacity required for success by building on existing research and public health programs in the LMIC;
  • To integrate, whenever possible, with other efforts to strengthen core research support capabilities needed to manage research and research training grants at the LMIC institution: including expertise in ethics and compliance issues, protection for human subjects, animal welfare, fiscal management, budgeting, program and grants administration, grant and report writing, preparation of scientific manuscripts, information technologies, technology transfer and management of intellectual property, data management, and Internet connectivity.
  • To build on established research training programs to network for research training among institutions within a country and regionally between countries

All applications to this program should have a central NCDs across the lifespan-related theme or focus although the theme may be as narrow or broad as deemed appropriate for the goals outlined in the FOA.

The specific NCDs that may be addressed must be relevant to the stated interests of the participating institutes, centers and offices (see “Specific Interests of the FOA Sponsors” section).

Research training programs are especially encouraged:

  •  That are relevant across NCDs.
  •  That emphasize lifecycle studies and early life determinants of chronic diseases (including genetic, epigenetic, environmental and lifestyle factors), co-morbid conditions and common risk factors and interventions relevant to multiple NCD conditions and their prevention.
  • For training in implementation research for NCDs in general.

The programs are expected to both support trainees to conduct research and, as appropriate and needed to go beyond traditional training models to develop multifaceted and novel training paradigms targeted to the special needs of LMIC investigators and institutions.

Where well established research and/or research training programs exist in LMIC institutions, proposals for research training hubs and networks within countries or regions are encouraged.

The Need for a Multidisciplinary Approach:

Risk factors for NCDs are complex and differentially amenable to control. Environmental influences, lifestyle factors and diverse socio-economic influences and epigenetic changes interact with the proximal causes (such as genetic vulnerability, trauma and infection) of many chronic disorders to influence their trajectory and severity.

Increasing evidence for the prenatal and childhood roots of chronic NCDs provide possible avenues for early prevention of and intervention for NCDs. During the past several decades, improvements in health care have led to a decrease in child mortality and an increase in life expectancy in LMICs. However, many of the factors that previously contributed to early mortality remain and influence later health outcomes. These positive trends have, therefore, set the stage for a complex epidemiology of health and disease as more children survive into adulthood predisposed by early disease, malnutrition and adverse environmental and psychological influences and experiences to later development of chronic diseases such as cardiovascular and cerebrovascular disease, diabetes, cancer, mental illness, substance abuse, developmental and neurodegenerative diseases and disorders.

During the remainder of the lifecycle, social and environmental factors such as environmental pollutants and chronic stress continue to influence health. However, individual behaviors and exposures such as physical inactivity, poor diet, tobacco, alcohol and drug abuse become increasingly important risk factors influencing the trajectory of NCDs. It is critical to develop a deeper understanding of the complex motivations that contribute to decision making and risky behavior in resource poor settings.

In addition to generating evidence to prevent and treat chronic diseases, it is imperative that the research findings be incorporated into community practice in an efficient and timely manner. Because of the formidable gap between innovations in health and their delivery to communities, another goal of the FIC Strategic plan is to “bridge the training gap in implementation research.” Implementation Research is the scientific study of methods to promote the integration of research findings and evidence-based interventions into health care policy and practice with a greater emphasis on the resources and context of local care settings and the needs of multiple stakeholders. Training researchers in the nascent field of implementation science is strongly encouraged as part of research training programs under this FOA.

The factors that are responsible for onset and prevention of chronic disease are so diverse that it is essential that those trained gain a broad appreciation for the need for research across health disciplines as diverse as genetics, medicine, nutrition, psychology, behavioral health, epidemiology, population studies, health law, environmental health, and public health, as well as many disciplines not traditionally associated with health research such as business administration, economics, urban planning, information science, communications, organizational and management theory, finance, individual and systems-level behavioral change, statistics, anthropology, learning theory, and marketing.  While no one trainee can acquire expertise in all these fields, training might include development of team projects that include trainees from multiple fields of expertise.

Types of Training:

In the context of this FOA, “trainees” are individuals from the host/target LMIC(s) eligible for research training under this FOA and according to the applicant’s proposed selection criteria.

The proposed training is expected to strengthen sustainable research and research training capacity at the LMIC institution. The program application should incorporate an appropriate mix of long-, medium- and short-term training opportunities and in-country mentored research to address the research training needs for NCDs identified for the LMIC. Applicants are encouraged to design multidisciplinary research training programs and teams.

Training can take place in the U.S. or LMIC, with the goal for most of the training to occur within the LMIC by the end of the initial grant award period. Applications involving already existing research training collaborations under other programs at the same LMIC sites are expected to begin with a substantial level of research training within the LMIC which take advantage of the research training infrastructure already created (such as faculty and courses). Training-related research should always be carried out in the LMIC. In addition to early career short-, medium- and long-term training, mid-career training is also allowed. The actual training mix should be justified according to the assessed needs and already existing infrastructure and the level of research capacity and training infrastructure in the LMIC.

For example:

  • In LMICs with weak research infrastructure and where few established NCD-related researchers and potential faculty exist to support an institutional research training program, more degree-related research training in the U.S. may be necessary to develop the initial cadre of researchers who can then go on to be mentors and faculty in the LMIC for future trainees.
  • In LMICs where substantial research and training infrastructure and expertise already exist, but without a strong focus on NCDs, a mix of activities that augment existing research, training and personnel resources at the LMIC institution(s) may be proposed. The LMIC activities would enhance their individual and institutional capacity to identify, undertake and successfully complete NCD studies and to utilize the results from research that they and others conduct to influence teaching, implementation and country policy.

While innovative research training models for NCDs are encouraged, typically research training programs involve the following:

  • Long-term (master’s or doctoral degree and other training that is six months or longer) training for the full range of skills necessary to plan, conduct, manage and disseminate the results of research on NCDs with the understanding that the focus of thesis and training-related research will be in the LMIC.
  • Advanced degree or non-degree research training may be supported at a U.S. or foreign institution. Research trainees who are also training as clinicians must devote their time to the proposed research training and must confine clinical duties to those that are an integral part of the research training experience.
  • Medium-term (three- to up to six-months) training or mentoring, which may include specialized research, policy or administrative/business skills necessary to conduct research that is planned or ongoing and translate results for interventions and policy.
  • Short-term (less than three months) training or mentoring that focuses on research skills and methodology, laboratory skills necessary to support research, ethics and compliance issues, grant writing, peer review, preparation of scientific manuscripts, data management, technology transfer, medical informatics, and other relevant areas.

Additional institutional capacity-building efforts are encouraged. These may include, but are not limited to, in-country training workshops in advanced techniques; distance learning; and interaction with other national and regional efforts to strengthen the ability of institutions to identify and undertake successful research and research training in NCDs to influence teaching, implementation and country policy.

Trainee Research

Proposed research training can take place in the U.S. or a foreign country, but training-related research should be carried out in the LMIC.

Scientific research training for clinicians and healthcare professionals including physicians, nurses, dentists, social work professionals and other practitioners is encouraged.

It is expected that LMIC trainees will disseminate the results of their research at scientific conferences and in peer-reviewed publications.

Advanced in-country mentored research may be undertaken by the trainee in his/her home country upon completion of his/her initial period of long-term training under the program (Master’s, Ph.D., post-doctoral or other long-term training).

All training-related research projects in which trainees are involved under this award must be independently peer-reviewed through scientific review procedures established by the applicant institution, and have written evidence of documentation of education in the protection of human subjects for the trainee, compliance with the required federal citations, and approval from an institutional (or ethical) review board or committee at the applicant institution and, if different, at the LMIC institution in which the research is being conducted.

Where appropriate, the design of training-related research projects should account for potential sex and gender differences that may affect the questions asked and the analyses performed. These might include different responses to and impacts of health interventions, differences in physiology, and different behavioral bases for disease prevention strategies.

This NCD-LIFESPAN program strongly encourages principal investigator/program directors (PIs/PDs) to include women, and individuals from groups underrepresented in biomedical and behavioral research in the country (including individuals from racial, ethnic and socially disadvantaged backgrounds and those living with disabilities), as faculty and research trainees at all sites.

Specific Interests of the FOA Sponsors

NIH institutes and Centers (ICs) participating in this announcement will consider applications for funding. Consultation with NIH staff before submitting an application is strongly encouraged. Applicants should carefully note which ICs participate in this announcement and view their respective areas of research interest and requirements below in this FOA. Applicants can obtain additional information and research interests for each of the FOA’s sponsoring partners by contacting the partner program official listed in this announcement (Section VII. Agency Contacts).

The Fogarty International Center (FIC) is interested in all eligible applications relevant to its mission. However, FIC is most interested in and will prioritize research training applications that 1) cover multiple NCD areas/topics and co-morbid conditions and/or 2) train in research disciplines applicable across NCD areas/topics, co-morbid conditions and settings (for example, but not limited to, training in epidemiology, demographics, implementation science, genetics/epigenetics, bioinformatics, biomedical engineering, health technology). For RENEWAL applications FIC will only fund direct applications from the LMIC site. The FIC Strategic plan (http://www.fic.nih.gov/About/Pages/Strategic-Plan.aspx) states the following relevant goals: 1) Build research capacity through individuals, institutions, and networks to meet future and evolving global health challenges; 2) Stimulate innovation in the development and implementation of technologies and other locally relevant solutions to address global health problems; 3) Support research and research training in implementation science; 4) Advance research on prevention and control of the dual burden of communicable and non-communicable diseases and disabilities; and 5)  Build and strengthen partnerships to advance global health research and research capacity.

NIH IC Partner Interests

Following are examples of specific areas of interest provided by the participating NIH partners:

The National Institute of Neurological Disorders and Stroke (NINDS) encourages the development of innovative research training programs in mechanistic, epidemiological, prevention, translational and clinical research in the areas of neurological disorders and stroke (please see: http://www.ninds.nih.gov/disorders/disorder_index.htm for specific diseases and disorders of interest to NINDS).

The mission of the National Institute of Environmental Health Sciences (NIEHS) is to discover how the environment affects people in order to promote healthier lives. The NIEHS is interested in supporting research training in LMICs 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.  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.  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, climate change and human health, and research exploring exposures during early life stages or critical windows of susceptibility that may directly or indirectly affect the risk of developing disease.

The National Center for Complementary and Integrative Health (NCCIH) is interested in supporting training programs investigating the use of complementary approaches for Chronic, Non-Communicable Diseases and Disorders, for which these approaches are most frequently used. These would include, but not be limited to, investigations of the impact of complementary health modalities in alleviating chronic pain syndromes and inflammatory processes, and improving health and wellness. Complementary health approaches of interest to NCCIH include both mind-body and natural product approaches. Training programs can propose secondary data analyses, non-interventional, observational, or epidemiological clinical research, or basic mechanistic and non-clinical translational research. NCCIH will not support training programs proposing interventional clinical trial research through this FOA.  Applicants are strongly encouraged to contact NCCIH program staff prior to submission.

The National Institute of Mental Health (NIMH) is interested in training programs that provide education in state-of-the-art research skills (e.g., novel study designs, data analytic and modeling techniques, data collection tools, conceptual approaches, bioinformatic methods, genotyping technologies) needed for addressing the objectives of the current NIMH Strategic Plan. NIMH encourages but does not limit research training to educational activities that provide trainees with the expertise and tools to:

  • chart the course of neuropsychiatric disorders over the lifespan in order to understand ideal times and methods for intervention to prevent, preempt progression of, or treat mental disorders and hasten recovery;
  • describe the molecules, cells, and circuits associated with typical and atypical behavior;
  • identify genomic, epigenomic, and other factors such as the environment and experience across diverse populations that are associated with mental illnesses
  • Identify clinically useful biomarkers and behavioral indicators that predict change across the trajectory of illness examine the interactions of neurobiological and environmental/social factors that affect brain development, resulting in behavioral outcomes (e.g. expression of cognitive impairment, coping, adaptation, response to interventions);
  • conduct psychosocial and biomedical intervention trials that identify and test the mechanisms, moderators, and predictors (e.g. biological, genetic, behavioral, experiential, environmental) of intervention response and side effects in different patient populations;
  • develop new preventive and treatment interventions based on discoveries in genomics, neuroscience, and behavioral science;
  • develop innovative approaches for the delivery of psychosocial and biomedical interventions by different kinds of providers and within different service settings;
  • develop and test models and methods for implementing mental health interventions: 1) in diverse systems of health care; and 2) to meet the needs of groups with inadequate access to evidence-based mental health services (e.g. based on age, sex, gender, stage of illness, race/ethnicity, rural or urban setting, or other factors);
  • improve the efficiency and effectiveness of existing mental health services; and
  • develop innovative service delivery models to optimize the outcomes of mental health services received in diverse communities and populations

The National Institute on Aging (NIA) promotes strategies to build global aging research capacity and supports collaborative research between U.S. scientists and those in other countries, to influence the development of biomedical and behavioral research internationally related to aging.  Studies that draw data from across the lifespan are especially encouraged.

Special Note: Because of the differences in individual Institute and Center (IC) program interests for this FOA, prospective applicants MUST consult the IC-Specific Information, Requirements and Staff Contacts, to make sure that their application is appropriate for the requirements of one of the participating NIH ICs. Prior consultation with NIH staff is strongly encouraged.

Deadlines:  October 13, 2018 (letters of intent); November 13, 2018, November 12, 2019, November 13, 2020 (full proposals)

URL:  https://grants.nih.gov/grants/guide/pa-files/PAR-18-901.html

Filed Under: Funding Opportunities