and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) Autism Speaks (http://www.autismspeaks.org/) |
Fogarty International Center (FIC) |
|
Funding Opportunity Title |
Brain Disorders in the Developing World: Research Across the Lifespan (R21) |
Activity Code |
R21 Exploratory/Developmental Research Grant Award |
Announcement Type |
Reissue of PAR-08-113 |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
PAR-11-031 |
Companion FOA |
PAR-11-030 , R01 Research Project Grant TPA-10-720 |
Catalog of Federal Domestics Assistance (CFDA) Number(s) |
93.989, 93.866, 93.273, 93.865, 93.279, 93.113, 93.242, 93.853 |
FOA Purpose |
This Funding Opportunity Announcement (FOA) encourages exploratory/developmental planning grant applications proposing the development of innovative, collaborative research and research training projects, between high income country (HIC) and low- to middle-income country (LMIC) scientists, on brain and other nervous system function and disorders throughout life, relevant to LMICs. The planning grants are expected to lead to full research programs which contribute to the long-term goals of building sustainable research capacity in LMICs to address nervous system development, function and impairment throughout life and to lead to diagnostics, prevention, and treatment strategies. |
Posted Date |
November 12, 2010 |
Open Date (Earliest Submission Date) |
December 10, 2010 |
Letter of Intent Due Date |
Non-AIDS Related Applications: December 10, 2010, December 10, 2011, (New Date January 14, 2013 per NOT-TW-12-015), Original Date December 10, 2012 AIDS Related Applications: March 11, 2011, March 11, 2012, March 11, 2013 |
Application Due Date(s) |
(Changed to January 10, 2011, January 10, 2012, and (New Date February 14, 2013 per NOT-TW-12-015), Previously January 13, 2013 by 5:00 PM local time of applicant organization per NOT-TW-11-007) |
AIDS Application Due Date(s) |
April 11, 2011, April 11, 2012, April 11, 2013 |
Scientific Merit Review |
June/July 2011, June/July 2012, June/July 2013 |
Advisory Council Review |
October 2011, October 2012, October 2013 |
Earliest Start Date(s) |
December 2011, December 2012, December 2013 |
Expiration Date |
April 12, 2013 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The R21 grant will provide support to assess needs, to initiate preliminary studies and training, and to organize, plan, prepare, and assemble the information and data for an application for a more comprehensive R01 application involving collaboration between the HIC and LMIC investigators.
The main goals of the application should be to: 1) assess research needs (define the problem and determine the magnitude of and factors involved in the problem to be addressed in the countries in question) and training needs for a follow-up R01 submission; 2) develop collaborations and needed resources; 3) show feasibility and generate preliminary data for the collaborative research to be proposed in a follow-up R01 submission; and 4) integrate capacity building/collaborator training into the proposed research program.
Applicants should propose specific milestones and a timeline to meet these goals. During the R21 award period, the applicant should:
Pilot research projects should demonstrate feasibility of certain aspects of the research approaches and develop further research directions. Training, informal meetings, workshops and small conferences may be conducted as necessary to develop the research and collaboration and for assessment of needs. New analyses of extant data sets and development or use of new methodologies or approaches may also be proposed. These activities may also serve to identify which specific research questions show the greatest promise for advancement in specific countries and settings. Travel among sites for these purposes may be proposed.
Each exploratory/planning R21 grant should also present a description of the anticipated longer-term goals of the collaboration as it develops into an application for an R01 grant. One expected outcome of the work under the R21, will be a detailed assessment of the specific research issues and capacity building/training needs in the LMIC that the proposed follow-up R01 will address. The relevance of the proposed research to the health of the host endemic country should be justified.
In addition, the planned involvement, if any, of the LMIC institution and faculty in formulating treatment and prevention policies locally, nationally, regionally or internationally should be noted.
The evolution and vitality of the biomedical sciences require a constant infusion of new ideas, techniques, and points of view. These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data. The R21 mechanism is intended to encourage new exploratory and developmental research projects. These studies may involve considerable risk but may lead to a breakthrough in a particular area, by using the R21 mechanism, the NIH seeks to foster the introduction of novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential to substantially advance biomedical, behavioral, or clinical research.
Collaboration:
The purpose of this R21 is to foster initial development of collaborative work focused on brain disorders across the lifespan and relevant to LMICs; accordingly, investigators need not demonstrate any history of prior collaboration in the R21. However, those factors in the investigators background and/or institutional circumstances that would facilitate success in such collaboration should be clearly delineated.
Plans for coordination of research and associated collaborator training between the partner country institutions should be described and should include regular meetings (virtual and/or physical).
Research Capacity Building Activities
In addition to pilot research studies the proposed program should contain explicit strategies or plans to assess the research and research capacity needs and to strengthen this capacity through research training, career development, mentoring and/or other models. The assessment may include, but is not limited to, needed skills and expertise in laboratory, clinical, epidemiological and social science research. Research training for the LMIC collaborators and their staff, in the context of the proposed R21 and subsequent R01 research, may take place at any of the collaborating sites and may vary, depending on the strengths of the particular investigators and institutions that apply and specific training and other capacity building needs to support research and future interventions in the LMIC. The major portion of the proposed research must be conducted at the LMIC site(s) and the majority of the funds must be used for research and research-related costs at the LMIC site (including collaborator training). Any research at the HIC site must also involve training for participating LMIC country collaborators.
All projects should:
Activities undertaken under the R21 planning grant may also include, but are not limited to:
Background
Mobilizing the scientific community to address the shifting global burden of disease and disability and thereby investing in NCD research and research training is one of the Fogarty International Center’s primary goals in its Strategic Plan for 2008-2012. 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. These positive trends have set the stage for a complex epidemiology of health and disease as more children survive into adulthood handicapped by early disease, malnutrition and adverse experiences and/or later develop chronic diseases including cognitive and neurodegenerative disorders prevalent in old age. Adverse socio-economic factors, such as poverty, conflict and gender inequalities, contribute to the initial causes (such as injury, psychological trauma, chronic adversity, genetic vulnerability and infection) of many nervous system disorders. These disorders, especially those brain disorders affecting cognitive and mental function, in turn decrease the ability of individuals and their societies to address the root causes and consequences of those adverse conditions which will continue to influence each generation.
World Health Organization data suggest that non-communicable diseases and disorders (NCD s) are rapidly becoming the dominant causes of poor health in all LMIC regions except sub-Saharan Africa (where they are second only to HIV/AIDS, as defined by contribution to years lived with disability or DALYs). Of the NCDs, nervous system diseases and disorders in aggregate contribute the most to the overall burden of disease and disability (more than a quarter, followed by cardiovascular disease and cancer) and contribute about a third of the burden due only to NCDs in LMICs (Global Burden of-Disease and Risk Factors Report, DCP2, 2006, http://www.dcp2.org/pubs/GBD/7/FullText ).
In fact, nervous system disorders account for four out of the six leading causes of years lived with disability (DALYs). They are: mental disorders, especially unipolar depression and bipolar affective disorder, substance-use and alcohol-use disorders, schizophrenia, and dementias. Neurological disorders such as epilepsy, migraine, Parkinson's disease, and multiple sclerosis make smaller but significant contributions. Stroke and perinatal asphyxia, with neurological complications, are also a significant problem in LMICs particularly since some of the causative factors of stroke such as hypertension are poorly treated in LMICs as compared to HICs.
Depression, the most common psychiatric disorder and the world’s fourth largest cause of DALYs also contributes substantially to mortality due to suicide, which in 2001 was a leading cause of death in many regions, ranking fifth in Eastern Europe and Central Asia, according Global Burden of Disease and Risk Factors.
Neurodevelopmental disorders and related cognitive disorders (such as mental retardation, behavioral disorders, learning disabilities and cerebral palsy) that result from abnormal prenatal development or influences during the prenatal and perinatal period, or from injury or insult to the brain and central nervous system during infancy or childhood are also clearly burdensome in LMICs, however their incidence is less well characterized. Many of the causes of developmental disabilities including genetic and nutritional factors, infectious diseases, environmental toxins, and traumatic events are, however, particularly common in resource-poor countries, suggesting that the prevalence there is expected to be high.
Communicable diseases along with maternal, perinatal and nutritional conditions still contribute disproportionately to DALYs in LMICs as compared to HICs. All of these conditions may lead to varied nervous system problems. Infectious and parasitic diseases, such as HIV and malaria, are a particular burden for LMICs, and especially sub-Saharan Africa, where they affect large numbers of individuals who are not adequately treated. However, very limited data are available on the epidemiology, natural history and pathogenesis of neurological problems caused by these diseases and associated opportunistic infections and co-morbidities in these settings.
The proportion of the global burden of disease attributable to mental, neurological and substance use disorders together is expected to rise worldwide in future because of the projected increase in the number of individuals entering the age of risk for the onset of many such disorders. However, the rise will be steeper in LMICs, because of the continuing and long lasting effects of early life trauma, infectious disease and malnutrition which contribute or lead to neurological and neurodevelopmental disorders and mental retardation. These problems pose a greater burden on vulnerable groups such as people living in poverty, those coping with disease and those exposed to emergencies. Disaster, war and conflict situations, especially prevalent in many LMICs, may lead to post-traumatic stress disorder (PTSD) which affects a substantial proportion of the overall population exposed to such conditions and which leads to persistent dysfunction. In addition, stigmatization and gender inequality amplify many of the key risk factors for nervous system disorders. At the same time, available care is frequently inadequate. In some countries, the overall physician-patient ratio can be low as 1:20,000, with even fewer psychiatrists and neurologists.
Despite their enormous burden of disease, nervous system disorders have been largely absent from the global health research agenda. In addition to research on the etiology, prevention and treatment of individual conditions and disorders, more information is needed on co-morbidities among nervous system disorders and between these disorders and other chronic NCD s. Many of these conditions exist together in LMICs and are likely to have more severe and complicated effects than any one in isolation and may even extend beyond the individual affected (for example maternal depression as a risk factor for infant stunting). Research on the social and economic impact of neurological, psychiatric, and developmental disorders is needed to inform interventions, implementation and policy. Research is also needed to further define the burden and identify knowledge gaps, needs, opportunities and methods to effectively reduce the burden and to lay the ground work for developing and testing interventions.
Some disabling brain disorders are readily treatable at low cost, and yet many in LMICs suffer untreated with detrimental individual, family and societal consequences. For example, epilepsy is a common brain disorder that disproportionately affects people in LMICs, roughly 85 percent of the total number affected worldwide. Although inexpensive and effective treatments are available, epilepsy is frequently untreated and even unrecognized in LMICs often because of stigmatization and lack of knowledge. For such disorders, implementation science that integrates social and cultural factors into education, media, policy and behavior change research is especially needed and appropriate.
Prevention of disability due to neurological impairment is possible in many situations with appropriate research leading to knowledge and interventions. For example, research to identify neurotoxins and their mechanisms can be combined with interventions to minimize human exposure to known neurotoxins by reduction in use or release to the environment and by appropriate safeguards in occupational settings.
Applicants are encouraged to refer for more background to recent publications summarizing the state of knowledge on the burden of nervous system disorders around the world including the following: Disease Control Priorities Related to Mental, Neurological, Developmental and Substance Abuse Disorders (contains five chapters from the Disease Control Priorities in Developing Countries, second edition, World Health Organization 2006, http://www.dcp2.org/file/64/WHO_DCPP%20mental%20health%20book_final.pdf) and Neurological, Psychiatric, and Developmental Disorders: Meeting the Challenge in the Developing World 2001, Institute Of Medicine, http://books.nap.edu/openbook.php?record_id=10111&page=R1).
Research Topics
Relevant research topics for this FOA are related to nervous system function and/or impairment from birth to advanced age and must be relevant to the collaborating LMICs. Research on co-morbidities and conditions that affect nervous system function at different life stages as well as across the lifespan are especially encouraged. Relevant research for these applications may range from basic science to epidemiological, clinical, health services and translational (e.g. translation of basic research to therapy and of clinical research to applications in the field) and implementation research. Applicants may propose a research and capacity building program on some aspect of nervous system function and/or impairment at any stage of life. In all cases near-term or potential future implications for, or relevance to, prevention, diagnostics, treatment or other interventions should be indicated or included in the research plan.
Examples of nervous system disorders contributing to the burden of disease in LMICs and relevant to this FOA, include but are not limited to, neurodevelopmental disorders (including autism, cerebral palsy, fetal alcohol syndrome, learning disabilities etc.), neurodegenerative diseases (such as Alzheimer's and Parkinson's Diseases), addictive disorders, seizure disorders such as epilepsy, neuropsychiatric disorders (such as unipolar depression, bipolar disorder, schizophrenia etc), posttraumatic stress disorder, dementias, encephalopathy, peripheral neuropathies, motor neuron diseases.
Examples of specific conditions that influence nervous system function across the lifespan include, but are not limited to genetic predispositions and epigenetic influences including pre-, peri- and post-natal trauma and environmental factors (such as maternal depression, in-utero drug and alcohol exposure, neurotoxic insults, perinatal hypoxia, child abuse and neglect, inadequate environmental stimulation and nutritional deficiencies), physical and psychological trauma (exposure to violence, rape, physical abuse, traumatic nervous system injury due to violence and accidents), infection of the nervous system by viral and parasitic diseases (such as HIV/AIDS, malaria, neurocysticercosis) and stroke.
Other factors affect healthy brain development, including access to appropriate health care and socioeconomic factors. Examples of some cross-cutting areas for research are:
Types of Research relevant to this announcement include basic research and epidemiology, as well as research on diagnostics, early interventions, clinical treatment, prevention, and health services that are culturally appropriate, feasible, and acceptable for implementation within the LMIC. This FOA encourages development of multidisciplinary and interdisciplinary research and the capacity in the LMIC to conduct such research, whenever relevant to the research question. Expertise may involve, but is not limited to, fields such as genetics, epidemiology, neurology, cognitive neuroscience, developmental neurobiology, neurotoxicology, neuroendocrinology, pharmacology, psychiatry, neuro-immunology, neuro-virology, and biotechnology (e.g., for development of diagnostic tools and treatments), as well as the behavioral and social sciences including health economics, health services and implementation science.
Specific Research Interests of the FOA Sponsors
Applicants can obtain information and research interests for each of the FOAs sponsoring partners at their Web sites and by contacting the partner program contact listed in this announcement. Some of the participating partners have provided additional statements of interest.
National Institutes of Health (NIH)
The National Institute on Aging (NIA) is interested in applications relevant to Alzheimer's disease and other degenerative diseases of the nervous system, and age-related changes in cognition and memory. Of interest also are studies on reducing disability and/or preventing or slowing additional decline among persons with neurological disabilities as they continue to age.
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is interested in applications that address alcohol-related birth defects (such as Fetal Alcohol Syndrome).
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is particularly interested in encouraging research on problems in child health and development, such as mental retardation, cognitive and behavioral disorders, neurodevelopmental disabilities and learning disabilities. Relevant research includes etiology, pathophysiology, screening, prevention, treatment, and epidemiology. Also of interest are studies on cognitive, social, and affective development, including studies in high-risk settings (e.g., in violent or abusive environments, or families experiencing stressors such as poverty, unemployment or parental depression). Biomedical, behavioral, and biobehavioral research in these areas is encouraged along with investigations of socio- and ethno-cultural, familial, individual, and biological influences. Also of interest are studies investigating the roles played by nutritional and hormonal factors in nervous system development and function. NICHD also encourages research on the effective use of information technologies for research, training, public health registries and tracking systems, data collection and management, point of care technologies and applications of new technologies for affordable screening and research in LMICs. NICHD is further interested in the training of LMIC investigators to conduct clinical trials and the inclusion of children in translational research, and the inherent ethical, legal and social issues that arise in such clinical research.
The National Institute on Drug Abuse (NIDA) is interested in applications which focus on behavioral, cognitive and neurobiological factors as antecedents to, or impacting on, consequences of drug abuse. Of particular interest are studies aimed at reducing drug abuse and addiction and its associated adverse social, behavioral, and health consequences (e.g., violence and infectious diseases transmission and including research related to the interaction between HIV/AIDS and abuse). The NIDA especially encourages research capitalizing on unique opportunities to study adverse environmental and socio-cultural effects on drug abuse patterns and behaviors in populations of LMICs (e.g., caregiver neglect or abandonment, large orphan populations or street children at risk for both drug abuse and HIV or HCV). In countries where abuse of high doses of individual drugs is more common than in the U.S. and Europe, the NIDA is interested in supporting studies on prenatal effects, cognitive consequences, epidemiological patterns, and associations with HIV/ AIDS and other transmitted diseases. The NIDA will give priority to meritorious research that builds upon existing NIDA-funded collaborations between HIC and LMIC colleagues.
The National Institute of Environmental Health Sciences (NIEHS) is interested in supporting research in LMICs to identify the causes of, and opportunities to prevent or ameliorate, the consequences of, neurotoxic insult to the nervous system throughout life. Research in LMICs is encouraged on how exposures to toxic environmental insults alter biologic processes, are linked to disease initiation or progression, or affect the risk of either disease development or distribution of disease in populations. Examples of environmental exposures of interest include industrial chemicals or manufacturing byproducts, metals, pesticides, herbicides, air pollutants and other inhaled toxicants, particulates or fibers, fungal, food or bacterially derived toxins (but not infectious agents, per se) and indoor air pollutants from cooking and other sources.
The National Institute of Mental Health encourages research that:
1) charts the course of neuropsychiatric disorders over the lifespan in order to understand ideal times and methods for intervention to preempt or treat mental disorders and hasten recovery; examines 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); promotes new psychosocial and biomedical intervention trials that focus on the moderators and predictors (e.g., biological, genetic, behavioral, experiential, environmental) of intervention response and side effects in different patient populations; develops innovative approaches to tailoring psychosocial and biomedical interventions to different kinds of providers and different intervention settings. Of interest also are development and testing of novel models and methods on ways to best implement effective mental health interventions: 1) in diverse systems of health care; and 2) to meet the needs of those groups, in a given setting, that typically have less access to quality mental health services (e.g., based on age, sex, stage of illness, race/ethnicity, rural or urban setting, or other factors).
2) targets 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 develops 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. NINDS will only make direct awards to U.S. (but not other HIC) institutions for collaborations between investigators from the U.S. and investigators in LMICs.
Other Participating Organizations
Autism Speaks (http://www.autismspeaks.org ) will consider support for scientifically meritorious autism-related research proposals and will provide direct funding to meritorious applicants.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Funding Instrument |
Grant |
Application Types Allowed |
New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
|
Award Budget |
Application budgets are limited to a budget for direct costs of up to $100,000 per year for up to two years in modules of $25,000 and need to reflect actual needs of proposed project. F&A costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004. Supplemental Budget Information: Networking meetings involving grantees of these awards will be held at a site in the U.S. each year, Funds should be budgeted for travel for these meetings by the PDs/PIs, LMIC collaborators, and/or other relevant individuals with significant day-to-day involvement in the activities performed under this award. |
Award Project Period |
Applicants may request a project period of up to two years. |
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions:
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For profit Organizations
Governments
Other
Foreign (non-U.S.) components of U.S. Organizations are allowed.
Exceptions: Financial institutions and international intergovernmental organizations are not eligible to apply for FIC research or training programs. However, staff of such institutions, if invited by eligible applicants, may serve as unpaid collaborators or consultants on such projects.
At least two institutions, one in a HIC and one in a LMIC will be involved as partners in the grant application. Non-US based HIC institutions must demonstrate special opportunities for furthering research programs through the use of unusual talent or resources in the HIC, relevant to the proposed project, and which either are not readily available in the United States or which augment existing U.S. resources
See (http://data.worldbank.org/about/country-classifications/country-and-lending-groups) for information on World Bank country classification tables and specifically use (http://siteresources.worldbank.org/DATASTATISTICS/Resources/CLASS.XLS) which is updated each year, to identify those countries considered low- middle- or high-income. Hong Kong-based institutions are not eligible as the primary LMIC partner institution. A second institution in mainland China must be involved as the primary collaborating HIC institution if an institution in Hong Kong is included as a partner institution. Taiwan is not listed in the World Bank income classification list but is considered high-income.
Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.
All Program Directors/Principal Investigators (PD/PIs) must
also work with their institutional officials to register with the eRA Commons
or ensure their existing eRA Commons account is affiliated with the eRA Commons
account of the applicant organization.
All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least four (4) weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Project Director/Principal
Investigator (PD/PI) is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple
Program Director/Principal Investigator Policy and submission details in the Senior/Key
Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions) for further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
This FOA provides an avenue for investigators in HICs and those in LMICs, with shared interests in brain and other nervous system disorders, to explore, initiate and implement research collaboration between themselves and their institutions. Therefore, at least two investigators, one from an institution in a HIC and one from an institution in a LMIC (see definitions above, in the Eligible Institutions section) must collaborate on the application. The contact PD/PI may be from the LMIC institution or from the HIC institution, but the collaborators must prepare the proposal jointly. While there is no cap on the maximum number of investigators or institutions involved, the applicant must discuss how the contributions of each member will be integrated in the proposed activities. Non-US based HIC PD/PIs must demonstrate special opportunities for furthering research programs through the use of unusual talent or resources in the HIC, relevant to the proposed project, and which either are not readily available in the United States or which augment existing U.S. resources.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
An individual investigator may be involved as PD/PI or primary collaborator on more than one application for the submission/receipt dates of this FOA, provided the applications are scientifically distinct.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity
The letter of intent should be sent, to:
Kathleen Michels, Ph.D.
Program Director
Division of International Training and Research
Fogarty International Center
31 Center Drive, MSC-2220
Building 31, Room B2-C39
Bethesda, MD 20892-2220
Telephone: 301-496-1653
Fax: 301-402-0779
Email: [email protected]
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Resource Sharing Plan
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the SF424 (R&R) Application Guide.
Appendix
Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
It is expected that the majority of funds awarded will be used for supplies, training costs, equipment, services, travel, and personnel at the LMIC site(s) and that any funds spent at the HIC site will be directly related to the collaborative research or training under the grant and will involve the LMIC collaborators.
Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
Important
reminders:
All PD/PIs must include their eRA Commons ID in the Credential
field of the Senior/Key Person Profile Component of the SF 424(R&R) Application
Package. Failure to register in the Commons and to include a valid PD/PI
Commons ID in the credential field will prevent the successful submission of an
electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA Commons
and for the Central Contractor Registration (CCR). Additional information may
be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.
Where appropriate, the design of projects should take into account 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 prevention strategies
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is the research on a problem of particular relevance for the LMIC involved?
Investigator(s)
Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? If training of the LMIC PD/PIs is necessary to carry out this work is the training well integrated into the research plan?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the project make use of unique or special expertise, resources, circumstances or environment of the LMIC site to frame or address the research question? Does the project propose innovative or special ways to incorporate capacity building or training into the research program at the LMIC site?
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed? For projects with multiple sites and/or multidisciplinary components, is there an adequate plan to
coordinate and integrate the research among the sites/components? Are the
administrative plans for the management of the research project appropriate,
including plans for resolving conflicts?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Are the resources necessary to perform the research available or obtainable at the LMIC site? Has the primary LMIC Collaborators home institution made a convincing commitment (e.g., provided a research/academic appointment and salary support)? Does the R21 proposal include a plan to assess what specific resource and training needs exist at the LMIC site to enable the site to successfully conduct the proposed research? Does the proposal include plans to begin to meet those needs?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.
Research Capacity Building
What is the potential for the LMIC institutions to improve their capacity and ability to address important issues in brain disorders research, develop independently-supported research programs and obtain financial support nationally and internationally? How will this occur? Does the proposed program contain explicit strategies or plans to assess the research capacity needs and to strengthen this capacity through research training, career development, mentoring and other models? Will the proposed research and collaboration lead to enhancement of specific departments in LMIC institutions and contribute to overall institutional excellence? Does the proposed project describe a plan to assess research and capacity building needs and ways to address those needs?
What is the potential for sustainable collaborations between the HIC and the LMIC scientists to be established? Does the research constitute a substantial scientific endeavor for the LMIC Collaborator, including creative and scientific input into the research proposal? Since the LMIC site and investigators should not be used merely to gather biological samples (clinical, plants, etc.) or behavioral data (interviews, surveys, etc.) are the LMIC Collaborators actively and fully involved in analyzing and interpreting the data?
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewals
Not Applicable.
Revisions
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.
As part of the scientific peer review, all applications will:
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the Fogarty International Center's Advisory Board and the appropriate national advisory council or board of co-sponsoring partners. . The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
Not Applicable.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.FSRS.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
eRA Commons Help Desk(Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]
National
Institutes of Health:
FIC/NIH
Kathleen Michels, Ph.D.
Program Director
Fogarty International Center (FIC)
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39, MSC 2220
Bethesda, MD 20892-2220
Telephone: 301-496-1653
Fax: 301-402-0779
Email: [email protected]
NIA/NIH
Dallas W. Anderson, Ph.D.
Program Director, Population Studies
Dementias of Aging Branch
Division of Neuroscience
National Institute on Aging (NIA)
National Institutes of Health
7201 Wisconsin Avenue, MSC-9205
Gateway Building, Suite 350
Bethesda, MD 20892-9205
Telephone: 301-496-9350
Fax: 301-496-1494
Email: [email protected]
NIAAA/NIH
Margaret M. Murray, M.S.W.
Chief, Health Sciences Education Branch
Office of the Director
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
5635 Fishers Lane, Room 2103, MSC 9304
Bethesda, MD 20892-9304
Telephone: 301-443-2594
Fax: 301-480-1726
Email: [email protected]
NICHD/NIH
Mary Lou Oster-Granite, Ph.D.
Health Scientist Administrator
Acting Chief
Mental Retardation and Developmental Disabilities Branch
Center for Developmental Biology and Perinatal Medicine
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Room 4B09G, MSC 7510
6100 Executive Boulevard
Bethesda, MD 20892-7510 (FedEx: Rockville, MD 20592)
Telephone: 301-435-6866
Fax: 301-496-3791
E-mail: [email protected]
NIDA/NIH
L.R. Stanford, Ph.D.
Developmental Neurobiology Program
Behavioral and Brain Development Branch
Division of Clinical Neuroscience, Development, and Behavioral Treatment
National Institute on Drug Abuse (NIDA)
6001 Executive Boulevard, Room 4232, MSC 9593
Bethesda, MD 20892-9593
Telephone: 301-402-3869
Fax: 301-443-6814
Email: [email protected]
NIEHS/NIH
Annette Kirshner, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Box 12233, MD EC-23
Research Triangle Park, NC 27709
Telephone: 919-541-0488
Fax: 919-541-5064
Email: [email protected]
NIMH/NIH
LeShawndra N. Price, Ph.D.
Office for Research on Disparities and Global Mental Health
National Institute of Mental Health (NIMH)
6001 Executive Boulevard, Room 8130, MSC 9659
Bethesda, MD 20892-9659
Rockville, MD 20852 (for express/courier service)
Telephone: 301-443-2847
FAX: 301-443-8552
Email: [email protected]
NINDS/NIH
Yuan Liu, Ph.D.
Chief, Office of International Activities
National Institute of Neurological Disorders and Stroke
(NINDS)
National Institutes of Health
NSC, 6001 Executive Blvd. Room 2187
Bethesda, MD 20892-9523
Phone: 301-496-0012
Fax: 301-480-1080
Email: [email protected]
ODS/OD/NIH
Rebecca B. Costello, Ph.D., F.A.C.N.
Office of Dietary Supplements, Office of the Director (ODS/OD)
National Institutes of Health
6100 Executive Blvd., Room 3B01, MSC 7517
Bethesda, Maryland 20892-7517
Tel: 301-435-2920
Fax: 301-480-1845
[email protected]
Other Participating
Organizations:
Autism
Speaks
Andy Shih, Ph.D.
Vice President of Scientific Affairs
1 East 33rd Street
4th Floor
New York, NY 10016
Telephone: 212-252-8584
Email: [email protected]
Dan Gerendasy, Ph.D.
Scientific Review Administrator
International Cooperative Programs
Center for Scientific Review (CSR)
National Institutes of Health
6701 Rockledge Drive, Room 5132
Bethesda, MD 20892-7843 (use ZIP 20817 for overnight mail)
Telephone: 301-594-6830
Fax: 301-480-1677
Email: [email protected]
FIC/NIH
Elizabeth Cleveland
Grants Management Specialist
Fogarty International Center (FIC)
National Institutes of Health
31 Center Drive, MSC-2022
Building 31, Room B2-C29
Telephone: 301-451-6830
Email: [email protected]
NIA/NIH
Lesa McQueen
Grants and Contracts Management Branch
National Institute on Aging (NIA)
National Institutes of Health
7201 Wisconsin Avenue, Suite 2N212
Bethesda, MD 20892-9205
Telephone: (301)
Fax: (301) 402-3672
Email: [email protected]
NIAAA/NIH
Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institutes of Health
5635 Fishers Lane, MSC-9304
Room 3023
Rockville, MD 20892-9304
Telephone: 301-443-4704
Fax: 301-443-3891
Email: [email protected]
NICHD/NIH
Bryan Clark
Grants Management Branch
The
Eunice Kennedy Shriver National Institute of Child Health and Human
Development (NICHD)
National Institutes of Health
6100 Executive Blvd., MSC-7510
Room 8A-01A
Bethesda, MD 20892-7510
Telephone: 301-435-6975
Fax: 301-480-4782
Email: [email protected]
NIDA/NIH
Carol Alderson
Grants Management Branch
National Institute on Drug Abuse (NIDA)
National Institutes of Health
6001 Executive Blvd., Room 4128, MSC-9541
Rockville, MD 20892-9541
Telephone: 301-594-5614
Email: [email protected]
NIEHS/NIH
Dorothy Duke
Grants Management Officer
National Institute of Environmental Sciences (NIEHS)
National Institutes of Health
79 TW Alexander Drive, Room 3403
Research Triangle Park, NC 27709
Telephone: 919-541-2749
Email: [email protected]
NIMH/NIH
Rebecca Claycamp
National Institute of Mental Health (NIMH)
National Institutes of Health
6001 Executive Blvd., Rm. 6122
Rockville, MD 20892-9605
Telephone: 301-443-2811
Fax: 301-480-1956
Email: [email protected]
NINDS/NIH
Tijuanna DeCoster
Grants Management Officer
National Institute of Neurological Disorders and Stroke
(NINDS)
National Institutes of Health
NSC, 6001 Executive Blvd. Room 2187
Bethesda, MD 20892-9523
Phone: 301-496-9231
Fax: 301-496-0219
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
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NIH Funding Opportunities and Notices
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