and Human Services (HHS)
EXPIRED
BRAIN DISORDERS IN THE DEVELOPING WORLD: RESEARCH ACROSS THE LIFESPAN
RELEASE DATE: November 7, 2002
RFA: TW-03-007 (This RFA has been modified, see PAR-05-100)
(see addendum NOT-TW-03-005)
Fogarty International Center (FIC)
(http://www.nih.gov/fic/)
National Eye Institute (NEI)
(http://www.nei.nih.gov/)
National Institute on Aging (NIA)
(http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
http://www.niaaa.nih.gov/
National Institute of Child Health and Human Development (NICHD)
(http://www.nichd.nih.gov/)
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS)
(http://www.niehs.nih.gov)
National Institute of Mental Health (NIMH)
(http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS)
(http://www.ninds.nih.gov/)
Office of Dietary Supplements (ODS)
(http://dietary-supplements.info.nih.gov/)
Canadian Institutes of Health Research (CIHR)/Institute of Neuroscience,
Mental Health and Addiction (INMHA)
(http://www.cihr.ca/)
Mexico - Consejo Nacional de Ciencia y Tecnolog a (Conacyt)
(http://www.conacyt.mx/)
LETTER OF INTENT RECEIPT DATE: February 11, 2003
APPLICATION RECEIPT DATE: March 11, 2003
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Training Plan
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations:
PURPOSE OF THIS RFA
This Request for Applications (RFA) solicits applications to plan and develop
collaborative research and capacity building projects on brain disorders
throughout life relevant to low- and middle-income nations. Applicants are
expected to develop innovative, collaborative research programs that would
contribute to the long-term goal of building sustainable research capacity in
neurological/neurodevelopmental (including sensory, motor, cognitive and
behavioral) impairment throughout life.
This RFA is joined by the following Institutes and Centers: NIH sponsors
include the Fogarty International Center (FIC), National Eye Institute (NEI),
National Institute on Aging (NIA), National Institute on Alcohol Abuse and
Alcoholism (NIAAA), National Institute of Child Health and Human Development
(NICHD), National Institute on Drug Abuse (NIDA), National Institute of
Environmental Health Sciences (NIEHS), National Institute of Mental Health
(NIMH), National Institute of Neurological Disorders and Stroke (NINDS) and
the Office of Dietary Supplements (ODS); for Canada, the Canadian Institutes
of Health Research (CIHR) and for Mexico, the Consejo Nacional de Ciencia y
Tecnolog a (Conacyt). These sponsoring organizations seek domestic and
international collaborative applications which address brain disorders in the
developing world and which build research capacity of low- to middle-income
countries to address brain disorders within their country or region.
This first phase of the "Brain Disorders in The Developing World: Research
Across the Lifespan" initiative, beginning in fiscal year 2003 (FY03), will
consist of two-year planning/development grants using the R21 grant
mechanism. The R21 grant will provide support to initiate preliminary
studies and to organize, plan, prepare, and assemble an application for a
more comprehensive R01 grant involving collaboration between high-income and
low- to middle-income country investigators and which incorporates both
research and capacity building.
The main goals of the R21 applications should be to assess needs, develop
collaborations and needed resources, show feasibility and generate
preliminary data for the collaborative research to be proposed in a follow-up
R01 submission. The applicants should propose specific milestones and a
timeline to meet these goals. During the R21 award period, the applicant
should:
o further define the type and area of research to be developed;
o develop and solidify collaborative relationships and understandings with
the partners in the developed and developing countries involved;
o assess current resources and needs, such as and including the need for an
institutional review board (IRB) for studies involving human subjects;
o develop and initiate a plan to address these needs to enable the proposed
research and capacity building to be successfully carried out;
o identify the training and other capacity-building opportunities to be
incorporated into the research application in the context of the proposed
research;
o initiate cross-training of collaborators where necessary for the proposed
research; and
o conduct pilot studies and generate preliminary data;
Projects should: 1) Involve a partnership between high-income and low-to
middle-income country individuals or research teams; 2) lead to pursuit of
basic, epidemiological, clinical, prevention, intervention or health services
research in the area of brain disorders of relevance to low- to middle-income
countries; and 3) build capacity as necessary in the proposed research area
to enable further research to take place.
An RFA for the second competitive phase of the "Brain Disorders in The
Developing World: Research Across the Lifespan" initiative is currently
planned to be issued in fiscal year 2005 (FY05), subject to availability of
funds. That RFA is planned to provide support for collaborative research and
capacity building to high-income and low- to middle-income country partners
through the R01 mechanism. The second phase RFA competition, as currently
planned, will not be limited to the R21 grantees under this competition, but
will be open to all eligible applicants.
RESEARCH OBJECTIVES
The overall intent of the program is three-fold: 1) to encourage
interdisciplinary collaborative approaches to identify and address brain
disorders of particular importance to low- and middle-income countries; 2) to
address brain disorders of significance to low- to middle-income nations by
promoting international cooperation between scientists and institutions in
these countries and investigators in the U.S. and other high-income nations
who are pursuing relevant research programs and 3) to build and enhance the
research capacity of low- to middle-income nations to identify and address
relevant brain/neuro-developmental disorders across the lifespan.
The main goals of the R21 application should be to: 1) assess needs (define
the problem and determine the magnitude of and factors involved in the
problem to be addressed in the countries in question), 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/ research training into the
proposed research program.
To meet the goals of the R21 application the application should provide a
clear plan with milestones and a time-line for the development of the
collaboration. Such efforts must include pilot research projects to
demonstrate feasibility of certain aspects of the research approaches and to
develop further research directions. Training, informal meetings, workshops
and small conferences necessary to develop the research and collaboration and
assess needs may be part of the plan. 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 grant should also present a description of the anticipated
longer-term goals of the collaboration as it develops into an application for
an R01 research grant with capacity building and training built in. As one
outcome of the work under the R21, grantees will be expected to provide a
detailed assessment of the specific research issues and capacity
building/training needs in the developing country that the proposed follow-up
R01 or other future application will address. The relevance of the focus of
the proposed research to the health of the host endemic country should be
justified. The assessment may include, but is not limited to, needed skills
and expertise in laboratory, clinical, epidemiological and social science
research. In addition, the involvement, if any, of the developing country
institution and faculty in formulating treatment and prevention policies
locally, nationally, regionally or internationally should be noted.
The applicants will also initiate development of needed resources and
infrastructure. Research training in the context of the proposed 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 the
need to build capacity to support research and future interventions. However:
1) any research at the high-income site must also involve training for
participating low- to middle-income investigators and 2) the major portion
(greater than 50 percent) of the proposed research must be conducted at the
low- to middle income country site or sites.
The purpose of this mechanism is to foster initial development of
collaborative work focused on brain disorders across the lifespan and
relevant to developing countries; accordingly, investigators need not
demonstrate any history of prior collaboration. However, those factors in
the investigators' background and/or institutional circumstances that would
facilitate success in such collaboration should be clearly delineated.
Relevant research for the R21 and follow-up applications may range from basic
science to epidemiological, translational (e.g. translation of basic research
to therapy and of clinical research to applications in the field), clinical,
operational and health services research.
Background:
During the past several decades, improvements in health care have led to a
decrease in infant mortality in the developing world. The continuing burden
of infectious disease and malnutrition, along with a growing burden of
chronic disease associated with aging populations, has resulted in a complex
epidemiological situation. Developed nations have relatively high
proportions of people aged 65 and over, but the most rapid increases in
elderly populations are in the developing world. The current aggregate
growth rate of the elderly population in developing countries is more than
double that in developed countries, and also double that of the total world
population. This increase in life expectancy is further complicated by the
widespread incidence of neurological, psychiatric, and developmental
disorders. With the exception of sub-Saharan Africa, brain disorders are the
leading contributor to years lived with disability in all regions of the
world.
Measures of mortality and disability do not include the social isolation and
stigma experienced by individuals affected with brain disorders, as well as
the financial hardship borne by affected individuals, their families, and the
communities in which they live. As a result of negative attitudes,
prejudice, and stigma, many affected with brain disorders remain undiagnosed
and untreated. In addition to poverty and gender inequality that underlie
many of the key risk factors for brain disorders, 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 the enormous burden of disease, brain disorders have been largely
absent from the international health research agenda. Policy makers began to
recognize the social and economic impact of brain disorders as a result of
the 1993 publication of the Global Burden of Disease Study. This landmark
report compared the total cost of various diseases on the basis of
disability-adjusted life years (DALYs), a measure that accounts for the
overall burden of disease by combining years of potential life lost as a
result of premature death with years of productive life lost because of
disability.
Responding to the growing awareness of brain disorders in the developing
world, the U.S. Institute of Medicine was charged to prepare a report that
would define the increasing burden, identify opportunities for effectively
reducing the burden, and identify areas for intervention, research, and
capacity building. The results were compiled in a report entitled
"Neurological, Psychiatric, and Developmental Disorders: Meeting the
Challenges in the Developing World" (2001, available at
http://books.nap.edu/books/0309071925/html/). Study sponsors included the
National Institutes of Health (Fogarty International Center, the National
Institute of Child Health and Human Development, the National Institute of
Neurological Disorders and Stroke, and the National Institute of Mental
Health), the U.S. Centers for Disease Control and Prevention, and the Global
Forum for Health Research.
The report brings together a growing body of evidence indicating that the
social and economic impact of neurological, psychiatric, and developmental
disorders is large and increasing. Present figures almost certainly
underestimate the impact of brain disorders, particularly in the developing
world. A sustained, comprehensive, and integrated research effort is key to
reducing the burden of brain disorders in the developing world. Among the
main recommendations of the report was the need to create both national
centers for training and research, as well as programs to facilitate
competitive funding for research on developmental disabilities and epilepsy
in resource poor nations.
This RFA focuses on neurodevelopmental disabilities, as well as on other
conditions and influences on the nervous system that affect cognition,
learning and memory across the lifespan.
Neurodevelopmental disabilities include conditions such as mental
retardation, behavioral disorders, learning disabilities and cerebral palsy
that result from abnormal prenatal development or influences during the
prenatal period, or from injury or insult to the brain and central nervous
system during infancy or childhood. In the U. S., approximately 12 to
18percent of children are disabled. Many of the causes of developmental
disabilities including genetic and nutritional factors, infectious
diseases, environmental toxins, and traumatic events are particularly
common in resource poor countries, suggesting that the prevalence is expected
to be even higher.
Examples of specific conditions that affect brain function across the
lifespan, include, but are not limited to, neurodegenerative diseases (such
as Alzheimer's and Parkinson's Diseases), neurotoxic insults, infection of
the nervous system by viral and parasitic diseases (such as HIV/AIDS and
malaria), pre- and post-natal environmental insults and trauma (e.g., fetal
alcohol syndrome, drug abuse/exposure, child abuse and neglect, shaken baby
syndrome).
Epilepsy is an example of a treatable brain disorder that affects an
estimated 40 million people in developing countries, roughly 85 percent of
the total number affected worldwide. Epilepsy commonly affects young adults
in the most productive years of their lives and frequently leads to their
being unemployed. Although cheap and effective treatments are available,
epilepsy is frequently untreated and even unrecognized in the developing
world often because of stigmatization and false beliefs. In such disorders,
research into interventions taking social and cultural factors into account
and involving education, media, policy and behavior are especially
appropriate.
HIV infection is an example of an infectious disease which is a major public
health problem in developing countries and that also has significant
neurological consequences. At the end of 2001, approximately 28.5 million
people in sub-Saharan Africa and 5.6 million people in South and South East
Asia were living with HIV/AIDS. In the developed world, neurological
complications such as HIV-1-associated dementia can occur in 20 percent of
symptomatic individuals. Symptoms of HIV-associated dementia include slowing
of motor and mental function with memory loss and language difficulty. Other
neurological complications, such as peripheral neuropathy and HIV-associated
myelopathy, can occur in 15 to 50percent of HIV patients in the developed
world. In addition, opportunistic brain infections, such as cryptococcus,
Toxoplasma gondii and JC virus, are seen in HIV-infected individuals.
Although a large number of individuals are HIV-infected in developing
countries, very limited data is available on the epidemiology, natural
history and pathogenesis of neurological disease caused by HIV and associated
opportunistic infections in these settings.
In order to address these and other health research issues relevant to brain
disorders in developing countries, the NIH is proposing a new research and
capacity building program on brain disorders with a focus on neurological
(including sensory, motor, cognitive and behavioral) impairment throughout
life, in low- to middle-income countries.
Research Topics
Relevant research topics should be related to neurodevelopmental disabilities
and neurological disorders, including cognitive, motor, sensory and
behavioral impairment from birth to advanced age. Research findings must be
relevant to the collaborating low- and/or middle-income nation(s). Some
examples are: mental retardation, seizure disorders such as epilepsy,
movement disorders such as Parkinson's and dementias - including those
related to age and those caused by HIV, malaria or other infection.
Research relevant to this announcement includes basic research and
epidemiology, as well as research on early interventions, clinical treatment,
prevention, and health services that are culturally appropriate, feasible,
and acceptable for implementation within the foreign site. This RFA
encourages development of multidisciplinary research, whenever relevant to
the research question. Expertise may involve but is not limited to fields
such as neurology, cognitive neuroscience (including functional brain
imaging), developmental neurobiology, neurotoxicology, neuroendocrinology,
pharmacology, psychiatry, neuro-immunology, neuro-virology, and biotechnology
(e.g., for development of diagnostic tools) as well as the behavioral and
social sciences.
Examples of some cross-cutting areas for research are:
o Ethnographic studies and other areas of social science, particularly to
address health systems and appropriate interventions within a given society
or group.
o Research focusing on gender and socioeconomic factors in the etiology and
treatment of the disorders to be addressed.
Suggested areas of research include, but are not limited to:
o Epidemiological studies
1) Descriptive epidemiology to describe and define the problem in the
countries in question by assessing needs and determining the magnitude and
factors involved in the problem to be addressed (e.g., research on trends in
incidence, prevalence or mortality; distribution of disease; determination of
populations at risk; determination of case definition/disease
classification);
2) Analytical epidemiology to identify potential etiological factors in the
populations of interest, including factors responsible for predispositions to
the neurological consequences of various infections,infestations, and/or
neurotoxins (e.g., identification of risk factors for neurological
consequences of disease onset or progression; classification and measurement
of exposure; magnitude and distribution of known risk factors).
o Genetic factors throughout life, beginning in the prenatal period, that
result in cognitive, behavioral, motor or sensory impairment or disorders.
o Natural history of common neurological diseases/disorders and the influence
of sociocultural or other environmental variables that impact upon this
course.
o Research on multiple insults, especially common in the developing world,
e.g., neurotoxic or traumatic insult plus infectious disease and/or
malnutrition. Studies examining the interactions of neurobiological and
environmental/social factors that affect brain development and resulting
behavioral outcomes are encouraged (e.g., expression of cognitive impairment,
coping, adaptation, response to intervention, etc.).
o Environmental factors across the lifespan, beginning in the prenatal
period, that result in cognitive, behavioral, motor or sensory impairment
including:
1. Natural and man-made neurotoxic exposures - e.g. prenatal exposure to
drugs of abuse, fetal alcohol syndrome, effects of neurotoxins/neurotoxicants
in homes, the outside environment, industrial and agricultural settings;
2. Malnutrition;
3. Infectious diseases such as cerebral malaria, neurocysticercosis/
tapeworm, HIV/AIDS and associated opportunistic infections, and other
parasitic diseases;
4. Physical trauma that is both intentional and unintentional (e.g. Shaken
baby syndrome, accidental injuries);
5. Psychological trauma (e.g. effects on brain function, including cognitive
and behavioral function, in victims of child abuse, neglect or abandonment,
torture and rape).
o Factors affecting cognitive, emotional and physical health and survival in
older persons.
o Research on other factors that impact on healthy brain development, such as
access to appropriate health care, availability of resources, preventive or
screening practices, etc..
o Research on potential interventions and how the success or failure of
interventions may be modulated by sociocultural and gender variables.
Primary outcomes of the proposed R21 activities should be specification of a
further research agenda with needed capacity building. The activities
proposed should include design and execution of small, preliminary studies to
demonstrate feasibility and obtain pilot data.
Other activities undertaken under the planning grant may include, but are not
limited to: discussions of the research problems to be addressed; the ways in
which the basic research could be applied to clinical issues; critical
evaluations of relevant research literatures; visits among the various
laboratories and clinics to familiarize members with each others' work in
detail; feasibility of co-funding/support from developing countries and
public/private institutions to assure sustainability; possible modifications
to paradigms and methods that might be necessary for use with patient
populations; determination of other research expertise that might need to be
added to the group, including social scientists; new statistical approaches or
methodologies that may need to be developed; priorities for a collaborative
research and capacity building program; evaluation of social, economic, and/or
political factors that might impact the research itself or the execution of
the research; an evaluation of bioethical and legal issues that could impact
research on neurologically impaired populations; an evaluation of other
components of the public health system that might impair or enhance research
on brain disorders; assessment of potential medical informatics programs that
could be developed to store data pertinent to future brain disorders research;
exploration of the feasibility for co-funding future research or academic
support for researchers from public or private agencies within the
collaborating developing country.
Specific Research Interests of the RFA Sponsors:
NIH:
The FIC is interested in all eligible applications that are responsive to
this RFA.
The NEI conducts and supports research that helps prevent and treat eye
diseases and other disorders of vision and which leads to sight-saving
treatments, reduces visual impairment and blindness, and improves the quality
of life for people of all ages. In the context of this announcement NEI would
particularly like to encourage research on eye diseases relevant to
developing countries and involving neuronal cell dysfunction and degeneration
(such as but not restricted to retinitis pigmentosa, age-related macular
degeneration, and glaucoma).
The 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 NIAAA is interested in applications which address alcohol-related birth
defects (such as Fetal Alcohol Syndrome).
The NICHD is particularly interested in encouraging studies in response to
this announcement which propose to address 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.
The 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).
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 developing countries (e.g., caregiver neglect
or abandonment, high 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, NIDA is
interested in supporting studies on prenatal effects, cognitive consequences,
epidemiological patterns, and associations with HIV/ AIDS and other
transmitted diseases. NIDA will give priority to meritorious research that
builds upon existing NIDA-funded collaborations between high-income and low-
to middle-income country colleagues.
The NIEHS is interested in supporting research in the developing world to
identify the causes and prevent or ameliorate the consequences of neurotoxic
insult to the nervous system throughout life. The Institute would especially
like to encourage applications for research with investigators in Vietnam,
Cambodia and Laos and research focusing on the consequences of exposure to
dioxin.
The NIMH is interested in research limited to areas relating to epidemiology,
natural history, and pathogenesis of HIV disease of the nervous system..
The NINDS encourages research across the spectrum of neurological disorders
to reduce the burden of neurological disease borne by every age group and
segment of society all over the world.
Canada: The Institute of Neurosciences, Mental Health and Addiction (INMHA)
of the Canadian Institutes of Health Research (CIHR) is interested in co-
sponsoring collaborative proposals between Canadian and low- to- middle-
income country investigators. Eligible applications include those dealing
with the spectrum of research related to neurological disorders, mental
illnesses and addictions.
Mexico: Conacyt/MMH will consider applications from or involving Mexican
investigators and proposing research collaborations on brain disorders
related to neurological dysfunction, mental illnesses and addictions.
Conacyt is particularly interested in research to develop innovative,
effective and evidence-based diagnostics and interventions for these
disorders along with means to reduce discrimination, improve access to
services and to raise public awareness.
MECHANISM OF SUPPORT
This RFA will use the NIH Exploratory Grant (R21) award mechanism.
Applicants for this R21 award may request direct costs of up to $100,000 per
year, in increments of $25,000, for a maximum of two years. The funded R21
grants will not be renewable.
Note that the R21 mechanism is specifically intended to support development
of collaborations, innovative ideas and research where preliminary data as
evidence of feasibility are sparse or do not exist. R21 grants are not
intended for large-scale undertakings or to support or supplement ongoing
research. Rather, R21-supported projects are intended to serve as a basis
for planning, strengthening and developing collaborations and conducting
pilot studies to obtain preliminary data for future research project grant
applications (R01).
This RFA uses just-in-time concepts. It also uses the modular budgeting
format. (see http://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, since you are submitting an application with direct costs in
each year of $250,000 or less, use the modular format for all applications.
Applications submitted by foreign institutions can request facilities and
administrative (F&A) costs up to a maximum of eight percent. Please see the
web site http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html
for more information on allowable F&A costs for foreign grants and domestic
grants with foreign components.
As an applicant, you will be solely responsible for planning, directing, and
executing the proposed project. Applications submitted in response to this
RFA may have a project period of up to two years. This RFA is a one-time
solicitation. Any future unsolicited competing continuation applications
based on this project will compete with all NIH investigator-initiated
applications and be reviewed according to the customary peer review
procedures
FUNDS AVAILABLE
The participating ICs intends to commit approximately $2 million dollars in
FY03 to fund approximately fifteen to twenty new grants in response to this
RFA. An applicant may request a project period of up to two years and a
budget for direct costs of up to $100,000 per year (including the total cost
of subcontracts) in modules of $25,000.
Because the nature and scope of the proposed research will vary from
application to application, it is anticipated that the size and duration of
each award will also vary. Although the financial plans of the ICs provide
support for this program, awards pursuant to this RFA are contingent upon the
availability of funds and the receipt of a sufficient number of meritorious
applications relevant to the interests of each RFA sponsor. Each award will
be administered by one of the participating NIH ICs or other participating
agencies although several may participate in the funding of any given
application. At this time, it is not known if this RFA will be reissued.
The Canadian Institute for Health Research (CIHR) will consider meritorious
applications, relevant to their missions, involving Canadian institutions.
CIHR will make the award of grants for meritorious applications of interest
to them. Applicants who wish to have their projects considered for
(co)funding by CIHR should include with their application a letter stating
that their application and summary statement may be shared with CIHR.
El Consejo Nacional de Ciencia y Tecnolog a (Conacyt) of Mexico
will consider meritorious applications relevant to its mission and which
involve Mexican institutions. Conacyt will make the award of grants for
meritorious applications of interest to them. Applicants who wish to have
their projects considered for (co)funding by Conacyt should include with
their application a letter stating that their application and summary
statement may be shared with Conacyt.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution is among the eligible
domestic or foreign institutions that are:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
o Units of State and local governments
o Faith-based or community-based organizations
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual from an eligible institution who has the skills, knowledge,
and resources necessary to carry out the proposed research under the
guidelines of this RFA, is invited to work with their institution to develop
an application for support. Individuals from underrepresented racial and
ethnic groups, as well as individuals with disabilities and women, are always
encouraged to apply for NIH programs.
The primary purpose of this announcement is to provide an avenue for
investigators to explore and initiate research collaborations between
investigators and institutions in the United States or other high-income
nations and low- and middle-income nations with shared interests in brain
disorders. Therefore, at least two investigators (one from an institution in
a high-income country and one from an institution in a low- to middle- income
country) must collaborate on the application as Principal Investigator (PI)
and Co-Investigator. The Principal Investigator (PI) may be the collaborator
from the low- to middle-income nation and institution, or from the U.S. or
other high-income nation and institution, but the collaborators must develop
the proposal jointly. While there is no cap on the maximum number of
investigators, the application needs to discuss how the contributions of each
member will be integrated in the proposed activities.
For operational and analytic purposes, the World Bank's main criterion for
classifying economies, gross national product per capita, will be employed
for this RFA to determine eligibility. A list of countries representing low-
and middle-income economies, which are eligible as low- to middle-income
countries for this program may be found at
http://www.worldbank.org/data/countryclass/classgroups.htm.
SPECIAL REQUIREMENTS
A single meeting involving grantees of these awards will be held in the
Washington, D.C. area, in the second year of the grant period, to share
information, discuss new insights and will include a grants-writing workshop.
For this meeting, funds should be budgeted for travel by the PIs and/or other
relevant individuals with significant day-to-day involvement in the
activities performed under this award.
Capacity Building: Greater than 50 percent of the direct costs requested must
be used in the collaborating low- and/or middle-income nation(s)for either
pilot research and/or capacity strengthening of foreign institutions as
necessary to carry out the proposed research program in the short- and long-
term. Capacity strengthening, which may include development of needed
resources and infrastructure (including IRBs at the foreign site for any
proposed research involving human subjects) and initiation of needed training
for collaborators, must be integrated into the planning process and the
research proposal.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues.
o GENERAL INQUIRIES regarding the scope and content of this Request for
Applications should be directed to:
Kathleen Michels, Ph.D.
Program Director
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39, MSC 2220
Bethesda, MD 20892-2220
Telephone: 301-435-6031
Fax: 301-402-0779
Email: [email protected]
http://www.nih.gov/fic/
o Direct your questions about SCIENTIFIC/RESEARCH ISSUES to the contacts
below:
CANADA:
CANADIAN INSTITUTES OF HEALTH RESEARCH
Astrid Eberhart
Institute Liaison
Institute of Neurosciences, Mental Health and Addiction
Canadian Institutes of Health Research
410 Laurier Avenue W., 9th Floor
Address Locator 4209A
Ottawa, ON K1A 0W9
Telephone: 613-941-4643
Fax: 613-941-1040
Email: [email protected]
MEXICO:
Dr Efrain Aceves
Director for International Affairs
El Consejo Nacional de Ciencia y Tecnolog a (Conacyt)
Avenida Constituyentes 1046
Col. Lomas Altas, cp. 11950
Delegaci n Miguel Hidalgo,
Mexico DF, Mexico
Telephone: 52-55-5327-76-15
Fax: 52-55-5327-75-32
Email: [email protected]
UNITED STATES:
FIC/NIH:
Kathleen Michels, Ph.D.
Program Director
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31, Room B2C39, MSC 2220
Bethesda, MD 20892-2220
Telephone: 301-435-6031
Fax: 301-402-0779
Email: [email protected]
NEI/NIH
Michael D. Oberdorfer, Ph.D.
Director, Strabismus, Amblyopia, and Visual Processing Program
Division of Extramural Research
National Eye Institute
Executive Plaza South, Suite 350
6120 Executive Blvd, MSC 7164
Bethesda MD 20892-7164
Telephone: 301-451-2020
Fax: 301-402-0528
Email: [email protected]
NIA/NIH:
Elisabeth Koss, Ph.D.
Assistant Director
Alzheimer's Disease Centers Program
Neuroscience and Neuropsychology of Aging
National Institute on Aging
National Institutes of Health
Gateway Building, Suite 3C307
7201 Wisconsin Ave MSC 9205
Bethesda, MD 20892-9205
Telephone: 301-496-9350
Fax: 301-496-1494
Email: [email protected]
NIAAA/NIH:
Margaret M. Murray, M.S.W.
Chief, International and Health Education Programs Branch
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health
6000 Executive Boulevard, Suite 302
Rockville, MD 20852
Telephone: 301-443-2594
Email: [email protected]
NICHD/NIH:
James W. Hanson, M.D.
Chief, Mental Retardation & Developmental Disabilities Branch
National Institute of Child Health and Human Development
Executive Building, Room 4B09G
6100 Executive Blvd., MSC 7510
Bethesda, MD 20892-7510
Telephone: 301-496-1383
Email: [email protected]
NIDA/NIH
Minda R. Lynch, Ph.D.
Branch Chief
Behavioral and Cognitive Sciences Research Branch
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse
National Institutes of Health
6001 Executive Blvd., Rm. 4282, MSC 9555
Bethesda, MD 20892-9555
Telephone: 301-435-1322
Fax: 301-594-6043
Email: [email protected]
NIEHS/NIH:
Annette Kirshner, Ph.D.
NIEHS-DERT
Box 12233, MD EC-23
Research Triangle Park, NC 27709
Telephone: 919-541-0488
Fax: 919-541-5064
Email: [email protected]
NIMH/NIH:
Jeymohan Joseph, Ph.D.
Chief, HIV Neuro-Virology, Genetics and Molecular Therapeutics Program
Center for Mental Health Research on AIDS
National Institute of Mental Health
National Institutes of Health
Room 6202, MSC 9619
6001 Executive Blvd
Bethesda, MD 20892-9619
Telephone: 301-443-3012
Fax: 301-443-9719
Email: [email protected]
NINDS/NIH:
Yuan Liu, Ph.D.
Program Director
National Institute on Neurological Disorders and Stroke
National Institutes of Health
NSC/2110B,6001 Executive Blvd, MSC 9529
Bethesda, MD 20892-9529
Telephone: 301-496-1917
Fax: 301-402-0182
Email: [email protected]
ODS/OD/NIH:
Rebecca B. Costello, Ph.D.
Deputy Director
Office of Dietary Supplements
National Institutes of Health
6100 Executive Blvd., Room 3B01, MSC 7517
Bethesda, Maryland 20892-7517
Telephone: (301) 435-2920
Fax: (301) 480-1845
Email: [email protected]
o Direct your questions about peer review issues to:
Alan L. Willard, Ph.D.
Chief, Scientific Review Branch
National Institute on Neurological Disorders and Stroke
National Institutes of Health
6001 Executive Blvd, Room 3208
Rockville, MD 20852 (couriers)
Bethesda, MD 20892-9529 (for US Mail)
Telephone: 301-496-9223
Fax: 301-402-0182
Email: [email protected]
o Direct your questions about financial or grants management matters to:
FIC/NIH:
Bruce Butrum
Grants Management Officer
Fogarty International Center
National Institutes of Health
Building 31, Room B2C29
Bethesda, MD 20892-2220
Telephone: 301-496-1670
Fax: 301-402-0779
Email: [email protected]
NEI/NIH
William W. Darby
Grants Management Officer
Division of Extramural Research
National Eye Institute
National Institutes of Health
Executive Plaza South, Suite 350
6120 Executive Blvd, MSC 7164
Bethesda MD 20892-7164
Telephone: 301-451-2020
Fax: 301-496-9997
Email: [email protected]
NIA/NIH:
Deborah Stauffer
Grants Management Specialist
National Institute on Aging
National Institutes of Health
7201 Wisconsin Avenue, Room 2C212
Bethesda, MD 20892-9205
Email: [email protected]
NIMH:
Brian Albertini
Grants Management Branch
National Institute of Mental Health
National Institutes of Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: 301-443-0004
Fax: 301-443-0219
Email: [email protected]
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
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.
The letter of intent is to be sent by the date listed at the beginning of
this document. The letter of intent should be sent to:
Kathleen Michels, Ph.D.
Program Director
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31, Room B2C39
Bethesda, MD 20892-2220
Telephone: 301-435-6031
Fax: 301-402-0779
Email: [email protected]
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: [email protected].
SUPPLEMENTAL INSTRUCTIONS:
Research Plan:
o Page limits for the research plan (sections a-d): 15 pages
o R21 Exploratory Grants need not include preliminary data although it is
recommended that relevant data be included if it supports the proposed
research.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications
requesting up to $250,000 per year in direct costs must be submitted in a
modular grant format. The modular grant format simplifies the preparation of
the budget in these applications by limiting the level of budgetary detail.
Applicants request direct costs in $25,000 modules. Section C of the
research grant application instructions for the PHS 398 (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step
guidance for preparing modular grant applications. Additional information on
modular grants is available at
http://grants.nih.gov/grants/funding/modular/modular.htm.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
application form must be affixed to the bottom of the face page of the
application. Type the RFA number on the label. Failure to use this label
could result in delayed processing of the application such that it may not
reach the review committee in time for review. In addition, the RFA title
and number must be typed on line 2 of the face page of the application form
and the YES box must be marked. The RFA label is also available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the Checklist, and three signed, photocopies, in
one package to:
Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application must be
sent to:
Alan L. Willard, Ph.D.
Chief, Scientific Review Branch
NINDS
6001 Executive Blvd, Room 3208
Rockville, MD 20852 (couriers)
Bethesda, MD 20892-9529 (for US Mail)
Telephone: 301-496-9223
Fax: 301-402-0182
Email: [email protected]
APPLICATION PROCESSING: Applications must be received by the application
receipt date listed in the heading of this RFA. If an application is
received after that date, it will be returned to the applicant without
review.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application. The
CSR will not accept any application that is essentially the same as one
already reviewed. This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications must
include an Introduction addressing the previous critique.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NINDS and the FIC. Incomplete applications will be
returned to the applicant without further consideration
Applications that are complete and responsive to the RFA will be evaluated
for scientific and technical merit by an appropriate peer review group
convened by the NINDS in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
o Receive a written critique
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications under
review, will be discussed and assigned a priority score
o Receive a second level review by the Advisory Councils or Advisory Boards
of the participating RFA sponsors.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments, reviewers will be asked to discuss the following
aspects of your application in order to judge the likelihood that the
proposed research will have a substantial impact on the pursuit of these
goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these criteria
in assigning your application's overall score, weighting them as appropriate
for each application. Your application does not need to be strong in all
categories to be judged likely to have major scientific impact and thus
deserve a meritorious priority score. For example, you may propose to carry
out important work that by its nature is not innovative but is essential to
move a field forward.
(1) SIGNIFICANCE: Does your study address an important problem? If the aims
of your application are achieved, how do they advance scientific knowledge or
impact health in the low- to middle-income country? What will be the effect
of these studies on the concepts or methods that drive this field?
(2) APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project? Do you acknowledge potential problem areas and consider alternative
tactics?
(3) INNOVATION: Does your project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does your project challenge
existing paradigms or develop new methodologies or technologies?
(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out
this work? Is the work proposed appropriate to your experience level as the
Principal Investigator and to that of the other researchers?
(5) ENVIRONMENT: Does the scientific environment in which your work will be
done contribute to the probability of success? Do the proposed studies take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements? Is there evidence of institutional support?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
(6) INTERNATIONAL RESEARCH COLLABORATION: In the course of the research,
what is the potential for sustainable collaborations between the developed
and developing country scientists to be established or strengthened? What is
the potential for the developing country institutions to improve their
capacity and ability to address important issues in brain disorders research,
develop independently-supported research and capacity development programs
and obtain financial support nationally and internationally? How will this
occur?
(7) RESEARCH CAPACITY BUILDING: Does the proposed program contribute to the
capacity of scientists and institutions in low- and middle-income nations to
perform research on brain disorders across the lifespan? Does the proposed
program contain explicit strategies or plans 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 foreign institutions and contribute to overall institutional
excellence?
(8) SPECIFIC R21 REVIEW CRITERIA:
The potential of the proposed planning grant to lay the foundation for future
collaborative research grant applications and the potential significance of
the proposed research and capacity building will be major considerations in
the evaluation of this R21 exploratory/developmental grant mechanism.
Because this R21 is designed to support planning, development and initiation
of innovative collaborative research and ideas, preliminary data as evidence
of feasibility of the project are not required to apply although it is useful
to include or cite pilot data where relevant and available. The applicant
is, however, responsible for presenting the background literature that
provides some basis for the approach and for developing a rigorous research
plan.
o PROTECTIONS: The adequacy of the proposed protection for humans, animals,
or the environment, to the extent they may be adversely affected by the
project proposed in the application.
o INCLUSION: The adequacy of plans to include subjects from both genders,
all racial and ethnic groups (and subgroups), and children as appropriate for
the scientific goals of the research. Plans for the recruitment and
retention of subjects will also be evaluated. (See Inclusion Criteria
included in the section on Federal Citations, below)
o DATA SHARING: The adequacy of the proposed plan to share data.
o BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: February 11, 2003
Application Receipt Date: March 11, 2003
Peer Review Date: June/July 2003
Council Review: September 2003
Earliest Anticipated Start Date: September 2003
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities (including geographic balance and programmatic
interests of the sponsoring organizations)
REQUIRED FEDERAL CITATIONS
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components
involving Phase I and II clinical trials must include provisions for
assessment of patient eligibility and status, rigorous data management,
quality assurance, and auditing procedures. In addition, it is NIH policy
that all clinical trials require data and safety monitoring, with the method
and degree of monitoring being commensurate with the risks (NIH Policy for
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12,
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of
the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a
clear and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research. This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the AMENDMENT "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research - Amended, October, 2001," published in the NIH Guide for Grants and
Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-
files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are
available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable;
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported
by the NIH, unless there are scientific and ethical reasons not to include
them. This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only
research using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).
It is the responsibility of the applicant to provide the official NIH
identifier(s)for the hESC line(s)to be used in the proposed research.
Applications that do not provide this information will be returned without
review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2) cited
publicly and officially by a Federal agency in support of an action that has
the force and effect of law (i.e., a regulation) may be accessed through FOIA.
It is important for applicants to understand the basic scope of this
amendment. NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore, we
caution reviewers that their anonymity may be compromised when they directly
access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving
the health promotion and disease prevention objectives of "Healthy People
2010," a PHS-led national activity for setting priority areas. This RFA is
related to one or more of the priority areas. Potential applicants may obtain
a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance: FIC - No. 93.989, NIMH - 93.242 and is not
subject to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review. Awards are made under authorization of the
Public Health Service Act, as amended (42 USC 241 and 287b) and administered
under Public Health Service (PHS) grants policies described at
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations
42 CFR 52 and 45 CFR Parts 74 and 92.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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