HEALTH, ENVIRONMENT AND ECONOMIC DEVELOPMENT
RELEASE DATE: October 15, 2002 (see addendum NOT-TW-03-004)
RFA: TW 03-005
Fogarty International Center (FIC)
(http://www.nih.gov/fic)
National Institute of Environmental Health Sciences (NIEHS)
(http://www.niehs.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/)
Office of Behavior and Social Science Research (OBSSR)
(http://obssr.od.nih.gov/)
OTHER PARTNER:
United States Geological Survey (USGS)
(http://www.usgs.gov/)
LETTER OF INTENT RECEIPT DATE: November 30,2002
APPLICATION RECEIPT DATE: December 30, 2002
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism 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 RFA is intended to encourage developmental and exploratory
research and research capacity-building in developing countries on
topics that combine the issues of health, environment and economic
development in order to improve scientific understanding of the
relationships among those factors, and suggest guidance for policy.
This announcement invites applications for funding of
interdisciplinary, international research collaborations to examine the
health effects of major economic development trends that affect the
natural environment. It particularly seeks research that, among other
things, focuses on developing a better understanding of the economic
behavior and incentives of individuals and groups that affect health
outcomes through changes in environmental conditions.
The following Institutes and Centers of the National Institutes of
Health (NIH), U.S. Department of Health and Human Services (DHHS)
intend to jointly fund applications from U.S. and international
applicants: the Fogarty International Center (FIC), the National
Institute of Environmental Health Sciences (NIEHS), the National
Institute for Child and Human Development (NICHD), the National
Institute on Drug Abuse (NIDA), and the Office of Behavioral and Social
Science Research (OBSSR). The National Institute of Child Health and
Human Development (NICHD) has an interest in demographic aspects of the
links between HIV/AIDS and related health issues, environment and
economic development, including population settlement and movement and
urbanization.
The U.S. Geological Survey (USGS) will provide, by agreement among
investigators, support through collaboration with USGS scientists for
research needs addressing the linkages between health, the environment,
and economic development through research projects as noted below. If
collaborative support from the USGS is of interest, applicants should
prearrange this collaboration with the appropriate USGS representative
listed in this announcement and document this support in their
applications.
The USGS studies, assesses, and develops and maintains National Data
Bases on the Nation's water (quantity and quality) resources, flora,
fauna, land characteristics, and mineral and energy resources; and
determines past ecological and climate histories. The USGS is also
developing expertise in better understanding and improving the linkages
between natural science information and the use of that information in
societal decisions. Information on potential collaborators and
resources within the USGS can be found on the World Wide Web at
http://www.usgs.gov.
Note that unconfirmed support from USGS or any other collaborator will
not be considered during initial peer review of an application. While
such collaborations could be added to a project after it has been
funded, investigators are encouraged to develop these collaborations
for the initial application.
The research supported by this proposed program will complement the NIH
program, International Studies on Health and Economic Development
(ISHED), at the NIH Fogarty International Center, and is intended to
pursue observational, intervention and policy research that:
1. Evaluates human health impacts of macroeconomic development trends
that alter the environment;
2. Encourages application and development of economic tools that
measure the impact of environmental change on human health;
3. Expands the collection and use of data to analyze links between
human health and the physical and biological environment, and their
mediation by socio-economic conditions;
4. Applies economic and risk analysis to the integration of ecosystem
and human health information;
5. Improves understanding of the economic, political and social
behaviors and incentives at the micro level that alter health outcomes
through environmental change in developing countries;
6. Identifies, tests, and evaluates policy alternatives to improve
health through economic and environmental strategies;
7. Communicates research results to international and national health,
economic development, and/or environmental policy-makers and the
public; and
8. Strengthens interdisciplinary research capacity to conduct analyses
of environment and health outcomes in developing countries and
countries in transition.
Definitions
For the purposes of this RFA, the following definitions should be
applied:
Economic Development: a sustained increase in average per capita
income on a national basis.
Developing Countries: low- and middle-income countries as listed at:
http://www.worldbank.org/data/countryclass/classgroups.htm
Countries in Transition: market economies that were formerly planned
economies, also listed at the above website among developing countries.
Economic Tools: Instruments used in conducting economic analysis,
including surveys, observations, econometric, published and unpublished
data sources.
Ecosystem: natural and human resources with emphasis on inter-
relationships among and between human and natural resource services
Environment: resources provided by nature, distinct from human beings,
with emphasis on human use and values of natural resources (e.g. water,
air, soil, etc.)
Externality: impacts (negative or positive) imposed on third parties by
an activity that is not accounted for in the decisions of the agent
creating the impact
Non-linear processes: relationships among variables that do not exhibit
a 1-to-1 progression, and that may exhibit unpredictable perturbations
Policy-maker: person or organization in a decision-making role used to
alter health, environment, or economic outcomes
Policy-relevance and dissemination: potential for practical
application by converting findings of the research from basic,
clinical, or epidemiological or environmental science into information,
tools, or resources that can be used and are made available for use to
policy-makers at local, national, and/or global levels.
Scientific Objectives
The goal of this RFA is to solicit applications for research studies
that generate and/or test hypotheses examining the interactions among
health, environment, and economic development, as well as the impact on
health status of development projects or policies that affect the
ecosystem. The research must be interdisciplinary and must include
plans for research capacity-strengthening and policy dissemination.
Such studies are not limited to, but may include:
o Microeconomic studies that examine health and environment
relationships at the individual, household, or business level using
epidemiological and surveillance data.
o Cross-sectional and longitudinal studies that examine health and
environment relationships across countries, regions or populations or
within the same population across time.
o Experimental approaches to examine the effects of alternative
policies and interventions (either health or environmental) on health
outcomes.
o Studies that analyze health and environmental relationships across
economic sectors.
o Studies that analyze the interplay between genetics and the
environment (gene-environment interactions) for susceptibility factors
and other non-therapeutic research, including etiological studies of
environmental exposure.
It is expected that some proposals may rely upon existing research
efforts in one or more fields by adding a component to become eligible
for Health, Environment, and Economic Development (HEED) consideration.
For instance, studies of environmental impacts may add a component on
health by gathering additional data and broadening the analytical
framework and methods. To utilize this incremental approach to HEED
research, however, it will be necessary to demonstrate that the
proposed new study is analytically sound, the new component is well
integrated with ongoing work, and that the research team is truly
international and inter-disciplinary.
RESEARCH OBJECTIVES
An important role of the FIC is to foster discovery and reduce global
health disparities by supporting international research collaborations
in basic, clinical and applied biomedical, behavioral and health
sciences. The opportunity to collaborate internationally provides
access to new information and perspectives, innovative concepts and
methods, emerging research technologies, and unique populations and
environments necessary to address global health problems. Research
performed under these conditions provides opportunities to change
behaviors and develop appropriate policies. Behavioral change is
favored when context-specific causes and motivations are understood.
Policy change is favored when committed individuals in leadership
positions have relevant information available to them, especially
information showing economic, health, or environmental gain from policy
changes.
The immediate objectives of this initiative are to encourage research
that: simultaneously applies the knowledge, tools, and results of a
variety of scientific disciplines including the natural, biomedical,
social and behavioral sciences; collects or enhances data that reflect
the interactions between human health and ecosystem health; and/or
informs, tests, or evaluates policy options to improve health outcomes
directly or indirectly affected by the natural environment or human
influences upon it. The ultimate objectives are to: (1) increase
understanding of the linkages among human behavior, environmental
responses, and epidemiological and clinical health outcomes; and (2)
develop and test clinical and policy interventions intended to mitigate
the negative effects of environmental and economic change on health
outcomes. Applicants must be prepared to undertake an interdisciplinary
research approach, incorporating to the maximum extent practical, tools
and approaches from the behavioral, social, environmental and biomedical
sciences. Applicants must also be prepared to carry out an explicit
research capacity-building effort as part of the research project,
disseminate information to a policy audience, and evaluate the
effectiveness of those activities.
This initiative is designed to attract investigative teams that include
a range of biomedical and non-biomedical fields, including, but not
limited to anthropology, epidemiology, toxicology, ecology, infectious
and non-infectious diseases, geography, geology, hydrology, sociology,
psychology, genetics, ethics, economics, political science, law, public
policy, environmental and process engineering, biostatistics, and
others. At least one person from each of the following disciplinary
areas must have an active and meaningful role in the application and
conduct of the proposed project: a social scientist, a health or
biomedical scientist, and an ecological or environmental scientist.
Background and Significance:
Most developing countries and countries in transition suffer from
contamination of air, land, and water; exposure of their populations to
industrial toxins; natural resource depletion; and ecosystem
deterioration. These conditions all exacerbate the spread of disease,
place stress on poorly functioning and overburdened health systems,
complicate disease etiology, and lead to depletion of human and
economic resources. This combination of environmental and health
problems in some developing countries is often exacerbated by natural
disasters, civil strife, and economic crises. Economic factors play a
crucial role in people's choices and decisions about both health and
the environment, and ultimately determine whether development will be
sustainable. Applied to issues involving both health and the
environment, the tools of economics and other social sciences will
provide insights into the causal relationships, assessment of impacts,
and policy options for ameliorating the costs and enhancing the
benefits of those choices. For example, the decision to construct a
dam to provide energy to a growing economy may be supported by cost-
benefit analysis on the basis of energy needs and environmental
impacts, but be questioned when the health impacts of the environmental
change are considered in the analysis.
The process of economic development has increased global
interdependence in numerous ways, leading to potential vulnerabilities
across countries arising from shocks or trends in economic,
environmental and health conditions. Further, economic development
alters ecosystem processes in ways that have direct health
implications. For example, greater exposure to environmental insults
through air, water, and food from industrialization, and increased
prevalence of non-communicable diseases from changing agricultural and
food systems are affecting health of developing country populations
around the world. Health risks to developing country populations from
environmental factors are believed to exceed the risk levels of
developed countries, but at a lower income threshold.
Long-standing premises about the relationship between health and
economic development, and environment and economic development are
being revisited and revised. In the first instance, the NIH program
ISHED, (see http://www.nih.gov/fic/programs/econ.html) aims to strengthen the
growing body of evidence that demonstrates how health affects economic
development through a variety of pathways, rather than solely being
determined by economic development. In the second instance, recent
literature in economics has refuted the assertion of the "environmental
Kuznets curve" that environmental conditions worsen up to a threshold
of income and then improve at income levels above that threshold. The
implied trade-off between the environment and income at low levels of
development may often be false. Similarly, while the relationship of
human health to environmental quality is generally thought to be
important, the linkages are complex and poorly understood, particularly
in developing countries. Nonetheless, presumed human health impacts
are routinely and frequently used to justify environmental policy laws,
decisions and programs, often with insufficient grounding in empirical
evidence.
Thus, while health, environment and human behavior interact intimately
in developing countries to hasten or impede development, there are many
situations in which we do not fully understand their interactions.
These complex links will only be understood and ultimately addressed
through rigorous, inter-disciplinary research. This research
initiative envisions partnerships between developed and developing
country scientists and is intended to create the evidence base for
policy-makers and citizens to address the critical environment-health
issues they face in their countries, and in the process to inform U.S.
and international policy makers in the formulation of environment,
development, and health policies.
Program Priorities
Health status is a key indicator of human well being, and increasing
attention is being devoted internationally and domestically to how
health interacts with other major trends affecting populations. These
include globalization, urbanization, environmental degradation, and
financial integration. The agenda for the September 2002 World Summit
on Sustainable Development identified health as an integral component
of sustainable development, and called for more efficient, equitable,
accessible and appropriate health care systems for the populations that
rely on them.
The health sciences have increasingly sought a better understanding of
their links to social and economic contexts. Substantial progress has
been made independently in the disciplinary fields of environmental
science, environmental economics, development studies and behavioral
sciences. This RFA seeks to create opportunities for integration of
research approaches and objectives across those and other relevant
disciplines.
While not an exhaustive list, among the issues that would be considered
responsive to this RFA are:
1. Environmental Health Risk Factors
There is growing awareness that environmental pollution affects human
health in myriad ways and contributes to a wide variety of diseases
with unknown etiology. Scientific methods for the assessment and
management of related risks to human health and the environment are
also improving rapidly, but scientific methods and the policies derived
from them are most often applied in developed countries where the
exposure levels and variability are relatively low. Insight can be
gained by studying environmental health risks and responses across
diverse populations across a range of socio-economic settings. The
results will inform all human-environment interactions, as well as
suggest opportunities to improve global health. Topics to explore in
this category include, but are not limited to:
o How environmental health risks are affected by structural changes in
developing country economies, such as shifts from rural to urban
lifestyles, changing modes of transportation, and openness to
international trade;
o The role of socio-economic status in determining vulnerability to
environmental health risks within sub-populations in developing
countries;
o Health impacts of major development projects, such as dams, mines,
and waterways, and how inclusion of those impacts would affect the
cost-benefit ratio of the projects;
o Health and environmental risks and benefits to producers and
consumers from agricultural chemical use. More broadly, evaluation of
how food production decisions (including land use, technology choice,
exposure to chemicals) affect environmental quality and population
health and nutrition, as well as farm income and food prices;
o The predicted impacts of global climate change on weather patterns
and agriculture in developing countries, such as changes in disease
transmission, vector ranges, food security, and nutrition, as well as
analysis of potential mitigation alternatives addressing these impacts.
2. Analysis of Decision-making and Risk
Advances in several fields in recent years point to the need to explore
how individuals and societies make decisions about matters that may
involve collective choices, externalities, non-linear processes, and
cultural, moral and other values. Issues involving health - individual
or public - and the environment are prime candidates for such complex
decision-making processes and also introduce uncertainty and temporal
variation. The simple logic of economic "marginal benefit-marginal
cost" analysis has limited application in these circumstances. Yet
economic methods, combined with the tools of other behavioral sciences,
provide the constrained choice framework needed to make predictions
about human behavior in the face of changing health and environmental
conditions. Topics to explore in this category include, but are not
limited to:
o Analysis of information use and information gaps for households and
individuals in making choices about health and environmental conditions
(both short- and long-term) and the consequences of critical
information gaps. For example, a model of the health and environmental
consequences of natural disasters that would demonstrate the effects of
discounting and uncertainty, and the conditions under which prevention
becomes cost-effective.
o Identification and analysis of market and policy failures that
create ways in which major land use changes, including deforestation,
affect risks of disease prevalence through changes in social and
biological processes.
o The role of social, versus private or government, decision-making in
health and environmental outcomes. Both health and the environment are
recognized as imposing externalities, and this "market failure" forms
the justification for government involvement in both sectors. Yet
"policy or institutional failures" are common problems in some
developing countries where governments may be weak, corrupt and/or
under-funded. Alternative social or institutional arrangements for
managing health and environmental needs devised by households or
communities can be identified and evaluated in terms of their
effectiveness. Examples include community-driven malaria control
through drainage of standing water pools and households making choices
about which member receives treatment for HIV/AIDS based on human
capital needs.
o Rural-urban and interregional population migration and the role of
health-seeking behavior. Health status varies greatly between rural
and urban areas in developing countries, as well as across regions and
countries. Yet, it is unclear how information and perceptions about
potential change in health status influence decisions about migration,
compared to information and perceptions about other factors, especially
economic ones.
3. Economic Measurement of Disease - Environment Interactions.
Tools for valuing non-market costs and benefits have been applied and
tested in increasing numbers of settings, providing crucial information
to policy-makers in setting of regulatory targets and in design of
intervention programs. Most of these applications have occurred in
developed country settings, and concerned environmental issues. Yet
the tools can also yield great insights for developing country policy-
makers and in the field of health policy and intervention design.
Better methods are needed for the valuation of morbidity, mortality and
latent risk reductions, including application of stated and revealed
preference methods, benefits transfer, and decision-based methods.
Most ambitiously, with appropriate data collection and analysis, the
methods could be applied in cases where health and environmental
impacts interact, leading to the ability to evaluate policy choices
more comprehensively and holistically. Topics to explore in this
category include, but are not limited to:
o Valuation of environmental health risk reduction, with particular
attention to health disparities within a population, including immuno-
compromised segments of the population. For example, apparent
increases in childhood asthma from indoor and ambient air pollution may
impose large costs in terms of cognitive development and eventually
reduce productivity levels.
o Assessment of the full costs and benefits (including productivity
impacts) of environmental technology choices that affect human health
at the individual or household level, e.g. cooking and fuel, transport,
etc.
o Assessment of the full costs and benefits (including productivity
impacts) of policy choices that have environmental and health impacts
at the population level, e.g. inadequate water and wastewater delivery
systems.
o How cultural and social factors and individual socio-economic status
affect the discounting of future health and environmental costs and
benefits.
MECHANISM OF SUPPORT
This RFA will use the National Institutes of Health (NIH) research
developmental/ exploratory grant (R21) award mechanism. The R21
mechanism is specifically intended to support innovative ideas 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 and strengthening future
research project grant applications (R01). FIC anticipates re-competing
this program in fiscal year 2005, using a research project (R01)
mechanism, contingent on availability of funds. Successful responses to
this solicitation must clearly outline how the work conducted during the
two-year period of this award would inform, enhance, and lead to a
longer-term (up to five-year) research project. They must also clearly
explain why the two-year award is necessary to the successful
implementation of the envisioned research project.
This RFA uses just-in-time concepts and the modular grant format (see
https://grants.nih.gov/grants/funding/modular/modular.htm). Applications
submitted by foreign institutions can request facilities and
administrative (F&A) costs up to a maximum of eight percent.
Applications submitted by domestic institutions can request facilities
and administrative (F&A) costs based on prior negotiated rates. Please
see the web site
https://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.
This RFA is issued for fiscal year (FY) 2003 and the anticipated award
start date is July 2003. Applications submitted in response to this RFA
may have a project period of two years. As an applicant, you will be
solely responsible for planning, directing, and executing the proposed
project.
FUNDS AVAILABLE
It is expected that approximately $1.5 million per year from all
supporting partners will be available beginning in FY 2003. Applicants
may request a project period of up to two years and a budget of up to
$100,000 per year in direct costs or four 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 of awards will also
vary. It is expected that approximately 12 new grants will be funded in
response to this RFA in FY 2003. This support is dependent upon the
receipt of a sufficient number of applications of high scientific merit,
the geographic pool of meritorious applications, and the availability of
funds. Although the financial plans of the ICs provide support for this
program, awards pursuant to this RFA are contingent upon the
availability of funds at FIC and the collaborating partners. Awards
will be administered by the FIC in cooperation with participating NIH
ICs and other participating agencies, although several may participate
in the funding of any given application.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the
following characteristics:
o For-profit and non-profit
o Public and private institutions, such as universities and colleges,
hospitals, and laboratories
o Units of state and local governmental
o Domestic and foreign
o Faith-based or community-based organizations
Foreign collaborators should be from Africa, Russia and Eastern Europe,
Asia (except Japan, Singapore, South Korea and Taiwan,) the Pacific
Island region (except Australia and New Zealand,) the Middle East
(except Israel,) Latin America or the Caribbean. The primary foreign
collaborator must either hold a full-time faculty research position or
should have a full-time faculty position with a strong research
commitment.
Note: Applicants should check
http://www.nih.gov/fic/regional/CountryInstructions.html for special
considerations relative to some potential collaborating countries.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge and resources needed to carry
out the proposed research 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, are
especially encouraged to apply.
SPECIAL REQUIREMENTS
This program is intended to generate useful scientific information and
policy implications. It is also intended to promote collaboration
among scientists in developed and developing countries, and in
different fields of expertise. Advances from this program are most
likely to be achieved by interdisciplinary efforts. For example,
collaboration among biomedical, behavioral, environmental, and social
scientists is expected to result in a greater degree of refinement and
insight in the selection and design of instrumental variables,
analytical tools, interpretation of results, and implications for
policy and programs. Toward this end, eligible proposals must be able
to demonstrate that the research plan has been developed cooperatively
by the international team and will be carried out cooperatively.
Research teams must include a social or behavioral scientist, health or
biomedical scientist, and a natural or environmental scientist.
The budget must include funds for up to two networking meeting or
workshop per year of all the grantees for the purpose of sharing
information and methods. The meeting(s) will be organized by the
program sponsors in collaboration with the grantees (at least two
grantees per award not from the same country should plan to attend).
The meeting(s) may be held outside the U.S. if deemed desirable to
advance the objectives of the program and if cost-effective.
The research plan must also include a section titled "Research Capacity-
building Plan" that addresses the need to integrate health, environment
and economic expertise in the developing country(ies), the contribution
of the project toward doing so, and how that contribution will be
evaluated. A long-term outcome of capacity strengthening is the
augmentation of scientific competence and skills nationally and
internationally and development of a cadre of researchers with proper
research training and support who can continue to carry out research.
The plan should specifically identify foreign members of the research
team whose capacity to undertake interdisciplinary research in their
country will be enhanced, identify specific professional goals (e.g.,
publications, training, progress toward a degree, broadening of research
scope, etc.) and a timetable for achieving them, and demonstrate how the
contributions of these team members are integral to the overall
objectives and conduct of the research. The plan should identify those
capacity-building procedures and plans for the two-year life of the
proposed R21 project, as well as a brief concept for the longer-term
full research project award.
The plan must also identify the relevance of the research to health,
environment, and/or development policy and programs in the developing
country(ies) and include a plan for dissemination of policy implications
to national and, as appropriate, international policy-makers. The
proposal must identify how the policy relevance and policy dissemination
requirements will be met by both the two-year R21 development/planning
award, as well as a prospective longer-term full research project award.
The program sponsors will work with the awardees during the grant period
to further develop the research translation and communication aspects of
their projects.
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 Direct your questions about overall administration, eligibility, and
scientific/research issues to:
Rachel A. Nugent, Ph.D.
Division of International Training and Research
Fogarty International Center
National Institutes of Health
31 Center Drive, Room B2C39, MSC 2220
Bethesda, MD 20892
Telephone: (301) 496-8733
Fax: (301) 402-0779
Email: nugentra@mail.nih.gov
Additional scientific/research questions may be addressed to:
Shobha Srinivasan, Ph.D.
Scientific Program Administrator
Chemical Exposures and Molecular Biology Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
National Institutes of Health
P.O. Box 12233, MD EC-21
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 541-2506
Fax: (919) 316-4606
Email: srinica2@niehs.nih.gov
Jerry Flanzer, Ph.D.
National Institute on Drug Abuse
National Institutes of Health
6001 Executive Blvd., Room 5274
Bethesda, MD 20892
Telephone: (301) 443-4060
Fax: (301) 443-9127
Email: jflanzer@mail.nih.gov
Rebecca L. Clark, Ph.D.
Demographic and Behavioral Sciences Branch
Center for Population Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B07, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-1175
Fax: (301) 496-0962
E-mail: rclark@mail.nih.gov
Virginia S. Cain, Ph.D.
Deputy Director
Office of Behavioral and Social Sciences Research
National Institutes of Health
1 Center Drive Room 256
Bethesda, MD 20892
Phone: 301-402-1146
Fax: 301-402-1150
E-mail: Virginia_Cain@nih.gov
Carl D. Shapiro, Ph.D.
Office of the Director
U.S. Geological Survey
104 National Center
Reston, VA 20192
Phone: (703) 648-4446 (Voice)
Fax: (703) 648-5470 (Fax)
Email: cshapiro@usgs.gov
o Direct your questions about peer review issues to:
Leroy Worth, Jr., Ph.D.
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
National Institutes of Health
P.O. Box 12233, MD EC-24
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 541-0670
Fax: (919) 541-2503
Email: worth@niehs.nih.gov
o Direct your questions about overall financial or grants management
matters to:
Bruce Butrum
Grants Management Officer
Fogarty International Center
31 Center Drive, Room B2, C39, MSC 2220
Bethesda, MD 20892
Telephone: (301) 496-1670
Fax: (301) 594-1211
E-mail: butrumb@mail.nih.gov
Additional questions about financial or grants management may be
directed to:
Jackie Russell
Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
National Institutes of Health
P.O. Box 12233, MD EC-24
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 541-0751
Fax: (919) 541-2860
Email: russell@niehs.nih.gov
Ms. Kathy Hancock
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17G, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-5482
Fax: (301) 402-0915
Email: kh47d@nih.gov
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:
Leroy Worth, Jr., Ph.D.
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
National Institutes of Health
P.O. Box 12233, MD EC-24
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 541-0670
Fax: (919) 541-2503
Email: worth@niehs.nih.gov
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 https://grants.nih.gov/grants/funding/phs398/phs398.html in
an interactive format. For further assistance contact Grants Info,
Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. 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 https://grants.nih.gov/grants/funding/phs398/phs398.html
includes step-by-step guidance for preparing modular grants.
Additional information on modular grants is available at
https://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:
https://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, one additional copy of the application must
be sent to each of the following persons:
Leroy Worth, Jr., Ph.D.
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
National Institutes of Health
P.O. Box 12233, MD EC-24
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 541-0670
Fax: (919) 541-2503
Email: worth@niehs.nih.gov
Rachel A. Nugent, Ph.D.
Division of International Training and Research
Fogarty International Center
National Institutes of Health
31 Center Drive, Room B2, C39, MSC 2220
Bethesda, MD 20892
Telephone: (301) 496-8733
Fax: (301) 402-0779
Email: nugentra@mail.nih.gov
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 FIC, NIEHS and cosponsors. Incomplete and/or
non-responsive 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 NIEHS 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 Fogarty International Center
Advisory Council and/or Advisory Boards of the cosponsors.
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 high 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 development
problem affecting health and the environment? If the aims of your
application are achieved, how do they advance scientific knowledge of
development, environment and health interactions? What will be the
effect of these studies on the concepts or methods that drive this
field? Will the study demonstrate methods that can be applied to
similar problems elsewhere?
(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) INVESTIGATORS: 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 other
researchers (if any)? Do you include personnel who can address
economic, health and environmental problems in an interdisciplinary
manner?
(5) ENVIRONMENT: Does the scientific environment in which your work
will be done contribute to the probability of success? Do the proposed
experiments take advantage of unique features of the scientific
environment or employ useful collaborative arrangements? Is there
evidence of institutional support?
ADDITIONAL SCIENTIFIC REVIEW CRITERIA:
Your application will be reviewed for satisfactory compliance with each
of the special requirements described above. You must meet all of
those requirements to be considered fully responsive to this RFA. In
addition, the following criteria will also be used to evaluate the
responsiveness of your proposal to the objectives of the program:
a) Capacity-Strengthening: Does your proposed program contribute to
the capacity of scientists in low- and middle-income nations to perform
research related to health, environment, and economic development? How
will your project enhance the ability of scientists in a developing
country to carry out interdisciplinary research? Does your proposed
program contain explicit strategies or plans to strengthen this
capacity through research training, career development, mentoring and
other modes? Will collaborating foreign scientists develop the
capacity to become independent investigators in health and environment
and development research? How will this occur? How will it assist
their ability to publish results in local or international scientific
journals?
b) Policy-Relevance: How does your project address important health
and environmental issues in a developing country? Does it address
priority concerns of policy-makers and the public in that country? How
will the results of your project provide information of importance to
decision-makers, and how will your project results be disseminated to
policy-makers and the public?
c) Evaluation: Do you provide a clear and concise plan or method for
assessment of the policy-relevance and research capacity-strengthening
components of your aims? How will you evaluate both the research
capacity building and policy-relevance, and dissemination
accomplishments of your project? What indicators, measures, and/or
milestones will you use and how will you report them to the intended
audience for your research beyond the funding agencies? Will your
evaluation plan address the method and effectiveness of policy-relevant
dissemination of your results?
d) Specific R21 review criteria: innovation of the project and
potential significance of the proposed research will be the major
considerations in the evaluation of the R21 exploratory grant
mechanism. Because the R21 is designed to support innovative ideas,
preliminary data as evidence of feasibility of the project are not
required. However, the applicant is responsible for presenting the
background literature that provides some basis for the approach and for
developing a rigorous research plan. Relevant pilot data should be
cited when available.
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
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 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: November 30, 2002
Application Receipt Date: December 30,2002
Peer Review Date: March 2003
Council Review: May 2003
Earliest Anticipated Start Date: July 1, 2003
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Responsiveness to special requirements
o Availability of funds
o Programmatic priorities, including geographic balance and interests
of cofunders
REQUIRED FEDERAL CITATIONS
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
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a
complete copy of the updated Guidelines are available at
https://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
https://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
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
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
https://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 No. 93.989, 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 https://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 Sand mental health of the American people.