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 http://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 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. 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 http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact Grants Info, Telephone (301) 435-0714, 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 http://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 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, 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 (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. 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 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 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 Sand mental health of the American people.


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