INTERNATIONAL STUDIES IN HEALTH AND ECONOMIC DEVELOPMENT (ISHED) RELEASE DATE: January 8, 2004 RFA Number: RFA-TW-04-003 (see addendum NOT-TW-04-001) Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: Fogarty International Center (FIC) (http://www.fic.nih.gov/programs.html) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.989 APPLICATION RECEIPT DATE: April 21, 2004 (per addendum NOT-TW-04-001) 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 Supplementary Instructions o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA This Request for Applications (RFA) solicits projects that examine the effects of health on microeconomic agents (individuals, households and enterprises) and aggregate growth (cross-country growth analysis), as well as explore how health finance and delivery systems are a source of variation in health outcomes. The specific purpose of this RFA is to provide an opportunity for the recipients of ISHED developmental awards made in this program in 2001 to compete for a full research project. Studies pursued must be relevant to populations in low- and middle- income nations and should preferably be either hypothesis testing or hypothesis generating. Longer-term objectives of the program are as follows: o support socio-economic surveys with rigorous biomedical and psychosocial assessments relating to functional performance and other measures of productivity; o improve and expand the quality of psychosocial and biological epidemiological data that support studies to measure and model economic outcomes; o examine the connections between health and the social environment at the level of the individual and broader community including the effects of social capital and infant/childhood antecedents of adolescent and adult well-being; o assist in the development of a system of metrics that equips researchers, service providers and policymakers with information needed to inform policy and effectively target public health interventions; o improve the quality and availability of health and economic data including longitudinal and inter-generational data sets; o establish the relative effectiveness of different financing and delivery options at community, regional and national levels to enable international comparisons; o build institutional capacity in low- and middle-income countries to incorporate health data in the measurement and modeling of economic performance. RESEARCH OBJECTIVES Background and Significance Over one hundred years after the industrial revolution, a large portion of the world remains impoverished. In the most compelling instance, the Organization for Economic Cooperation and Development indicates that the per capita income in Africa in 1992 was equivalent to that of Western Europe in 1820, and these disparities are widening. Correlates to economic development have been studied vigorously, but only modest attention has been paid to the relationship between health or demographic status and economic development. Over the past three decades the relationship between education and poverty (e.g., measured by wage rates) has been replicated in household surveys across numerous nations and now frequently is viewed as a "causal fact." These data have influenced development policies at national and multilateral levels. However, health has never ascended to a similar footing as a predictive indicator of economic performance. The foundations are now strengthening in support of the widely observed correlation between health and prosperity. Studies linking health and economic behavior have incorporated several broad avenues of investigation: macroeconomic studies to examine the relationship between country-level growth indicators and health; microeconomic studies that explore the dynamics of health and productivity at the individual or household levels; and studies that examine the effect of alternative health policies on economic outcomes. At both the macro-and microeconomic levels, the precise mechanisms and direction of causality have engaged brisk debate, and remain a key conceptual and empirical challenge in studies of the relationship between human capital, especially health and economic development. The lack of understanding of these relationships has impeded the development of effective forms of intervention. Causality likely is a virtuous cycle: increased income yields increased investments in health; and improved health results in greater economic productivity. Rigorous empirical assessment of these relationships involving both hypothesis testing and hypothesis generation will therefore enable us to more accurately evaluate the impact of health interventions on society. Scientific Objectives The goal of this RFA is to solicit applications for hypothesis testing and hypothesis generating studies that will examine the complex linkages between health and economic development. Categories of study may include but are not necessarily limited to: 1. Microeconomic studies that examine the link between health and economic growth at the levels of the individual, household and family. Examples include: o Studies to project the impact of population aging or of a particular disease or disability burden on individual or household economic activity, output and growth, or small enterprise (e.g. HIV, violence, malaria, TB, micronutrient deficiencies, mental health disorders, craniofacial disfigurement, visual impairment, chronic diseases). o Studies to expand the battery of useful physical and functional assessments that can be linked to economic indicators. 2. Cross-sectional surveys or longitudinal panel hypothesis testing or hypothesis generating studies of macroeconomic growth. Examples include: o Surveys or natural experiments to examine the relationship between investment in human resources, particularly education and health, and labor market outcomes. This might include the addition of a health module to an ongoing socio-economic survey or incorporating economic indicators in an ongoing health survey. o Studies to determine which factors link with macroeconomic growth, for example levels and patterns of educational attainment and performance (schooling); health status (life expectancy, mortality rates, disease prevalence or age specific biomarkers); population growth, density and age structure; personal and government savings (investment rates); physical capital stock; trade policy; quality of public institutions. o Studies of the impact of nutrition, primary care interventions, prevention services, health promotion, etc, on childhood growth and development and/or subsequent physical performance and work productivity. o Identification of indicator diseases or conditions to detect and monitor communities experiencing intense poverty; and the use of these indicators to conduct multi-sectoral studies of the cross-cutting effects of essential nutrition and adequate sanitation on both health and productivity. o Studies of the relationship between health and economic effects of traumatic events. 3. Natural opportunities and experimental approaches to examine the effects of alternative health policies on health and economic outcomes. Examples include: o Research to establish the relative impact of different financing options, including national and local taxes, user fees and health insurance on health outcome. o Research to examine the impact and optimal mix of private and public funding for health systems upon health outcome. 4. Research on the impact of decentralization of health systems upon health outcome (defined as the transfer of functions, resources and authority to local levels of government). This might include studies on the theoretical and conceptual background to understanding decentralization, the conditions for effectiveness, the study of decentralization to hospitals and local health centers and the operation of public-sector markets. o Research on the economic impact of preventive health policies (e.g., integration of mental/physical health services with other trauma victim assistance systems). MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research grant (R01) mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing- continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 1, 2004. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. The purpose of this RFA is to stimulate research on the complex dynamics of health and productivity in low- and middle-income nations and build a theoretical and empirical foundation for future explorations in this area. An applicant may request a project period of up to five years and a budget for direct costs of up to $400,000 per year. Because we anticipate that all budget requests will exceed $250,000, the modular grants requirements would not apply to this RFA. Applicants should budget funds in their grant application to attend an annual networking meeting of awardees. The meeting may be held either in the Washington, D.C. area or in a developing country location to be determined by FIC program staff and other participating institutions. FUNDS AVAILABLE The FIC intends to commit approximately $1 million in FY 2004 to fund competitive continuation grants in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs of up to $400,000 per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of FIC provides support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS This solicitation is open to a limited pool of investigators. Only previous recipients of developmental ISHED R01 awards from the 2001 competition are eligible to apply. Questions regarding eligibility should be directed to the FIC program contact listed in the RFA. SPECIAL REQUIREMENTS This program is designed to generate useful scientific information and also to promote collaboration between scientists in the United States and low-and middle-income nations with shared interests in the consequences of health and health policy for economic development. In this regard, the scientific questions should determine the nature of the collaboration. To achieve this end, eligible proposals must be jointly developed and demonstrate a transnational collaboration between a U.S. investigator(s) and an investigator(s) from a low- and middle-income nation(s). Demonstration of such collaboration will be an explicit review criterion. In operational terms, this might take the form of 1) a co-investigator and research staff from low- and middle-income nations supported under the protocol, and 2) protocol-related material support for a host institution in a low- and middle-income nation to stage field studies. (For operational and analytic purposes, the World Bank’s main criterion for classifying economies, gross national product per capita, will be employed for this RFA. A listing of countries representing low- and middle-income economies which are eligible for this program may be found at http://www.worldbank.org/data/countryclass/classgroups.htm). Where appropriate, the design of projects should take into account potential sex and gender differences that may affect the questions asked and the analyses performed. These might include different responses to and impacts of health interventions, differences in physiology, and different behavioral bases for disease prevention strategies. Inclusion of gender considerations will be an enhancing factor in the review of awards. All applications should explicitly state the policy relevance and potential use of the anticipated research results. Intended users can be local, regional, national or international public or private agencies or individuals. Potential policy results may apply to microeconomic or macroeconomic problems but must relate to the health and development priorities of the country in which the research is conducted. Moreover, multidisciplinary approaches to examining the dynamics of health and productivity are especially encouraged. Advances are most likely to be achieved through collaborations among disciplines of economics, epidemiology, demography, sociology, behavioral science and basic biological disciplines. For example, collaboration among economic and biomedical and behavioral scientists may result in more refined measurements of instrumental variables, including psychosocial factors. Applicants are encouraged to collaborate with the World Bank’s Global Development Network (GDN). The GDN is a growing association of research and policy institutes whose goal is to generate, share, and apply to policy knowledge about development. To this end, GDN seeks to support capacity-building activities in developing countries. Information about GDN is available on their web site at http://www.gdnet.org/. GDN’s research network covers all regions of the developing world (see below) and may therefore be a useful source of information about potential collaborators from developing countries. 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 scientific/research issues to: Rachel A. Nugent, Ph.D. Division of International Training and Research Fogarty International Center Building 31, Room B2C39 Bethesda, MD 20892-2220 Telephone: (301) 496-8733 Fax: 301-402-0779 Email: nugentra@mail.nih.gov o Direct your questions about peer review issues to: Sherry L. Dupere, Ph.D. Chief, Biology of Development and Aging IRG Center for Scientific Review 6701 Rockledge Drive, Room 5136 Bethesda, MD 20892-7840 (for express/courier service, use zip 20817) Telephone: 301-435-1021 Fax: 301-480-3567 Email: duperes@csr.nih.gov o Direct your questions about financial or grants management issues to: Bruce Butrum Grants Management Fogarty International Center Building 31, Room B2/C29 Bethesda, MD 20892 Telephone: (301) 496-1670 Fax: 301-594-1211 Email: butrumb@mail.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. 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/labels.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and five 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) APPLICATION PROCESSING: Applications must be received on or before 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. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight weeks. 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. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by FIC. Incomplete applications will not be reviewed. 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 CSR in accordance with the review criteria stated below. As part of the initial merit review, all applications will: 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 written critique o Receive a second level review by the FIC National Advisory Board. 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 evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The 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, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? ENVIRONMENT: Does the scientific environment in which the 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 REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: RESEARCH CAPACITY-BUILDING: Does the proposed program contribute to the capacity of scientists and/or institutions in low- and middle-income nations to perform research related to health and economics (e.g. health outcomes and economic linkages; microeconomics of health care)? Does the proposed program contain explicit strategies or plans to strengthen this capacity through training, career development or other modes? PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Application Receipt Date: February 11, 2004 Peer Review Date: June/July 2004 Council Review: September/October 2004 Earliest Anticipated Start Date: December 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities o Balance among projects to respond to the questions included in this RFA REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 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 "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 PA 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. 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.healthypeople.gov/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 287b) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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