This PA will remain active for three years, through the July 1, 2003 application receipt date. THE SCIENCE AND ECOLOGY OF EARLY DEVELOPMENT (SEED) Release Date: June 22, 2000 PA NUMBER: PAS-00-108 (see replacement PA-04-113) National Institute of Child Health and Human Development (http://www.nichd.nih.gov) National Institute of Mental Health (http://www.nimh.nih.gov) THIS PA USES THE “MODULAR GRANT” AND “JUST IN TIME” CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA. PURPOSE This Program Announcement (PA), jointly issued by the Demographic and Behavioral Sciences Branch (DBSB) and the Child Development and Behavior Branch (CDBB) of the National Institute of Child Health and Human Development (NICHD) and the Developmental Psychopathology and Prevention Research Branch of the National Institute of Mental Health (NIMH), invites research grant applications focused on creating a science base on the development of children living in low-income families. This PA falls under the Science and Ecology of Early Development (SEED) 2000 initiative. SEED 2000 is designed as a collaborative effort among the following agencies: U.S. Department of Health and Human Services [NICHD, NIMH, Administration on Children and Families (ACF), Office of the Assistant Secretary for Planning and Evaluation (ASPE), and the Centers for Disease Control and Prevention (CDC)], and the Department of Education (National Institute on Early Childhood Development and Education of the Office of Educational Research and Improvement, National Center for Education Statistics, and Office of Special Education Programs). Its main focus is to establish a research agenda on the development of children in low- income families that has scientific integrity and is highly relevant to policy makers. The overarching goal of the SEED initiative is to foster research on the multiple contexts of development--family, child care settings, schools, neighborhoods, communities and broader cultural contexts-- and their impact on the developmental trajectories of children in low income families. The NICHD, NIMH, and their SEED partners seek to stimulate systematic, multidisciplinary, and ecological research to understand the specific cognitive, linguistic, sociocultural, and economic factors, and the complex interaction among these factors, that promote or impede development of children in low-income families. It is expected that the research studies stimulated by this initiative will contribute scientific data on the developmental trajectories of low-income children and have relevant implications for emerging public policy issues, including health disparities. The purposes of this PA are threefold: (1) to examine the effects of poverty, as it interacts with a multitude of factors, on the developmental trajectories of children in low-income families; (2) to identify risk and protective factors for physical and mental health and cognitive, linguistic, affective, and social development among children growing up in low-income families; and (3) to identify social-ecological factors that affect the development of poor children and that can be used to guide and inform policy, including the design and implementation of effective interventions. 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 Program Announcement (PA) is related to one or more of the priority areas. Potential applicants may obtain “Healthy People 2010” at http://www.health.gov/healthypeople. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Only new applications may be submitted in response to this announcement; competing continuation applications for funded projects are not eligible. MECHANISM OF SUPPORT This PA uses the National Institutes of Health (NIH) research project grant (R01) and the Interactive Research Project Grant (IRPG) award mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to the PA may not exceed five years. Use of the IRPG, consisting of theoretically and collaboratively linked individual research project grants, is encouraged. For a description of the IRPG mechanism, please refer to: https://grants.nih.gov/grants/guide/pa-files/PA-96-001.html. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grants can be found at https://grants.nih.gov/grants/funding/modular/modular.htm. FUNDS AVAILABLE The NICHD intends to commit approximately $1.5 million and the NIMH intends to commit approximately $500,000 in total costs [direct plus Facilities and Administrative (F&A) costs] in FY 2001 to fund three to four new grants in response to this PA. SEED partner agencies may add funds to support or supplement projects in the program. An applicant may request a project period of up to five years. Because the nature and scope of the research proposed may vary, it is anticipated that the size of awards also will vary. Although this program is provided for in the financial plans of the NICHD and NIMH, awards pursuant to this PA are contingent upon the availability of funds for this purpose and the receipt of a sufficient number of meritorious applications. RESEARCH OBJECTIVES Background At present, the largest group of poor people living in the United States is children, and nearly one-fourth of poor children are under six years of age. Children in poverty are especially at risk for problems in physical and mental health, and cognitive and social development. Poverty among children is associated with an array of problems, including low birth weight, infant mortality, contagious diseases, and childhood injury and death. Poor children are at risk for developmental delays in intellectual development and school achievement. Compared to non-poor children, poor children tend to have lower average levels of school-related skills and their progress through school is slower and more subject to termination from dropout. Poor children also have relatively high rates of social/emotional and behavioral problems, including anxiety, social withdrawal, aggression, and delinquency; lack of self-esteem and self-efficacy; and psychological distress. Although poor children are at risk for problems, many are healthy, intellectually productive, and socially well-adjusted. The ecological context in which poor children develop has been significantly altered in the last two decades by major sociodemographic changes in community and family structure and population composition. For example, the increase in the rate of maternal labor force participation, the parallel increase in the enrollment of children in non-parental care facilities, and the rapid decline in the proportion of two-parent families have created different challenges and opportunities for poor families. The majority of poor children live in one- parent households, and the poverty rate for fatherless families is higher than for two-parent households. Today’s poor families are likely to have complex and shifting family structures, highly diverse ethnic and linguistic backgrounds, and uneven education and employment. Other factors that have drastically shaped the context in which families live include the recent changes in welfare reform, health care, and child welfare as well as the major economic expansion of the last decade. Communities also have undergone drastic changes. In this era of globalization and the emergence of the “network society,” concentrated urban poverty and related dimensions of economic disadvantage, such as racial and ethnic exclusion, have affected child development in ways that are not fully understood. Violence that children experience in their own homes and communities or through television, movies, and interactive video games is increasingly common as are substance abuse, periods of homelessness, and serious mental illness. Although there is an expanding body of research on the consequences on growing up poor for children and families, this research is, in general, discipline- specific, not well integrated across disciplines, and reveals some gaps. To address this issue, in October 1997, under the auspices of SEED, the NICHD convened a workshop to discuss the issues involved in crafting a research agenda that examines the impact of poverty on child development and health outcomes. The workshop participants included distinguished scientists in developmental psychology, economics, education, evolutionary biology, medicine, and sociology. The main goals of the workshop were to provide a multidisciplinary perspective on the research base on poverty and child development; to identify the most pressing scientific issues involving poverty and child development; and to offer new ideas and research questions that could lead us to develop a “new science” of research that is multidisciplinary, longitudinal, and that embraces an ecological approach to the study of child development. The group identified the following areas in which research is needed: 1. The nature of poverty and how to measure it The study of poverty and its effects on children needs to consider that poverty is best defined along a continuum that encompasses, but exceeds, the official poverty threshold, from the underclass through the working class. Poverty is a conglomerate of conditions and events; it is not a categorical variable and it needs to be studied in the context of ethnicity, culture, and race, taking into account the variability across and within groups. One of the fundamental issues related to estimating the effects of poverty on children’s outcomes is measurement. Future research should consider the recommendations of the National Research Council Panel on Poverty and Family Assistance: Concepts, Information and Needs, and Measurement Methods. However, investigators should not limit themselves to this definition and should consider other indices of economic well-being such as social capital, human capital, and economic resources. 2. The effects of family structure, family processes, and income poverty, and other indices of poverty, on child outcomes There is a compelling rationale and need for the development of a comprehensive program of research that can identify the full range of individual, social, economic, cultural, and community factors, and the interactions among these factors, that are directly relevant to the development of children in low-income families. Such a program of research needs to attend to children living in fragile circumstances, including homeless children, children in foster care, and children living in families affected by chronic physical or mental health problems such as depression or substance abuse. Research on these issues needs to address the multiple domains of development including physical and mental health, and social, emotional, cognitive and linguistic development. Debates continue over the extent to which income alone makes a significant difference in children’s lives. Many questions remain about the relative contributions of economic resources and parental characteristics to children’s outcomes. Research suggests that the timing of poverty has a significant effect on children’s outcomes and that income alone does not seem to make a significant difference in improving the physical health, mental health, or behavioral development of poor children. 3. The mechanisms through which poverty exerts its effects Research on poverty to date has documented an array of associations between poverty and child outcomes. However, there is little understanding of the pathways or mechanisms--the black box-- by which poverty (income and other aspects of poverty) has positive or negative effects on children’s development. To understand poverty’s effects on children’s outcomes, we need to examine how it affects their living environments, including composition, safety, structure, and social relationships as well as access to health care, child care, and other social services. We need research that advances our understanding of what is in the black box. 4. The role of communities and neighborhoods in children’s development There is an accumulating body of research that examines neighborhood effects on children’s development. If neighborhood effects on children’s outcomes exist, they are presumed to be constituted from social processes that involve collective aspects of community life. Departing from a social capital perspective, research needs to explore what determines and sustains social support for children. Research to date has focused on how mechanisms such as informal social support or social control bear on the well-being of children. Yet our understanding of the social mechanisms hypothesized to mediate the effects of neighborhood structural characteristics is still developing. Investigations of social mechanisms including spatial externalities, in conjunction with racial differences in spatial advantage and disadvantage, are beginning to emerge. Violence in communities, both intra-family and neighborhood, has a profound effect on children and families. 5. The implications of poverty for interventions Understanding the dynamics of poverty is essential to understanding how policies affect children’s development. Family poverty and children’s outcomes need to be understood in their social contexts, which have changed dramatically. There was a sense among workshop participants that research needs to focus on the factors or combination of factors that lead to change in children’s lives under different conditions of poverty. The challenge for researchers and others is to gain insight into what is the optimal timing for interventions and what interventions are optimal for whom, when, and under what conditions. 6. The appropriateness of existing measures of child development and the development of new measurement tools and methodologies In terms of measures, workshop participants suggested that existing instruments are not sufficient to predict outcomes across socioeconomic and cultural groups. For example, recent research suggests that many existing measures of the proximal child-rearing environment (e.g., the HOME Inventory) may be less useful for low income families than they are for higher income families and may not capture elements of parenting relevant for minority groups. Consequently, there is a need to develop new measurement tools that can capture both commonalities and differences across ethnic and cultural groups. In addition to the need for new tools for the study of poverty and its effects on children’s outcomes, there was a collective sense among the participants that research studies need to use a diverse range of research methodologies, including both longitudinal and ethnographic designs, and a combination of both qualitative and quantitative measures. In conclusion, workshop participants noted that the field of child development has not fully integrated relevant socioeconomic data with children’s developmental trajectories. For example, economic studies of time use have not traditionally been linked to studies on children’s development. There is little research on how various cognitive and socio-emotional characteristics that influence language, memory, learning, and planning ability develop in impoverished environments. Similarly, little is known about how environmental factors, including family and peer group contexts, and societal norms, shape children’s socio-emotional characteristics and, in turn, influence children’s engagement in cognitive tasks, or how socio-emotional development in the context of poverty affects various facets of cognitive development (e.g., language, memory, reasoning, and theory of mind). While there are protective mechanisms that moderate the effects of poverty and result in better outcomes for some children, these are poorly understood. Likewise, little is known about how ethnic and cultural variation interacts with poverty to affect children’s development. Further, research on early brain development has not been linked to differences in the factors that mediate the effects of poverty on children’s development. At a more macro level, research has paid little attention to the way geographical mobility due to economic needs influences the stability and quality of housing and schooling and, consequently, children’s developmental trajectories. In light of recent social, cultural, and economic changes that have increased the diversity of the U.S. population, there is a need for new theories and research that specifically address the development of children in poverty and the diverse social and cultural contexts that shape children’s developmental trajectories. The intent of this initiative is to stimulate this work and to encourage interdisciplinary collaborations among scientists from different fields. Objectives and Scope A major goal of this research initiative is to obtain converging scientific evidence that ultimately can become the base for a “new science” that seeks to understand the diverse developmental trajectories of children in low-income families, how development is enhanced or impeded in low income communities, the effects of a complex mix of factors on development, and the optimal points for interventions. This initiative solicits studies that focus specifically on the integration of research on environmental, social, economic, and developmental factors that affect developmental processes and outcomes for children, and that draw on current theoretical and methodological advances in behavioral research. Specifically, this initiative encourages research that (1) is multidisciplinary; (2) uses existing sources of data and/or justifies new data collection efforts; (3) is or can be linked to other relevant national efforts across disciplines; and (4) has relevance for public policy. Specifically, this initiative seeks collaborative, interactive research projects to address these overarching research questions: o What are the effects of poverty on child development? o What are the mechanisms through which poverty affects child development? o What are the moderators (e.g., demographic, family, neighborhood, and policy factors) of the effects of poverty, that is, what provides for positive child development in the face of poverty and what compromises development? o What interventions are effective in preventing or mitigating the adverse effects of poverty on child development? What mechanisms or moderating factors should they target? o What is the role of child care, as a mechanism, moderator, or intervention, in child developmental trajectories? How do family characteristics and child care act together to promote or impede optimal child development? In addition to the above questions, this PA addresses two cross-cutting issues, namely measurement and theory. Are current measures and theories of child development adequate to capture and characterize the development of children given the variety of family structures, community and economic influences, and ethnic and cultural diversity of the current U.S. population? How might existing measures be modified and what new measures must be developed to address the complex issues in the social ecology of early development? The issue of measurement should extend not only to measurement of child development in different settings, but also measurement of poverty and its concomitants. Although researchers may choose to focus on measurement and/or theory issues alone, their work should contribute to answering one or more of the research questions. Research Priorities and Examples of Research Questions The following research priorities and examples of research questions are offered to illuminate areas of particular interest to the NICHD, NIMH, and SEED partners. Examples of research questions that address the objectives of this PA include, but are not limited to: Effects of poverty on child development o How do children who live in impoverished conditions develop self-regulation and the ability to manage stress? How do they develop values and goals? How do learning, memory, and planning ability develop in different contexts such as the home environment, school or day care setting, and the neighborhood? How do the relations between these different contexts promote or impede optimal child development? o How do families' characteristics (e.g., household structure, relations with kin outside the household, parents' age, parents' education, and psychological resources) influence children’s development? How do neighborhood and community characteristics (e.g., neighborhood cohesion, access to services, violence) influence families and children and shape the processes by which poverty affects child developmental outcomes? o What are the mutual influences of a child’s health, genetics, nutrition, mental health, and personal characteristics on child outcomes and how do conditions of poverty interact with these factors? How do children’s age, gender, and temperament interact with parents' characteristics to influence parenting patterns? How do the interactions between parent and child characteristics in predicting child outcomes differ in different physical and social environments? What is the role of culture in shaping how poverty influences children’s outcomes in different family and social contexts? o How do early childbearing and unwanted pregnancy affect fathers' and mothers' parental behaviors? How do these affect child outcomes? How are these effects augmented or minimized by income, SES, and other economic factors? Does extended family or community support directly or indirectly affect child outcomes? o What are the pathways to competence and healthy development for low income children, minority children, and children with special needs? What factors promote healthy development and what factors or combinations of factors place children at risk for poor developmental outcomes? o What are the emotional and behavioral problems and disorders experienced by children living in poverty? What are the factors related to impoverished conditions that may place children at risk for future mental health problems and disorders? o How does family income in the early years affect children’s early and later development? Is there variability by ethnic or cultural group? If income inequality is not the primary reason for poor children’s unequal opportunities, how do additional resources translate into child resources? What are some implications for interventions? o How do low-wage working families cope with work demands, such as irregular hours and shift work; with family responsibilities, including child care needs, training and education, responsibility for caregiving to elderly parents, and/or managing other family members' health needs; and with instability of housing and employment? What is the effect of various coping strategies on child development? o What role do fathers play in child-rearing and child care and how does their involvement with their children and their families relate to children’s school readiness? What influence do fathers have on children at different developmental stages? How does father involvement vary by cultural group? How is father involvement influenced by his relationship with the child’s mother as well as his own characteristics including economic resources, mental health, and parenting attitudes? How do fathers and children create nurturant, positive relationships in the context of the family, neighborhood, and community? o How does the community context affect poverty? How do communities create environments that are safe and stimulating for children? Why do some children succeed while others do not? What are the relations between the family and other contexts? What are the community and family resources? How do they combine to affect development? What formulas work successfully and which lead to failure? Mechanism through which poverty affects child development o What are the pathways or mechanisms through which income, or lack thereof, influences children’s outcomes? How does variation in children’s characteristics (e.g., health, biogenetic contribution, temperament) account for differences in developmental outcomes? How do pathways vary as a function of children’s family, neighborhood, community, and other environmental characteristics? o What are the various mechanisms (e.g., timing of poverty, parenting in impoverished environments, intra-family allocation of resources, the contribution of fathers and other caregivers to the development of their children, and neighborhood influences) that transmit or buffer the effects of poverty? o What are the cultural and ethnic variations in the mechanisms through which factors related to poverty influence children’s outcomes? Interventions o How do focused vs. comprehensive intervention approaches vary in terms of child outcomes? How do programs that target the child or the family differ from those that also address other aspects of the child’s environment such as the school, neighborhood, or community? How do different intervention approaches affect children’s outcomes in different cultural and ethnic groups? What are the processes by which interventions affect change in different cultural and ethnic groups? o How can the development of children living in poverty be enhanced? What are effective strategies for promoting healthy development? What strategies are effective for fostering positive social and emotional development and its role in children’s school readiness? What strategies are effective for promoting language and literacy development in young children? o What are effective mental health services and interventions for children and their families who are experiencing poverty? Which mental health prevention models are appropriate and effective for children who live in impoverished conditions? Are there innovative interventions for mental health problems for children and families who are living in poverty? Child care o What type of child care arrangements do low-income parents make for their children? How do quality of care and type of care interact with home factors, and how do these interactions affect child outcomes? How do children in multiple child care arrangements fare in comparison to children in single child care arrangements? How do parents balance their own needs with the needs of their children when choosing child care? o What is the quality of care that is purchased by low-income families with the help of subsidies? How does the use of subsidies affect the quality, safety, and stability of care that children receive? Do parents who receive child care subsidies make different choices regarding the type and quality of care for their children than low-income parents who do not receive subsidies? o Given that many children experience multiple child care arrangements, as well as multiple caregivers, what role do secondary caregivers play in children’s physical, social, cognitive, and emotional development? How do children who spend their time in different child care settings of different quality differ from those children who spend their day in more stable environments? How does kinship involvement in child care vary by cultural and ethnic group? How do secondary caregivers influence development at different developmental stages? How do different child care arrangements and kinship networks interact with family, neighborhood, and community characteristics to affect children’s outcomes? Research Designs and Data Sources The utilization of existing data is encouraged for its cost-efficiency whenever scientific goals can be met by its use. There is a wide range of such data collected in the U.S. and available for research purposes. Each data set has its particular strengths and weaknesses, which the investigator must understand and deal with. Such resources include, but are not limited to, the Study of Income and Program Participation, Panel Study of Income Dynamics, and the National Longitudinal Survey of Youth. Researchers may be aware of, and have access to, other data that are appropriate for answering the questions they wish to address. For a description of these various datasets please see http://www.nichd.nih.gov/cpr/dbs/resources.htm. New data collection is justifiable if existing data are not appropriate to the aims of the proposed study. In such cases, scientific sampling procedures are highly desirable to ensure that sample biases do not vitiate the research objectives. Prior contact with the program staff listed under INQUIRIES, below, is strongly encouraged for any applicant considering such an effort. Applicants proposing new data collection are encouraged to make their data available for use by other researchers and should outline plans for accomplishing this in the application. Applicants proposing research that draws on social scientific approaches that have not been widely applied to research on poverty and child development are particularly encouraged to apply. Collaborations involving anthropologists, historians, economists, sociologists, political scientists, epidemiologists, and psychologists may be needed to advance theoretical and methodological approaches to the study of children’s developmental trajectories. Therefore, applicants are encouraged to consider research designs which are innovative, integrative of multiple perspectives, and which utilize, as appropriate, a range of methods and analytic techniques. SPECIAL REQUIREMENTS It is the intention of the SEED program to support projects that will accumulate information that not only furthers the scientific understanding of child development from an ecological perspective, but also informs public policy. Therefore, Principal Investigators from projects funded under the SEED initiative will be expected to engage in an interactive, collaborative process; each participating Principal Investigator will be expected to participate in workshops and conferences designed to further the research/public policy dialogue. These initiatives encourage the participation of junior scholars who might develop links with researchers to explore training opportunities. Annual Meeting for Investigators Principal Investigators will be expected to attend an annual SEED Investigators Meeting to share findings, research approaches, and core instruments or data elements. Applications should include in the budget development sufficient funds to support travel for the Principal Investigator to one three-day meeting in Washington, DC, in each of the requested years of support. NIH SEED investigators will interact with staff from SEED agencies and their contractors and grantees at these events. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects unless a clear and compelling rationale and justification are provided 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 research involving human subjects should read the “NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research,” published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994, and available at: https://grants.nih.gov/grants/guide/notice-files/not94-100.html. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH 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 or 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," published in the NIH Guide for Grants and Contracts, March 6, 1998, and available at: https://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff also may provide additional relevant information concerning the policy. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (revised 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. These forms are available at most institutional offices of sponsored research, on the Internet at https://grants.nih.gov/grants/funding/phs398/phs398.html, and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-710-0267, E-mail: email@example.com. Application Instructions: Interactive Research Project Grant (IRPG) Applications A description of the Interactive Research Project Grant may be found at: https://grants.nih.gov/grants/guide/pa-files/PA-96-001.html. An IRPG group consists of the coordinated submission of two or more applications for related research project grants (R01) that do not require extensive shared physical resources. Although these applications must describe the objectives and scientific importance of the collaboration, each project must be capable of being accomplished independently. The Principal Investigators may be from one or more institutions. Each application will be reviewed independently for scientific merit and those judged to have substantial merit will be considered for funding both as an independent award and as a component of the proposed IRPG group. A separate application must be prepared by each participating institution/Principal Investigator. It is important that all applications comprising the IRPG group cite this PA on line 2 of the application face page (see below). Application Instructions: Modular Grant Applications The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in- time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers, and NIH staff. The research grant application form PHS 398 (revised 4/98) is to be used in applying for these grants, with the modifications noted below. Applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in a ccordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD: Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT: Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION: Prepare a Modular Grant Budget Narrative page. (See https://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the Total Direct Costs requested for each year. This is not a Form Page. Under Personnel, list key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of Total Costs (Direct plus F & A) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH: The Biographical Sketch provides information used by reviewers in the assessment of each individual’s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: https://grants.nih.gov/grants/funding/modular/modular.htm. - Complete the educational block at the top of the Form Page; - List position(s) and any honors; - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years; - List selected peer-reviewed publications, with full citations. o CHECKLIST: This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and telephone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. Submission Instructions The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. 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) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or 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 discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that 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. (1) 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? (2) 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? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) 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)? (5) 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? In addition to the above criteria, in accordance with NIH policy, all applications also will be reviewed with respect to the following criteria: o The adequacy of plans to include both genders, minorities, and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects also will be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o 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. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priorities. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquires regarding programmatic issues to: Natasha Cabrera, Ph.D. Demographic and Behavioral Sciences Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B13, MSC 7510 Bethesda, MD 20892-7510 Telephone: 301-496-1174 FAX: 301-496-0962 E-mail: firstname.lastname@example.org Cheryl Boyce, Ph.D. Developmental Psychopathology and Prevention Branch Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6200, MSC 9617 Bethesda, MD 20892-9617 Telephone: 301-443-0848 FAX: 301-480-4415 E-mail: email@example.com Direct inquiries regarding fiscal matters to: Mr. Michael Loewe Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: 301-496-5481 FAX: 301-402-0915 E-mail: firstname.lastname@example.org AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.864 (Population Research), 93.865 (Research for Mothers and Children), and 93.121 and 93.242 (NIMH). Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372, or to Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-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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