DEVELOPMENT OF COMMUNITY CHILD HEALTH RESEARCH RELEASE DATE: May 7, 2002 RFA: HD-02-008 PARTICIPATING INSTITUTES AND CENTERS (ICs): National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov) LETTER OF INTENT RECEIPT DATE: June 17, 2002 APPLICATION RECEIPT DATE: July 23, 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 The National Institute of Child Health and Human Development (NICHD) invites cooperative agreement applications for the development of a community-linked collaboration to investigate disparities in maternal and child health. The purpose of the solicitation is to support community-research institution partnerships that will work together over a two and one-half year span to plan a multi-site, multi-level study that examines how community, family, and individual level influences interact with biological influences and result in health disparities in pregnancy outcome and infant and early childhood mortality and morbidity. The long-term goals are to decrease fetal and infant mortality and improve child health in minority urban and rural communities. RESEARCH OBJECTIVES Nature of the Research Problem Attempts to explain disparities in child health arising along racial, ethnic and socio-economic gradients have proliferated during the last decade. Many approaches arising from biomedical and social-behavioral perspectives have made progress in developing a satisfying explanation, but usually such attempts have fallen short of a complete explanation. At the same time, the need for greater involvement of minority communities in health disparities research has become increasingly appreciated. Such involvement can help assure that the science addresses relevant issues in their communities and that an effective platform to translate scientific findings is created. In order to address these needs, it is necessary to field a study that blends biomedical and socio-behavioral science and establishes partnerships with disadvantaged communities from the earliest stages of the study. This RFA invites applications from research sites that wish to combine these factors into a multi-site, multi-method study of community child health that is predicated on community partnerships with the scientific team. Background Racial and ethnic disparities in maternal and child health are widespread. Disparities appear to be closely related to the social conditions associated with poor communities and fragmented families. For example, infant deaths are highest among many of our nation"s urban and rural minorities. Sudden Infant Death Syndrome (SIDS) is the leading cause of post-neonatal mortality, accounting for approximately 28 percent of such deaths. SIDS rates vary widely by race and ethnicity. According to 1999 period linked files, the rate of SIDS was 1.3/1000 live births among blacks, 0.56/1000 among whites, 0.37/1000 among Hispanics, and 0.31/1000 among Asian/Pacific Islanders. Among American Indians and Alaskan Natives, SIDS is the leading cause of overall infant mortality, with a rate of 1.47/1000 live births, which is almost three times that of whites. The basis for the racial disparity is not fully determined. Gains in reducing the disparity will come from continued efforts in the implementation and evaluation of the "Back to Sleep" campaign, expanded research into the etiology and pathogenesis of SIDS, and the development of new prognostic, therapeutic, and preventive strategies. Although many of the remaining deaths in the post-neonatal period are due to a range of diagnoses such as infections, accidents, neglect, and abuse, the diagnosis of a large proportion of the deaths is still undetermined. It is important to understand the contributions of biological, medical, behavioral, and social factors in all causes of unexpected early childhood deaths in high-risk communities. In this way, complete diagnosis and effective interventions can be achieved. In addition, fetal death rates are higher among blacks compared with whites. The rate of fetal deaths 20 weeks or greater in 1998 was 12.3/1000 live births plus fetal deaths among black mothers and 6.7/1000 live births plus fetal deaths among white mothers. The late fetal mortality rate (28 weeks gestation or greater) is also higher among blacks (5.3/1000 compared with 3.4/1000). Some studies show that unexplained antenatal stillbirths, which represent about half of late fetal deaths, share characteristics with SIDS. Preterm birth affects 11.6 percent of all births in the United States and is a major contributor to infant morbidity and mortality. Within preterm birth, there is a significant health disparity, with preterm births at less than 32 weeks occurring almost 2.5 times more often to African American mothers than whites. Prematurity, intrauterine growth retardation, and their complications supercede all other conditions (including congenital anomalies) as the primary cause of infant morbidity and mortality in the African American population, with deaths attributed to short gestation and low birthweight almost four times that of white infants. While technology has contributed significantly to improving neonatal survival over the past several decades, especially in relation to those diseases and disorders that are specific sequelae of preterm birth and low birthweight, a disproportionate contribution to the overall post-neonatal deaths and infant morbidity from infection, respiratory problems, child abuse, etc. occurs in survivors of prematurity and low birth weight. Additionally, these infants are also at higher risk for SIDS in the post-neonatal period. Despite improvements in the cause-specific rates of fetal, infant, and early childhood mortality and morbidity in recent years, the health disparities remain. Scientific Knowledge to be Achieved Through Research Supported by the RFA The family and community are important influences on child health. The family and community also frame the context through which private and public resources are mobilized to address child health problems. Research on community and family effects on child health has demonstrated that these influences are real and the next logical step for such research to take is to ask how they work to produce child health outcomes. Traditional research on infant mortality and morbidity has focused on either the environmental factors, i.e. individual, family or community influences, or on the biologic etiologies and mechanisms. Such approaches have failed to acknowledge the important synergism of these different sources of vulnerability. This deficiency is most apparent in health disparities where traditional approaches have failed to explain adequately the causes of these disparities. The next logical step for research to take is to specify social and behavioral processes that combine to produce biological pathways by which disparities in health arise at birth and through early childhood. The work supported by this RFA will create a foundation that will support such a study in the future. Each Collaborating Site (CS) will have assembled an interdisciplinary team that is well versed in the considerable body of research on child health that exists in the biomedical and social-behavioral sciences. Each CS will have articulated sample studies that demonstrate how the community/family/individual pathways produce biological activity that influences child health. The work of the Community Child Health Research Collaboration will be to identify a feasible research work plan that combines both the biomedical and social-behavioral approaches into a new type of study that addresses the deficiencies in the contributing research traditions. Objectives of this Research Program This RFA represents phase 1 of the development of a community-linked research collaboration for maternal and child health. The purpose of the solicitation is to create a community–linked collaboration of cooperative agreements that will work together over a 2 1/2 year span to plan a multi-site, multi-level study that examines how community, family, and individual level influences interact with biological influences and result in health disparities in pregnancy outcome and infant and early childhood mortality and morbidity. The goal of the phase 1 research program is to blend the substantive theory, measurement regimes, and study designs found in the biomedical, social, and behavioral sciences into a study of infant mortality and child health in order to improve our understanding of the complicated interplay of environmental and genetic factors that produce biological outcomes. The products of phase 1 will be a plan of action that describes the hypotheses, design, and content of a multi-site, multi-level study and preliminary work at each site that creates a foundation upon which to build such a study. The scope of the solicitation includes the blending of social, behavioral, and biomedical approaches into a coherent community-linked study. The concept of community used in the research includes not only geographic neighborhoods and catchment areas, but also the set of institutions that affect health directly or indirectly. The objectives of the studies to be planned within the Community Child Health Research Collaboration in phase 1 are to increase knowledge regarding the prevalence, causes, and pathogenesis of (1) unexpected death of the fetus in late pregnancy, infants at birth, and children ages zero to three years, (2) other infant deaths that are unrelated to neonatal events, and (3) infant and early childhood morbidity in high-risk minority populations. NICHD is interested in promoting studies that include the contribution of underlying genetic factors, prenatal and newborn conditions, and infectious agents, and their interaction because these factors may illuminate approaches for health gains through screening and therapeutic intervention. The multi- site, multi-level study in phase 2 will examine how community, family, and individual level influences interact with biological influences and result in health disparities in pregnancy outcome and infant and early childhood mortality and morbidity. The research requested in phase 1 by this RFA will create a plan of action to implement the work of phase 2. Another phase 2 objective is to provide communities with trained researchers and the scientific infrastructure to monitor and improve public health. Researchers who are representative of the communities in which these health problems are evident provide valuable perspectives and insights that increase the relevance, validity, and acceptance and acceptability of research efforts and facilitate the implementation of interventions. The RFA requests that investigators plan for the development of a research-integrated training program for minority investigators that advances the scientific goals of this solicitation by strengthening the scientific infrastructure needed to maintain and improve the health of the public. Specifically, the objectives of the RFA for phase 1 are: o Establish functional community partnerships to conduct research aimed at reducing disparities in maternal and child health, o Conduct exploratory studies of community perceptions of health disparities and the factors viewed as most salient in contributing to them and assess issues of salience to the community that may affect the research goals and design, o Formalize the collaboration structure and operations, o Develop a set of testable hypotheses for phase 2, o Develop design strategies and instruments for phase 2 to include conducting pilot studies, o Develop plans for a training program to provide promising minority investigators with opportunities to increase their research skills and competencies by their active involvement in the planned research efforts and through more traditional educational experiences, o Develop plans to create a common core study supplemented by site-specific research, o Produce a report summarizing the achievements toward these objectives and an assessment of the feasibility of proceeding to phase 2, o Develop plans for pooling data across sites and for sharing data with investigators outside of the study. Types of Research Approaches Sought Applicants should consider the following research approaches when developing sample research studies: epidemiology, mechanistic studies employing measures of infection, immune function, genetic susceptibility, pathology, and physical, social, psychological, and cultural determinants of health behavior. It is desirable to blend the following types of approaches that are commonly found in the social sciences with biomedical approaches, e.g. population-based analysis, ethnography, network analysis, and multi-level analysis. Examples of Research Topics Examples of health outcomes that can be the target of phase 1 activities include, but are not limited to, the following: o Preterm delivery, o Intra-uterine growth retardation, o Stillbirth (fetal death at or later than 20 weeks), o Specific causes of infant mortality that demonstrate health disparity, o Infant and early childhood morbidity to include: failure to thrive, hearing or vision impairment, fetal alcohol syndrome (FAS), cerebral palsy, inadequate immunization, recurrent infections, reactive airway disease and other respiratory problems, injures or repeated hospitalizations, o Primary prevention of infant and early childhood mortality and morbidity, particularly among the economically disadvantaged who would benefit most from such interventions. The community and family are thought to be central in implementing preventive approaches to child health. The research collaboration assembled through this RFA should be prepared to identify approaches to prevention that might be useful to explore in phase 2 of this study. Project Organization The purpose of the cooperative agreement grants for phase 1 is to develop the resources and infrastructure for participation in the Community Child Health Research Collaboration in phase 2. Only those applicants who are successful in receiving phase 1 support will be eligible to compete for participation in phase 2. The Community Child Health Research Collaboration will develop and conduct protocols with common elements, which address the needs of the minority populations served by Collaborating Sites. The applicant Collaborating Site (CS) for the phase 1 grant should be a partnership between an academic institution and a community institution(s). The Principal Investigator (PI) will represent the academic institution and should have a demonstrated record of working with the community. The co- Principal Investigator (co-PI) will represent the community institution. The community institution can be defined by geographic limits and/or by a functional mission. These individuals will serve as the responsible leaders for the CS. It is expected that both the PI and co-PI will partner to identify scientific objectives and create a platform for communication with the community in all stages of the scientific endeavor. The partner/affiliated academic institution (subsequently referred to as the "academic institution") must have a track record of social, behavioral, and biomedical research and research training. A Steering Committee will be assembled from among phase 1 awardees. In the planning phase, the Steering Committee will provide a forum to share program activities and potential directions for phase 2. The Committee will consist of the Principal Investigators and Co-Principal Investigators of all awarded grants, and NIH staff. Each site and NIH will have one vote on the Steering Committee. The Steering Committee will be charged with the task of combining multiple perspectives and research agendas across sites into a coherent plan of action. MECHANISM OF SUPPORT This Request for Applications will use the National Institutes of Health (NIH) Cooperative Research Project Grant (U01) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. NICHD may create a future opportunity (phase 2) to implement the plan of action created by the collaboration established by this RFA. The anticipated award date is April 1, 2003. The NIH U01 is a cooperative agreement award mechanism in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award." FUNDS AVAILABLE NICHD intends to commit approximately $750,000 in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2003 to fund four to six new grants in response to this RFA. An applicant should request a project period of two and one-half years and a budget for direct costs of up to $125,000 per year for the first and second years of the project. For the third year, up to $63,000 direct costs should be requested. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary. Although the financial plans of the NICHD provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic o Faith-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary 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 always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Minimum Catchment Populations Clinical study centers with urban populations should have a catchment population with at least 8,000 births per year, and those with rural populations at least 3,000 births per year in order to apply. Budget Applicants should request funds for travel up to $10,000 per year for the PI, Co-PI, and one to two staff to attend regular Steering Committee meetings in Bethesda, MD that will occur every three months and will involve interaction with the staff of NICHD and related public and private organizations. Applicants should budget for the site and team specific activities that will occur in parallel with the Bethesda meetings. Data Collection and Sharing It is anticipated that there will be a Data Coordinating and Analysis Center in phase 2. In phase 1, the awardees will develop plans for the activities of the Center and address issues related to human subject protection, including confidentiality and community needs, and data sharing with investigators outside of the Collaboration. Cooperative Agreement Terms and Conditions of Award Cooperative agreements are assistance mechanisms and are subject to the same administrative requirements as grants. The special Terms and Conditions of Award are in addition to, not in lieu of, otherwise applicable OMB administrative guidelines, HHS, PHS, and NIH grant regulations, policies, and procedures, with particular emphasis on HHS regulations at 42 CFR Part 74 and 92. Facilities and Administrative cost (indirect cost) award procedures will apply to cooperative agreement awards in the same manner as for grants. Business management aspects of these awards will be administered by the NICHD Grants Management Branch in accordance with HHS, PHS, and NIH grant administration requirements. The cooperative agreement funding mechanism will require collaboration among the NICHD Project Scientists and the Principal Investigators of the Collaborating Sites. The NICHD Project Scientists will coordinate the activities of the Collaboration, and will facilitate communication and the exchange of information. 1. The Primary Rights and Responsibilities of the Awardees All awardees will agree to accept the participatory and cooperative nature of the group process. All awardees are required to submit annual progress reports to NICHD, as appropriate, and to provide study and site performance information as stipulated by NICHD. The Principal Investigator of each Collaborating Site will play an important role in the design of the phase 1 plan of action. Each Principal Investigator will have primary responsibility for work that establishes a community link at their site and to gather preliminary information necessary to prepare their site for phase 2 studies. The awardees will retain custody of, and primary rights to their data developed under this award, subject to Government rights of access, consistent with current HHS, PHS, and NIH policies. Each investigator will have the right to publish based on the work of their individual research programs, according to the publication policies developed by the Steering Committee. Each Principal Investigator will also work cooperatively to propose a phase 2 plan of action involving all of the participating sites. The Collaborating Sites specifically will: o Develop active community links at their site to sustain and plan phase 2 activities. o Work cooperatively with other Collaboration sites to create a plan of action and study protocol for phase 2. o Gather information and operationalize constructs with respects to the community environment at their site to support phase 2 operations. o Carry out pilot studies developed by the Steering Committee. o Present research concepts, plans, progress, and results to the Steering Committee. o Publish and disseminate results of both independent and shared research. When joint protocols are completed, publish in collaboration with other involved Collaboration Sites. o Collaborate with other awardees and the NIH. o Obtain local institutional review board (IRB) approval of all study protocols implemented at U.S. or foreign sites and comply with both IRB and Collaboration policies and procedures. o Generate, if feasible, additional research proposals, including shared protocols, for consideration for inclusion in the Collaboration. o Attend and participate in all Collaboration conference calls and Steering Committee meetings. 2. NICHD Responsibilities NICHD Project Scientist The NICHD Collaboration Project Scientists will be staff from the Pregnancy and Perinatology Branch and the Demographic and Behavioral Sciences Branch of NICHD. The Project Scientist is a partner within the Collaboration representing the government"s interest in the substantive work of the Collaboration. The primary role of the Project Scientist is to facilitate the work of the Collaboration. He/she will: o Assist in all functions of the Steering Committee, including: reviewing and commenting on each stage of the program before subsequent stages are started, recommending the options of adding, modifying or terminating aspects of the program. o Assist with accomplishing the objectives of phase 1 so that the collaboration is prepared to embark on action for phase 2. o Assist in the analysis, interpretation, and reporting of findings in the scientific literature and other media to the community at large and the public policy community within the Federal government. NICHD Project Officer NICHD will appoint a Project Officer, apart from the Project Scientists, who will: o Have the option to withhold support to a participating institution if technical performance requirements, such as compliance with the protocol, are not met. o Carry out continuous review of all activities to ensure objectives are being met. o Exercise the normal stewardship responsibilities of an NIH Program Officer. 3. Collaborative Responsibilities The overall guidance and management of the Collaboration will be provided by a Steering Committee as described below: Steering Committee Responsibilities Planning and implementation of the cooperative aspects of the study will be done by a Steering Committee consisting of the Principal Investigator/co- Principal Investigator from each participating awardee institution and the NICHD Project Scientists. NICHD will have one vote that will be split evenly between the two NICHD Project Scientists. The Steering Committee will: o Plan the design and implementation of the plan of action for phase 2. o Participate in decision-making regarding gathering preliminary information at the participating sites and operationalizing key constructs regarding the community and other environmental factors at participating sites. o Formulate publication policy and appoint a Publication Subcommittee, as judged necessary by the Steering Committee. Publish results, conclusions, and interpretations of the cooperative planning activity. Due publication credit will be given to all work done cooperatively. o Agree to accept the coordinating role of the committee and the cooperative nature of the group process. Data Safety and Monitoring Committee A Data Safety and Monitoring Committee (DSMC) will be established by NICHD, if needed, and will advise the Collaboration on research design issues, data quality and analysis, and ethical and human subject issues. 4. Arbitration Procedures When agreement between an awardee and NICHD staff cannot be reached on programmatic and scientific-technical issues that may arise after the award, an arbitration panel will be formed. The panel will consist of one person selected by the Principal Investigators, one person selected by the NICHD staff, and a third person selected by these two members. The decision of the arbitration panel, by majority vote, will be binding. These special arbitration procedures in no way affect the awardees right to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16. 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: V. Jeffery Evans Ph.D., J.D. Demographic and Behavioral Sciences Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B07, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1176 FAX: (301) 496-0962 Email: evansvj@mail.nih.gov or Marian Willinger, Ph.D. Pregnancy and Perinatology Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B03, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6896 FAX: (301) 496-3790 Email: mw75q@nih.gov o Direct your questions about peer review issues to: Robert Stretch, Ph.D. Acting Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510 Bethesda MD 20892-7510 Rockville MD 20852 (for express/courier service) Telephone: (301) 496-1485 Email: stretchr@mail.nih.gov o Direct your questions about financial or grants management matters to: Kathy Hancock Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17K, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5482 FAX: (301) 480-4782 Email: hancockk@mail.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 NICHD 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: V. Jeffery Evans, Ph.D., J.D. Demographic and Behavioral Sciences Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B07, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1176 FAX: (301) 496-0962 Email: evansvj@mail.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 GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS: Applications must provide and/or address the following: o Descriptions of catchment populations (size and demographic characteristics) to include the number of births per year, term and preterm, within racial/ethnic groups, o Documented late fetal and infant mortality rates, within racial/ethnic groups: overall and cause-specific for 1992-1999, o Descriptions of the staff and programs in place for the recruitment and evaluation of families and infants at risk within the community, o Demonstrated capacity to conduct obstetric, pediatric, and social and behavioral research, documentation of the formation of an interdisciplinary team combining appropriate biomedical, social, and behavioral expertise to include their expertise and strengths. o Demonstration of how the PI and co-PI at each site will function in the working arrangement such that each will have an equal voice in the development of a research and training infrastructure for conducting the community-linked studies, identification of areas to be studied and the development of hypotheses to be tested, and the implementation of protocols to be carried out, o Plans for gathering demographic information at each site and for measuring community and family constructs within each study population, o The Research Methods section of the application should include descriptions of two sample research studies that will lead to improved pregnancy outcome and early childhood health. The sample research studies will serve as a starting point for deliberations within the Steering Committee and will enable reviewers to evaluate the substantive approaches that the site is best equipped to perform. Investigators will not be expected to perform these studies at their site during phase 1. These sample studies should be designed based on a theoretical total catchment of the Collaboration of 25,000 pregnancies/year for four years of enrollment, and should utilize outcome estimates based on the site-specific data provided above. The application should contain sections addressing background and significance, specific aims, and research approaches, including the measurement of key constructs and processes and strategies for data collection and analysis, to accomplish the following: (1) apply theory from the social and behavioral sciences to explain how community/family/individual influences interact with biological processes that determine birth outcomes and early life health and development, and/or (2) apply theory from the social and behavioral science to explain how community/ family/individual influences affect therapeutic or preventive interventions, and/or (3) provide evidence for the significance of these theoretical constructs to their community. The descriptions of sample research studies should be limited to 14 pages for both sample studies. The page limit for the entire research plan is 25 pages. o Evidence of a working relationship between the community organization and affiliate research institution that is capable of supporting research, training, and information dissemination, o Plans for developing a training program with affiliated institutions, including objectives of training, the integration of the training objectives with the research objectives of the proposed projects, a description of types or professional backgrounds of trainees, the general research skills to be acquired through training, and the current unmet research training needs to be impacted by the training effort o The Collaborating Site may represent a consortium of sites within a community. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center for Scientific Review National Institutes Of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Robert Stretch, Ph.D. Acting Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510 Bethesda MD 20892-7510 Rockville MD 20852 (for express/courier service) APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NICHD. 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 NICHD 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 National Advisory Child Health and Human Development Council 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 research proposed address an important problem? If the aims of the sample studies are achieved, how do they advance scientific knowledge and improve the public health? 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 analytic plans outlined in the sample studies appropriate to the aims of the Community Child Health Research collaboration as outlined in the RFA? Are the sample studies feasible in the context of the community served by your application. Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts? Do the sample studies employ novel approaches or methods? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the Principal Investigator and to that of other researchers (if any)? Is an appropriate multidisciplinary team assembled to carry out the work? (5) ENVIRONMENT: Does the scientific and community environment in which the work will be done contribute to the probability of success? Do the proposed approaches take advantage of unique features of the scientific and community environment and employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: 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. OTHER REVIEW CRITERIA: o The potential of the site to fit into a multi-site study of community child health. o The value of the investigating team to a multi-level, multi-method investigation of community child health and the ability to contribute to an inter-disciplinary research effort. o The adequacy of plans to establish a functioning community partnership. o The adequacy of plans for the development of a research-integrated training program for minority investigators that advances the scientific goals of this solicitation by strengthening the scientific infrastructure needed to maintain and improve the health of the public. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: June 17, 2002 Application Receipt Date: July 23, 2002 Peer Review Date: November 2002 Council Review: January 2003 Earliest Anticipated Start Date: April 1, 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice- files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research, updated racial and ethnic categories in compliance with the new OMB standards, clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398, and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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 Nos. 93.864 and 93.865, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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