DATA COORDINATION CENTER FOR THE NIH-DC INITIATIVE TO REDUCE INFANT MORTALITY IN MINORITY POPULATIONS Release Date: January 9, 1998 RFA: HD-98-003 P.T. National Institute of Child Health and Human Development Office of Research on Minority Health Letter of Intent Receipt Date: February 2,1998 Application Receipt Date: March 27, 1998 PURPOSE The National Institute of Child Health and Human Development (NICHD), in cooperation with the National Institutes of Health (NIH) Office of Research on Minority Health (ORMH), invites new and renewal applications from institutions desiring to participate with the NICHD under a cooperative agreement as the Data Coordination Center (DCC) in support of an ongoing multi-center research program designed to investigate topics related to the high infant mortality among minority populations in Washington, DC. It is the objective of this initiative to expedite the development of answers to these problems through a cooperative research network of participating centers in Washington, DC in cooperation with the NICHD. Research topics to be addressed include studies and interventions in women during pregnancy, infants and young children, as well as non-pregnant women during the preconception or interconception phase. Funding will be provided by ORMH and NICHD. The current Data Coordinating Center has been the Initiative Data Center since July 1993 and is supported through August 31, 1998. Applicants must be able to provide the services of the Data Coordination Center (DCC) for the network of research organizations established via a prior Request for Applications (RFA HD-96-005) including providing management support and consultation in the design, execution, and analysis for multi-institutional experimental studies in the field of infant mortality, ensuring that the studies are of the highest scientific integrity and meet rigorous statistical standards, providing consultation in epidemiology, statistics, and intervention design methodology, and providing logistic support for multi-site protocols. The DCC will be functionally independent of all research sites, although it could be physically located at one of them. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-lead national activity for setting priority areas. This Request for Applications (RFA), Data Coordination Center for the NIH-DC Initiative to Reduce Infant Mortality in Minority Populations, is related to the priority areas of infant mortality, fetal deaths, low birth weight, high risk pregnancies and prenatal care. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402- 9325, (Telephone 202/512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic 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. Institutions may submit singly or in partnerships with two or more organizations or groups. For-profit organizations interested in applying under this RFA should note that no profit or fees may be requested under this kind of assistance award. In addition, since there are no cost principles applicable to for-profit organizations receiving financial assistance awards, those set forth in Federal Acquisition Regulations in 48 CFR Part 31.2 will generally be used. Organizations should have experience in functioning as a statistical and data coordinating center for multi-center and community based research, including randomized controlled trials and observational studies of both a medical and psychosocial nature. The need for continuous and active communication among sites and with the NICHD dictates that only U.S. institutions with a branch or central office in the Washington, DC metropolitan area are eligible to apply. MECHANISM OF SUPPORT The administrative and funding instrument to be used for the DCC to assist the community in undertaking this coordinated population-based research effort will be a cooperative agreement mechanism, the NIH research demonstration cooperative agreement (U18). The major difference between a cooperative agreement and a research project grant is that there will be substantial NIH scientific and/or programmatic involvement with the awardee above and beyond the levels required for traditional program management of grants [Grants Policy Statement, DHHS Publication (OASH) 94-50, 000 (rev. April 1, 1994)]. Details of the responsibility, relationship and governance of the study to be funded under a cooperative agreement are discussed later in this document under the Section "Terms of Agreement." The total project period for an application submitted in response to this RFA may not exceed five years. The anticipated award date is September 1998. At this time, the NICHD has not determined whether or how the solicitation will be continued beyond the present RFA. Awards and level of support depend on receipt of a sufficient number of applications of high scientific merit. FUNDS AVAILABLE It is anticipated that one award for the Data Coordinating Center will be made with an estimated total cost of $500,000 (including direct, and facilities and administrative costs) for the entire program for the first year. These funds will be allocated to Phase I: protocol design and implementation planning and Phase II: protocol implementation and participant recruitment. The actual cost of each approved protocol will be determined in Phase I (see budget section for allowable costs). This Grant will be co-funded by NICHD and ORMH (Year 01 to be funded by ORMH). Although this program is provided for in the financial plans of the NICHD and the ORMH, the award of a grant pursuant to this RFA is also contingent on the availability of funds for this purpose. RESEARCH OBJECTIVES A. Background Infant mortality among blacks continues to be twice as high as among whites. In 1992, the infant mortality rate among whites in the U.S. was 6.9 per 1000 births and for blacks 16.8 per 1000 births, and the black-white ratio was 2.4:1. The overall infant mortality rate (provisional data) for the U.S. in 1994 was the lowest ever at 7.9 per 1000 births, but in Washington, DC, it was 20.1 per 1000 births. Similar disparities among blacks and whites exist for other birth outcomes related to infant mortality such as low birth weight and preterm delivery. Known risk factors of poor perinatal outcome include young maternal age, low level of maternal education, poverty, inadequate housing, lack of social support, being unmarried, late or no prenatal care, unintended childbearing, adverse health behaviors during pregnancy like smoking, drinking and drug abuse, as well as a number of medical risk factors, including preeclampsia, premature rupture of the membranes, urinary tract and vaginal infections. Certain causes of infant deaths occurring post-neonatally, such as infections, injuries and sudden infant death syndrome, are more common among black infants. B. Objectives and Scope To address these issues among minority populations in Washington, DC, the NICHD and the ORMH established a cooperative research network among six institutions in Washington, DC and the NICHD, as well as a Data Coordinating Center in September 1992. Recent recompetition has resulted in a revised network of four primary grantee sites. The Steering Committee for Phase I of this initiative identified a number of areas of research interest and coordinated the development of protocols which have been implemented. Studies currently being completed include an intervention to improve parenting skills among high risk mothers leading to better utilization of preventive health services for their infants, an adolescent pregnancy prevention school-based program, a study of barriers, motivators and facilitators to early entry and maintenance of prenatal care, a baseline study of injuries among infants and young children leading to emergency room visits in Washington, DC, a study of the determinants of lack of age- appropriate immunization coverage, and a study of characteristics of health services in neonatal intensive care units among most hospitals in Washington, DC. Information about these studies can be obtained from the NICHD as listed in the INQUIRIES section of this RFA. This initiative calls for innovative investigations leading to a better understanding of the determinants and risk factors of the high rates of infant mortality and low birth weight among minorities in Washington, DC and development of interventions leading toward a reduction of those risk factors. Projects in Phase II may be population-, clinic- or hospital-based or may deal with selected population groups. Study populations may be pregnant women, women of childbearing age, adolescents, or young infants, who reside in Washington, DC at the time of the investigation. Potential research topics may cover the development and testing of health education/health promotion interventions to effect a reduction in smoking, drinking, drug abuse or other adverse health behaviors during pregnancy. Other studies may deal with interventions during the preconceptual and interconceptual period to increase family planning service utilization and to reduce the risk of adverse birth outcome among high-risk women. Examples of types of research that could be conducted under this Cooperative Agreement include, but are not limited to: o The development of effective outreach strategies to enhance participation in prenatal care. o The development of health education/health promotion interventions which are shown to be effective in this population, directed toward smoking, drinking and drug abuse, or other behaviors o Investigations and interventions aimed at preventing preterm delivery or intrauterine growth retardation. Because of the complex nature of the problem of the high infant mortality rate in Washington, DC involving social, demographic, health care delivery, access and utilization of health and social services and barriers to them, as well as medical and clinical problems impinging upon infant survival, the research approaches to address these problems involve contributions from many different disciplines, including sociology, behavioral sciences, health education, health service delivery, clinical obstetrics and pediatrics, nursing, epidemiology and statistics, and possibly some others. Examples of possible specific investigations (listed mainly for illustrative purposes) include: o There is an extensive research literature on smoking interventions in women before and during pregnancy, some of which have been tested in high risk inner city populations. Based on the currently available knowledge, a smoking intervention might be developed and tested in this population. o Findings from clinical trials which address the prevention of various obstetrical complications, including preeclampsia, if proven to be beneficial could be incorporated on a population basis into the content of prenatal care to test their overall efficacy in an inner city population. o The previous cooperative agreement included surveys and observational studies of barriers, motivators and facilitators of prenatal care, childhood injuries, and age-appropriate immunizations. Interventions could be developed to increase early entry and adherence to prenatal care schedules, reduce injuries in young children or increase immunization rates in children under the age of two building on the results of these Phase I studies. Although the studies funded under the associated Cooperative Agreement will differ in terms of their focus or disciplinary perspective, it is expected that investigators, through the Steering Committee, will develop common protocols and quality control procedures and will share the data generated by it. The selected protocol(s) will be subject to external scientific review by an uninvolved expert group, the Scientific Advisory Board, and external community review by the Community Advisory Board. The study will proceed into the implementation phase only with the concurrence of both the awardees and the NICHD. Factors that will be considered in choosing projects to be implemented include: (1) studies that are feasible to undertake in the proposed research population, (2) financial resources available to the network, and (3) strategies that are likely to be the most productive and cost-effective in addressing the research priorities of the network. The awardee is expected to cooperate with the multi-disciplinary investigators at the four grantee sites and at other participating clinical centers and with the Program Officer, the Program Coordinator, and other participating NICHD staff in the design and conduct of protocols, analysis of data, and reporting of result of Initiative research. Systems for data collection, analysis, coordination, and quality assurance are essential. Required data summaries will be provided to the Steering Committee, NICHD, the Data Safety and Monitoring Committee, and others as determined by the Steering Committee. Logistical support will be required. To provide this support and consultation to the participating organizations, the DCC will need a staff of epidemiologists, biostatisticians, research assistants, programmers, data clerks, word processors, trainers, and support staff. The DCC will work with the Steering Committee and serve as a technical support organization to this Committee by implementing the decisions of the Steering Committee regarding protocol development, protocol execution, data processing, and analysis. Minimum requirements for the Data Coordinating Center (DCC) are described below. General The Data Coordinating Center must have either their central or a branch office located in the Washington, DC metropolitan area. The applicant must demonstrate prior experience as a Data Coordinating Center in multi-center and community based studies in prenatal, perinatal, and infant studies during the previous five years. The Principal Investigator, and other staff, must have appropriate expertise and capability in epidemiology, biostatistics, data management, data analysis, and project management. Design The DCC staff must be willing to collaborate with the study investigators in the development of study protocols including patient eligibility criteria, randomization and/or stratification techniques, treatment and/or follow-up schedules, specification of primary and secondary outcomes, sample size determination, statistical analysis plans and a projected timetable of tasks to be conducted. The DCC will be expected to provide expert epidemiological advice in the selection of topics of research and in the development and implementation of protocols as needed. Prior to the initiation of a study, the DCC will collaborate with the study investigators in the development of the data collection forms and will take the lead on the development of detailed manual of operation and training manuals. The DCC will assume principal responsibility for the design of sampling and/or randomization procedures, specification of the performance monitoring procedures, and training of the study personnel in the data processing procedures. Applicants should provide a description of their experience in designing these different types of projects with special emphasis on epidemiological and the statistical expertise required, as well as examples of past or current projects requiring this expertise. Execution The DCC will provide information processing support during the execution of each study protocol. The DCC will serve as the repository for clinical and central laboratory data, and will provide the microcomputer-based remote data entry system and the mainframe-based centralized data entry, management, and analysis system. Throughout the execution of each study the DCC will provide ongoing training of study personnel with regard to data processing procedures, distribute updates to study documents, review eligibility and monitor enrollment of study patients, provide computerized editing of submitted data, assist in the clinical review of data collected on study patients, monitor and prepare periodic reports on protocol performance, and conduct interim statistical analysis of emerging results including patient safety issues. Analysis The DCC will apply appropriate statistical methodology to the analysis of data collected for the studies supported by the Cooperative Agreement to ensure the highest scientific and statistical standards. It will assure expert epidemiological input in this analysis. To ensure that all patient outcomes are properly documented, a final check of each study patient"s data record will be conducted to resolve any outstanding missing or inconsistent data items. The applicant must show experience in the conduct statistical analyses for the presentation of results and the collaboration with the clinical investigators in preparing manuscripts for publication. The DCC will ensure that all relevant study documents and data are organized and archived for future access. Logistic Management Support The DCC will assist in the coordination and execution of all Initiative meetings and conferences including, but not limited to: scheduling, site selection, information dissemination, and minutes preparation. The DCC will provide logistical support the NICHD program office for such items as: participant directory, calendar dissemination and project files. The applicant should describe: (1) proposed methods to be used to facilitate communications among the DCC staff, Initiative investigators, and the NICHD staff, (2) proposed staffing patterns for providing DCC functions from protocol design through analysis (This should include provisions for adjusting staff time commitments during the life of the study.), and (3) proposed administrative and management structure that would support and enhance the operational structure while assuring continuing attention to cost-efficiency and productivity. Reporting The applicant must have the capacity to generate monthly reports on subject enrollment and progress for several concurrent studies, appropriate reports for the use of the Data Safety and Monitoring Board meetings, and special reports as required. Guidance and Management Structures It is expected that the first year of this initiative will be devoted to the prioritization of proposed research projects, the detailed development of common protocols, manuals of operation, training manuals, etc., the finalization of implementation plans and time lines, and budget development. Protocols will be implemented and evaluated in the following years of the initiative. The management structure of the NIH-DC Infant Mortality Initiative includes four committees: (1) A Steering Committee, (2) A Scientific Advisory Board, (3) The Community Advisory Board, and (4) Data and Safety Monitoring Board. The roles of these committees are defined in the section on Terms and Conditions of this RFA. SPECIAL REQUIREMENTS The NICHD invites applications from the current DCC (competing renewal application), current members of the NIH-DC Initiative to Reduce Infant Mortality in Minority Populations in the District of Columbia and from new applicants. Applicants must be able to demonstrate relevant research support experience pertinent to the objectives delineated in this RFA, qualifications of key personnel, and proven capacity to support recruitment of community, clinic or hospital based populations for the interventions being considered. Applicants must also demonstrate a willingness and ability to participate in a cooperative program of research and evaluation with other successful applicants. The following terms and conditions will be incorporated into the award statement and provided to the principal investigator(s) as well as the institutional officials at the time of award. Minimum requirements for applications are described below (See Application Procedures and Review Criteria). The current DCC must describe in general terms a contingency plan to transfer all DCC functions for Phase I of the NIH-DC Initiative from the incumbent to another DCC entity which may be successful in the competition for Phase II. This contingency plan should address the feasibility of transferring specific DCC functions at various stages of development, including design, data processing, and analysis. All transfers should be completed within six months of award. The current DCC must also demonstrate past progress and the ability to meet the Terms and Conditions of this award. New applicants must describe in general terms, a contingency plan to accept all DCC responsibility and functions for Phase I of the NIH-DC Initiative that might be transferred from the incumbent DCC. This plan should address the feasibility of transferring specific DCC functions at various stages of development, including design, data processing, and analysis. All transfers should be completed within six months of award. Terms and Conditions of Award These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, DHHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other DHHS and NIH grant administration policies. The administrative and funding instrument used to assist the scientific community in conducting studies and interventions as part of the NIH-DC Infant Mortality Initiative will be a cooperative agreement (U18), an assistance mechanism (rather than an acquisition mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient’s activity by involvement in, and otherwise working jointly with, the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NICHD staff designated below. A. Awardees Rights and Responsibilities The tasks or activities in which the DCC will have primary substantial responsibilities include: Collaboration with the awardees of the Cooperative Community-Based Perinatal Studies and Interventions in Minority Populations (RFA HD-96-005), Provision of assistance in the development of research protocols for specific studies, including interventions, Assistance in the design and preparation of data collection instruments and manuals, Provision of statistical advice in the design, analysis and interpretation of projects, Provision of consultation and assistance in the implementation of the projects selected by the steering committee, Training of project staff at the sites in the use of study instruments to ensure standardization of procedures and integrity of data, Design and implementation of efficient Research Data Management Systems, Monitoring of data collection, including quality control, and performance of analyses and interpretation of data, Provision of easy to use data archives with appropriate documentation of procedures, problems, and analyses performed, Presentation of study instruments, manuals, and protocols for final approval by the Steering Committee, Aid in the publication and dissemination of results. In addition, the DCC will provide logistic management support to the awardees of the Cooperative Community-Based Perinatal Studies and Interventions in Minority Populations (RFA HD-96-005) and the NICHD. Awardee of the Cooperative Community-Based Perinatal Studies and Interventions in Minority Populations (RFA HD-96-005) will retain custody of and have primary right to their site’s data developed under their awards, subject to Government rights of access consistent with current HHS, and NIH policies. The data developed under this award will not be disseminated publicly prior to publication or presentation of study results in a peer reviewed forum. The awardees of the Cooperative Community-Based Perinatal Studies and Interventions in Minority Populations (RFA HD-96-005) will establish policies and procedures which direct their collaborative operations, including a publication policy. These documents may be amended and supplemented as approved by the Steering Committee. B. NICHD Staff Responsibilities Responsibility for review and oversight of these cooperative agreements will reside with the NICHD Program Officer. This role will include the following: oversight to assure the scientific merit of studies, interventions and trials done under this initiative, assistance in the efficient conduct of studies, interventions and trials, including ongoing review of progress, possible redirection of activities to improve performance, and frequent communication with other members of the Steering Committee, and initiation of a decision to modify or terminate a study based on the advice of the Data Coordinating Center, the Data Safety and Monitoring Board, the Community Advisory Board , the Scientific Advisory Board, and/or the Steering Committee. The NICHD Program Officer will have voting membership on the Steering Committee, and its subcommittees. The NICHD Program Coordinator will provide traditional extramural program management. In addition, the Program Coordinator will assist in coordination across institutions and will serve as Executive Secretary of the Scientific Advisory Board, the Community Advisory Board, and any Data Safety Monitoring Boards constituted for clinical trials reporting findings to the Steering Committee and protocol investigators. The NICHD Program Coordinator will monitor the data management and quality assurance systems and evaluate the cost- effectiveness of the Data Coordinating Center using consultants as appropriate. Criteria will include the quality and quantity of participation in collaborative Initiative research, timeliness of their efforts, data reports prepared for the Steering Committee and subcommittees, biannual and annual progress reports, and site visit findings. NICHD intramural staff may collaborate with awardees in the formulation of studies, and in the analysis and reporting of results. Grants Management responsibility: A grants management specialist in the Grants Management Branch, NICHD will administer the business and financial management aspects of the award. The NICHD reserves the right to terminate or curtail a study in the event of substantial shortfall in participant recruitment, follow-up, data reporting, quality control, or other major breach of a protocol, a study reaches a major study endpoint substantially before schedule with persuasive statistical significance, qualified scientific investigators are not available to participate in the study, or human subject ethical issues that may dictate a premature termination. The NICHD also reserves the right to withhold support from the DCC if technical performance requirements such as protocol support, data acquisition and analysis targets, and adequate quality assurance of data are not met. C. Collaborative Responsibilities The management of the NIH-DC Infant Mortality Initiative includes four committees whose functions are as follows: (1) A Steering Committee will be responsible for the overall coordination of the study including: protocol prioritization, finalization, implementation and conduct of studies, and the preparation of publications. The Steering Committee will be composed of the awardee Principal Investigators, the Principal Investigator from the Data Coordinating Center and the NICHD Program Officer, each having one vote. The chairperson of the Steering Committee will be an outside consultant chosen by the NICHD in consultation with the Steering Committee. The program coordinator, scientific consultant, and a staff member from the Grants Management Branch will attend Steering Committee meetings. The Steering Committee chairperson will chair all meetings of this committee. The Steering Committee will meet three to four times per year. (2) A Scientific Advisory Board will advise the NICHD and the Steering Committee on the scientific merit and technical soundness of protocols which have been developed before their implementation. This advisory board will have expertise in areas relevant to the research topics of this initiative and will be chosen by the NICHD in consultation with the Steering Committee. The NICHD Program Coordinator will act as executive secretary of this Board and report the findings to the Steering Committee and Protocol investigators. (3) The Community Advisory Board will advise the NICHD and the Steering Committee on issues related to community acceptance and sensitivities, as well as appropriateness of a given research protocol. This advisory board will consist of individuals with a demonstrated knowledge of, and a history of involvement with, the community and will be chosen by the NICHD in consultation with the Steering Committee. (4) Data and Safety Monitoring Board will be established as needed to monitor the safety of ongoing interventions or clinical trials and advise on research design issues, data quality and analysis, and ethical and human subject aspects. Members of the Board will represent expertise in ethics, clinical trial design, and other disciplines relevant to the intervention or trial for which they are constituted. The members of the Board will be chosen by the NICHD. The DCC prepares confidential reports for the DSMB meetings, The DCC Principal Investigator participates as an ex-officio member, and the NICHD Program Coordinator serves as the Executive Secretary. The collaborative protocols will be approved by the Steering Committee. Data will be submitted centrally to the Data Coordinating Center. The Steering Committee will define rules regarding access to data and publications. An independent Data and Safety Monitoring Board will review progress of clinic trials at least annually and report to the NICHD. Awardee of the Cooperative Community-Based Perinatal Studies and Interventions in Minority Populations (RFA HD-96-005) and the DCC will be required to accept and implement the common protocol(s) and procedures approved by the Steering Committee. D. Arbitration Any disagreement that may arise on scientific matters (within the scope of the award), between award recipients and the NICHD may be brought to arbitration. An arbitration panel will be composed of three members -- one person selected by the principal investigator, one person selected by the NICHD, and a third person selected by the two prior selected members. The decision of the arbitration panel, by majority vote, will be binding. These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, DHHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other DHHS and NIH grant administration policies. These special arbitration procedures described above in no way affect the right of a recipient of a cooperative agreement assistance mechanism to appeal an adverse determination in accordance with PHS regulations at 42 CFR Part 50, Subpart D and DHHS regulations at 45 CFR Part 16 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," which have been published in the Federal Register of March 28, 1994 (FR 59-14508-14513) and the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. LETTER OF INTENT Prospective applicants are asked to submit, by February 2, 1998, a letter of intent that includes a descriptive title of the research, the name, address and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. 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 the NICHD staff to estimate the potential review workload and avoid conflict of interest in the review. A letter of intent is to be sent to: Barbara Wingrove, M.P.H. Division of Epidemiology, Statistics and Prevention Research National Institute of Child Health and Human Development Building 6100, Room 7B07, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 594-1302 FAX: (301) 480-0649 Email: Barbara_Wingrove@NIH.GOV APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research 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, email Budget In preparing requested budgets, the form pages in the research grant application form PHS-398 (Revised 05/95) must be used. Facilities and administrative costs will be awarded in the same manner as for research project grants. Allowable costs and policies governing the research grant programs of the NIH will prevail. In planning the budget section of the application, each applicant should submit budget estimates for all years. The first year’s budget for Phase I: Protocol design and implementation planning will be limited to the following maximum allowances: Principal Investigator/Senior Biostatistician/Epidemiologist 60% effort Epidemiologist/Study Design Methodologist 50% effort Senior/Research Statistician 100% effort Logistic Support Administrator 100% effort Secretary 50% effort Supplies and small equipment (itemize and justify) Not to exceed $4500 Travel to Steering Committees based upon four meetings a year lasting one day each attended by no more than three individuals. Other expenses (itemize and individually justified) Not to exceed $2500 Budgets for tasks associated with implementation of protocols for years 2 through 5 must be estimated. Actual annual budgets for subsequent years of the Initiative of the NIH-DC Initiative to Reduce Infant Mortality in Minority Populations in the District of Columbia will be based on individual protocols. Budgets for protocols will be based on specific protocol requirements and availability of funds. The methods to calculate these costs will be used as the basis for individualizing cost recovery for individual protocols. Agreement will be reached by discussions between NICHD Staff and the successful applicant. Periodic adjustment of these reimbursement arrangements will be made based on actual experience with individual protocols. The RFA label available in the PHS-398 application form must be affixed to the bottom of the face page of the application. Failure to do this 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 checked. The signed, typewritten original of the application, including the Checklist, and three signed exact photocopies should be sent 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: Susan Streufert, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E03A, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) Applications must be received by March 27, 1998. If an application is received after that date, it will be returned to the applicant without review. The 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 also not accept an 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. Letter of Intent Receipt Date: February 2, 1998 Application Receipt Date: March 18, 1998 NICHD Council Review: June 1998 Anticipated Award Date: September 1998 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and for responsiveness by the NICHD. Incomplete 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 scientific peer review group convened by the NICHD in accordance with the review criteria stated below. As part of the initial merit review, a process may be used in which applications will be determined to be competitive or noncompetitive based on their scientific merit relative to other applications received in response to this RFA. Applications determined to be noncompetitive by the scientific review committee will be withdrawn from further consideration, and the Principal Investigator will receive a summary statement reflecting the reviewers" evaluation. Applications judged to be competitive will be further discussed and assigned a priority score. They will then receive a second level review by the National Advisory Child Health and Human Development Council (NACHHD). General Considerations All applications will be judged on the basis of their scientific and technical merit and the documented ability of the investigators to meet the RESEARCH OBJECTIVES of the RFA. Review Criteria A. Professional Staff Available o Expertise of the proposed staffing, including the proposed Principal Investigator: including, as applicable, staff with a background in perinatal and reproductive epidemiology, retrieval and linkage of data from existing data sources, biostatistics, data management, and information retrieval. Review will focus on expertise, qualifications, experience, commitment and continued substantial availability of key personnel. o Demonstrated staff experience and capability to develop multi-center collaborative research protocols, particularly in perinatal epidemiology and in biostatistics. o Experience and training of relevant staff in community-based projects and intervention trials o Documented experience and expertise of personnel involved in data management and data processing aspects of the project in the management of large data sets, designing and documenting appropriate systems, computer programming, data coding, on-site and remote data entry, data editing, quality control, file building, file manipulation, data analysis, and data archiving o Organizational and administrative abilities of the Principal Investigator and other team members B. Institutional Capabilities (Research Design and Methods) While it is critical that key individuals have the expertise described under "Professional Staff Available" above, it is equally important that the institution have the demonstrated capabilities that are itemized as follows: o Expertise in the design of surveys, case-control studies, cohort studies and interventions. o Documented understanding of the basic elements required for a data coordinating center: This should include an understanding of computer logistics, programming, coding, data processing, file building, file and program documentation, and file maintenance. o Ability to finalize research protocols and questionnaires and to monitor quality control: This should include prior and/or current experience relative to the development of protocols, design and pretesting of questionnaires and other research instruments, and interaction with multi-disciplinary teams. An indication of procedures used for training of staff in the use of these protocols and questionnaires and quality control of data collection across several sites would be most useful. o Demonstrated ability to design and implement efficient Research Data Management Systems: Applicants should describe their methodology for preparing study manuals of operation, keeping track of data, providing ready accessibility of data at any point in the study, maintaining current documentation, and maintaining backups of all data entered. o Demonstrated ability in the management of large data sets, designing and documenting appropriate systems, computer programming, data coding, data entry, data editing, quality control, file building, file manipulation, data analysis, and data archiving o Demonstrated experience in the use and linkage of data from existing data sources C. Resources and Environment o Adequacy of facilities and equipment available, including computer hardware and software, for use by this project as well as any new equipment requested under this award. This should also include the capacity of personal computers, work stations, mainframe capability or access (such as access to the IBM Mainframe maintained by DCRT at NIH), software programs available, and ability to access remote data entry facilities. D. Logistic Support o Demonstrated ability to provide logistic support to multi-site research studies, including scheduling, dissemination of information, meeting administration, minutes production and information archiving. E. Special Strengths Applicant Would Bring to the Initiative Special research strengths in the field of maternal-child health which would be relevant to the NIH-DC Initiative to Reduce Infant Mortality in Minority Populations in the District of Columbia. This could include specific scientific capabilities which are relevant and which might be shared or made available to the initiative and which would extend the scientific productivity of the research. F. Budget Appropriateness of the proposed budget for the proposed work, evidence of cost- effectiveness. G. Inclusion of Women and Minorities Appropriateness of plans for compliance with the NIH policy on inclusion of women and minorities. The initial review group will also examine the provisions for the protection of human subjects and the safety of the research environment. AWARD CRITERIA Applications recommended by the NICHD Council will be considered for award principally on scientific and technical merit as determined by initial review. Program balance, that is, the scope and variety of research strengths to enable a successful collaborative program, will be considered. Availability of funds may also determine the award made. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: Barbara Wingrove, M.P.H. Division of Epidemiology, Statistics and Prevention Research National Institute of Child Health and Human Development 6100 Building, Room 7B07, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 594-1302 FAX: (301) 480-0649 Email: Barbara_Wingrove@NIH.GOV Inquiries regarding fiscal matters should be made to: Ms. Mary Ellen Colvin Grants Management Branch National Institute of Child Health and Human Development 6100 Building, Room 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1303 FAX: (301) 402-0915 Email: AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.865, Research for Mothers and Children. The award will be made under the authority of the Public Health Service Act, Section 301 (42 USC241), and administered under PHS grant policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74 and 92. This program is not subject to review under the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The NIH 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 NIH mission to protect and advance the physical and mental health of the American people.

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