Full Text HD-95-004 DATA ACQUISITION AND ANALYSIS CENTER FOR BEHAVIORAL RESEARCH NIH GUIDE, Volume 23, Number 22, June 10, 1994 RFA: HD-95-004 P.T. 34 Keywords: Behavioral/Social Studies/Service Data Management/Analysis+ National Institute of Child Health and Human Development Application Receipt Date: September 13, 1994 PURPOSE The National Institute of Child Health and Human Development (NICHD) invites applications for a cooperative agreement to participate as the Data Acquisition and Analysis Center (DAAC) in support of planning and conducting research on the contexts of development and developmental outcomes of children who are participating in Phase II of the NICHD Study of Early Child Care (SECC). The NICHD has an active interest in the support of research on the development of children who have been placed in child care arrangements during their infancy. In 1988, NICHD issued a Request for Applications (RFA) for a cooperative agreement titled "Effects of non-parental infant day care on child development." The data collection for the study that ensued will terminate at the end of 1994 and NICHD intends to extend this cooperative agreement for an additional five years for the purpose of follow-up studies of the same cohort of children. The requested follow-up will include (a) observational and test data collection at two time periods between the ages of three and seven and (b) telephone and/or mail data collection in the periods between the face-to-face data collection periods. This RFA is for the Data Acquisition and Analysis Center for the second phase of the study, starting in the beginning of 1995 and to be continued for a period of five years. The Data Acquisition and Analysis Center (DAAC) for Phase II of the NICHD Study of Early Child Care (SECC) will provide leadership and consultation in the execution, close-out and analysis of the Phase II study. It will ensure that the results of the study and its subprotocols are of the highest scientific integrity and meet rigorous statistical standards. The Data Acquisition and Analysis Center will be functionally independent of all research sites, although it could be physically located in one of the participating institutions. 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-led national activity for setting priority areas. This RFA, Data Acquisition and Analysis Center for Behavioral Research, is related to the health of children and their families. It is also related to the Minority Health Initiative of the National Institutes of Health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, units of State and local governments, and eligible agencies of the Federal government. Applications from minority]y and women investigators are encouraged. Evidence of existing research capabilities for multi-site studies must be demonstrated. MECHANISM OF SUPPORT The mechanism used to support this research is the Cooperative Agreement (U01), 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 NICHD staff's involvement in the research and by NICHD staff working jointly with the award recipient in a partner role. It is, however, understood that NICHD staff is not to assume direction, prime responsibility, or a dominant role in the research activity. Specifically, in the case of the NICHD SECC, the study will continue to be conducted as a collaboration among awardees at the data collection sites, the awardee at the DAAC and the NICHD scientific program staff. Details of the responsibilities, relationships and governance of the DAAC to be funded under the cooperative agreement are discussed later in this document under the section "Terms and Conditions of Award." The total requested project period for an application submitted in response to the present RFA may not exceed five years. The anticipated start date is April 1995. At this time, the NICHD has not determined whether or how this solicitation will be continued beyond the present RFA. FUNDS AVAILABLE It is anticipated that one award will be made for a data acquisition and analysis center for Phase II of the NICHD SECC. The estimated total cost for the first year is $ 750,000. Although this program is provided for in the financial plans of NICHD, the award of grants pursuant to this RFA is contingent on the scientific and technical merit of the application and on the availability of funds for this purpose. RESEARCH OBJECTIVES Research Goals and Scope The specific goal of the requested follow-up is to continue to investigate the contexts of development and their impact on the same developmental domains investigated in the first phase of the study (the study of the children from one through 36 months of age). Therefore, applicants for the DAAC need to present a plan for data acquisition, monitoring, reduction and analysis for a follow-up study that is comprehensive, describing the environments of child development and tapping the social, emotional, cognitive, linguistic, academic and health aspects of the development of children. The applicants will need to demonstrate expertise in handling all aspects of (a) observational and test data collection at two time periods between the ages of three and seven and (b) telephone and/or mail data collection in the periods between the face-to-face data collection periods. In addition, applicants need to spell out their plan for creating a data set that is compatible with that developed by the DAAC involved in Phase I of the study. This is important because the data sets from Phase I and Phase II of the study will need to be merged to allow analyses across the different age periods. SPECIAL REQUIREMENTS The Director of the DAAC for the second phase of the SECC will join the Steering Committee in designing the specific research protocols. She or he will participate in the development of operation manuals to guide the implementation of the study in the ten research sites. During the implementation of the study, the data center will provide feedback regarding the data collected and interim analyses as guided by the steering committee. The DAAC must have expertise in research design as well as in statistical methods appropriate for multi-site longitudinal research designed primarily by developmental psychologists using questionnaires, interviews, observations and tests as methods of data collection. The DAAC will serve as a centralized information management system for collecting, editing, storing and analyzing data. It will be responsible for ensuring data integrity, accuracy, and accessibility to the investigators of the study. It will be responsible for the timely production of operation manuals detailing the study. It will maintain strict independence from the other sites participating in the cooperative agreement and will compile, as needed, progress reports of ongoing components of the study. Examples of additional functions of the DAAC are: o Develop methods for data and videotape storage that are compatible with those used in Phase I of the NICHD SECC; o Finalize manuals describing protocols developed by the Steering Committee; o Contribute to the development of mechanisms for standardizing data collection from all sites and implement quality control procedures; o Enter data into computerized data sets; o Develop plans for appropriate statistical analyses; o Provide the Steering Committee with reports on data; o Create public use data sets. To promote the development of a collaborative program and to facilitate the work of the DAAC, the DAAC director and select staff members need to meet face-to-face with subcommittees of the Steering Committee and with the full Steering Committee on a regular basis. At such meetings, the DAAC Director will contribute to the planning of the study, to the monitoring of its execution, and to the making of decisions pertaining to data acquisition and analysis. The applicant should specify the number of meetings that are required in order to effectively conduct the business of Phase II of the SECC. Terms and Conditions I. The primary responsibilities of the DAAC are to: o Collaborate with the awardees of the NICHD SECC in the way prescribed below. o Contribute to deliberations of the Steering Committee and serve as a voting member of the Steering Committee. o Provide assistance in the development of research protocols. o Participate in the design of data collection instruments and manuals. o Prepare the final forms for data collection instruments and produce the final versions of the manuals. o Provide consultation and assistance in the implementation of the studies planned by the steering committee. o Monitor the sites to ensure standardization of procedures and integrity of the data. o Design and implement efficient research data management systems. o Provide easy to use data archives with appropriate documentation of procedures, problems, and analyses performed. o Assemble, check for quality, and document all the data collected at the collaborating sites in line with the objectives set by the Steering Committee. o Carry out data reduction and analysis in line with requests from the Steering Committee or its subcommittees. o Present the Steering Committee with results based on Steering Committee or subcommittee requests. o Assist the Steering Committee in the publication and dissemination of results. II. Scientific Program Staff Involvement The NICHD scientific project coordinator will be a Health Scientist Administrator from the Human Learning and Behavior Branch, Center for Research for Mothers and Children. The NICHD scientific project coordinator will: o Participate in the development of protocols for specific aspects of the study. o Participate in the monitoring of the progress of ongoing studies, including field data collection, standardization of methods across study sites, adherence to protocol and quality control procedures. o Participate in data analysis, interpretation, and publication of study results. The NICHD reserves the right to terminate or curtail the DAAC in the event of substantial shortfall in data acquisition, quality control, data analysis or other major breach of the responsibilities of the DAAC. III. Collaborative Responsibilities o Steering Committee. The principal investigators from the awardee institutions, the Director of the DAAC, the NICHD scientific project coordinator and an independent chairperson constitute the Steering Committee for Phase II of the NICHD SECC. This Steering Committee is the "corporate" principal investigator for the study and it plans and oversees all the scientific work associated with the NICHD SECC. Members of the Steering Committee collaborate with the other awardees who are members and with NICHD scientific project coordinator. They contribute to the development of the various research protocols that make up the comprehensive protocol of the SECC. They design and prepare data collection instruments and manuals. They contribute to plans for data reduction, data analyses and paper writing based on the results of the study. The DAAC will be required to implement the data acquisition and analysis plans developed and/or approved by the Steering Committee. o Subcommittees. Subcommittees will be established by the Steering Committee, as it deems appropriate. The NICHD scientific project coordinator will serve on subcommittees as deemed necessary and appropriate. o For the duration of the cooperative agreement, the combined, common data set is managed by the DAAC. For the duration of the cooperative agreement, the Steering Committee coordinates the publication related activities of the investigators and the DAAC. IV. Arbitration Procedures When agreement between the awardee and the NICHD staff cannot be reached on scientific/programmatic 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 of the study, one person selected by the NICHD staff and a third selected by these two individuals. The decision of the arbitration panel, by majority vote, will be binding. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. STUDY POPULATION 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 is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the inclusion of Women in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. 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 9, 1994 (FR 59 11146-11151), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from the above sources or from the program staff listed below. Program staff may also provide additional relevant information concerning the policy. Since the cohort for the study is already in place, the applicant is advised to build in procedures to safeguard against selective attrition of gender or racial/ethnic groups. Such procedures need to be reported in the application. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for the award. This form is available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20982, telephone (301) 584-7248; and from the NICHD scientific project coordinator listed under INQUIRIES. Additional Information Information about the NICHD SECC Phase I, about the plans made by the Steering Committee for Phase II, and about characteristics of the data set for Phase I of the study will be provided by NICHD staff at an open meeting to be held in Bethesda Maryland on June 17, 1994. All interested applicants are invited to attend at their own cost. Details about the meeting will be provided by the scientific project coordinator listed under INQUIRIES. To permit evaluation of the merits of an application (peer review) information is needed on the following topics: Professional staff available: Description of the current staffing, including the proposed principal investigator and co-principal investigator(s). The DAAC should include staff with background in statistics and developmental psychology. Expertise in demography, sociology and economics would be helpful. A demonstration of staff experience and capability to develop research protocols is critical. Information about training and experience of relevant staff, especially in large scale, multi-site studies in the social sciences would be required. Documentation should be provided showing that the personnel involved in data management and data processing aspects of the project have experience in 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. Expertise in research methodology: The staff of the proposed DAAC must demonstrate expertise in the design of surveys, cohort studies, multi-site studies and in-depth research in developmental psychology. Applicants must provide a description of their experience in designing such studies with special emphasis on the statistical expertise required, as well as examples of past or current projects requiring such expertise. The applicants must document their understanding of basic elements required for a DAAC. This should include an understanding of computer logistics, programming, coding, data processing, file building, file and program documentation, and file maintenance. The applicants must demonstrate their 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 research protocols, design and pretesting of questionnaires and other research instruments. An indication of expertise in coordinating the training of staff in the use of these protocols and questionnaires and expertise in ensuring quality control of data collection across several sites would be most useful. The applicants must demonstrate their ability to design and implement efficient Research Data Management Systems. The applicant should describe methodology to prepare study manuals of operation, keep track of data, provide ready accessibility of data at any point in the study, maintain current documentation, and maintain backups of all data entered. Since this competition is for a DAAC for the second phase of the NICHD SECC, the applicants must demonstrate their willingness to work with the data acquisition and analysis centers that have worked on the first phase of the study. Resources and environment: The application should include descriptions of: o Facilities and equipment. The facilities and equipment available, including computer hardware and software for use by the project. o Support systems and services. Support systems and services which are currently provided by the applicant's organization. o Data systems available. Current data systems controlled by the applicant or available to the applicant for use in connection with the NICHD SECC. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. 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 2a of the face page of the application form and the YES box must be marked. The applicant must submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two copies of the application must be sent under separate cover to: Susan Streufert, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E03 Bethesda, MD 20892 REVIEW CONSIDERATIONS Review Method 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, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. In addition to standard criteria used in NIH peer review for the evaluation of scientific and technical merit, special additional evaluation criteria for the application are as follows: o Experience with large, multi-site behavioral science studies; o Expertise in statistics, developmental psychology and related disciplines (demography, sociology, behavioral pediatrics); o Demonstrated ability to finalize protocols, questionnaires and other research instruments; o Demonstrated ability to serve as data center in multi-site collaborative investigations including quality control and training staff. 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 Facilities and equipment available; o Staffing, including the ability to draw on backup resources when demand increases. AWARD CRITERIA The anticipated award date is April 1, 1995. Applications recommended by the NICHD Advisory Council will be considered for award based upon (a) scientific and technical merit; (b) sufficient compatibility of features that promise to enhance collaboration; and (c) availability of funds. Application Receipt Date: September 13, 1994 Review by NICHD Advisory Council: January 31, 1995 Anticipated Award Date: April 1, 1995 INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Sarah L. Friedman, Ph.D. Center for Research for Mothers and Children National Institute of Child Health and Human Development Building 61E, Room 4B05 Bethesda, MD 20892 Telephone: (301) 496-6591 FAX: (301) 402-2085 Bitnet: SF2@NIHCU Direct inquiries regarding fiscal matters to: Mary Ellen Colvin Office Of Grants and Contracts National Institute of Child Health and Human Development Building 61E, Room 8A17 Bethesda, MD 20892 Telephone: (301) 496-1303 FAX: (301) 402-0915 Bitnet: QMI@NIHCU AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.865. Awards are made under the authorization of the Public Health Services Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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