NETWORK ON THE NEUROBIOLOGY AND GENETICS OF AUTISM: COLLABORATIVE PROGRAMS OF EXCELLENCE IN AUTISM (CPEA) DATA COORDINATING CENTER RELEASE DATE: July 10, 2002 (see addendum NOT-HD-02-009) RFA: HD-02-015 National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov) National Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov) LETTER OF INTENT RECEIPT DATE: October 25, 2002 APPLICATION RECEIPT DATE: November 26, 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) and the National Institute on Deafness and Other Communication Disorders (NIDCD) solicit applications for the establishment of a Data Coordinating Center (DCC) to support the ongoing NICHD/NIDCD Network on the Neurobiology and Genetics of Autism: Collaborative Programs of Excellence in Autism (CPEAs). The CPEA is a cohesive, multi-site, cooperative research program of site- specific and collaborative research begun in 1997 that both individually and collectively conducts research on the etiology/pathophysiology, brain structure and/or function, behavior, genetics, and clinical course of autism. CPEA projects use common diagnostic measures and both site-specific and common core research measures to advance knowledge about autism and related disorders. This Network requires each CPEA, in addition to their site- specific research programs, to participate in trans-Network collaborative studies for which no single project has the needed expertise and/or subject population to investigate individually. A Data Coordinating Center (DCC) will serve to centralize and standardize the data that can be used for addressing collective questions by the Network, as well as serving as a central repository to facilitate the timely ability of the Network to address urgent public health concerns related to autism. Finally, the DCC will put data sets into a common format that will facilitate their use by CPEA member projects and could eventually serve as a data archive to preserve the data for later secondary analyses. Because the NIH plans to fund other Center programs of similar magnitude to the CPEAs that will also be devoted to autism research (e.g., the Studies to Advance Autism Research and Treatment (STAART) Centers, RFA MH-02-001), applicants should provide evidence that they have the capability to expand the scope of services provided to accommodate the needs of additional NIH initiatives, as needed. RESEARCH OBJECTIVES Background The Network on the Neurobiology and Genetics of Autism: Collaborative Programs of Excellence in Autism (CPEA) conducts research on autism spectrum disorders, which are present from birth or very early in development, and affect essential human behaviors such as communication, social interaction, and the establishment of relationships with others. These developmental disorders, for which there is presently no cure and no approved medical treatment, generally have lifelong effects. International epidemiologic studies indicate that rates of classic autism have more than doubled within the past 15 years (to one in 1000 prevalence for classic autism and one in 500 for the broader autism spectrum). Recent studies suggest an even more dramatic rise in cases of milder variants within the autism spectrum, with specific sites reporting prevalence rates of one in 150 or greater. Although precise neurobiological mechanisms have not yet been determined, it is clear that autism spectrum disorders may result from a number of factors, including genetic susceptibility, developmental mechanisms intrinsic to the brain, and extrinsic factors. The goal of the CPEA Network is to elucidate the genetic and neurobiologic factors that underlie the clinical manifestations of these disorders and, ultimately, to contribute to their prevention and cure. The CPEA Network of 10 multidisciplinary projects was established over a two- year period in response to an RFA issued in 1997 to address gaps in autism research identified by an international group of autism experts at a 1995 NIH conference on the State of the Science in Autism. Using common diagnostic standards and a core of common measures as well as site-specific measures, each individual CPEA is responsible for multidisciplinary, site-specific research that draws on the special expertise and resources in its own CPEA, as well as for participation in collaborative studies that require the combined subjects and expertise of multiple projects across the Network. This cooperative capability has enabled the Network to address questions of high scientific relevance and pressing public health urgency that would not be possible within the resources of a single, multidisciplinary project. Each CPEA is studying particular basic and clinical aspects of the biological etiology or pathophysiology, brain structure and/or function, and clinical course of autism. Each multidisciplinary project has a unique focus and research plan. In addition, all projects use a common diagnostic protocol, core measures, and procedures to collectively address some research questions that require greater resources and/or sample sizes than any single project. Individually and/or collectively, the CPEAs investigate the causes, pathophysiology, diagnosis, and developmental course of autism. CPEAs are not required to participate in all collaborative studies, but are expected to be active participants in selected collaborative studies that require their specific expertise or resources. To date, such projects include completed and ongoing Network projects in areas such as genetics, communication, head circumference, early cognitive development, and executive function. More detailed information concerning the scientific activities of the CPEA network can be found at http://www.nichd.nih.gov/autism/cpea.cfm and at http://www.nichd.nih.gov/autism/bib.cfm. Collaborative studies have also addressed urgent public health issues. Examples include clinical trials of the neuropeptide secretin (heralded as a cure for autism, but whose safety and efficacy had never been tested for children), an ongoing study of the hypothesized link between trivalent Measles/Mumps/Rubella (MMR) vaccine and the development of late onset or regressive autism (Collaborative Autism Regression/Vaccination Study), and a relatively recent collaborative effort to gather genetic data from all singleton proband families (in addition to genetic materials that were already being collected in selected CPEAs from multiplex families). Studies designed to advance the application of methodological development in genetic analysis, neuroimaging, neuropsychology, and clinical research as applied to research on autism are also being conducted. Research Scope The NICHD and NIDCD intend to extend the CPEA Network, through a competitive, peer-reviewed process, for an additional five years to support established teams of investigators for research focused on basic and clinical research on the neurobiology and genetics of autism. The extension of this Network will enable investigators to take advantage of the collective resources of the CPEA to address questions of high scientific and/or clinical relevance. In concert with the DCC, CPEAs will complete data collection, data reduction, and analyses from the first five years of the Network, including ongoing collaborative studies in progress, and design and implement new collaborative studies. The NICHD and NIDCD intend for the extension of collaborative activities to be conceptualized and carried out by the Principal Investigators of the CPEAs in collaboration with the DCC. This Request for Applications invites applications to serve as the DCC for the CPEA Network, with capability of expanding to a similar role for other potential NIH initiatives. Guidance and Management Structure A Steering Committee, a Network Advisory Board, and a Data Safety and Monitoring Committee (DSMC) will provide the overall guidance and management of the CPEA Network. In addition, the Steering Committee will establish written Policies and Procedures that govern its operations, including publications. These documents will be reviewed periodically and may be amended at the discretion of the Steering Committee. MECHANISM OF SUPPORT This RFA will use NIH Cooperative Research Project Grant (U01) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. 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 Although both the NICHD and the NICDC support the CPEA network sites, the NICHD will be the sole supporter of the CPEA DCC. The NICHD intends to commit approximately $4.5 million in total costs [direct plus Facilities and Administrative (F&A) costs] for the five years from FY 2003 to FY 2007 to fund one DCC grant in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs of up to $500,000 in direct costs in the first year. Although the financial plans of 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. At this time, it is not known if this RFA will be reissued. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organization 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 Institutions that are currently a part of the CPEA Network may apply for a DCC grant, however, there should be no overlap of the duties of the personnel proposed in the DCC application and the duties of the personnel in the CPEA research site. 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 Application Requirements Applicants must address the following to be considered responsive to this RFA: o Evidence of Successful Past Performance Data Center applicants must demonstrate prior experience in the design, conduct, data analysis, and data management of major collaborative clinical research projects involving pediatric through adult populations, and provide evidence of successful performance as a DCC for multi-site studies during the previous five years. o Appropriate Staff Expertise and Capability The DCC will consist of a Principal Investigator, a project coordinator, and other staff deemed necessary to carry out its mission. The proposed DCC staff must be prepared to cooperate effectively in all network functions with NICHD and the CPEA Research Sites. The Principal Investigator and other staff must have appropriate expertise and capability in biostatistics, developmental study design, development and support, data management, data analysis, and project management, including, but not limited to staff and site training and quality assurance procedures. o Capacity and Ability to Manage Data and Communications DCC applicants must have the ability to assist in designing protocols appropriate for pediatric through adult populations, data collection forms, manuals of operation, and data collection systems, including distributed data entry. Applicants must have experience in developing and maintaining data quality control systems. Applicants also must provide evidence of data management and program support capabilities by describing standard operating procedures that address: (1) plans for data collection, management, analysis, and data quality control, and (2) plans for supporting an electronic mail/communications system to participants of the CPEA. o Evidence of Reporting and Publications Capabilities DCC applicants must provide evidence of their capacity to generate monthly reports on subject enrollment for several concurrent studies, quarterly reports on enrollment and CPEA Research Site performance (including any efforts to reallocate study resources), appropriate reports for the use of the DSMC, Network Advisory Group, and Steering Committee meetings, and other special reports, as required. The applicants must demonstrate successful experience in assisting investigators in preparing manuscripts for publication. o Experience in Providing Logistical and Other Support Services DCC applicants must provide evidence of successful experience in arranging logistical support services for multi-center research, for example, meeting and conference support. o Evidence of On-site Monitoring Capabilities DCC applicants must have experience and demonstrate capability in organizing and conducting on-site monitoring of multi-center research studies. o Evidence of Technology Transfer and Data Management Training Capabilities DCC applicants must demonstrate their capability to assist the CPEA Research Sites to enhance their data management and communications activities. Evidence of training and technical assistance expertise and experience in this area must be provided. o Evidence of Management Capability DCC applicants must provide evidence of superior ability to: (1) estimate appropriate and reasonable resources needed for individual projects in their role as the DCC for the CPEA Network, (2) manage those resources efficiently during the research, (3) adjust the assigned staff and other resources in response to changing work needs as the projects undertaken by network members unfold, (4) report these resource allocations to NICHD periodically, (5) subcontract with outside organizations to supplement these resources, as needed, and (6) provide for an expansion of services to other NIH initiatives as deemed appropriate. Budget Guidelines The NICHD intends to commit a total of approximately $4.5 million to fund one Data Coordinating Center for the five years from FY 2003 to FY 2007. For the purposes of this RFA, Data Coordinating Center applicants should provide a first-year budget request of up to $500,000 in direct costs. Based on the expected growth in the number and extent of the collaborative network studies over the course of the award, the NICHD anticipates that the budgets for the Years 02 through 05 will escalate proportionately. The first year budget request submitted with the application should include, at a minimum, the following: o Salary and administrative support for the Principal Investigator, project coordinator, and other staff as required to meet the first-year responsibilities of the Data Center. Future budgets will be determined on a year-to-year basis, depending on the needs of the CPEA and possible additional NIH initiatives in autism research. o Estimated travel costs and related expenses for the Principal Investigator and other Data Center staff for travel to required Steering Committee meetings (three times per year in Bethesda, Maryland). o Estimated travel costs and related expenses for the Principal Investigator and other Data Center staff for travel, once per year, to each of the research sites for the purposes of assisting in the standardization of collaborative protocols across sites, data management and analysis, and quality control and quality assurance. Individual site visits will be subject to approval by, and coordination with, the NICHD Project Officer. o Travel and logistical support expenses for members of the DSMC and the Network Advisory Board. For the purposes of this RFA, applicants should estimate three meetings per year for the DSMC, one meeting per year for the Network Advisory Board, and a committee composition of five to seven members. o Expenses related to communications, supplies, equipment, and other items identified as essential to the establishment and operation of the DCC. o Clearly specified plans and procedures for monitoring of DCC budgetary expenditures. o Estimated cost of accumulating and maintaining network data, and preparing datasets for network analysis. Percent Effort The DCC Principal Investigator must expend at least 40 percent effort annually on the award in each year of support. Cooperative Agreement Terms and Conditions of Award Cooperative agreements are assistance mechanisms and are subject to the same administrative requirements as grants. The following terms and conditions will be incorporated into the award statement and provided to each Principal Investigator as well as the institutional officials at the time of the award. These terms are in addition to, and not in lieu of, otherwise applicable OMB guidelines, HHS Grant Administration Regulations at 45 CFR Part 74 and 92, and other HHS, PHS, and NIH grant administration policies. The NICHD Grants Management Branch, in accordance with HHS, PHS, and NIH Grant Administration policies, will administer business management aspects of these awards. The administrative funding instrument used for this program will be the U01, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH scientific and/or programmatic involvement with the PI is anticipated during performance of the activities. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the PI"s activities by involvement in and otherwise working jointly with the PI in a partnership role, it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the PI for the project as a whole, although specific tasks and activities may be shared between the awardee and the NIH Project Scientists assigned to the CPEA network. The NIH Project Scientists include those from the NICHD and the NIDCD since both Institutes support the individual CPEA sites. The tasks and activities shared between the DCC PI and the NIH Project Scientists are described more fully below. The cooperative agreement funding mechanism will require collaboration among the NIH Project Scientists, the DCC Principal Investigator, and the Principal Investigators of the CPEA Network Sites. The NICHD Project Scientist will coordinate the activities of the CPEA Network, and will facilitate communication and the exchange of information. 1. Primary Rights and Responsibilities of the Awardee The awardee will agree to accept the participatory and cooperative nature of the group process. The Data Center grant will be administered by NICHD, but as part of the overall network, the Data Center will be involved with both the NICHD and the NIDCD. For example, the awardee is required to submit annual progress reports to NICHD, as appropriate, and to provide study and site performance information as stipulated by NICHD and NIDCD. The DCC will provide research support services to the CPEA Network. These will include establishment and maintenance of a centralized information management system to help the CPEA Network Research Sites collect, edit, store, analyze, publish, and disseminate results from their individual projects as well as from shared research. The DCC will serve as a central repository for data on all new collaborative projects, and may assume responsibility for data management for studies undertaken before the award of the grant. It will assist the NIH Project Scientists of the NICHD and NIDCD in monitoring research progress, and will work to ensure data integrity, accuracy, and accessibility among all CPEA research sites. It will offer technical assistance and analytical support for all sites, as needed. All activities of the DCC must be closely coordinated with the Steering Committee. In support of all research projects undertaken by the CPEA Network, the DCC staff will: o Support the activities of the Network Advisory Group, Steering Committee, and the DSMC through provision of materials/documentation support, meeting planning and logistics, and conference call coordination. o Provide advice on study design (including designs relevant to developmental/longitudinal research questions), data collection, data analysis, and publication development to all CPEA research projects. o As an essential element of support to the Network Steering Committee, provide the necessary statistical expertise and expertise in data analysis, to ensure optimization of study design and potential outcomes. Actively participate in and, as deemed appropriate, lead the analyses of collaborative CPEA studies and assist CPEA participants in the drafting and publication of collaborative study results. o Prepare, design, and disseminate operations manuals, data collection forms, databases, and results reporting summaries for CPEA research projects. o Compile for the Network Advisory Group, the Steering Committee, the DSMC, the NIH Project Scientists of the NICHD and NIDCD, site visit reports, monthly and quarterly subject enrollment reports, meeting summaries, quarterly Research Site performance and progress reports, and other reports as needed. o Create and maintain a high-quality database to support collaborative research, supervise all data collection procedures, and arrange for the most efficient transfer of study data where indicated. o In collaborative studies, provide support, as necessary, to ensure that all CPEA Network sites and investigators fully comply with NIH regulatory requirements, including Human Subject Protections, informed consent, reporting of adverse events, human and animal subject safety and welfare provisions. o Provide training to all Research Site personnel as needed for standardization of collaborative protocols across sites, data management and analysis, and quality control and quality assurance. o In coordination with the NIH, provide periodic, on-site, quality control monitoring at the Research Sites for those studies being performed at that site. o Organize and participate in regular conference calls and network meetings. 2. NICHD and NIDCD Responsibilities NICHD and NIDCD Project Scientists: The NICHD and NIDCD Network Project Scientists are partners within the Network representing the government"s interest in the substantive work of the Network. The primary role of the Project Scientists is to facilitate the work of the Network and to connect the Network to public policy operations within the government. 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, exercising the option of recommending the addition, modification or termination of aspects of the program. o Assist with the development of common protocols. 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 Scientist, who will: o Have the option to withhold support to a participating institution if technical performance requirements, such as compliance with the collaborative protocols, are not met. o Carry out continuous review of all activities to ensure objectives are being met and all regulatory, fiscal, and administrative matters are handled according to NIH guidelines. o Perform other duties required for normal program stewardship of grants. 3. Collaborative Responsibilities A Steering Committee, a Network Advisory Board, and a Data Safety and Monitoring Committee (DSMC) will provide the overall guidance and management of the CPEA Network. In addition, the Steering Committee will establish written Policies and Procedures that govern its operations, including publications. These documents will be reviewed periodically and may be amended at the discretion of the Steering Committee. Steering Committee Planning and implementation of the cooperative aspects of the study will be done by a Steering Committee consisting of the Principal Investigator of each of the Research Sites, the Principal Investigator of the DCC, and the NICHD and NIDCD Project Scientists. The NIH Project Scientists of NICHD and NICDC have a total of one shared vote when voting on the Steering Committee. All other participants have one vote each. The Steering Committee will formulate a research plan for cooperative research that will distill the several individual cooperative research plans into a coherent plan. The cooperative research plan will be agreed upon by majority vote of the Steering Committee, but each Principal Investigator will have the right of approval for any aspect of the cooperative research plan involving them. Due publication credit will be given to all work done cooperatively. The Steering Committee will: o Agree to accept the coordinating role of the committee and the cooperative nature of the group process. o Plan the design and implementation of the cooperative research protocols. o Advise the NIH regarding allocation of funds for cooperative research protocols. o Advise the NIH regarding allocation of funds for individual research protocols. o Formulate publication policy and appoint a Publication Subcommittee, as judged necessary by the Steering Committee. o Publish results, conclusions, and interpretations of the cooperative protocols. Network Advisory Board A Network Advisory Board will advise the Steering Committee in the identification and prioritization of topics for Network research. The Advisory Board, chosen by NICHD and NIDCD, will comprise senior scientists in the areas central to the work of the Network who are not affiliated with NICHD or NIDCD or part of the Network. As well as serving in an advisory capacity to the Steering Committee as deemed necessary, the Advisory Board will serve as the second level of review for projects approved by the Steering Committee as part of the research activities of the Network. The Network"s scope is defined as the sum of the approved individual and cooperative research plans of participating cooperative agreements in the Network. Data and Safety Monitoring Committee A Data and Safety Monitoring Committee (DSMC), established by NICHD and NIDCD, will advise the NIH and the CPEA Network, including the DCC, on research design issues, data quality and analysis, and ethical and human subject issues. It also will monitor the safety of any ongoing clinical research. DSMC membership will include, but not be limited to, individuals with expertise in clinical trial design and conduct, and relevant basic, medical, neurobiological, and behavioral sciences research. The DCC will prepare reports and provide coordination, support, and funding for travel and logistics arrangements related to DSMC meetings and actions. 4. Arbitration Procedures When agreement between an awardee and NIH 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 NIH staff, and a third person selected by the first two members selected. 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: Dr. Lisa Freund National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B05, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6879 FAX: (301) 480 0230 Email: freundl@mail.nih.gov o Direct your questions about peer review issues to: Robert Stretch, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1485 FAX: (301) 402-4104 Email: rstretch@nih.gov o Direct your questions about financial or grants management matters to: Nicolas Mitrano Grants Management Specialist Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6976FAX: (301) 480-4783 Email: mitranon@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: Dr. Lisa Freund National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B05, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6879 FAX: (301) 480 0230 Email: freundl@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 https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: https://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. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510 Bethesda, MD 20892 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-1485 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 review, comments on the following aspects of the application will be made in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in the assignment of the overall score, which is to reflect the overall impact of the project on the field, weighing the criteria appropriately for each application. An application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high merit rating. Applications submitted in response to this RFA will be reviewed on the following criteria relevant to the successful establishment and performance of a data coordinating center. o Organizational experience and capabilities, including, but not limited to: adequacy of site support, governance support, and staff training plans, including onsite training: adequacy of plans to guarantee the quality and integrity of collected data, adequacy of plans to maintain accurate and timely information on the progress of studies and site performance, adequacy of plans to facilitate and maintain close communication with NIH and among the other CPEA Network components, evidence of high-quality past performance in relevant data coordination activities, flexibility of plans to respond to the changing analytic needs of the CPEA Network, adequacy of plans and procedures for monitoring DCC expenditures, and demonstrated willingness and ability to adhere to the terms and conditions of the Cooperative Agreement award. o Staff experience and capabilities, including, but not limited to: adequacy of the proposed resources, including staffing, for supporting the CPEA Network, demonstration of innovative analytic approaches to evaluating research data, and adequacy of the qualifications and research experience of the management and analytic team. o Specialized capabilities and experience in large scale network coordination, including, but not limited to: adequacy of experience in and plans for conducting periodic onsite monitoring of multi-site studies, adequacy of previous experience with design, administration, management, and coordination of multi-site studies, demonstrated willingness and ability to expand resources, personnel, and facilities to serve as the DCC for other NIH initiatives if deemed appropriate to meet future needs. 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. RECEIPT AND REVIEW SCHEDULE Letter of Intent Date: October 25, 2002 Application Receipt Date: November 26, 2002 Peer Review Date: May 2003 Council Review: June 2003 Earliest Anticipated Start Date: July 1, 2003 AWARD CRITERIA Criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Responsiveness to the goals and objectives of the RFA 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: https://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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete copy of the updated Guidelines is available at https://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 https://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 https://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 https://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. 93.865 (NICHD) and 93.173 (NIDCD) 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 https://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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