DATA COORDINATING CENTER FOR NATIONAL COLLABORATIVE PEDIATRIC CRITICAL CARE RESEARCH NETWORK RELEASE DATE: May 27, 2004 RFA NUMBER: RFA-HD-04-015 - (Reissued as RFA-HD-08-027) EXPIRATION DATE: August 10, 2004 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.865 LETTER OF INTENT RECEIPT DATE: July 9, 2004 APPLICATION RECEIPT DATE: August 9, 2004 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) is interested in research in pediatric critical care, and has issued a Request for Applications (RFA-HD-04-004 http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-04-004.html) for the Collaborative Pediatric Critical Care Research Network to support approximately six Core Clinical Centers in clinical, translational, and descriptive research to investigate the safety and efficacy of treatment and management strategies in the care of critically ill children. As well, the Network will support research to enhance understanding of the pathophysiology of critical illness in childhood and its relationship to morbidity and disability in childhood. The Network will be funded by Cooperative Agreements, and will include a Data Coordinating Center to provide statistical expertise, assistance in study and protocol design, and analysis for Network trials and studies. Additionally, the Data Coordinating Center (DCC) will support a registry of pediatric critical illness so that accurate epidemiology and trends in pediatric critical care may be tracked nationally. The resources of the DCC will be used to collect and analyze data, and the professional staff will collaborate in study selection and design with the Network Steering Committee. Data collection from non-Network sites or consortia, as well, will be managed by the DCC upon instruction of the Network Steering Committee. Areas of interest include all major areas of pathophysiology in pediatric critical illness. RESEARCH OBJECTIVES Background NICHD is interested in clinical and basic research in pediatric critical care, especially as it relates to outcomes for the growing population of children with special health care needs. In an attempt to respond to the need for well- designed clinical trials, and translational and descriptive studies in pediatric critical care medicine, NICHD is establishing a Collaborative Pediatric Critical Care Research Network. Support of approximately six Clinical Centers in clinical, translational, and descriptive research to investigate the safety and efficacy of treatment and management strategies in the care of critically ill children is envisioned. The Network will consist of approximately six clinical centers and a data coordinating center. Applicants for the Data Coordinating Center should read RFA-HD-04-004, announcing the Collaborative Pediatric Critical Care Research Network (PCCR Network) at http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-04-004.html) to learn more about the scope, structure, and function of the PCCR Network. Modern critical care medicine has introduced a vast array of technological, pharmacologic, and strategic treatment plans, enabling children once thought to be beyond the reach of modern medicine to survive after life-threatening illness or injury, or the repair of serious congenital anomalies. These modalities of treatment have evolved with little scientific evaluation, because of both the acuity of the situations in the pediatric intensive care unit (PICU) and the rapid development of pediatric critical care. Indeed, because of the urgency attending critical illness in childhood, a new therapy or modality may be tried empirically; if the child's condition improves, this may rapidly evolve into a standard critical care practice, expected and demanded by practitioners, families, and patients. Scientific study of these practices, especially as linked to outcomes in childhood, has been inadequate to date. It is envisioned that the application of the scientific method to the evaluation of pediatric critical illness and practice in the PCCR Network will be greatly enhanced by the Data Coordinating Center solicited by this RFA. Scope The list below outlines some of the areas to be addressed by the Network, but is neither exhaustive nor exclusive: o traumatic and non-traumatic brain injury; o pulmonary physiology, particularly disabling pulmonary function as a residual of critical care in childhood or the neonatal period; o pediatric critical traumatic injury of any organ system from any modality; o sepsis in previously healthy and immunocompromised children; o use of newer modalities of mechanical ventilation, both invasive and noninvasive; o children who have received organ (solid and bone marrow) transplantation; o acute illnesses of childhood superimposed on the underlying medical fragility of special health care needs; o the rapid transfer of new technologies to pediatric critical care medicine; o strategies to reduce the cost and preserve the quality of critical care for children; o innovative methodologies in circulatory, renal, and pulmonary advanced life support; o multiple organ system failure and dysfunction (MOSF) of any etiology (infectious, non-infectious, unknown); o cardiopulmonary arrest, particularly studies evaluating critical care interventions and decision-making, and developmental outcomes; o near drowning, especially studies of the issues surrounding decision making in withdrawal of support; o morbidity and disability in survivors of pediatric critical care, including studies of family adaptation and the impact of critical illness in childhood on siblings and family dynamics; o studies of the impact of neonatal complications and pathophysiology on the incidence and course, throughout childhood, of critical illness; o pulmonary physiology, especially in the unique context of critical illness in childhood; o gastrointestinal function and immunonutrition. The scope of activities envisioned for the DCC in support of these and other Network activities includes: o Expert assistance in the design, conduct, data analysis, and data management of collaborative clinical, translational, and descriptive research projects in pediatric populations, ages birth to 21. This includes the special pediatric issues of consent. o Utilization of electronic technology to design and produce smooth data collection systems, so that data is directly entered into the DCC system at the Network clinical centers; modification and re-design of such systems as appropriate for new and emerging study protocols. o Provision of appropriate and capable leadership and expertise in biostatistics, developmental study design, data management, data analysis, and project management, including, but not limited to, staff and site training and quality assurance procedures. o Provision of research support activities in designing data collection modules, operational and procedure manuals, quality control systems, and an electronic mail/communications system for Clinical Center Principal Investigators and Research Nurses. o Provision of meeting and conference support, including logistical support services for multi-center research, and communication facilitation. o Organization and conduct of multi-site monitoring activities in conjunction with the NICHD Project Scientist. o Provision to NICHD of regular reports of enrollment and the allocation of resources, and appropriate response to changing work needs, new protocols, and staff. MECHANISM OF SUPPORT This RFA will use the 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 anticipated award date is April 01, 2005. 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 The NICHD intends to commit approximately $500,000 in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2005 to support up to one new grant in response to this RFA. An applicant may request a project period of up to five years and a budget for total costs of up to $500,000 in the first year and up to $1 million in subsequent years. Although the financial plans of the NICHD provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic institutions/organizations o Foreign institutions are not eligible to apply The need for continuous and active communication among sites and with the NICHD dictates that only U.S. institutions are eligible to apply. Organizations should have experience in functioning as a statistical coordinating center for multi-center research, including randomized controlled trials and observational studies of both a medical and a psychological nature. 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 his/her 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. Qualifications of the Principal Investigator should include: o The Principal Investigator, and other staff, must have appropriate expertise and capability in biostatistics, data management, data analysis, and project management. o The Principal Investigator must possess a doctoral degree in an appropriate field and be willing to commit at least 75 percent effort on Network activities. In exceptional cases, the PI may plan to devote less than 75 percent time, but should provide a detailed plan as to how they he/she will provide adequate leadership and technical support to the project, especially during the first two years of the Collaborative Pediatric Critical Care Research Network. SPECIAL REQUIREMENTS Minimum Requirements for the Data Coordinating Center o Staff must be prepared to cooperate effectively in all Network functions with NICHD and the clinical centers. o The DCC must demonstrate prior experience as a data coordinating center in multicenter studies in children or other vulnerable populations during the previous five years. o The DCC must have the ability to assist in designing protocols, data collection forms, manuals of operation, and data collection systems, including distributed data entry. o The DCC must have experience in developing and maintaining data quality control systems. o The Data Center must have the capacity to generate monthly reports on subject enrollment for several concurrent studies, quarterly reports on enrollment and clinical center performance (including efforts to reallocate study resources), appropriate reports for the use of the Network Data Safety and Monitoring Committee meetings, and special reports as required below. o The DCC must demonstrate successful experience in assisting clinical investigators in preparing manuscripts for publication. o The DCC must have experience in providing logistical services for multicenter clinical trials, e.g., assuring the appropriate preparation and delivery of study medications to the Clinical Centers. o The DCC must provide evidence of superior management capability as evidenced by the capacity to: (a) estimate appropriate and reasonable resources needed for individual projects in its role as the Data Center for multicenter research, (b) manage those resources efficiently during the research, (c) adjust the assigned resources as the work changes qualitatively and quantitatively during the research, (d) report these resource allocations to NICHD periodically, and (e) sub-contract with outside organizations in order to supplement its own resources, as needed. Cooperative Agreement Terms and Conditions of Award The following Terms and Conditions will be incorporated into the award statement. They are to be followed in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92, and other HHS and NIH grant administration policies. The administrative and 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 NICHD Project Scientist. Facilities and Administrative cost (indirect cost) award procedures apply to cooperative agreements in the same manner as for grants. Business management aspects of these awards will be administered by the NICHD Grants Management Branch in accordance with HHS and NIH grant administrative requirements. 1. Awardee Rights and Responsibilities The awardee is expected to cooperate with the clinical investigators at the Network Clinical Centers, and with the Project Scientist and Program Officer and other participating NICHD staff, in the design and conduct of protocols, analysis of data, and reporting of results of Network research. Systems for data collection, analysis, coordination, and quality assurance are essential. Required data summaries will be provided to the Network Steering Committee, the subcommittees, NICHD, the Data Safety and Monitoring Committee, and others as determined by the Steering Committee. Logistical services, including provision of study drugs, collecting and storing of biological fluids, and other supplies for the conduct of research, may be required. The Awardee will agree to accept the participatory and cooperative nature of the collaborative research process. The Data Coordinating Center grant will provide research support services to the Clinical Centers comprising the Network. These will include establishment and maintenance of a centralized information management system to help the Network sites, the Steering Committee, and the NICHD to edit, store, analyze, publish, and disseminate results from the shared research. The DCC will serve as a central repository for data on all collaborative Network projects. The DCC will assist the NICHD Project Scientist, Project Officer, and the Steering Committee in monitoring research progress, and will work to ensure data integrity, accuracy, security, and accessibility. Specifically, the DCC will: o Support the activities of the Advisory Board, Steering Committee, and the Data Safety Monitoring Board (DSMB) through provision of materials and documentation, meeting planning and logistics, and conference call coordination. o Provide advice on study design, data collection, data analysis, and publication development in all Network research projects. o Prepare, design, and disseminate operations manuals, data collection forms, databases, and results reporting summaries for Network projects and protocols. o Compile for the Advisory Board, the Steering Committee, the DSMB, the NICHD Project Scientist and Project Officer, site visit reports, monthly and quarterly reports of research activities (including, but not limited to, subject enrollment), meeting summaries, quarterly research site performance reports from each Clinical Center, and other reports as needed. o For Network collaborative studies, provide support, in concert with the NICHD Project Scientist and Project Officer, as necessary, to ensure that all Network sites and investigators fully comply with NIH regulatory requirements, including Human Subject Protections, informed consent, reporting of adverse events, and human and animal subject safety and welfare protections. o Provide training at all Clinical Center sites for personnel as needed for standardization of collaborative protocols across sites. o In coordination with the NICHD Project Scientist and Project Officer, provide periodic, on-site, quality control monitoring at the Clinical Center research sites for the Network studies being performed at that site. Awardees will retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. 2. NIH Responsibilities NICHD Project Scientist: The NICHD Project Scientist will have substantial scientific-programmatic involvement during conduct of this activity, through technical assistance and participation as one voting member of the Steering Committee. NICHD Project Officer: The NICHD will appoint a Project Officer, apart from the Project Scientist, who will: o Carry out continuous review of all activities to ensure that the objectives are being met and that all regulatory, fiscal, and administrative matters are handled according to NIH guidelines. o Have the option to withhold support to a participating institution if technical performance requirements are not met. o Perform other duties required for normal program stewardship of grants. 3. Collaborative Responsibilities The management of the National Pediatric Collaborative Critical Care Research Network includes three committees whose functions are as follows: o A Steering Committee will be responsible for protocol development and selection. Protocols that originate with investigators outside the Steering Committee may be presented for review as well, if two of the Principal Investigators and the NICHD Project Scientist concur. The structure of the Steering Committee is outlined above. o An Advisory Board will advise the Steering Committee in the identification and prioritization of topics for Network research. The Advisory Board, chosen by the NICHD with the advice of the Steering Committee, will be composed of individuals with expertise in clinical trials, biostatistics, epidemiology, pediatric rehabilitation, pediatric pulmonology, developmental pediatrics, and pediatric surgery. o A Protocol Review Committee will review and approve all clinical protocols before initiation. 4. Arbitration Process Any disagreements that may arise in scientific or programmatic matters within the scope of the award between grantees and the NIH may be brought to arbitration. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D, and HHS regulation at 45 CFR Part 16. An Arbitration Panel will help resolve both scientific and programmatic issues that develop during the course of work that restrict progress. The Arbitration Panel will be composed of three members: a member selected by the Steering Committee without NIH staff voting, a member selected by NICHD, and a member with expertise in the relevant area selected by the other two members. 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: Carol E. Nicholson, M.D., M.S. Pediatric Critical Care and Rehabilitation Program National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 2A03, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6843 FAX: (301) 402-0832 Email: email@example.com 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: firstname.lastname@example.org o Direct your questions about financial or grants management matters to: John ‘Chris’ Robey Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6996 FAX: (301) 451-5510 Email: email@example.com 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: Carol E. Nicholson, M.D., M.S. Pediatric Critical Care and Rehabilitation Program National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 2A03, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6843 FAX: (301) 402-0832 Email: firstname.lastname@example.org SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SUPPLEMENTARY INSTRUCTIONS: Please see the SPECIAL REQUIREMENTS section, above, for additional application instructions and requirements. The Research Plan section of the application should include the following information: (1) Overview (2) Description of relevant capabilities and experience (3) Research plan detailing the strategy to be used in executing the responsibilities of the Data Coordinating Center All three sections must be included within the page limit for the Research Plan as specified in the PHS 398 application instructions. (1) Description of Items to be Included in the Overview The Overview to the application should provide a summary of the capabilities and commitment of the applicant DCC to collaborative, multicenter research involving vulnerable populations. If the applicant DCC has substantial experience with, or staff expertise in, research involving vulnerable populations outside the pediatric age group, special sensitivity to the issues of informed consent in the critically ill, research under emergency circumstances, or experience in multi-center research in children, it should be summarized here. Additionally, a statement of intent to collaborate in a manner consistent with the terms and conditions of award should be included in the Introduction. (2) Description of Capabilities and Experience to be Included in Application o Describe previous successful collaboration in multicenter research, especially in pediatrics, within the last five years. o Describe the available and/or planned facility and how it has been used for multicenter clinical research as well as coordination of basic and translational studies. o Describe how the DCC staff's strengths in biostatistics, data management, data analysis, and project management have been used in multicenter research. o Describe the extent of commitment of the Data Center Principal Investigator to this multicenter clinical research. o Describe the processes used in assisting protocol design, forms and manual preparation, and in data collection for previous multicenter clinical, translational, and/or descriptive research. o Describe the processes used in data quality control in previous multicenter clinical research by the proposed DCC team. o Describe the reports prepared by the proposed DCC team on data and performance of Clinical Centers in previous multicenter clinical research. o Summarize the proposed DCC team's contributions in preparing manuscripts from previous multicenter clinical research. o Describe logistical services arranged by the DCC in support of previous multicenter clinical research. o Describe the organizational systems used by the proposed DCC to assign and adjust its resources to participate in multicenter clinical research. o Illustrate the calculation of costs of the proposed DCC’s contribution to the performance of a specific research protocol conducted in a multicenter setting during the past five years. The sample size, quantity of data accumulated and analyzed, and the number of publications should be specified. (3) Material to Include in the Research Plan Section: Description of Research Strategy and Execution o Statement of intent to collaborate in a manner consistent with the terms of the award. o Plans and estimated timetables for initial and subsequent Network protocols o Plans for staff allocation to meet the demands of the plans and timetables described above. o Propose methods to be used to facilitate communication between Data Center staff and other components of the Network, including NICHD and the Clinical Centers. o Describe any planned modifications in the organizational systems to assign and adjust resource allocation during protocol performance. This should include any potential for outsourcing to increase efficiency or to meet short- term needs. o Describe the applicant's perception of her/his/their potential role in the Network. o Describe procedures to increase operational efficiency and decrease costs while protecting the integrity of the data and the quality of the analyses. o Describe the method to be used by the proposed DCC to calculate all operational costs per protocol and per enrolled patient for all Data Center functions. o Propose an operational structure for providing and coordinating all Data Center functions for several Network protocols simultaneously. This should include lines of responsibility/authority for professional staff. o Propose an idealized staffing pattern for providing Data Center functions from protocol design through analysis. This should include provisions for adjusting staff time commitments during the life of a study. o Propose an administrative and management structure that would support and enhance the operational structure. o Assume that two new protocols, including one randomized clinical trial and one observational, descriptive study, were planned but not yet implemented. Assume, for this exercise, that the two studies will generate data on 1500 items for the randomized trials, and on 300 for the observational study during the first year of the Network. Using these assumptions, estimate the minimal base costs associated with providing professional and support staffing, and with the preparations necessary to receive and process data from the two studies during the first year. o Describe any modifications in the applicant's current processes used to provide Data Center functions that may be made if the applicant were to be selected as the Network Data Center. o Propose administrative and management functions that would assure continuing attention to cost-efficiency and productivity. This should include adjustment of resource allocation during protocol performance and the potential for outsourcing to improve efficiency or to meet short-term needs. These are examples only of material that may be included in the application to demonstrate the capability of the applicant as a Data Coordinating Center. It is not necessary to address each one; they are suggestions of topical areas to indicate the strength of an applicant. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Robert Stretch, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-1485 FAX: (301) 402-4104 Email: email@example.com APPLICATION PROCESSING: Applications must be received on or before 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. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight weeks. 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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. 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 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 written critique o Receive a second level review by the National Advisory Child Health and Human Development Council. REVIEW CRITERIA EVIDENCE OF SUCCESSFUL PAST PERFORMANCE: Quality of the Data Center applicant's prior experience in the design, conduct, data analysis, and data management of major collaborative research projects, including those involving pediatric populations, and successful performance as a DCC in the previous five years. APPROPRIATE STAFF EXPERTISE AND CAPABILITY: Quality of the Principal Investigator's plans to cooperate effectively in all PCC Network functions; demonstrated appropriate expertise and capability in biostatistics, study design, development and support, as well as data analysis, project management, and staff site training and quality assurance procedures. EVIDENCE OF MANAGEMENT CAPABILITY: Assessment of the DCC applicant's ability to: 1) estimate appropriate and reasonable resources for research studies 2) manage research resources efficiently during study execution 3) enhance collaboration among sites/investigative teams of the research Network ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below.) INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below.) CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL CONSIDERATIONS 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 Receipt Date: July 9, 2004 Application Receipt Date: August 9, 2004 Peer Review Date: October/November 2004 Council Review: January 2005 Earliest Anticipated Start Date: April 01, 2005 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. 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 at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. 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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