Full Text HD-94-021 CHILD HEALTH RESEARCH CENTERS NIH GUIDE, Volume 23, Number 27, July 22, 1994 RFA: HD-94-021 P.T. 04, AA Keywords: Biomedical Research, Multidiscipl Children (Patients) Pediatrics National Institute of Child Health and Human Development Letter of Intent Receipt Date: October 1, 1994 Application Receipt Date: January 18, 1995 PURPOSE The National Institute of Child Health and Human Development (NICHD) supports a program of Child Health Research Centers (CHRC), intended to provide resources to speed the transfer of knowledge gained through studies in basic science to clinical applications that will benefit the health of children. This will be accomplished by increasing the number of pediatric medical centers that can stimulate and facilitate the application of research findings to pressing pediatric problems, as well as increasing the number and effectiveness of pediatric investigators who have a grounding in basic science and research skills that can be applied to the health problems of children. 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 Request for Applications (RFA), Child Health Research Centers, is related to several priority areas. 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 A CHRC grant is awarded to a children's hospital or a department of pediatrics of an approved medical school in the United States of America that has as a primary teaching site either a general children's hospital or a children's program with an identifiable organizational structure that is part of a larger medical institution. Recipient institutions must have the clinical pediatric specialties and subspecialties and the discrete clinical and research facilities sufficient to ensure the linkage of basic research and clinical application that will meet the purposes of the CHRC program. The applicant institution must also meet the standard eligibility requirements for research grants established in the PHS Grants Policy Statement (rev. 4/94). The CHRC must have a strong, well-established research base, resting on the interests of established investigators who make their expertise available to the junior investigators and act as mentors or senior collaborators for them. The research must relate to the current areas of interest of the research program of the NICHD and should be broadly-based, not defined by a specific disease category or organ system. There should be an adequate pool of junior investigators likely to benefit from career development under the guidance of established investigators. In addition, each Center must have a scientifically sound and equitable system for choosing which junior investigators and which projects are to be supported. Finally, there should be evidence of an institutional commitment to support of the Center resources and to the development and retention of pediatric investigators. MECHANISM OF SUPPORT Support for this program will be through Center Core Grant (P30) awards, which provide core support for laboratories and administrative resources applicable to a number of different research projects. Policies that govern the grants award programs of the PHS will prevail. The support of grants pursuant to the RFA is contingent upon ultimate receipt of appropriated funds for this purpose. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. The maximum will be $400,000 for direct plus indirect costs in the first year, with no increases for inflation in subsequent years. The number of awards will be influenced by the amount of funds available to the NICHD, by the overall merit of applications, and by their relevance to program goals. Applications from institutions not previously funded for Child Health Research Centers will compete on an equal basis with competing continuation applications. It is expected that RFAs similar to this one will be issued in FY 1995 and FY 1996. FUNDS AVAILABLE The estimated total costs awarded will be $2.4 million for the first year of support. It is anticipated that six or more awards (new and competing continuations) will be made. The maximum amount will be $400,000 for direct plus indirect costs in the first year, with no increases for inflation in subsequent years. The number of awards will be influenced by the overall merit of applications and by their relevance to program goals. RESEARCH OBJECTIVES A CHRC grant provides pediatric research institutions, both developing and established, an opportunity to build a greater capacity for nurturing pediatric investigators. Established investigators whose research is already funded by NIH or other sources through competitively reviewed grants or contracts combine to establish in their institution a center of research excellence. Individuals with a wide range of scientific backgrounds, especially those with basic science orientation, are encouraged to interact with each other and with newly trained pediatricians just embarking on their research careers. A shared core laboratory, which provides services to complement and extend the capabilities of the established investigators to facilitate the career development of new investigators, may be a major part of the Center. The established investigators make available their expertise, guidance, and laboratory facilities, which together with the shared core laboratory comprise the laboratory resources of the Center, to be utilized by junior investigators for research projects which will enhance their basic science knowledge and skills. Support for conducting these projects is provided by the Center grant. The CHRC grant may provide funds for three purposes: A. Administration of the Center. B. Improvements in the child health-related research program of an institution in an area of scientific excellence through the establishment and maintenance of a shared core laboratory. C. Support for new projects, conducted by junior investigators, designed to enhance their research skills and produce preliminary data which could lead to successful competitive grant applications to the NIH or other agencies (New Project Development Funds), thereby providing a bridge between formal research training and the receipt of independent research grants. The novel feature of these grants is the flexibility in the use of the funds awarded for research support and career development, so that decisions about which new projects and which junior investigators are to be supported are made by the grantee institution. Both competing (renewal) and noncompeting continuations of a CHRC grant are contingent on demonstration of good judgment in these decisions, as indicated by scientific progress, success in the initiation of new competitively-supported research grants and contracts, and the development of new pediatric investigators. Components of a CHRC A. Principal Investigator The principal investigator of the CHRC is the chairperson of the department of pediatrics or the chief of the pediatric service. He or she is responsible for development and maintenance of the Center as an institutional resource and for its general oversight, appointing the program director and members of the advisory committee (see below). He or she makes the decisions as to appropriate recipients of the Center funds for research and career development, taking into consideration recommendations from the Center advisory committee. The principal investigator does not receive salary or fringe benefit support from the CHRC for this responsibility. B. Administrative Staff The day-to-day administration of the Center grant may be made the responsibility of a senior faculty member, called the program director, supported for up to 10 percent time and effort for this activity. The program director must be a physician knowledgeable about pediatric research, with a record of success at laboratory or clinical investigation and preferably a demonstrated skill in career development. The principal investigator may also serve as program director, with appropriate support. The program director may be assisted by a part-time Center-supported secretary. Administrative staff funds may also be used for a well-qualified recruitment officer, supported up to 20 percent time and effort, to enhance participation in the program by women and by members of minority groups under-represented in pediatric research (see below). C. Advisory Committee The advisory committee is a group of Center scientists, drawn from the pediatric department and from other departments or institutions as appropriate, who have interests and expertise relevant to modern pediatric research. The advisory committee should be chaired by the principal investigator and should include the program director, the core laboratory director, and some or all of the established investigators. It may also include the recruitment officer and any other persons considered potentially contributory by the principal investigator. It is the function of the advisory committee to evaluate applications for the use of the Center's New Project Development Funds and make recommendations to the principal investigator as to appropriate awardees. It evaluates ongoing activities annually, makes recommendations as to their continuation, and recommends to the principal investigator priorities for use of the resources of the core laboratory. For these functions the committee may utilize institutional or outside consultants as necessary. The advisory committee provides expert counsel essential to the principal investigator for his or her administration of the Center. Its meetings should be regular and its evaluation activities formalized. Minutes of the advisory committee meetings will be scrutinized as part of any competing continuation application. D. Established Investigators At least six established investigators, supported by NIH or other competitively-awarded grants, are required for a CHRC. They should be expert in the application of new advances in basic science methodology to problems of human development and pediatric disease that are relevant to the mission of the NICHD and within its authority to support. Their research interests must contribute to areas that justify their collective designation as a Child Health Research Center, making the CHRC attractive to recently-trained pediatricians as a place to develop their investigative careers. The established investigators need not be pediatric department members; linkage to other departments can enhance the power of the CHRC, and is expected to be a key feature of each Center. When a junior investigator is to be supported by the Center through New Project Development Funds, at least one of the established investigators must agree to provide his or her expertise as a mentor and collaborator and allow the junior investigator access to his or her laboratories. The established investigators do not receive support for their salaries or fringe benefits from the Center grant. Established investigators may be added as appropriate to the roster of an ongoing funded Center. E. Laboratory Resources The laboratory resources of the CHRC comprise the research laboratories of the established investigators, as well as a shared core laboratory to be utilized by the established investigators and the Center-supported junior investigators whose activities they will supervise. The justification for the shared core laboratory is its provision of a cost-effective expansion or centralization of the research resources that make the Center a magnet for beginning investigators. The CHRC grant may support professional supervision of the shared core laboratory (core laboratory director, maximum 50 percent time and effort), as well as technical assistance, supplies, and equipment purchase and maintenance. The principal investigator, program director, and core laboratory director are responsible for efficient and equitable utilization of the core laboratory on the basis of recommendations from the advisory committee. Core laboratory log books are subject to review by NICHD staff and outside consultants upon request of the former. There must be an institutional commitment to this shared core laboratory, which may take the form of alterations and renovations to establish it, the purchase of research equipment, the assignment of research space, and/or the support of personnel. Creative approaches to stimulating interactions between diverse investigators who can contribute to Center goals are particularly desirable. The laboratories of the established investigators are not supported directly by the Center grant. Funds for supplies, small equipment, and technical assistance needed for the conduct of Center-supported research projects in these laboratories are provided through New Project Development Funds. Support for projects conducted in the core laboratory by recipients of New Project Development Funds may come either from those funds, from the core laboratory budget, or from both. F. New Project Development Funds The principal investigator, after considering recommendations from the advisory committee, is to use Center funds to make annual awards to junior faculty members for the pursuit of research projects which will utilize the Center laboratory resources and established investigator expertise. The projects may be clinical or non-clinical, as long as they relate to the goal of the Center. Each junior investigator must be under the mentorship of an established investigator who will provide supervision of the research to be undertaken. The maximum award to any individual for a project in this category is $50,000 per year. These funds may be used to defray the costs of materials, supplies, technical assistance, and miscellaneous expenses generated by these projects in the laboratories of the established investigators who serve as preceptors and collaborators of the awardees; for supplies needed for work in the core laboratory which are beyond the capacity of that laboratory's budget; for small items of equipment; for travel; and for a portion of the salaries and fringe benefits of the junior investigators. These funds may not be used for patient care costs such as inpatient bed days or outpatient visits, except for clinical laboratory analyses essential for the research. The recipient of New Project Development Funds should be a physician who has completed pediatric training, who has not previously been the principal investigator of a competitively awarded NIH research grant or contract* (except for an NICHD-supported R03 grant), and who is no more than three years beyond fellowship training at the time the first New Project Development Fund award is made. The awards are renewable at the discretion of the principal investigator, contingent upon presentation of evidence of satisfactory progress to the advisory committee and the NICHD in the Center annual progress report. Each recipient should make a commitment of time and effort to research which is appropriate for the magnitude of the award. Institutions with CHRC grants are encouraged to develop novel mechanisms for recruiting qualified pediatricians to become grant-supported investigators in the Center. Such mechanisms could include, for example, part-time appointments for persons with families and special efforts to recruit members of minority groups. *Note: This restriction does not apply to NIH CIDA (K08) awards or any of its precursors (CIA, PSA), which are career development awards and not research grants. Recipients of New Project Development Funds are especially encouraged to apply for CIDA awards, which may be held prior to, concurrently with (subject to the relevant CIDA salary restriction), or subsequent to New Project Development Funds. Allowable Budgetary Items and Supportable Activities Allowable costs in NIH grants are governed by rules set forth in the Public Health Service Grants Policy Statement and the NIH Guide for Grants and Contracts unless otherwise stated on the Notice of Grant Award. Under these rules the principal investigator may exercise flexibility in meeting unexpected Center requirements by rebudgeting or requesting approval to rebudget among categories within the total direct cost budget of the Center (as shown on the Notice of Grant Award), within the ceilings set in these guidelines. CHRC grants are for five years, at a maximum level of $400,000 (direct plus indirect cost) annually, and are renewable. Competing continuation (renewals) are limited by Congressional action to one five-year period. No institution will be funded for a CHRC for more than ten years in any twelve-year period. That is, institutions which have been funded for a new CHRC and one competing continuation may not reapply until after a lapse of two years. An institution not funded for a competing continuation application may make a new application when a new RFA is issued. Items fundable under a CHRC grant include: A. Administration 1. Salaries and support for a Center program director (maximum 10 percent time and effort), a part-time secretary, and a recruiting officer (maximum 20 percent time and effort). 2. Administrative support services, including supplies, duplicating equipment, telephone, or maintenance contracts for equipment when not covered by institutional overhead charges. 3. Travel of principal investigator and Center program director to administrative meetings with NICHD staff and to an annual scientific meeting of Centers. B. Shared Core Laboratory (maximum annually) 1. Salaries and support for shared core laboratory staff. 2. Supplies and animals. 3. Scientific equipment (purchase and maintenance). 4. Computer facilities. C. New Project Development Funds (maximum $200,000 annually) Up to $50,000 annually can be used to provide support for projects of individual junior investigators which are pursued in their own laboratories, in the shared core laboratory, and/or in the laboratories of the established investigators. For each person supported in this category, the maximum expenditure for equipment is $7,000 annually and for travel $1,500 annually. The grant application should indicate the number of awards proposed for each year, and provide evidence that this number of worthwhile projects is likely to be forthcoming. No investigator may receive more than one such award per year. It is not a requirement that any CHRC grant be funded at the allowable budgetary maximum in any particular year. The number of New Project Development Awards to be supported must be commensurate with the institution's capacity to develop and recruit appropriate candidates. Small size is not a disadvantage for Center funding, provided the support for core resources (administration, shared core laboratory) is in proportion to the activity in new investigator development which is the Center's primary purpose. To encourage use of these funds only for the most deserving candidates, requests will be considered for the carry-over of unexpended New Project Development Funds into subsequent budget periods. Items not fundable under a CHRC grant include: 1. Direct support of the laboratories, salaries, fringe benefits, travel, and research projects of the established investigators, except for reimbursement for costs from New Project Development Funds within the Center. 2. Salary and support for central institutional administrative personnel usually paid from institutional overhead charges, such as budget officers, grant assistants, and building maintenance personnel. 3. Salary and support for administrative activities such as public relations or health and educational services. 4. Travel of principal investigator, program director, core laboratory director, or established investigators to scientific meetings. 5. Costs of clinical care, such as patient bed days or outpatient visit charges. 6. Alterations and renovations. Application Format A. Text Applicants should follow the instructions for applications included in the "National Institute of Child Health and Human Development Research Center Programs P30 Center Core Grant Guidelines," except where these are at variance with these specific guidelines for CHRC grants. Since P30 Guidelines were not designed primarily to be used for CHRC-type applications, considerable flexibility in format will be permitted. Applicants should take care, however, that adequate information is provided for evaluation with respect to the eleven review criteria described above. Prospective applicants are urged to discuss their plans with Institute staff. Specific research projects proposed for support need not be described in the initial application. However, a brief description of examples of junior investigators who might be supported through this award, their training background, research areas in which they would work, and established investigators who would supervise them might provide evidence that enough worthy projects will be available to justify the requested budget. B. Budget Each application submitted in response to this RFA should include several separate budget pages (plus any budget justification pages): 1. A composite budget, the sum of the other budgets, in categories, for the first year. New project development funds should be listed under Other Expenses. 2. A budget for the administrative core (unless no funds are requested for this core), including personnel or supplies, travel for the principal investigator and program director to the Centers' meeting, and any other expenses requested, for the first year. 3. A budget for the shared core laboratory (unless no funds are requested for this laboratory), including personnel, equipment, supplies, and other expenses. 4. A budget for New Project Development, providing under Other Expenses the total dollars and minimum number of positions requested, according to the following format: (Example) New Project Development Awards: 3 @$ 50,000 or 5 @$ 30,000 = $150,000 The New Project Development Funds budget need not be allocated into categories, since these will vary with the situations of the recipients. However, it should be specified to what extent these funds will be used for salaries. The number of such awards planned should be appropriate for the size of the institution, the number and skills of the established investigators, and the magnitude of the request for Center administration and core laboratory resources. 5. The usual future-year continuation page, listing New Project Development Awards under Other Expenses. STUDY POPULATIONS 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, and Concerning the Inclusion of Minorities 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 these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by October 1, 1994, a letter of intent that includes a descriptive title of the proposed Center, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of this RFA. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NICHD staff to estimate the potential review workload, to recruit appropriate reviewers, and to avoid possible conflicts of interest in the review. The letter of intent is to be sent to Dr. Ephraim Levin at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-710-0267. The RFA label available in the application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of an application such that it may not reach the review committee in time for review. The title of the application on page 1 of the grant application must be "CHILD HEALTH RESEARCH CENTER." The phrase "PREPARED IN RESPONSE TO RFA HD-94-021" must be typed on line 2a of the face page of the application. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact 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 additional copies of the application must also be sent to: Susan Streufert, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E01 Bethesda, MD 20892 Applications prepared in response to this RFA must be received by January 18, 1995. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA 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. REVIEW CONSIDERATIONS Applications will be reviewed by NICHD staff for responsiveness to the RFA. A non-responsive application will be returned to the applicant. Responsive applications may be subjected to a triage by a peer-review group to determine their scientific merit relative to the other applications received in response to this RFA. The NICHD will withdraw from competition those applications judged to be noncompetitive and notify the applicant and institutional business official. Applications considered responsive to this RFA and competitive will be reviewed for technical merit by an Initial Review Group convened by the scientific review staff of the NICHD solely to evaluate these applications. Criteria for the initial review are described below. Following review by the Initial Review Group, applications will be evaluated by the NICHD Advisory Council for program relevance and policy issues before awards are made. Review Criteria A. The review criteria for the evaluation of new and competing continuation CHRC applications include the following: 1. Relevance of the research at the Institution to programmatic needs of the NICHD. 2. Probable impact of the Center on enhancing the capacity of the grantee institution for developing well-qualified new pediatric investigators, thereby advancing pediatric research at the grantee institution, in the local medical environment, and in the nation, especially with regard to the application of basic research developments to clinical problems in pediatrics. 3. Quality and productivity of the research activities of the participating established investigators, and relevance of their programs to the NICHD mission. 4. Nature and quality of the shared core laboratory: technical merit, scientific justification, evidence of cost-effectiveness, procedures for quality control and allocation of resources, qualifications of the core laboratory director and technical staff, and probable utility to the investigators. 5. Institutional commitment to the requirements of the program, such as recruitment efforts, salaries, equipment, or other forms of cost sharing. 6. Evidence for a pool of prospective investigators, trained locally or recruited from elsewhere, who could benefit from receiving support from the Center. 7. Opportunities for faculty positions emphasizing research for recipients of New Project Development Funds at the applicant institution or elsewhere. 8. Previous success of the institution in developing new pediatric investigators. 9. Efforts to develop novel mechanisms for recruiting candidates for New Project Development Awards from groups under-represented in pediatric research. 10. Procedures established for evaluating candidates for New Project Development Funds and providing internal quality control of ongoing research. 11. For renewal (competing continuation) applications, or subsequent new applications from an institution with a previously-funded Center, success of the Center-funded junior investigators in producing research publications and in obtaining independent, competitively-funded support for pediatric research. B. Non-competing continuations: Annual progress reports of a CHRC grant will be reviewed by NICHD staff and outside consultants in order to confirm that the Center is continuing to meet its goal of recruiting promising new pediatric investigators and stimulating and facilitating their career development. In addition, each Center will be asked to send some of its recent recipients of research support as well as the principal investigator and/or program director to an annual meeting. One purpose of this meeting will be to allow these junior investigators to present their Center-supported research to their peers as well as to other critics. Center principal investigators and program directors are expected to make a special effort to attend these meetings to demonstrate their support of the program and the junior investigators. In addition, they will have an opportunity at these meetings to exchange ideas about common problems and make suggestions to NICHD staff about possible modifications in the program. AWARD CRITERIA The anticipated date of award is September 1, 1995, based on the following timetable: Letter of Intent Receipt Date: October 1, 1994 Application Receipt Date: January 18, 1995 Initial Review Date: March 1995 Review by Advisory Council: June 1995 Scientific merit and technical proficiency, based on the demonstrated and projected capabilities described in the application will be the predominant criteria for determining funding priorities. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions for potential applicants is welcome. Direct inquiries regarding programmatic issues and address the letter of intent to: Ephraim Y. Levin, M.D. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Building, Room 4B11 6100 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-5593 Direct inquiries regarding fiscal matters to: Ms. Mary Ellen Colvin Office of Grants and Contracts National Institute of Child Health and Human Development 6100 Building, Room 8A17 6100 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-1303 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.865, Research for Mothers and Children. Awards are made under the authority of the Public Health Service 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 Part 52 and 45 CFR Part 74. 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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