KV4@CU.NIH.GOV (04/19/91)
HUMAN GENOME PROGRAM DEVELOPMENTAL GRANTS RFA: HG-91-04 National Center for Human Genome Research Letter of Intent Receipt Dates: May 9, 1991; September 14, 1991 Application Receipt Dates: July 9, 1991; November 14, 1991 The National Center for Human Genome Research (NCHGR) announces the availability of developmental grants (P20) to provide support to groups of outstanding investigators who wish to develop interdisciplinary research programs on genome problems. The P20 grant allows such investigators to develop scientific strategies, carry out pilot projects, and establish collaborations that are needed for the conduct of interdisciplinary research. P20 grants are not renewable; however, continued support for the interdisciplinary research groups and scientific projects developed through the use of the P20 mechanism may be sought through an application for a program project or center grant. BACKGROUND The National Institutes of Health is currently engaged, along with several other Federal, private, and international organizations, in a research program designed to characterize the genomes of selected organisms, including the human. This research program, which has been named the Human Genome Project, has the following interrelated scientific goals: (1) the construction of high-resolution genetic linkage maps; (2) the development of physical maps, with an emphasis on methodology that allows investigators access to the mapped DNA; (3) the development of technology to determine the complete nucleotide sequence of the DNA of selected organisms, including the human; (4) the development of the capability for collecting, storing, distributing, and analyzing genome data; (5) the development of appropriate new technologies to achieve these goals; and (6) the examination of the ethical, legal, and social implications of the Human Genome Project itself. The product of the Human Genome Project will be a set of information and material resources that will be available to the entire research community and will facilitate further research and application of the knowledge gained to the prevention, diagnosis, and therapy of disease. The detailed scientific goals for the first five years of the NCHGR research program include: expanding the human genetic map to a resolution of two to five centimorgans; constructing complete physical maps of the DNA of certain model organisms and, in cooperation with the Department of Energy, all human chromosomes; and developing new technology to increase both the efficiency and accuracy as well as lower the cost of physical mapping and DNA sequencing. Attaining these goals will require a considerable amount of innovative research. Many important research efforts in this field will be of a scope appropriate to a single investigator or a small number of investigators. However, other necessary research efforts will be of a scope and complexity that will require interdisciplinary approaches that can only be adequately pursued by a group of investigators, representing diverse disciplines, working cooperatively. In the cases of both individual investigator-led and interdisciplinary research projects, outstanding investigators may be interested in developing approaches that would significantly advance the Human Genome Project but which may not be well enough realized to compete for an individual research (R01), program project (P01), or center (P30, P50) grant. In the case of the former, the NCHGR has initiated a program of grants for support of pilot projects/feasibility studies that would allow such ideas to be evaluated and plans for a regular research project to be developed (see NIH Guide for Grants and Contracts, Vol. 19, No. 28, July 27, 1990, p. 3). Similarly, the establishment of the interdisciplinary collaborations and/or large research projects that are normally supported by program project and center grants often requires extensive planning, strategy development, or execution of preliminary experiments before a group of investigators is ready to submit a grant application. Planning such an effort requires considerable commitment and may also require funding. To encourage investigators to undertake the effort of planning complex projects and acquiring the necessary preliminary data and key biological reagents, the NCHGR will offer non-renewable developmental grants (P20) of limited size and duration. OBJECTIVES AND SCOPE OF HUMAN GENOME PROGRAM (HGP) DEVELOPMENTAL GRANTS The primary purpose of the HGP developmental grant will be to provide support for a group of investigators to develop interdisciplinary collaborations and strategies, to obtain preliminary results to demonstrate feasibility, and to develop a research plan addressing a major research goal of the Human Genome Project to be used as the basis for an application for an HGP program project or center grant. The objectives for an HGP developmental grant may include, but are not limited to: 1. Preliminary or feasibility studies to gather sufficient data to demonstrate the potential of an idea or the validity of an approach, to acquire or demonstrate technical competence, or to evaluate other technical factors involved in the development of a project that addresses a major goal of the Human Genome Program; 2. Recruitment of new investigators whose expertise would strengthen the overall program project or center grant application; 3. Inter- or intra-institutional planning to develop research strategies, including the establishment of a timetable or milestones, for the program project or center grant application. It is important to note that the award of a developmental grant by the NCHGR does not imply a commitment to future funding of any program planned with the support of such a grant. A separate application must be submitted for such a program; such an application will be evaluated on the basis of its own merit. SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN RESEARCH STUDIES NIH policies concerning research on human subjects apply to this program. For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded from this requirement. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. ELIGIBILITY Investigators at academic, nonprofit, or for-profit institutions in the United States are eligible. Usually, only one developmental grant will be funded at an institution. While a single institution must be the applicant, a multi-institutional arrangement (consortium) is possible if there is a compelling reason for it and if there is clear evidence of close interaction among the participants. Collaboration with industry is encouraged. In such a collaboration, plans for the industrial contribution should be well-integrated into the design and execution of the project, to encourage cross-fertilization of ideas and rapid application of the research to practical purposes. ALLOWABLE COMPONENTS OF HGP DEVELOPMENTAL GRANT (P20) APPLICATIONS Each applicant should consider the strengths and weaknesses of the planned research group plus the expertise and the preliminary data that would be required to demonstrate the technical competence necessary for a successful interdisciplinary program project or center grant application. The following components are allowable in HGP developmental grant applications. Any of them may be incorporated into the structure that will best fit the needs of the applicant. 1. Pilot projects/Feasibility studies. Research projects of limited scope to generate data needed to demonstrate technical feasibility, to validate an experimental approach, and/or to provide key reagents needed to undertake an interdisciplinary genome research project may be proposed. Costs required for carrying out individual projects may be requested. Generally, funds for renovation of existing facilities or to purchase substantial amounts of equipment will not be allowed. If such requests are made, they must be justified in terms of the critical nature of the equipment for the success of the overall objectives of the developmental grant, rather than for the planned program project or center grant. Start-up funds for feasibility studies to be carried out by new faculty who will be needed for the proposed interdisciplinary study can be requested under this component. 2. Administrative/Planning core. Each developmental project must designate a director who will be the key figure in the scientific planning and subsequent administration of the proposed HGP project. Planning efforts should be described in terms of the necessary feasibility studies, recruitment of new investigators, establishment of new collaborations, development of plans for data release and outreach to the scientific community, and other components that will strengthen and broaden any existing programs in the research area of the proposed project. An internal steering committee is strongly recommended. Funds may be requested for the purpose of obtaining outside advice and for necessary administrative personnel. Costs are allowable in accordance with the cost principles outlined in OMB Circulars A-110, A-21, and A-122, and the provisions in DHHS Administration of Grants Federal Regulations Title 45 Part 74 and the PHS Grants Policy Statement, provided they fall into one of the categories below. It is important to recognize that, even though a cost may be allowable, it is the responsibility of the applicant to adequately justify the inclusion and amounts of all items for which funding is requested. NONALLOWABLE COSTS FOR HGP DEVELOPMENTAL GRANTS Funds from HGP Developmental grants (P20s) may not be used to provide salary and support for central institutional administrative personnel usually paid from institutional overhead charges. TERM OF SUPPORT The funding level for HGP developmental grants will be $750,000 total costs per year for a maximum of three years. It is anticipated that up to five developmental grants (up to $3,750,000) will be awarded depending upon the appropriation of funds for this purpose and the quality of the applications received. The awards are not renewable and normally supplements are not allowed. The Human Genome Initiative has established a series of specific objectives and milestones to be accomplished in a limited period of time. As the initial objectives are reached, the focus of the HGP program projects and center grants will change. In order to ensure that developmental grants remain focused on appropriate goals and make sufficient progress towards establishing the interdisciplinary effort needed to apply for a program project or center, frequent programmatic assessments will be necessary. In addition to yearly staff review through progress reports, the directors of developmental grants will be asked to attend the annual center directors meetings. METHOD OF APPLYING Applicants should use Standard Form PHS 398, revised 10/88, which is available from most institutional business offices or from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892 (Telephone: (301) 496-7441). In order to assure proper identification of the application, line 2 of the application form should state "Human Genome Program Developmental Grant, HG-91-04." Applications are limited to 30 pages in length. As a guideline, it is suggested that approximately ten pages will be sufficient to describe the planned mission and structure of the proposed project and three to five pages to describe each feasibility study. Each project should be presented in the format used for the NIH research grant (R01), but in greatly abbreviated form. Further information about the format of the application is included in "Human Genome Program Developmental Grant Instructions," which is available from Dr. Peterson at the address below. The RFA label available in the 10/88 revision of 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 your application such that it may not reach the review committee in time for review. In order to be reviewed promptly, applications must be complete when submitted. Late submission of material designed to either complete or expand the application may result in deferral of the application. The original and four copies of the application must be submitted to: Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892 To assist the review staff of NCHGR in conducting a timely review, applicants are requested to send, at the same time the application is submitted, two copies of the completed application to the Office of Scientific Review at the following address: Office of Scientific Review National Center for Human Genome Research National Institutes of Health Building 38A, Room 604 9000 Rockville Pike Bethesda, MD 20892 Telephone: (301) 402-0838 LETTER OF INTENT Applicants are strongly urged to contact the individual listed below by telephone and with a letter of intent, to indicate that they plan to submit an application for an HGP developmental grant. The letter should include the name of the principal investigator and key co-investigators, the title and subject of the planned research, and a brief project description. The letter of intent is due two months prior to the receipt date and must be sent to: Jane L. Peterson, Ph.D. Chief, Research Centers Branch National Center for Human Genome Research National Institutes of Health Building 38A, Room 610 9000 Rockville Pike Bethesda, Maryland 20892 Telephone: (301) 496-7531 REVIEW PROCEDURES There will be two receipt dates for this RFA: July 9, 1991 and November 14, 1991. Future RFAs for HGP developmental grants will be published if there is a continuing need to stimulate interdisciplinary genome research. If the application submitted in response to this RFA is substantially similar to a research grant application already submitted to the NIH for review, but which has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA which is essentially identical to one that has already been 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. Applications received in response to this announcement will be reviewed in accordance with the usual NIH peer review procedures. Applications will first be screened for responsiveness to this RFA by NIH staff. Those deemed non-responsive will be returned to the applicant. If a large number of applications is received, they may undergo a preliminary peer review to identify the most meritorious ones. Principal Investigators on applications that are deemed non-competitive by this peer review will receive only a brief critique, and these applications will not be reviewed further. The remaining applications will then be evaluated for scientific merit by the Genome Research Review Committee. Subsequent to evaluation by this initial review committee, applications will receive a second-level review by the National Advisory Council for Human Genome Research. Applications will be accepted in accordance with the following schedule: Letter of Intent Receipt: May 9, 1991 September 14, 1991 Application Receipt: July 9, 1991 November 14, 1991 Initial Review: October, 1991 February, 1992 Council Review: January, 1992 May, 1992 Anticipated Award Date: April 1, 1992 July 1, 1992 REVIEW CRITERIA The following criteria will be used in reviewing developmental grant applications: 1. The potential of the plans for leading to a project that will make a significant contribution to achieving the goals of the Human Genome Program; 2. The qualifications and capabilities of the Principal Investigator and other key investigators for mounting an interdisciplinary research program of high merit; 3. The scientific merit of the pilot and feasibility studies and their potential for contributing to the overall project; 4. The adequacy of the available resources and the quality of the research environment. It is important that interdisciplinary genome projects be in a strong and diverse research environment that will augment the ability of the program to address the goals of the Human Genome Project, to facilitate future application of the research results, and to provide the opportunity for multidisciplinary collaborations; 5. The adequacy of the planned administrative structure, including the ability of the Principal Investigator to provide the intellectual and administrative leadership for the project; 6. The institutional commitment to the program, including commitment to any recruitments that may be needed to complement existing scientific expertise; 7. Provisions for the protection of human subjects and the humane care of animals; and 8. Appropriateness of the requested budget for the work proposed. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to NCHGR. The following will be considered in making funding decisions: 1. Quality of the proposed project as determined by peer review; 2. Programmatic balance of NCHGR research. Before preparing an application, it is extremely important that investigators communicate with NCHGR staff, who can provide information about areas of genome research supported by NCHGR and assistance in choosing a focus for the application; 3. Availability of funds. INQUIRIES For more information, please contact: Jane L. Peterson, Ph.D. Chief, Research Centers Branch National Center for Human Genome Research National Institutes of Health Building 38A, Room 610 9000 Rockville Pike Bethesda, MD 20892 Telephone: (301) 496-7531 For information regarding NIH grants policy, please contact: Alice H. Thomas Grants Management Officer National Center for Human Genome Research National Institutes of Health Building 38A, Room 613 9000 Rockville Pike Bethesda, Maryland 20892 Telephone: (301) 402-0733 This program is described in the Catalog of Federal Domestic Assistance No. 93.172. Awards will be made under the authority of the Public Health Service Act, Sections 301 (Public Law 78-410, as amended by 42 U.S.C. 241) 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 to Health System Agency review.