Full Text DK-94-013 CENTERS OF EXCELLENCE IN MOLECULAR HEMATOLOGY NIH GUIDE, Volume 22, Number 43, November 26, 1993 RFA: DK-94-013 P.T. 04 Keywords: Hematology Biology, Cellular Biology, Molecular Biomedical Research, Multidiscipl 0715132 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: February 4, 1994 Application Receipt Date: March 17, 1994 PURPOSE This Request for Applications (RFA) invites investigators to submit research applications for Centers of Excellence in Molecular Hematology. The emphases for this program are fourfold: (1) to create a focus for multi-disciplinary investigations into the cellular and molecular basis of genetic diseases of the blood; (2) to encourage the efficient assembly of the needed expertise, equipment, and technologies to generate advances in molecular hematology; (3) to attract new scientific expertise into the study of the molecular mechanisms of hematologic diseases and disorders; and (4) to utilize cellular and molecular biology techniques to develop methods to characterize, identify, treat, and cure inherited diseases of the blood and genetic diseases of other systems. Individual institutions with both basic and clinical research capabilities are eligible to apply for a grant under this announcement. Inter-institutional collaborative research arrangements are also appropriate and encouraged. Coordination for such arrangements must be evident and clearly meaningful and appropriate for the research proposed. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Centers of Excellence in Molecular Hematology, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible to apply. Minority individuals and women are encouraged to submit as Principal Investigators. MECHANISM OF SUPPORT Support of this program will be through the NIH specialized center (P50) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Except as otherwise stated in this announcement, awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement. FUNDS AVAILABLE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) expects to award up to three center grants for molecular hematology research in fiscal year 1994. The anticipated awards are for five years and are contingent upon the availability of appropriated funds. The total amount of available funds to support this program is anticipated to be no more than $2.25 million per year. No applicant may request more than $750,000 in total costs (including both direct and indirect costs) in the initial budget period. A standard escalation factor may be used for subsequent budget periods. The award date for these grants will be September 30, 1994. RESEARCH OBJECTIVES During the past two decades, major advances have been made in understanding the molecular basis for inherited diseases. The clinical and biochemical effects of some diseases have been clarified, and the molecular defects have been described in an ever-increasing number of genetic disorders. Notable examples of this new knowledge are the genes for Cooley's anemia, sickle cell disease, and hemophilia. Application of sensitive biochemical and molecular techniques has made molecular diagnosis of these disorders a reality. Now, with these important diagnostic achievements in hand, even greater efforts must be directed toward development of technologies to formulate specific therapies for these and other debilitating hematologic disorders. Centers of Excellence in Molecular Hematology will allow development of the broad range of scientific expertise and technologies involved in investigation of genetic diseases and genetic therapy to be brought together in a unified effort. The technologies include knowledge of viruses, cell culture, bone marrow cells, growth factors, animal models, and the molecular basis of genetic diseases. The development of Centers as an organizational mechanism will promote the joint efforts of both basic scientists and clinical researchers toward the study of gene structure and function, the structural biology of proteins and the complex biochemistry of protein interactions, the mechanisms of hematopoietic gene regulation and of differential gene expression during hematopoietic cell maturation and differentiation, and clinical research to test the efficacy and safety of therapeutic strategies derived from basic investigation. These studies will have as their ultimate goal the development of preventive, curative, or intervention strategies in the treatment of genetic diseases. This may include somatic gene therapy and will require involvement of a broad range of investigators with training as virologists, experimental hematologists, molecular geneticists, cell biologists, veterinarians, and clinicians. Concentration of efforts such as vector development, creation of animal models, and the application of advanced instrumentation will allow economies of scale and will generate technologies that will be broadly applicable to the understanding of molecular disorders. These centers also will serve the function of facilitating the training of new professional personnel to satisfy future manpower needs. The capability to design and implement strategies for clinical application of molecular genetic knowledge will be essential for the Centers. However, Center funds will not be available for full-scale clinical trials, and investigators will be encouraged to apply for support of clinical trials by other mechanisms. Due to the breadth of expertise in a variety of disciplines needed for successful application of molecular genetic technologies to genetic diseases, some applications will combine expertise from several institutions. Therefore, applicants are encouraged to propose consortium arrangements with other suitable institutions with needed expertise. Such consortia may include geographic separation, as long as acceptable plans for effective collaboration are proposed. Where possible, applicant institutions are strongly encouraged to develop relationships with traditionally minority institutions and investigators. Areas addressed by the NIDDK Centers of Excellence in Molecular Hematology should relate to announced research emphases of the NIDDK in the area of hematologic research. The program's areas of emphasis include the molecular and cellular biology of hematopoiesis; hematopoietic stem cell biology; erythropoietin and other hematopoietic growth factors; erythrocyte metabolism and ion transport; hematopoietic membrane biology; hemoglobin biosynthesis and regulation; and iron absorption, storage and metabolism. Administrative guidelines are available from the NIDDK that describe the Centers of Excellence in Molecular Hematology (P50) and the application process for the Centers. These guidelines should be requested before applying for a Center of Excellence in Molecular Hematology Grant. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or Principal Investigator may be included with the application. SPECIAL REQUIREMENTS Successful applicants are expected to attend a yearly meeting of Center Directors convened by the NIDDK. Funds to support travel to this meeting may be requested in the budget proposed for the center. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Item 4 (Research Design and Methods) of the Research Plan AND summarized in Item 5, Human Subjects. Applicants/offerors are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations; i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics. The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention [and preventive strategies], diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. 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. If the required information is not contained within the application, the application will be returned without review. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by February 4, 1994, a letter of intent that includes a descriptive title of the proposed research, 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 the RFA in response to which the application may be submitted. 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 is helpful in planning for the review of applications. It allows NIDDK staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 Telephone: (301) 594-7515 FAX: (301) 594-7503 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. The form is available from 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 PHS 398 application form must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and check the YES box. Applications must include the following items: A Table of Contents; A Rationale for the proposed Center and a Statement of Objectives; Institutional Environment and Resources; Organization and Administrative Structure of the Center; Specific Managerial Responsibilities for the Center; Travel funds in the proposed budget for an annual meeting of Center Directors; A description of the method for replacement of the Center Director (should the need arise); A description of the proposed research projects; A description of the proposed cores; A description of the procedure to be used for the addition/deletion of cores and projects during the proposed period of operation; A description of the administrative relationship of the Center to the applicant institution. 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 time of submission, two additional copies of the application must also be sent under separate cover to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 Applications must be received by March 17, 1994. If an application is received after that date, it will be returned to the applicant. REVIEW CONSIDERATIONS Upon receipt, applications will be examined for completeness and responsiveness. Incomplete applications or non-responsive applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the program requirements and criteria stated in the RFA is an NIDDK staff function. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIDDK. If the number of applications is large compared to the number of awards to be made, a preliminary scientific peer review may be conducted and applications withdrawn from further competition when they are not competitive for the award. The NIDDK will notify the applicant and institutional official of this action. Those applications judged to be competitive will be reviewed for scientific and technical merit in accordance with the usual NIH peer review procedures by an initial review group specifically convened for this RFA. Following this review, the applications will be given a secondary review by the NIDDK Advisory Council unless not recommended for further consideration by the initial review group. The review criteria for individual research projects include: o The scientific, technical or medical significance and originality of the proposed research; o The feasibility and adequacy of the experimental design; o The qualifications and research experience of the proposed personnel; o The availability of resources necessary for the research; o The appropriateness of the budget and timetable in relation to the scope of the proposed research; The review criteria for scientific cores include: o The appropriateness and utility of the core to the proposed Center; o Each core unit must provide facilities or services to at least two research projects recommended for approval; o The quality of the proposed facilities or services including administrative arrangements for utilizing the core; o The qualifications, experience, and commitment of the personnel involved in the core; o The appropriateness of the budget. The review criteria for the overall Center program include: o The scientific merit of the program as a whole; o The significance of the overall goals of the Center; o The cohesiveness and multi-disciplinary scope of the Center and the coordination and interrelationship of the projects and cores to the common theme of the Center; o The leadership, scientific expertise, and commitment of the proposed Center Director. Administrative Considerations o The institutional environment for and resources available to Center investigators; o The institutional commitment to the proposed Center; o The administrative leadership necessary to provide for the quality control of supported projects in the Center, the allocation of funds, and the ability to foster communication and cooperation among Center investigators; o The appropriateness of the budget in relation to the proposed activities of the Center; o The adequacy of addressing the protection of human subjects, animal welfare, and biohazard issues. AWARD CRITERIA The anticipated date of award is September 30, 1994. Factors that will be taken into consideration in making awards include the scientific merit of the proposed Center as determined by peer review and the availability of funds and programmatic balance among the topics represented in this RFA. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: David G. Badman, Ph.D. Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 5A-04 Bethesda, MD 20892 Telephone: (301) 594-7541 FAX: (301) 594-7501 Inquiries regarding fiscal matters may be directed to: Aretina D. Perry Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 649 Bethesda, MD 20892 Telephone: (301) 594-7543 Schedule Letter of Intent Receipt Date: February 4, 1994 Application Receipt Date: March 17, 1994 Initial Review: July 1994 Second Level Review: September 1994 Anticipated Date of Award: September 30, 1994 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.849. Awards are made under authorization 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 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. .
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