Full Text DK-94-016 RESEARCH USING THE UNITED STATES RENAL DATA SYSTEM NIH GUIDE, Volume 23, Number 6, February 11, 1994 RFA: DK-94-016 P.T. Keywords: National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: April 20, 1994 Application Receipt Date: May 20, 1994 PURPOSE The purpose of this initiative is to invite grant applications for biomedical research questions that can be answered using the United States Renal Data System (USRDS) database. Awarded funds will be used to generate a tailored data file through the USRDS Coordinating Center, and to support the independent analysis of the data file by the investigator. 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), Research Using the United States Renal Data System, is related to the priority area of diabetes and 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 and foreign organizations, both public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Minority individuals and women are encouraged to submit as Principal Investigators. MECHANISM OF SUPPORT Support of this program will be through the investigator initiated research project grant (R01) mechanism. Each grant award will be capped at $100,000 total cost (including direct and indirect cost) per year for a maximum of two years. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement. This RFA is a one-time solicitation. Generally, future unsolicited competing continuation applications will compete with all investigator- initiated applications and be reviewed according to the customary peer review procedures. The earliest possible award date will be April 1, 1995. FUNDS AVAILABLE It is anticipated that approximately five awards will be made; however, this funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the award of grants pursuant to this RFA is also contingent upon the availability of funds designated for this purpose. A total of $500,000 dollars have been set aside for this RFA in FY 1995. RESEARCH OBJECTIVES The number of patients being treated for End-stage renal disease (ESRD) in the United States has increased steadily since 1977. The total number of U.S. patients with treated ESRD was over 210,000 in 1990. End-stage renal disease treatment is costly. The 1990 estimated federal Medicare payments for ESRD patients averaged $36,600 per patient. The estimated total 1990 direct medical payments for ESRD by public and private payers was $7.26 billion. ESRD is a very serious condition, with high hospitalization rates and death rates. Thus, research to decrease the morbidity and mortality due to ESRD is urgently needed. The USRDS is a database with information on treated end stage renal disease patients and their treatment facilities in the United States. It is designed to serve as a resource to the academic and clinical medicine communities. The database contains information on approximately 462,000 Medicare patients who have had ESRD therapy at any time since 1976, including basic demographics, the primary medical diagnosis that led to renal failure, dialysis records, hospital records, and transplant information. For patients included in any of the USRDS special data collection studies, the specially collected information can be linked with their master file. In addition to patient-specific information, the database contains details on the 2,646 institutions that provide ESRD treatment services. Limited information is also available on non-Medicare funded ESRD patients who are being treated by the Department of Veterans Affairs. The USRDS database is supplemented by data from the U.S. Census Bureau. All release of data will be in compliance with the U.S. Privacy Act of 1974, and other relevant legislation. This information on patients may be supplied in encrypted form, so that identification of individuals is precluded. In addition, investigators seeking to use the data must supply written assurances that they will not use the data to attempt to identify individuals. Since 1989, the USRDS Coordinating Center has produced an annual data report which contains descriptive and analytic epidemiologic data on ESRD patients. The USRDS database has been very successful in providing data on several important issues in the biomedical research and clinical nephrology community. However, there are many other important questions that could be posed, and there is a multitude of data that can be analyzed. The purpose of this RFA is to solicit applications from investigators to pose and answer important biomedical and health research questions relevant to ESRD in the United States. Specific questions that would be considered responsive to this RFA include, but are not limited to, the following examples: o the relative incidence, prevalence, mortality, morbidity, and survival associated with various co-morbid conditions, causes of ESRD, modes of ESRD treatment, or subgroups of the treated ESRD population in the United States; o examination of the relative burden of disease in various minority groups; o ecologic analyses that relate prevalence of predisposing diseases to incidence and prevalence of treated and untreated ESRD in various subgroups of the population. o Analyses combining a biomedical research question and a health services research question. Creativity in using the data to develop descriptive, analytic, and hypothesis generating studies is encouraged. Applications proposing to investigate issues with a large impact on the health, well being, morbidity and mortality of treated ESRD patients will be considered responsive to this RFA. Investigators are urged to become familiar with the structure and data elements currently contained in the USRDS database, including data elements from relevant special studies. This information (including data dictionary, structure of the database, special studies data collection instruments) can be obtained from the Director, Epidemiology Program, Division of Kidney, Urologic and Hematologic Diseases, NIDDK, (301) 594-7586 (see INQUIRIES Section below). In addition, copies of the USRDS Annual Data Reports may be useful. The United States Renal Data System Annual Data Reports may usually be found in dialysis units, nephrology department libraries, and medical libraries; a copy of the 1993 Annual Data Report can be ordered through the National Technical Information Service (703) 487-4600, order number PB 93 202 786, for $77. The USRDS data release policy includes the following provisions: The sole purpose of providing the data is the conduct of legitimate biomedical and health services research by the Principal Investigator (PI). The investigator will not use the data to identify individual persons or institutions represented on the file. The investigator will not combine or link the data provided with any other collection or source of information that may contain information specific to individuals on the file, unless specific, written authorization has been obtained through the approval process. The investigator will not use the data for purposes that are not related to biomedical or health services research. The investigator will not publish or otherwise disclose the data in the file to any person unless the data have been aggregated (that is, combined into groupings of data such that the data are no longer specific to any individual within each grouping) and no cells (aggregates of data) contain information on fewer than 10 individuals. A copy of any aggregation of data intended for publication will be submitted to the USRDS Project Officer for review prior to publication; if the publication is not in conformity with the Privacy Act, it will not be published until revised to adhere to the Privacy Act provisions. Appropriate administrative, technical, procedural, and physical safeguards shall be established by the investigator to protect the confidentiality of the data and to prevent unauthorized access to it. The safeguards will provide a level of security outlined in OMB Circular No. A-130, Appendix III-- "Security of Federal Automated Information Systems," which sets forth guidelines for security plans for automated information systems in Federal agencies. The investigator is encouraged to contact Dr. Camille Jones (301-594-7586) or the USRDS Project Officer, Dr. Lawrence Agodoa (301-594-7553) to discuss the data request and to request a copy of the USRDS Data Release Policy and the USRDS Agreement for Data Release Form. Both may be reached via mail at the following address: KUH/NIDDK, Westwood Building, Room 3A-06, 5333 Westbard Avenue, Bethesda, MD 20892. The USRDS database Coordinating Center may also be contacted for information about the database (313-998-6610). The official request to the USRDS for USRDS data can be submitted at any time and must be done separately from submitting an application to the NIH in response to this RFA. If the only way that the investigator will be able to do the analysis is with funding from this RFA, the investigator should submit the request for USRDS data after the application has been approved. The USRDS process of reviewing a written request for data and generating and releasing the data takes approximately three months. 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 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. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. 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 April 20, 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. The letter of intent is to be sent to the Chief, Review Branch, Division of Extramural Activities at the address listed under INQUIRIES. 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. 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. 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 May 20, 1994. If an application is received after that date, it will be returned to the applicant. The Division of Research Grants (DRG) 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, it is allowable to submit the same project as both an R01 and as a component project of a program project. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications previously reviewed. Such applications must not only include an introduction addressing the previous critique but also be responsive to this RFA. REVIEW CONSIDERATIONS Upon receipt, applications will be initially reviewed by the DRG for completeness. Incomplete 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. If the application is not responsive to the RFA, NIDDK staff will return it to the applicant. 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 review if 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 further 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 may be given a second level review by the NIDDK Advisory Council unless not recommended for further consideration by the initial review group. Review criteria for this RFA are as follows: o Scientific/medical/public health significance of the proposed research. o Adequate justification and rationale for the project. Knowledge of literature with respect to the topic of interest. o Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research. o Realistic cost estimates for generating and analyzing the data. Appropriateness of the proposed budget and duration in relation to the proposed research. o Availability of resources necessary to perform the proposed research. o Qualifications and experience of the Principal Investigator and staff in epidemiologic research and clinical nephrology. o If the researcher is from a foreign country, the uniqueness of research such that it can only be performed outside of the United States must be demonstrated. AWARD CRITERIA The anticipated date of award is April 1, 1995. Applications will compete for available funds with all other applications recommended by the initial review group. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review. o Availability of funds. o Programmatic balance among the studies recommended for funding. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. Direct inquiries regarding programmatic issues to: Camille A. Jones, M.D., M.P.H. Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A-06 Bethesda, MD 20892 Telephone: (301) 594-7586 FAX: (301) 594-7501 Inquiries regarding fiscal matters may be directed to: Ms. Trude McCain 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: April 20, 1994 Application Receipt Date: May 20, 1994 Initial Review: Fall 1994 Second Level Review: January 1995 Anticipated Date of Award: April 1, 1995 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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