Full Text DK-94-009 RESEARCH ON HIV INFECTION IN THE GENITOURINARY TRACT NIH GUIDE, Volume 23, Number 1, January 7, 1994 RFA: DK-94-009 P.T. 34 Keywords: AIDS Urogenital System Biology, Cellular Biology, Molecular Medical/Diagnostic Imaging National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Child Health and Human Development Letter of Intent Receipt Date: March 9, 1994 Application Receipt Date: April 20, 1994 PURPOSE The Division of Kidney, Urologic, and Hematologic Diseases of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Center for Population Research of the National Institute of Child Health and Human Development (NICHD) solicit regular research (R01) and First Independent Research Support and Transition (R29) grant applications for support of studies focused on infections of the Human Immunodeficiency Viruses (HIV) and the effects of such infections on the genitourinary tract. HEALTHY PEOPLE 2000 The 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, Research on HIV Infections in the Genitourinary Tract, is related to the priority area of HIV infections. 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 or nonprofit organizations, whether public or private, such as universities, colleges, hospitals, laboratories, units of State or 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 NIH grant-in-aid research project grant (R01) and FIRST (R29) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under Public Health Service (PHS) grants policy as stated in the PHS Grants Policy Statement and in this announcement. 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 total requested project period for applications submitted in response to this RFA may not exceed 5 years. The earliest possible award date will be September 30, 1994. FUNDS AVAILABLE For FY 1994, $500,000 will be committed by the NIDDK and $300,000 by the NICHD to fund applications submitted in response to this RFA. It is anticipated that 3 new awards will be made by the NIDDK and an additional 2 new awards by the NICHD; however, this funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. Applicants must limit their requests to not more than $160,000 direct costs for the initial budget period. Although this program is provided for in the financial plans of the NIDDK and the NICHD, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES The purpose of this announcement is to solicit applications to support cellular and molecular studies that focus on the effects of the HIV infection on the genitourinary tract. Such studies might include for example: tissues/fluid/secretions involving the urine, semen, bladder, urethra, prostate, testes, seminal vesicles, and epididymides. Broad areas for investigation could include the location of the HIV in such tissues and the effect(s) of the HIV infection on the cellular structure/function of these tissues. It is also of interest to study the effectiveness of pharmacological therapy on eradicating HIV infection in these tissues and to study the pathogenesis and treatment of urological disorders secondary to HIV infection. Studies that focus on the effect(s) of HIV infections on the physiology of the genitourinary tract as monitored by established clinical methodologies such as urodynamics, radiographic, and sonographic technologies are encouraged. The various factors that influence the genitourinary manifestations of HIV infections need to be elucidated as well as the effects on the function(s) of the genitourinary tract as a result of the various treatment modalities for HIV. Applications for clinical studies in urodynamics and urinary tract infections that have no relationship to HIV infection are not requested. Program project grant applications (P01) are not suited to this announcement. SPECIAL REQUIREMENTS Applicants who receive an award through this announcement are expected to attend a yearly meeting (convened by the NIDDK and the NICHD) of investigators to discuss progress and exchange research information. Funds to support the travel to these meetings may be included in the proposed budget. STUDY POPULATIONS It is NIH policy that women and minorities must be included in clinical study populations unless there is a good reason to exclude them. The study design must seek to identify any pertinent gender or minority population differences. 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 go 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 is 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. 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 March 9, 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 is being 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 FAX: (301) 594-7503 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) must be used in applying for these grants. The form is available from most institutional offices of sponsored research or from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892. For developing programs that deal with clinical populations, applicants may wish to consider utilization of General Clinical Research Center (GCRC) facilities. More information on the GCRC program is available from Dr. Bernard Talbot at the National Center for Research Resources, telephone: (301) 594-7945. The RFA label available in the 9/91 revision of 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 your 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 5333 Westbard Avenue Bethesda, MD 20892 At time of submission, two additional copies of the application should 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 April 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 announcement 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 or R29 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. FIRST Award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. REVIEW CONSIDERATIONS Upon receipt, applications will be initially reviewed by 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 and NICHD staff function. If the application is not responsive to the RFA, the staff will contact the applicant to determine whether it should be returned to the applicant, or whether it should be held until the next regular receipt date and reviewed in competition with all other applications. 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. Applications may be triaged by an NIDDK peer review group if the number of applications is large compared to the number of awards to be made. Applications may be withdrawn from further competition if they are judged to be non-competitive. The NIDDK and the NICHD staff 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 or NICHD Advisory Council unless not recommended for further consideration by the initial review group. Review criteria for RFAs are generally the same as those for unsolicited research grant applications. o scientific/technical merit criteria specific to the objectives of the RFA; o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly but not exclusively in the area of the proposed research; o availability of resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; and o if an application involves activities that could have an adverse effect upon humans, animals, or the environment, the adequacy of the proposed means for protecting against or minimizing such effects. AWARD CRITERIA Funding decisions will be made based on the initial review group and national advisory council recommendations, program relevance and balance, and availability of funds. The anticipated date of award is September 30, 1994. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. Direct inquiries regarding programmatic issues to: Ralph L. Bain, Ph.D. Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Suite 3A-05 Bethesda, MD 20892 Telephone: (301) 594-7556 Donna Vogel, M.D., Ph.D. Reproductive Medicine Unit National Institute of Child Health and Human Development 6100 Building, Room 8B01 Bethesda, MD 20892 Telephone: (301) 496-6515 Inquiries regarding fiscal matters should 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 Ms. Melinda Nelson Office of Grants and Contracts National Institute of Child Health and Human Development 6100 Building, Room 8A17 Bethesda, MD 20892 Telephone: (301) 496-5481 Schedule: Letter of Intent: March 9, 1994 Application Receipt: April 20, 1994 Initial Review: July 1994 Second Level Review: September 20-21, 1994 Anticipated Award: September 30, 1994 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.849 (NIDDK) and 93.864 (NICHD). Awards are 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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