Full Text AI-94-027 ENHANCEMENT AWARDS FOR UNDERREPRESENTED MINORITY RESEARCHERS IN HIV/AIDS NIH GUIDE, Volume 23, Number 34, September 23, 1994 RFA: AI-94-027 P.T. 34, FF Keywords: AIDS Biomedical Research, Multidiscipl National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: December 23, 1994 Application Receipt Date: February 21, 1995 PURPOSE The goal of this support is to enable underrepresented minority investigators to establish clinical or basic AIDS research programs. To move towards this goal, the National Institute of Allergy and Infectious Disease (NIAID) encourages applications from underrepresented minority investigators for both basic and clinical investigations in AIDS and AIDS-related research. Several features have been employed to achieve these goals. These include the fostering of specific collaborations between more established investigators and the Principal Investigator (PI) to enhance refinement and implementation of each proposed project to maximize the chances for success. Support will also be provided for laboratory staff of the qualified PI, including postdoctoral scientists who will augment the research program established by the grantee. Applications in all basic and clinical areas of HIV/AIDS research are encouraged. 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), Enhancement Awards for Underrepresented Minority Researchers in HIV/AIDS, is related to the priority area of HIV infection. 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 investigators from underrepresented minority groups from domestic, for-profit, not-for-profit and non-profit organizations, private and public institutions such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Foreign institutions are ineligible for awards under this program. For this RFA, "underrepresented minorities" are defined as primarily African Americans, Hispanics, Native Americans, and Pacific Islanders. Institutions must have sufficient research infrastructure and a core of investigators already conducting basic, behavioral, clinical, or epidemiological biomedical research to ensure a nutritive environment for this award. Reviewers will give priority to investigators at those institutions having a graduate program in the medical sciences and a minimum of 10 NIH research grants (P01, R01, R03, R15, R29, R55, U01, U18) and/or a direct plus indirect cost funding level for these awards totalling $3 million. Successful applicants will have earned the Ph.D., D.V.M., D.D.S., M.D., or Pharmacy degree and must demonstrate training and expertise in research commensurate with the requirements of this award. In general, applicants should have successfully completed at least two years of postdoctoral training (or equivalent training for clinicians) in relevant biomedical research at the time of submission of the application. Participants in NIH minority programs, such as the NIH Research Supplements for Minority Investigators Program and Research Centers in Minority Institutions (RCMI) Program with the above qualifications are encouraged to apply, as well as those individuals who have been funded by minority supplements from NIAID (Initiatives for Underrepresented Minorities in Biomedical Research Supplement (IUMBRS)). More senior investigators with relevant experience in fields other than AIDS research (which may include R01-type funding) are also eligible to compete for this award as a vehicle for entry into AIDS research. However, investigators who have previously received funding in AIDS research at the unsolicited R01 or equivalent level are not eligible for this award and should refer to other programs supported by NIAID. NIAID staff listed under INQUIRIES should be consulted for details concerning eligibility requirements. Applications from minority women are especially encouraged. MECHANISM OF SUPPORT The support mechanism for this program is the individual research project grant (R01), under which it is the responsibility of the applicants to plan, direct and execute the proposed projects. This award is not a supplement to ongoing, funded studies. All potential applicants are strongly encouraged to consult with NIAID staff listed under INQUIRIES prior to preparation of the application regarding eligibility requirements and scientific scope. Because the nature and scope of the research proposed as well as the facilities available to the applicant in response to this RFA may vary, it is anticipated that the size of the awards will also vary. This RFA is a one-time solicitation. Following termination of this award, any future unsolicited applications from the awardee will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE The NIAID anticipates awarding four to six R01 awards, for a total (direct and indirect) cost of approximately $1.2 million for the initial year of funding. However, the total number and amount of funding is dependent on the receipt of a sufficient number of applications of high scientific merit and on the availability of funds. RESEARCH OBJECTIVES Background The disproportionate impact of the AIDS epidemic upon minority populations within the United States and Puerto Rico may be viewed from two different perspectives. First, the frequency of occurrence of the disease is increasing at a disproportionately high rate in minorities. Second, certain minorities are significantly underrepresented as investigators in clinical and basic AIDS and AIDS related research. Increasing the participation of underrepresented minority investigators in virtually all fields of biomedical research is a continuing NIH priority. The National Institutes of Health (NIH) currently supports a wide variety of minority programs for biomedical research, encompassing high school through postdoctoral training. These include the Minority Access to Research Careers (MARC) Program, Minority Biomedical Research Support (MBRS) Program, Research Centers in Minority Institutions (RCMI), the NIH Research Supplements for Minority Investigators Program (also called Initiatives for Underrepresented Minorities in Biomedical Research Supplement, (IUMBRS)), the AIDS Planning Grant to the Association of Minority Health Professions Schools (AMHPS), and the Minority Health Initiative (MHI). Although each of these minority programs has demonstrated success in specific areas, recent studies indicate that only a few minority investigators become well established in mainstream research, primarily because of an absence of essential components necessary for a competitive scientific career (see Science, "Minorities in Science", 258:1175-1237, 1992). Key components of a successful career in competitive AIDS research include: 1. Interaction with a critical mass of scientists at all levels, who are involved in biomedical research at the PIs institution and are available for advice and collaboration; 2. Establishment of collaborations with investigators at other institutions who are at the forefront of biomedical research; 3. Securing sufficient release from a heavy teaching load, which could otherwise significantly diminish the time available for research and training of junior colleagues; 4. Accessing a constantly increasing repertoire of current state-of-the-art technology, needed for the proposed investigations. This kind of growth is a career-long process that is enhanced and maintained by the close collaborations listed above. Goals and Objectives The goal of this program is to increase the number of underrepresented minority investigators performing independent competitive HIV/AIDS research and enhance their long-term research potential. Applicants may propose research in any clinical or basic AIDS and AIDS-related research areas including: o Pathogenesis: especially, clinically based, multidisciplinary research of HIV pathogenesis, HIV molecular biology, the study of correlations of host factors with disease course, the influence of cofactors such as cytokines or other infectious agents on disease course. o Epidemiology and natural history: clinical factors associated with disease, natural history of HIV infection and clinical predictors of disease course, behavioral change studies, design of more effective risk-reduction interventions. o Vaccine research and development: studies of the natural immune responses to HIV-related infection, mucosal immunity, genetic variation, mechanisms by which opportunistic pathogens avoid immune surveillance, novel ways of stimulating protective immune responses, development of methods for enrollment and retention of minorities and women in vaccine trials. o Therapeutics research and development: primary infection and opportunistic infections are targets for NIAID-funded research and include discovery and development of better therapeutic strategies and antiretroviral drugs, the emergence and mechanisms of viral resistance to drugs, immune-based strategies, other novel approaches to therapy including gene therapy and development of methods for enrollment and retention of minorities and women in therapeutic trials. o Pediatrics disease: mechanisms of perinatal transmission, prevention of perinatal transmission, and pediatric pathogenesis and therapeutics also encompassing opportunistic infections common to HIV-infected children. Specific research questions of the highest priority can be found in the current NIAID HIV/AIDS Research Agenda. Contact program staff listed under INQUIRIES for additional information. SPECIAL REQUIREMENTS The special requirements are: o The PI be a member of an underrepresented racial minority group. o The PI must establish a collaborative network with at least three established investigators with expertise relevant to the research proposed by the PI. At least two of the established investigators should have expertise in AIDS or AIDS-related research. See below and under Special Instructions for additional details. DAIDS staff may be consulted for assistance in identifying potential collaborators. However, responsibility for identifying and obtaining commitments from collaborators rests solely upon the applicant. The collaborators will have the following responsibilities to the grantee: 1. Assist in the development of the application responding to this RFA; 2. Provide assistance in scientific, technical and managerial areas required for fulfilling the goals of this award throughout its tenure. The PIs institution will have the following responsibilities: 1. To authorize release time. Each applicant is expected to commit at least 75 percent of his/her time and effort. Applicants should include a letter from the responsible institutional official guaranteeing release from all but 25 percent of administrative and teaching responsibilities should the grant be awarded. Failure to implement the agreed amount of release time may result in termination of the award. 2. To provide adequate facilities for the proposed studies. This may be confirmed during a pre-award site visit by DAIDS staff. An annual meeting be held. It is suggested that applicants include a request in the budget for funds to cover attendance of the PI and one collaborator (preferably, the more senior established investigator) at an annual meeting to be held at the NIH or at a site designated by NIAID. This will provide an opportunity to discuss significant research findings, problems, collaborations and overall progress and evolution of the program. 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 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by December 23, 1994, a letter of intent that includes a descriptive title of the proposed research, the names and affiliation(s) of the principal investigator and other key personnel, including members of the collaborative network and the number and title of this RFA. While the letter of intent is not required, is not binding, and does not enter into subsequent peer review deliberation, it provides NIAID staff with information on the number and scope of applications to be expected, allows estimation of the potential review workload, and avoids conflict of interest in the review. The letter of intent is to be sent to Dr. Dianne Tingley at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev.9/91), the standard application form for research grants. Application kits are available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants (DRG), National Institutes of Health, Westwood Building, Room 449, Bethesda, Maryland 20892, telephone (301) 710-0267. Applications must adhere to the format and requirements specified in the PHS application kit. The official deadline for receipt of applications in response to this RFA is February 21, 1995. Applications that do not address the objectives of this RFA will be considered nonresponsive and applicants will be contacted, as described under REVIEW CONSIDERATIONS. Therefore, applicants are strongly encouraged to discuss their research plans with DAIDS program staff before preparing their applications. The RFA label available in the PHS 398 application kit must be affixed to the bottom of the face page of the application. To assure the identification of your application with this RFA, the "YES" box must be marked in item 2a of the face page of the application and the RFA number (RFA AI-94-027) and title "Enhancement Awards for Underrepresented Minority Researchers in HIV/AIDS" entered in the provided spaces in item 2. Submit, in one package, a signed typewritten original of the application including the Checklist and appendices, and three signed, exact single-sided photocopies of the application, to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission to the Division of Research Grants, also submit two additional exact copies of the application including five sets of appendices and letters of support and curricula vitae directly to Dr. Dianne Tingley at the address listed under INQUIRIES. Applications received after the receipt date will not be eligible for this award. DRG will not accept an application in response to this RFA that is essentially the same as one pending initial review, unless the applicant withdraws the pending application. DRG will not accept an application that is essentially the same as one already reviewed. This does not preclude the submission of a revision of an application already reviewed. Any revised application, however, must include an introduction addressing the previous critique. Special Instructions The following information is provided in addition to the instructions found in the PHS 398 form. Collaborative Network It is required that the PI establish an external committee consisting of at least three established scientists who will form a collaborative network, each scientist with expertise relevant to the proposed study. It is strongly recommended that one of the scientists be a more senior individual who has been involved in AIDS research for five to ten years, is a recognized leader in the field, has authored or co-authored peer-reviewed papers in AIDS or AIDS-related research, and is the leader of a substantial scientific program. The other two investigators (at least one of whom should be involved in AIDS or AIDS-related research) should be established scientists who are still very active in the laboratory, field, or community, who have published at least three substantial, peer-reviewed papers in their area of expertise, and are experienced in the area of technical or theoretical aspects of the proposed studies. It is important that the applicant include letters from the collaborators indicating their intent and availability to serve in this capacity. Collaborators should provide their curriculum vitae to be submitted with the application in response to the RFA to indicate the relevance of their area of expertise. Letters must be submitted with the original application and the entire package submitted by the submission deadline. DAIDS staff may be consulted for assistance in identifying potential committee members. However, responsibility for identifying and obtaining commitments from collaborators rests solely upon the applicant. The collaborators will have the following responsibilities to the grantee: 1. Assist in the development of the application responding to this RFA; 2. Provide advice and assistance, as needed, in experimental design, technical aspects of work and all areas of scientific and/or administrative concern required for fulfilling the goals of this award; 3. Visit the institution of the PI, as needed. It is anticipated that several trips by collaborators to the institution of the PI may be necessary, especially in the first year of the award. Collaborators will be reimbursed for limited travel to the laboratory of the PI and can be paid as consultants or through consortium/ contractual arrangements. One of the members of the collaborative network per award will be reimbursed for travel to the annual meeting of the program and this trip should be specifically included in the budget request. Travel and per diem fund requests for collaborators may not exceed $4000 per year. 4. Permit usage of equipment and facilities by the PI at the collaborator's institution, as appropriate. The cost of reagents and materials including animals used by the PI to perform critical experiments (as part of this proposal) that must be performed in the laboratory of a collaborator may also be requested. PIs can apply for travel to/from the collaborators' laboratories. Per diem expenses for performance of critical experiments at collaborating institutions by PIs may also be requested, when appropriate. Other responsibilities of the PI and the PI's institution: 1. Requests for support of one graduate student to begin year two through four is permitted as appropriate. 2. Requests for support of postdoctoral fellows are permitted as appropriate. If requested in later years, they will be supported with program and collaborators' approval. 3. The effort of the PI on this grant must be at least 75 percent. 4. A letter of commitment from the PI's institution confirming the release of 75 percent of the PI's time must be submitted with the application. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NIAID. Incomplete applications will be returned to the applicant without further consideration. If NIAID staff find that the application is not responsive to the RFA, it will be returned without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAID in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. Review Criteria The submitted applications will be assessed by the following review criteria. o The significance and novelty of the proposed studies and their relevance to the AIDS epidemic should be clearly demonstrated. o The relative potential of the applicant to take maximum advantage of the unique features of this award and to achieve the goals described above is a critical factor in evaluation of the proposed research program. The applicant must have completed at least two years of postdoctoral research, must be able to interact effectively with administrators, colleagues, collaborators, subordinates and NIH staff, and must be capable of establishing and directing an independent research laboratory (see ELIGIBILITY REQUIREMENTS). o The scientific and technical merit of the proposed research, including choice of appropriately sensitive and reproducible assay systems, and/or culturally appropriate approaches to clinical studies, will be carefully evaluated. o The suitability and feasibility of the proposed experimental strategies for achieving the goals as outlined in the application. o The availability at the institution of appropriate equipment and space needed to perform the studies. o The presence of a critical mass of scientists at the institution funded by a minimum of 10 NIH research grants (P01, R01, R03, R15, R29, R55, U01, U18) and/or a direct plus indirect cost funding level for these awards totalling $3 M. o It should be documented that a minimum of three collaborators to form an external committee or collaborative network have been identified and are truly committed to facilitating the success of this award. The appropriateness and usefulness of the collaborators' scientific and technical expertise should be demonstrated. o The budget and time frame should be appropriate for all research proposed; AWARD CRITERIA The final number and specific amounts of awards to be made will depend upon the consideration of the following and upon the availability of funds: o Results of the initial scientific and technical merit review and pre-award site visit (if applicable); o Potential contribution of the proposed research to the goals and objectives of the RFA; o Program balance; o Diversity of applicants and scientific approaches; o In making awards, preference may be given to proposed projects that will impact upon the disease in minority populations disproportionately affected by the epidemic in the United States. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Janet M. Young Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2C36 6003 Executive Boulevard Bethesda, MD 20892-7620 Telephone: (301) 402-0755 FAX: (301) 480-5703 INTERNET: enhance@nih.gov Direct letters of intent and inquiries regarding the scientific review process to: Dr. Dianne Tingley Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C07 6003 Executive Boulevard Bethesda, MD 20892-7610 Telephone: (301) 496-0818 FAX: (301) 402-2638 INTERNET: dianne_tingley@nih.gov Direct inquiries regarding fiscal matters to: Ms. Carol Alderson Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B27 6003 Executive Boulevard Bethesda, MD 20892-7610 Telephone: (301) 496-7075; FAX: (301) 480-3780 INTERNET: carol_alderson@nih.gov Schedule Technical Meeting for Applicants: September 28, 1994 Letter of Intent Receipt Date: December 23, 1994 Application Receipt Date: February 21, 1995 Scientific Review Date: June 1995 Advisory Council Date: September 1995 Anticipated Award Date: September 1995 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, 93.856 -Microbiology and Infectious Diseases Research and 93.855 - Immunology, Allergic and Immunological Diseases Research. Grants are awarded under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under the PHS grant policies and Federal Regulations, most specifically at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of the Executive Order 12372 or Health Systems Agency Review. The Public Health Service 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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