RFA-AI-00-011: TREATMENT OF HIV AND ASSOCIATED COMPLICATIONS IN HEMOPHILIACS

Department of Health
and Human Services (HHS)

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TREATMENT OF HIV AND ASSOCIATED COMPLICATIONS IN HEMOPHILIACS Release Date: April 4, 2000 RFA: AI-00-011 National Institute of Allergy and Infectious Diseases http://www.niaid.nih.gov/ National Heart, Lung, and Blood Institute http://www.nhlbi.nih.gov/ National Institute of Child Health and Human Development http://www.nichd.nih.gov/ Letter of Intent Receipt Date: May 26, 2000 Application Receipt Date: June 27, 2000 THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. PURPOSE This initiative will provide funding for investigator-initiated research focusing on the unique effects of HIV and its complications on the hemophilic population. It seeks to support clinical research applications to test and improve pathogenesis or therapeutic concepts. The need for this solicitation is based upon the outcomes of a workshop designed to identify research areas targeting the clinical issues unique to the HIV-infected hemophilic population. Research areas include: short and long-term outcomes of antiretroviral therapy, protective resistance to HIV-infection, non-progression to AIDS, and co-infection with Hepatitis C. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Treatment of HIV and Associated Complications in Hemophiliacs, is related to Priority Area #18: HIV Infection Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. 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 and local governments, and eligible agencies of the Federal government. Foreign institutions are ineligible. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed four years. At this time, it is not known if this RFA will be reissued. The anticipated award date is March 1, 2001. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at <http://grants.nih.gov/grants/funding/modular/modular.htm> FUNDS AVAILABLE The National Institute of Allergy and Infectious Diseases (NIAID) the National Heart, Lung, and Blood Institute (NHLBI), and the National Institute of Child Health and Human Development (NICHD) intend to commit approximately $3 million in FY 2001 to fund three to twelve new grants in response to this RFA. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of the NIAID, NHLBI, and NICHD provide support for this solicitation, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of applications of outstanding scientific and technical merit. At this time, it is not known if this RFA will be reissued. RESEARCH OBJECTIVES Background Research on the HIV-infected hemophilic population was initiated more than 10 years ago. An RFP issued in FY 1988 resulted in an award to establish and maintain a system for recruiting HIV-infected hemophiliacs and their partners into AIDS Clinical Trials Group (ACTG) studies. This contract was renewed in FY 1993, however during the latter years of this contract, as treatments became more widely available, enrollment of this special population into ACTG studies decreased progressively, making it impractical to renew the contract. Although the treatment and management of HIV in hemophiliacs broadly follows established standards of care, it has been recognized that HIV and its associated complications have unique effects on hemophiliacs that requires the joint endeavors of specialists in many disciplines, namely infectious disease, hepatology, immunology, hematology, and epidemiology. The Division of AIDS (DAIDS), NIAID, NIH convened a workshop, Strategies for Treatment of HIV & Associated Complications in the Hemophilia Population , on October 1, 1999 to assess the status of NIH- funded research relating to the treatment of HIV and associated complications in hemophiliacs. Workshop participants defined a number of key issues requiring further study that are the basis for the objectives of this new RFA. Through this solicitation, research in the HIV-infected hemophilic population will now focus specifically on the defined scientific needs within this special disease population. Scope and Objectives This initiative is intended to encourage innovative approaches to address aspects of pathogenesis, treatment, and management of HIV infection and its complications that are unique to the HIV-infected hemophilic population. This initiative is not intended to support the establishment of cohorts of HIV-infected hemophiliacs, but to facilitate collaborative research with on-going cohorts. Investigators with access to existing cohorts and large repositories of biologic samples from the relevant populations and appropriate controls are particularly encouraged to apply. This initiative will support research to: (1) Delineate short and long-term outcomes of antiretroviral therapy, e.g., benefits, and adverse effects of HIV therapy (2) Investigate mechanisms defining resistance to HIV infection in HIV- negative individuals exposed multiple times to potentially contaminated blood products (3) Investigate mechanisms responsible for delayed or non-progression of HIV disease, e.g. genetic, immunologic, and virologic factors (4) Evaluate the impact of Hepatitis C Virus (HCV) infection on HIV infection, and the impact of HIV infection on HCV infection by investigating the relationships between such factors as HCV viral load, HCV-induced liver disease, HCV genotype and quasi-species, HCV treatment and response to therapy, HCV host and immune factors, and, HIV viral load, HIV treatment and response to therapy, HIV disease status and progression (5) Evaluate effects of HIV, HIV therapies, and HIV complications on hemostasis 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 policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," that was published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994, available on the web at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the Inclusion of Children as Participants in Research Involving Human Subjects that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, telephone number, and e-mail address 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 a subsequent application, the information that it contains allows NIAID staff to estimate the potential review workload and to avoid conflicts of interest in the review. The letter of intent is to be sent to Dr. Peter Jackson listed under INQUIRIES by the Letter of Intent Receipt Date listed in the heading of this RFA. SPECIFIC APPLICATION PROCEDURES FOR MODULAR GRANTS The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. Budget Instructions Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD: Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT: Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION: Prepare a Modular Grant Budget Narrative page. (See <http://grants.nih.gov/grants/funding/modular/modular.htm> for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. o Under Personnel: List key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. o For Consortium/Contractual costs: Provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH: The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: <http://grants.nih.gov/grants/funding/modular/modular.htm> - Complete the educational block at the top of the form page. - List position(s) and any honors. - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. - List selected peer-reviewed publications, with full citations. o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. TRADITIONAL PHS 398 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: GrantsInfo@nih.gov. In addition, the PHS 398 form and instructions can be found on the Internet at http://grants.nih.gov/grants/funding/phs398/phs398.html. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. 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 2 of the face page of the application form and the YES box must be marked. The sample RFA label is available at the following URL: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Please note that this is in a pdf format. Submit a signed, typewritten original of the application, including the Checklist and three signed photocopies, in one package to: Center For Scientific Review National Institutes Of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to Dr. Peter Jackson listed under INQUIRES. Applications must be received by the Application Receipt Date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) 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. The CSR 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 already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the CSR for completeness and by the NIAID for responsiveness. Incomplete and/or non-responsive applications will be returned to the applicant 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 will be used by the initial review group in which applications receive a written critique and undergo an evaluation in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the Advisory Council or Board of one of the co-sponsoring Institutes. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of the criteria listed below will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project(s) proposed in the application Additional scientific/technical merit criteria specific to the objectives of the RFA and the award mechanism must be included if they are to be used in the review. SCHEDULE: Letter of Intent Receipt Date: May 26, 2000 Application Receipt Date: June 27, 2000 Peer Review Date: October 15, 2000 Council Review: November, 2000 Earliest Anticipated Start Date: November 27, 2000 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities 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: Margaret Matula, R.N., M.G.A. Division of AIDS National Institute of Allergy and Infectious Diseases 6700-B Rockledge Drive, Room 5157, MSC 7624 Bethesda, MD 20892-7624 Bethesda, MD 20817 (for express/courier service) Telephone: (301) 402-2302 FAX: (301) 480-4582 Email: mm154j@nih.gov Rebecca P. Link, Ph.D. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 10178, MSC 7950 Bethesda, MD 20892-7950 Bethesda, MD 20817 (for express/courier service) Telephone: (301) 435-0070 FAX: (301) 480-1046 Email: linkr@nhlbi.nih.gov Anne Willoughby, M.D., M.P.H. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Blvd, Suite 4B11J Rockville, MD 20852 Telephone: (301) 402-0699 FAX: (301) 496-8678 Email: aw55g@nih.gov Direct inquires regarding review matters to: Dr. Peter Jackson Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6700-B Rockledge Drive, Room 2154, MSC 7616 Bethesda, MD 20892-7616 Bethesda, MD 20817 (for express/courier service) Telephone: (301) 496-8426 FAX: (301) 402-2638 Email: pj8v@nih.gov Direct inquiries regarding fiscal matters to: Jane Unsworth Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6700-B Rockledge Drive, Room 2128, MSC 7614 Bethesda, MD 20892-7614 Bethesda, MD 20817 (for express/courier service) Telephone: (301) 402-6824 FAX: (301) 480-3780 Email: junsworth@niaid.nih.gov AUTHORITY AND REGULATIONS This program is supported under authorization of the Public Health Service Act, Sec. 301 (c) and 405 (42 USC 241 and 284). The Catalogue of Federal Domestic Assistance Citations are Sec. 93.856, Microbiology and Infectious Diseases Research, and No. 93.855 - Immunology, Allergy, and Transplantation Research. Awards will be administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74 and 94. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems review. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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