Full Text CA-97-009 AIDS-ONCOLOGY CLINICAL SCIENTIST DEVELOPMENT PROGRAM NIH GUIDE, Volume 26, Number 9, March 21, 1997 RFA: CA-97-009 P.T. 34 Keywords: AIDS Cancer/Carcinogenesis Oncology National Cancer Institute Letter of Intent Receipt Date: April 25, 1997 Application Receipt Date: July 16, 1997 PURPOSE The National Cancer Institute (NCI) invites applications for Clinical Scientist Development Program Awards to support institutional, multidisciplinary, training programs focused on the HIV/AIDS Oncology field. The goal of the program is to train a cadre of clinicians with the highly specialized skills necessary to address the clinical and research problems associated with AIDS-related malignancies. There is an important need for trained AIDS-Oncology specialists to exploit research opportunities, conduct patient-oriented research, and provide the clinical management skills necessary for advancement in this field. 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 Application (RFA), AIDS-Oncology Clinical Scientist Development Program, is related to the priority area of human resource development in cancer research. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-0047-0 or Summary Report: Stock No. 017-001-00473-1) from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Institution: 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. Applicant organizations should have well-established research programs with adequate peer-reviewed grant support and highly qualified faculty in clinical and basic science departments. Minorities and women are encouraged to apply as principal investigators. Clinical Candidates: All candidates for support under this program award must currently be physicians holding the M.D. or D.O. degrees. In addition, they should have completed a minimum of one year of sub- specialty training, for example in Hematology, Gynecology, or Oncology disciplines prior to joining this training program. Appointments of clinical candidates to the program must be for a minimum of two years. The candidate must be willing to devote a minimum of 75 percent of full-time professional effort to the basic/clinical research program. The remaining 25 percent can be divided among other clinical and teaching activities only if they are consonant with the program goals, i.e. the candidate's development into an independent clinical investigator. Candidates appointed under this program award must be U.S. citizens or noncitizen nationals, or have been lawfully admitted for permanent residence and possess an Alien Registration Card (I-151 or I-551) or some other verification of legal admission as a permanent resident. Noncitizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states, but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible. Candidates who are or have been former principal investigators on NIH research projects (R01), FIRST Awards (R29), sub-projects of program project grants (P01) or the equivalent, are not eligible for appointment under this program. MECHANISM OF SUPPORT Support for this program will be through the National Institutes of Health's (NIH) grant-in-aid, the Institutional Clinical Scientist Development Award (K12). Applicants will be responsible for the planning, direction, and execution of the proposed project. Except as otherwise stated in this RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. This RFA is a one-time solicitation. Generally, future competitive continuation applications will compete with all investigator- initiated applications. Should the NCI determine that there is a sufficient continuing program need, a request for competitive continuation and/or new applications will be announced. FUNDS AVAILABLE Total costs of $1,500,000 for the first year, $3,000,000 for years two and three, and $1,500,000 for the fourth and final year will be committed to fund applications which are submitted in response to this RFA. It is anticipated that approximately five awards will be made. This funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. The total project period for applications submitted in response to the present RFA should not exceed four years. The earliest feasible start date for the initial awards will be December 31, 1997. Although this program is provided for in the financial plans of the National Cancer Institute (NCI), the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background: Malignancies have been associated with HIV/AIDS since the beginning of the epidemic in the early 1980s. As the AIDS epidemic continues, additional AIDS-defining malignancies have been identified; larger numbers of HIV-infected individuals have been diagnosed with malignancies as improved anti-retroviral and opportunistic infection management has allowed them to live longer. The AIDS Malignancy Working Group, which includes NCI staff and extramural scientists, identified the need for interdisciplinary training programs to provide the spectrum of clinical and research skills necessary for conducting patient-oriented research in conjunction with appropriate management of patients with HIV/AIDS malignancies. At the present time, there is no specific subspecialty of Medicine in the area of HIV/AIDS, nor are there any formal, nationally recognized training programs integrating the specialized skills in Hematology, Oncology disciplines, and Infectious Diseases needed to address AIDS- related malignancies. The expanding population of patients with HIV/AIDS and malignancies have complex multi-system illnesses, requiring the expertise of physicians with considerable multidisciplinary knowledge. Most investigators pursuing research in the HIV/AIDS field have had sub-specialty training in Infectious Diseases and most Oncology programs have no formal training in AIDS Oncology. It is clear that advances in the field of HIV/AIDS Oncology will require highly specialized expertise and "cross-training" of clinicians. Interdisciplinary training is essential to developing a cadre of experts in clinical and translational research to move the field forward and to contribute to the competent management of HIV- infected individuals with malignancies. Environment: Institutions should have well-established basic and clinical research programs in the areas of oncology, hematology, and infectious diseases. Departmental/Divisional collaborations should be arranged in order to achieve the required multidisciplinary training. The program must include clinical researchers with expertise in AIDS- related malignancies and experience in postdoctoral research training. There should also be sufficient numbers of patients with AIDS and AIDS-related malignancies available to sustain a credible training program. Program: Applicants should provide details of the content and scope for a TWO YEAR interdisciplinary training program for each candidate. The proposed training program must provide didactic, research, and clinical components that will integrate knowledge and skills across disciplines relevant for clinical research and care for AIDS patients with malignancies, for example, Oncology disciplines, Hematology and Infectious Diseases The program should prepare clinicians to handle the clinical complexities of patients with HIV/AIDS and malignancies. Additionally, the program should provide laboratory/translational research training in areas directly involved in AIDS research or in related fields of immunology, virology, or molecular biology. The research component should focus on the skills necessary for translating research results into clinical experiments, procedures, and trials directly involving patients with AIDS/HIV malignancies. For example, it will not be sufficient within the scope of this initiative to use human cells and other clinical materials in an isolated basic laboratory setting as the total research experience. Applicants should clearly address the following issues: 1) arrangements for organizational interactions and collaborations necessary to achieve the objectives of this RFA; 2) the qualifications of the faculty mentors, highlighting their clinical and basic research projects and prior training experience; 3) the availability of appropriate mentors who would have responsibility for the candidate's clinical/research program and day-to-day progress; 4) the availability of sufficient numbers of patients with AIDS and AIDS-related malignancies; 5) procedures to be used to announce the program and to select appropriate candidates, mentors, and projects; and 6) the establishment of an Advisory Committee (see Special Requirement) to provide an oversight function and annual evaluation of the AIDS-Oncology Clinical Scientist Development Program as a whole. Special Requirements: The Principal Investigator must establish an Advisory Committee for this program. The various departments/divisions participating in this program should be represented on the committee. Examples of the Committee's responsibilities might include: selecting physician candidates, assigning preceptors, approving each candidate's clinical research development plan, evaluating each candidate's progress, and monitoring the overall effectiveness of the program. Each candidate should have one or more preceptor(s) who are accomplished investigator/clinicians in their field. The advisor(s) should assume responsibility for devising a career development and clinical research plan with the candidate, obtaining the concurrence of the Advisory Committee, and providing day-to-day advice. Plans for an annual evaluation of the program by the Advisory Committee should be described. The Annual Progress Report for the grant should provide a summary of this evaluation and include a description of the clinical research and career progress of each candidate describing how laboratory and clinical research and practice are being integrated. These Annual Reports will be closely monitored by NCI staff to ensure that the grant is achieving the goals of the RFA and for a final evaluation to determine the success and need for a continuation of the program beyond the initial four year period. ALLOWABLE COSTS In order to provide sufficient diversity and distribution of programs, direct costs for the (01) year should not exceed $300,000, and any increases in future year positions should be incremented gradually with appropriate justification. The budget should take into consideration that each candidate should receive a minimum of two years of training. Peer review will assess the quality of resources available to support the type of program proposed and the number of training positions requested within the above limitations. Salary: Clinical research candidates will be provided salary support of up to $50,000 each year, plus applicable fringe benefits commensurate with the applicant institution's salary structure for persons of equivalent qualifications, experience, and rank. The institution may supplement the NCI contribution; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary may not require extra duties or responsibilities that would interfere with the purpose of this award. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution salary scale. The total salary requested must be based on a full-time 12 month staff appointment. Other Expenses: $20,000 per candidate will be provided annually to partially support supplies, equipment, travel, tuition, and other costs which are essential for the individual's clinical research development program. Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance , etc. is not allowed. Indirect Costs: Indirect costs will be provided at a rate not exceeding eight percent of total direct costs of each award, exclusive of tuition, fees, and expenditures for equipment. 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 are 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," which have been 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. LETTER OF INTENT Prospective applicants are asked to submit, by April 25, 1997, a letter of intent that includes a descriptive title of the proposed program, the name, address, telephone and FAX numbers, and E-mail address of the Principal Investigator, the names of other key personnel, the 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 allows NCI staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Dr. Vincent J. Cairoli Division of Cancer Treatment, Diagnosis, and Centers National Cancer Institute Executive Plaza North, Room 520 Bethesda, MD 20892-7390 Telephone: (301) 496-8580 FAX: (301) 402-4472 Email: VC14Z@NIH.GOV APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained 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: ASKNIH@odrockm1.od.nih.gov; and from the program administrator listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 5/95) 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. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies in one package to: DIVISION OF RESEARCH GRANTS 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: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard Bethesda, MD 20892-7405 Rockville, MD 20852 (express/courier service) Applications must be received by July 16, 1997. If an application is received after that date, it will be returned to the applicant without review. 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. The DRG will not accept any application that is essentially the same as one already reviewed. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NCI. Incomplete or unresponsive applications will be returned without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit in accordance with the review criteria stated below by an appropriate peer review group convened by the NCI. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. All applications will receive a second level of review by the National Cancer Advisory Board. REVIEW CRITERIA Review criteria will include: o Scientific and administrative leadership qualifications and experience of the Principal Investigator. o Qualifications of faculty mentors: adequacy of peer-reviewed clinical and basic cancer research projects, publications and training experience in the context of achieving the objectives of this RFA. o Recruitment and selection plans for appointees and the availability of high quality candidates. o Appropriateness of detailed plans for a comprehensive program to provide physician appointees with the proper integration of knowledge and skills in oncology and infectious diseases necessary for clinical research and care of patients with AIDS-related malignancies. o Appropriateness of an environment to promote collaborations among clinicians and research scientists as well as departmental/division programs. o Adequacy of facilities and other resources. o Availability of sufficient AIDS and AIDS-related malignancy patient populations and clinical materials to support appropriate clinical research experiences. o Adequacy of the membership and functions of the program Advisory Committee. o Effective plans for program oversight and evaluation to be reported in the Annual Progress Report. o Adequacy of the proposed means for protecting human subjects and vertebrate animals against hazardous or unethical research procedures and for protecting the privacy of human subjects. Budget The review group will critically examine the proposed budget and recommend an appropriate budget for each approved application within the guidelines stated above. AWARD CRITERIA Applications will compete for available funds with all other scored applications submitted in response to this RFA. The following will be considered in making decisions: quality of the proposed project as determined by peer review, availability of funds and program priority. The NCI will notify the applicant of the National Cancer Advisory Board's (NCAB) action. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding Career/Training issues to: Dr. Vincent J. Cairoli Division of Cancer Treatment, Diagnosis, and Centers National Cancer Institute Executive Plaza North, Room 520 Bethesda, MD 20892-7390 Telephone: (301) 496-8580 FAX: (301) 402-4472 Email: VC14Z@NIH.GOV Direct inquiries regarding Clinical issues to: Ellen Feigal, M.D. Division of Cancer Treatment, Diagnosis, and Centers National Cancer Institute Executive Plaza North, Room 741 Bethesda, MD 20892 Telephone: (301) 496-2522 FAX: (301) 402-0557 Email: FEIGALE@CTEP.NCI.NIH.GOV Direct inquiries regarding Fiscal/Administrative matters to: Ms. Kelli Oster Office of Administrative Management National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800, ext 261 FAX: (301) 496-8601 Email: OSTERK@GAB.NCI.NIH.GOV AUTHORITY AND REGULATION This program is described in the Catalog of Federal Domestic Assistance Number 93.398, Cancer Research Manpower. Awards are made under the 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 grant policies and Federal Regulations 42 CFR Part 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. The Public Health Service strongly encourages all grant and contract 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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