CLINICAL INVESTIGATOR AWARD FOR RESEARCH ON SPECIAL POPULATIONS NIH GUIDE, Volume 21, Number 6, February 14, 1992 PA NUMBER: PA-92-41 P.T. 34 Keywords: Cancer/Carcinogenesis Diagnosis, Medical Disease Prevention+ Treatment, Medical+ National Cancer Institute Application Receipt Dates: June 1, 1992, October 1, 1992, February 1, 1993 PURPOSE The Comprehensive Minority Biomedical Research Program, Division of Extramural Activities, National Cancer Institute (NCI), announces the availability of Clinical Investigator Awards for Research on Special Populations. The term "special populations" refers to those population segments that may experience or are known to experience high cancer rates and are underserved in terms of: cancer prevention and control programs (e.g., smoking cessation and health screening programs); diagnostic and treatment modalities; study for special risk factors or underlying biological differences; and access to routine medical care. The definition of special populations includes: African Americans, Alaska Natives, American Indians, Asian Americans, Pacific Islanders, Hispanics, the elderly, and low-income groups. The award will enable candidates to undertake three to five years of special study and supervised research experience tailored to individual needs with a sponsor (or sponsors) who is competent to provide research guidance. This award is intended to cover the transition between postdoctoral research experience and an independent research career and to acquaint the candidate with the often unique challenges and circumstances involved in designing research protocols directed toward improving the health of groups comprising a significant and often disproportional percentage of individuals at risk from high cancer morbidity and mortality rates. It is anticipated that the experience and results achieved by the awardee from this special grants program, in the majority of cases, will provide the basis for successful competition in the independent research support programs of the NCI. 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 Program Announcement (PA), Clinical Investigator Award for Research on Special Populations, is related to the priority area of cancer research. 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 The award is designed to provide intensive, supervised research experience on the above designated topics. Although the award is primarily for individuals with an M.D. degree, applications will be accepted from M.D.s and D.O.s who have a Ph.D. or an equivalent research degree if special circumstances can be shown such as a Ph.D. in an unrelated field or an intervening period of clinical training since the completion of the Ph.D. These applications will be considered on a case-by-case basis. If the candidate has less than three or more than seven years of postdoctoral experience at the time of application, a strong justification for an exception must be included in the application and must be clearly indicated as such. Candidates must have completed their clinical training by the time of award, have documented competence in clinical activities, and have research experience in the chosen area of interest. Candidates must provide evidence of a serious intent for research and academic careers and an interest in medical issues associated with special populations. Candidates from minority and non-minority institutions may apply. Applicants for this Clinical Investigator Award may not submit a concurrent application for an NIH Research Career Development Award (K11), Academic Award (K07), First Independent Research Support and Transition (FIRST) Award (R29), or a research project grant (R01). However, an Awardee of this program may apply subsequently for a research project grant or a FIRST Award. The grantee institution must be a domestic nonprofit research institution, school, or comparable institution with strong, well-established research and training programs, adequate numbers of highly trained faculty in clinical and basic science departments, and development of independent research careers. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health Clinical Investigator Award (K08). Applicants will be responsible for the planning, direction, and execution of the proposed project. Except as otherwise stated in this PA, awards will be administered under PHS Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. Conditions of the Award Applicants may request three to five years of support. Awards are non-renewable and non-transferable from one awardee institution to another. Funding beyond the first year of the grant is contingent on satisfactory progress during the preceding year. Allowable costs may include: o Awardee's Salary: a maximum of $50,000 per year for full-time support; in addition, fringe benefits will be provided. Institutional supplementation is permitted. o Research Support: a maximum of $10,000 annually for years 01 and 02 and $20,000 annually for succeeding years to provide the categories listed below. o Equipment: specialized research equipment essential to the proposed program. The available facilities should include most of the necessary equipment. o Supplies: consumable supplies essential to the proposed program. o Travel: domestic travel essential to the proposed program. o Tuition for Training Courses: if essential to the awardee's individual research development program. o Other: publication costs, patient costs, and other expenses necessary for the research program. Indirect Costs - The indirect cost rate may not exceed eight percent of the total allowable direct costs. The grantee institution's share of the fringe benefits may be paid as a direct cost (if not treated as an indirect cost) on that portion of the salary provided by the Clinical Investigator Award. RESEARCH OBJECTIVES o To increase the number of physician-investigators in medical oncology, surgical oncology, preventive oncology, and diagnostic and therapeutic radiology and epidemiology, nutrition, and behavioral medicine, as they relate to cancer, who are committed to investigate the unique problems facing special populations. o To provide an opportunity for clinically trained physicians with a commitment to research to develop as independent biomedical research investigators. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical research grants and cooperative agreements will be 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 should 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 in adequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study populations must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Section 2, A-D of the Research Plan AND summarized in Section 2, E, 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 includes 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. If the required information is not contained within the application, the review will be deferred until the information is provided. 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 will be 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. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying to this program. These forms are available at most institutional business offices, from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, 5333 Westbard Avenue, Bethesda, MD 20892, and from the NCI program director named below. Submit a signed, typewritten original of the application, including the Checklist, and four signed, exact photocopies, in one package to the address below. The photocopies must be clear and single sided. DIVISION OF RESEARCH GRANTS National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892 At time of submission, send two additional copies of the application to: REFERRAL OFFICER Division of Extramural Activities National Cancer Institute Westwood Building, Room 848 5333 Westbard Avenue Bethesda, MD 20892 The receipt dates for all applications are found in the form PHS 398 instructions. The title and number of this announcement must be typed on line 2 of the application face page and the box must be checked YES. Candidates must provide a description of the proposed research and career development plan for the period of the award in Section 2 of the application under the heading "Research Plan." The candidate must be prepared to commit full-time effort to the objectives of this award. It is required that a minimum of 75 percent effort be devoted to the research program. The remaining 25 percent may be divided among other activities such as teaching and clinical training pursuits only if they are consonant with the program goals, i.e., the awardee's development into an independent biomedical research investigator. The reasons for a commitment to research in the problems facing special populations with respect to cancer must be indicated. The sponsor must provide: o His/her concept of a development and research plan for the awardee. o A current curriculum vitae with a complete bibliography and research support. o A letter indicating his/her evaluation of the proposed awardee and his/her willingness to provide guidance and support. Evidence of the commitment of the institution to the candidate's research and development must be provided. Adequate access to populations comprised of one or more of the groups targeted by this award must be demonstrated. REVIEW PROCEDURES Upon receipt, applications will be reviewed initially by the Division of Research Grants (DRG) for completeness and will be assigned on the basis of Public Health Service referral guidelines. Incomplete applications will be returned to the applicant without further consideration. Applications will be reviewed for scientific and technical merit by an appropriate peer review group convened by the relevant Institute or Center. Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. Criteria for the initial review include: o The candidate's potential for a career in independent research. o The candidate's commitment to a research career. o The overall merit of the candidate's plan for research and the development of research skills. o The quality of the candidate's clinical training and experience. o The institutions's ability to provide quality facilities, resources, and opportunities necessary to the candidate's research development. o Presence of highly trained faculty in clinical and basic science departments relative to the area of study. o The ability and plans of the sponsor (or sponsors) who will provide the candidate with the guidance necessary for career development in research. The review group will recommend an appropriate budget for each approved application. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among research areas of the announcement INQUIRIES Written and telephone inquiries to clarify any issues or questions from potential applicants are encouraged and may be directed to: Dr. Lemuel A. Evans Division of Extramural Activities Comprehensive Minority Biomedical Program National Cancer Institute Building 31, Room 10A04 Bethesda, MD 20892 Telephone: (301) 496-7344 FAX: (301) 402-0062 For information regarding budgetary/administrative issues related to this PA, contact: Ms. Carolyn Mason Grants Management Specialist National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800, Extension 59 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.398, Cancer Research Manpower. Awards are made under the authority 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 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. .
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