MINORITY ONCOLOGY LEADERSHIP ACADEMIC AWARD PA: PA-92-33 P.T. 34, FF Keywords: Cancer/Carcinogenesis Oncology Clinical Medicine, General Epidemiology Disease Prevention+ National Cancer Institute Application Receipt Dates: February 1, 1992, June 1, 1992, October 1, 1992 PURPOSE The Comprehensive Minority Biomedical Program, Division of Extramural Activities, National Cancer Institute (NCI), invites academic health centers and other professional schools that employ, educate, or serve a preponderance of minority faculty, staff, trainees, and communities to submit applications for support of an individual to pursue leadership activities in the development of research and training programs in clinically oriented cancer research (defined as including population research; surgical, medical, or radiation oncology; cancer prevention and control; epidemiology and biostatistics; nutrition; clinical pharmacology and clinical trials; behavioral medicine; and related areas of cancer research). The purpose of this initiative is to address underrepresentation of minority groups in research projects as investigators and subjects in research projects involving human populations. One method of addressing this problem is to broaden the experience of the faculty at minority health professional schools that serve these populations in the initiation and participation in cancer research. In doing so, the pool of clinical biomedical investigators in all aspects of cancer research will be increased, and trainees will become more cognizant of research opportunities in oncology and related disciplines. These institutions represent a unique concentration of minority faculty, trainees, and patients to address the needs outlined above. 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, Minority Oncology Leadership Academic Award, is related to the priority area of cancer. 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 AND REQUIRED ELEMENTS Minority School A minority health professional school is defined as a medical, dental, pharmacy, public health, or equivalent school in which students of minority ethnic groups, including African Americans, Hispanics, American Indians, and Asians or Pacific Islanders, comprise a significant proportion of the enrollments and that has a commitment to the special encouragement of minority faculty, students, and investigators. Candidate To be eligible, candidates must: o Have an appropriate clinical academic appointment at a minority health professional school at the time the award is activated. The candidate must be a citizen, a non-citizen national of the U.S., or have been lawfully admitted to the U.S. for permanent residence. o Have appropriate documented research experience and background in a clinical oncology specialty and/or cancer research. o Specify a program for enhancement of personal research skills as needed, and for the conduct of research in one or more areas cited in this announcement. Proposed research must be described in sufficient detail for reviewers to evaluate the likelihood of success of this element of the plan. All sources of support proposed for this activity must be indicated. o Present a program for developing or improving clinical cancer research and training capabilities at the grantee institution. o Commit a minimum of 60 percent total time and effort to the research and development aspects of the program. o Agree to report annually on the status of the program and to meet annually to exchange information with NCI staff and other awardees. o Specify a plan for evaluating the effect of this award on the candidate and institution. The minority health professional school must: o Name and sponsor a senior or mid-level faculty member with research competence and a major career interest in oncology and/or clinical cancer research and related training programs. o Present plans to develop or improve cancer-related research and research training educational programs. o Identify and document the availability of resources (populations, patients, manpower, materials, equipment, laboratory facilities) necessary to implement the proposed program. o Provide the candidate with time to acquire any new skills necessary for individual professional development and for the development of the program. o Provide evidence of commitment from the highest levels of administration and from the sponsoring Departmental chairpersons to implement the proposed program and to coordinate it with other ongoing activities. o State the mechanisms planned for continued institutional support of the program in the future. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health academic/teacher award (K07). Applicants will be responsible for the planning, direction, and execution of the proposed project. 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. Awards are non- renewable and non-transferable from one awardee to another. Funding beyond the first year of the grant is contingent on satisfactory progress during the preceding year. Awards may be requested for a period of three to five years. Allowable costs include: o A portion of the salary of the faculty leader up to a maximum of $50,000 per year and related fringe benefits. o Costs for further optional preparation of the faculty leader in additional clinical or basic research methodologies (this aspect of the program is not to exceed the equivalent of one academic year total over the duration of the award). o Domestic travel expenses for the awardee to attend professional meetings, training courses, and an annual two-day awardee meeting in Bethesda, MD. o Partial salary support up to $40,000 per year for one additional faculty or staff researcher as a direct participant in research-related activities or services. o Up to $10,000 per year in supplies for research activities. o Indirect costs not to exceed a maximum of eight percent of direct costs, exclusive of tuition fees, if any. o The total award may not exceed $100,000 in direct costs per year. RESEARCH OBJECTIVES This award is aimed at encouraging and assisting a designated leader in any of the minority health professional schools to increase his/her institution's efforts in clinical cancer research in areas such as medical oncology, prevention, etiology, diagnosis, treatment, or control; and to aid in establishing a cadre of faculty and staff capable of developing new research protocols and increasing participation in intervention studies and clinical trials in these areas. These awards offer opportunities for supporting start-up or expansion of such activities and are intended to meet needs that have not been addressed by other types of awards available from the NCI or other Federal agencies. Priority is given to those minority institutions with an interest in and commitment to expansion of clinical cancer research-related activities in local populations. STUDY POPULATIONS It is the NIH policy that women and minorities must be included in clinical study populations unless there is a good reason to exclude them, and the study design must seek to identify any pertinent gender or minority population differences. SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES 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. 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 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. REVIEW PROCEDURES AND CRITERIA Review Procedure Upon receipt, applications will be reviewed by the Division of Research Grants (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 announcement is an NCI program staff function. Applications that are judged non-responsive will be returned to the applicant. Questions concerning the relevance of proposed research Program Announcement may be directed to program staff as described in the INQUIRIES section. Applications will receive technical review by an initial review group appointed by the NCI, with secondary review by the National Cancer Advisory Board. Review Criteria o Background and potential of the named candidate as a leader in research and training activities in oncology and cancer and demonstration of effectiveness as a leader within the institution. o Merit of the candidate's personal plan for development and his/her plans for fostering increased research and training within the institution. o Scope and nature of the collaboration and commitment among participating departments and/or schools. o Merit of the institutional plan to strengthen research and training activities beyond the current status of activities and capacities. o Appropriateness and potential efficacy of the proposed use of funds to achieve the goals of the award. o Potential of the institution for recruitment and utilization of clinical populations and research training of clinical researchers. o Commitment of the institution to strengthen clinical cancer research and to support the candidate's efforts in this regard. METHOD OF APPLYING The research grant application form PHS 398 (rev. 10/88 and 9/91) must 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, telephone 301/496-7441, 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 DRG at 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 (2) 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 title and number of this announcement must be typed in line 2 and the box must be checked YES. INQUIRIES Direct inquiries regarding programmatic issues to: Dr. Lemuel 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 Written and telephone inquiries concerning the objectives and scope of this Program Announcement and inquiries about whether or not specific proposed research would be responsive are encouraged and should be directed to Dr. Lemuel Evans at the above address. The Program Director welcomes the opportunity to clarify any issues or questions from potential applicants. For information regarding budgetary/administrative issues, contact: Ms. Carolyn Mason Grants Management Specialist Grants Administration Branch 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. National Institutes of Health, Public Health Service, Department of Health and Human Services authorization: Public Health Service Act, Service 413, as amended by Public Law 99-158, 42 U.S.C. 285a: Public Health Service Act, Section 487, as amended by Public Law 99-158, 42 U.S.C. 288. Federal Agency: National Institutes of Health, Public Health Service, Department of Health and Human Services authorization: Public Health Service Act, Section 301, Public Law 78- 410, 42 U.S.C. 241, and Section 412, as amended by Public Law 99.158, 42 U.S.C. 285a-1.
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