Full Text CA-96-006 MINORITIES IN MEDICAL ONCOLOGY NIH GUIDE, Volume 25, Number 4, February 16, 1996 RFA: CA-96-006 P.T. 34, FF Keywords: Oncology National Cancer Institute Letter of Intent Receipt Date: March 14, 1996 Application Receipt Date: May 14, 1996 PURPOSE The Comprehensive Minority Biomedical Program of the National Cancer Institute (NCI) announces the availability of minority medical oncology awards. The purpose of these awards is to: o Encourage recently trained underrepresented minority clinicians to acquire clinical training and research experience in clinical oncology; o Increase representation of minorities in clinical oncology. These awards will provide the opportunity for recent, clinically trained underrepresented minority physicians and D.O.'s to gain sufficient research and clinical experience to become practicing clinical oncologists with experience in biomedical research. 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), Minorities in Medical Oncology, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-0001-00474-0 or Summary Report: Stock No. 017-0001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS This award is designed to provide an intensive, supervised clinical and research experience for underrepresented minority physicians. The award is intended for individuals with an M.D. or D.O. degree. For the purpose of this award, underrepresented minorities are defined as individuals who are African Americans, Latinos (Mexican American, Cuban, Puerto Rican, Central American), Native Americans, and non-Asian Pacific Islanders. Awards will be limited to individuals who are citizens or permanent residents of the United States. Candidates for the award should have broad clinical training, demonstrate individual competence in clinical activities, must document a serious intent for a research and/or clinical career in clinical oncology, and must document a sensitivity to cultural issues impinging upon the practice of medicine among the major U.S. ethnic populations. The candidates must be nominated by an institution on the basis of qualifications, interests, accomplishments, motivation, and the potential for a career in oncology. Evidence of the institution's commitment to the applicant's clinical and/or research development must be documented. Candidates must have at least one sponsor or advisor who is recognized as an accomplished clinician, and at least one sponsor or advisor who is recognized as an accomplished independent investigator in the proposed research area. Applicants for this award may not concurrently submit an application for an NIH Research Career Development Award, or a Mentored Research Scientist Development Award (K01). Current principal investigators on PHS research grants are not eligible applicants. The grantee institution must be a domestic non-profit research institution, school or comparable institution with well- established training programs in clinical oncology and biomedical research in oncology including clinical trials, adequate numbers of highly trained faculty in the clinical and biomedical sciences areas as they relate to cancer, and a demonstrated commitment to the development of the clinical and research careers of young physicians in oncology. MECHANISM OF SUPPORT Awards in response to this RFA will use the Clinical Investigator Award (K08). Planning, direction and execution of the proposed training program will be the responsibilities of the applicant and the sponsor(s). The total project period for an application submitted in response to this RFA may not exceed four years. The anticipated award date is September 30, 1996. Each award is non-renewable and non-transferable from one awardee to another awardee. Funding beyond the first year of the award is contingent upon satisfactory progress during the preceding year, as documented in the required Progress Report. FUNDS AVAILABLE The estimated total costs available for the first year support of the program is $750,000. There will be approximately nine new awards made at a direct cost level of $65,000 per year. RESEARCH OBJECTIVES Background Substantial national and local efforts have been made and are continuing to be made to reduce cancer morbidity and mortality in the general population. However, in spite of these efforts, projections made for 1994 were 1.2 million newly diagnosed cancer cases and approximately 550,000 cancer deaths. Past patterns of cancer incidence and mortality predict that a disproportionate share of this increase in U.S. cancer incidence and mortality will be borne by minorities. Specifically, past and current SEER data show Hispanics residing in New Mexico and Arizona have been excess cancer incidences of the cervix, stomach and gallbladder. American Indians from New Mexico and Arizona show excess cancer rates for stomach, cervix uteri, liver and gallbladder cancers, with the incidence rate for gallbladder cancer being the highest of any racial group; and rates for this group for the period 1975-1984 showed the poorest survival of any racial group for 8 evaluated cancer sites. Alaska Natives have the highest cancer incidence rates among any racial group for cancer of the oral cavity and pharynx, colon and rectum, cervix uteri, and kidney and pelvis; and the incidence of gallbladder cancer is comparable to that of American Indians. Finally, cancer mortality rates for all sites for Blacks are almost 2.5- times greater than for Whites. Contributing to the cancer burden of U.S. minorities is their limited access for treatment to minority physicians with appropriate cultural sensitivities. This is largely due to the small numbers of U.S. minority clinical oncologists. Data from the American Medical Association for 1994 show that of 11,224 U.S. oncologists, only 184 (1.6 percent) were of African American descent, 336 (3.0 percent) were of Hispanic descent, and 3 (0.03 percent) were of Native American descent. Current statistics on medical specialties among U.S. medical school graduates do not portend a significant change in this situation. Specifically, of the total 1993 medical school graduates (15,555), only 0.9 percent had selected oncology as their area of specialization, and only 0.2 percent (30) of graduates selecting an oncology specialization were underrepresented minorities. In 1994, only 11.2 percent of all medical school applicants were underrepresented minorities, a proportion that had not changed significantly from the value of 10.8 percent six years earlier. A reduction in the overall mortality rate in minority populations would substantially impact known cancer statistics. Cultural barriers to cancer diagnosis/treatment and to preventive health care advice will take on added importance as the techniques of molecular epidemiology are increasingly applied to identify minority individuals and family members at high risk for cancer. As a result of this new technology, physicians will increasingly be called upon to deal with culturally sensitive issues, such as prophylactic surgery for family members, and/or major changes in lifestyle possibly even including childbearing. It is therefore imperative that a sufficient number of minority oncologists be available so that access to care is not limited by the number of oncologists sensitive to cultural issues. Additionally, the oncologists must have an understanding of the new technologies being developed that will assist in the diagnosis/treatment of cancers and the predictions of cancer risk. This understanding can best be provided by a research experience in the development/application of these technologies. Areas of research of particular interest for this purpose might include but are not limited to the development and applications of biomarkers for assessing cancer risk in minority populations; cancer treatment or prevention clinical trials targeting minority populations; and psychosocial aspects of cancer prevention and control in defined populations. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of 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 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, Volume 23, Number 11, March 18, 1994. 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 March 14, 1996, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone and FAX numbers 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 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: Lester Gorelic, Ph.D. Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 620 - MSC 7405 Bethesda, MD 20892-7405 Rockville, MD 20852 (express/courier service) Telephone: (301) 496-7344 FAX: (301) 402-4551 Email: gorelicl@dea.nci.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 Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: girg@drgpo.drg.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 (express/courier service) At time of submission, two additional copies of the application must be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 636 - MSC 7405 Bethesda, MD 20892-7405 Rockville, MD 20852 (express/courier service) Applications must be received by May 14, 1996. 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. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Information to be Included in the Application Candidates must provide a description of the proposed research and clinical career training development for the period of the award in section 2 of the application under "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 25 percent effort be devoted to the research program, and that the remaining effort be devoted to clinical training in medical oncology. The percent effort devoted to research can be uniformly distributed over the four-year award period, or can be concentrated during one year of the four-year award period. The reasons for a commitment to clinical oncology practice in underserved minority populations and to research in these populations must be clearly described. The sponsor(s)/advisor(s) for the clinical and research aspect of this award must provide: o Her/his concept of a clinical and/or a research plan for the candidate. o A current curriculum vitae with a complete bibliography and listing of research support. o A letter indicating her/his evaluation of the proposed candidate and her/his willingness to provide guidance and support Evidence of the commitment of the institution to the candidate's clinical and research training, and career development, must be provided. Finally, adequate access to underserved populations for the purposes of clinical training and research must be demonstrated. The applicant institution must provide a signed statement of the candidate's eligibility for this award in terms of both being a minority underrepresented nationally in clinical oncology and a U.S. citizen. Where appropriate, the candidate must provide a copy of the Alien Registration Receipt card. The candidate also must provide, where applicable, information on other past, current and pending awards, including all federal and non-federal fellowships, grants or contracts. For each grant listed, the candidate must provide the complete grant number, the subject of the research, the title of the candidate's position, and the candidate's percent effort. The candidate should provide a detailed plan for her/his clinical and research development programs. This plan should not be prepared by the sponsor. The candidate's input should be shown clearly, as this input represents a criterion for evaluating the candidate's clinical and research potentials. This plan should include the following information: o Aspects of the candidate's educational and training background that qualify her/him for participation in the program described; o Areas in the candidate's educational and training background that can be developed by the proposed program; o Sufficient detail in the description of the proposed clinical training program to permit adequate evaluation. (If, during the course of the outlined study, the awardee should find that she/he would like to alter the direction or emphasis of the research, such a change may be made with the approval of the sponsor and of the National Cancer Institute); o How these plans are intended to promote the candidate's career in clinical oncology; o The strength of the commitment of the candidate to the practice of clinical oncology in the U.S. minority population. o Adequate justification of all budget items; o A list of all centers, institutions or laboratories that will participate in the clinical and research development programs. This list should include the names of the sponsors and other investigators who have agreed to participate in the program, and the resources and space available to the candidate. Each sponsor and institution must provide a letter indicating support of this program and a commitment of space and resources. These letters must be submitted as part of the application; o Four copies of each of the candidate's publications. The candidate must also provide three letters of reference. These letters should be forwarded by the referees directly to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 636 - MSC 7405 Bethesda, MD 20892-7405 Rockville, MD 20851 (express/courier service) Budget Salary: The proposed salary should be based upon the candidate's training, experience and accomplishments,but should not exceed $50,000 per year (excluding fringe benefits). The salary must be consistent with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications,rank and responsibilities. Allowable Costs: Supplies, Travel, Equipment, Fringe Benefits, and Other Expenses. The award will provide up to a total of $15,000 per year for the costs necessary for the pursuit of the objectives of this program. The award may not be used to support the awardee's private clinical practice, professional consultation, or other comparable activities. Any fees for providing medical services generated by the awardee must be handled as specified by PHS policy. An awardee may, however,engage in scholarly writing, deliver occasional outside lectures and serve in an advisory capacity to the public or to non-profit organizations, provided such activities are incidental in the amount of time involved and are consistent with institutional policy. Awards will not be made to individuals who have substantial administrative responsibilities. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NCI program staff. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, DRG staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate NCI peer review group with the review criteria stated below. 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, assigned a priority score, and receive a second level review by the National Cancer Advisory Board. Review Criteria o the candidate's potential for a career in clinical oncology. o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research. o the overall merit of the candidate's plan for clinical training. o the overall merit of the candidate's plan for research and the development of research skills appropriate to the practice of modern clinical oncology. o the candidate's commitment to the servicing of the U.S. medically underserved populations. o the quality of the candidate's clinical training and experience. o objectives, design, and direction of the clinical and research training programs. o caliber of research advisors including successful competition for research support. o training environment, including the institutional commitment, the quality of the facilities, and the availability of research and clinical support. o appropriateness of the proposed budget and duration in relation to the proposed research. The initial review group will also examine the adherence to special requirements, and the provisions for the protection of human and animal subjects, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research. AWARD CRITERIA The anticipated date of award is September 30, 1996. Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Lester S. Gorelic, Ph.D. Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 620 - MSC 7405 Bethesda, MD 20892-7405 Rockville, MD 20852 (express/courier service) Telephone: (301) 496-7344 FAX: (301) 402-4551 Email: gorelicl@dea.nci.nih.gov Direct inquiries regarding fiscal matters to: Mrs. Joan Metcalfe Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243 - MSC 7150 Bethesda, MD 20892-7150 Rockville, MD 20852 (express/courier service) Telephone: (301) 496-7800 ext 228 FAX: (301) 496-8601 Email: metcalfj@gab.nci.nih.gov AUTHORITY AND REGULATIONS This program is described in the catalog of Federal Domestic Assistance No. 93.398. Awards are made under 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 grants policies and Federal Regulations 42 CFR 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 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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