Full Text PAR-97-071 INTERDISCIPLINARY TRAINING IN GENETIC EPIDEMIOLOGY OF CANCER NIH GUIDE, Volume 26, Number 21, June 20, 1997 PA NUMBER: PA-97-071 P.T. 34 Keywords: PHYSIOLOGICAL/DEVELOPMENT PROCESS Genetics Immunology National Cancer Institute Application Receipt Dates: September 15, 1997; January 15, May 15, and September 15, 1998 PURPOSE The National Cancer Institute (NCI) uses Program Announcements (PAR) to designate areas of high priority. Special consideration for funding will be given to scientifically meritorious applications that meet the objectives and program priorities described in the PAR. The Cancer Training Branch invites applications providing the multidisciplinary research training essential to furthering the field of genetic epidemiology of cancer. The purpose of this Program Announcement is to stimulate the development of a diversity of comprehensive research training programs in the genetic epidemiology of cancer. A major goal of these programs is to provide students, young investigators and established researchers interested in diverse aspects of the genetic epidemiology of cancer with new research skills and a breadth of expertise that encompasses the many disciplines now merging into this expanding field. Therefore, a wide spectrum of research training (T32, F32, F33), career (K07, K08), and education (R25) grant mechanisms will be used to further the goals of this PAR (see MECHANISMS OF SUPPORT section). A previous basic research initiative and other efforts have stimulated the expansion of the research base which is necessary to support research training programs in genetic epidemiology. A second parallel goal of this PAR is, therefore, to build on the developing research base by promoting the development of the inter- and intra- institutional infrastructures necessary for providing training in the genetic epidemiology of cancer that would be accessible to interested investigators at different stages of career development. This announcement is intended primarily to solicit new applications. However, because it is critical to increase the number of comprehensively trained researchers in this area, and because the proposed training milieu could benefit from the experience of an existing program, grantees with existing institutional National Research Service Award (T32) training grants in cancer genetics or epidemiology are encouraged to submit competing supplemental applications in order to expand their programs. Existing institutional National Research Service Awards (T32) programs focused on the genetic epidemiology of other diseases are encouraged to submit new applications if they would like to expand their programs to include the genetic epidemiology of cancer. 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 PAR, "Interdisciplinary Training in Genetic Epidemiology of Cancer," 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: 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit and for-profit organizations, public and private, such as universities, colleges, hospitals, research laboratories, units of State and local governments, and eligible agencies of the Federal Government. Foreign organizations are not eligible to apply for these grant awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Specific eligibility requirements for individuals will vary for the different grant mechanisms; therefore, guidelines should be requested for the appropriate grant program(s) in which one is interested (see INQUIRIES section). In general, applicant organizations should have well-established research programs with adequate peer-reviewed grant support and highly qualified faculty. Candidates for career and fellowship awards, and trainees or students appointed to institutional awards must be U.S. citizens or non-citizen 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. Non-citizen 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. MECHANISMS OF SUPPORT Applications will be accepted for the following types of grant awards in order to provide interdisciplinary research training and education programs in the genetic epidemiology of cancer for investigators at different stages of their scientific careers: National Research Service Awards (NRSA) to institutions (T32 Awards), which will support predoctoral and/or postdoctoral students; National Research Service Awards (NRSA) to individuals at the postdoctoral (F32) and junior and senior faculty (F33) levels; Mentored Clinical Scientist Development Awards (K08) for individuals with clinical degrees, and Preventive Oncology Academic Awards (K07) for academic or professional doctorates; and Educational Awards (R25) for Short-Term Training/Education Courses. There is a wide range of salaries, stipends, other expenses and budgetary caps among the different grant mechanisms. Therefore, it is important to obtain specific guidelines for these grant mechanisms of support which are available from the NCI (see INQUIRIES Section). The Institutional NRSA (T32) and the Education Program (R25) Short- Term Training Courses are likely to involve active collaborations or special arrangements between institutions, departments, and/or research/cancer centers, and others that have the necessary expertise and resources to fulfill the objectives of this PAR. Any of these entities may act as the applicant organization, as long as the qualifications of the preceptor faculty and the focus of the program are on interdisciplinary research training in the genetic epidemiology of cancer. Except as otherwise stated in this PAR, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 94-50,000, revised April 1, 1994. FUNDS AVAILABLE Funds will be provided from the following three budgets: National Research Service Awards Program (T32, F32, F33); Careers Program (K07, K08), and the Cancer Education Program (R25). RESEARCH TRAINING OBJECTIVES Background There is a paucity of scientists versed in the cross-disciplinary techniques and issues necessary to perform and review modern genetic epidemiology investigations, particularly in a fast paced field such as cancer research. Cross-disciplinary approaches in the genetic epidemiology of cancer have traditionally been difficult to achieve. Cancer geneticists have focused on the genetic components of this disease with less consideration for the effect of environment on phenotype, while cancer epidemiologists have primarily focused on environmental factors with little attention to exploring genetic mechanisms that might explain the epidemiologic data. During the last decade, genetic epidemiology has entered a new era with recent advances in molecular genetics technology, the mapping of the human genome, the understanding of biological and genetic mechanisms underlying cancer, and the evolution of statistical techniques for analyzing data from complex disorders. These advances have given new impetus and direction to research efforts in the genetic epidemiology of cancer. Additionally, the availability of predictive genetic testing for cancer predisposition has stimulated the development of new approaches to the ethical, behavioral and legal issues engendered by these tests. In April/May 1992 the NCI convened a conference/workshop entitled "Genetic Epidemiology of Cancer: a Multidisciplinary Approach" with the purpose of developing recommendations to facilitate the transfer and adaptation of the technological, methodological and conceptual approaches of the many disciplines merging into genetic epidemiology (Seminara, D; Obrams, G.I.: Genetic Epidemiology of Cancer: A Multidisciplinary Approach. Genet Epidemiol, 1994; 11 (3): 235-254). The consensus of the workshop was that existing cancer training programs are primarily focused on specific areas of expertise, and are not providing the continuum of cross-disciplinary exposures necessary for trainees to become proficient and to thoroughly understand the current issues in genetic epidemiology of cancer. These recommendations were amplified at a subsequent workshop on the genetic epidemiology of cancer, held in June, 1996, in Frederick Maryland. Further information about the conference is available on the NCI website at: http://www-dceg.ims.nci.nih.gov/conference/ Efforts have been made to address the issues identified in these workshops. However, there still remains a distinct lack of integration between the appropriate departments in the schools of medicine and schools of public health. In addition, there is little or no research training support available specifically for middle and senior level scientists and clinicians who would like to acquire expertise in the requisite disciplines for genetic epidemiology. Therefore, individuals embarking on a research career, as well as established scientists interested in this multifaceted field, may find it difficult to gain the required knowledge and exposure to research areas different from those in which they were trained. Program Objectives and Scope This PAR seeks to establish a variety of comprehensive research training programs in the genetic epidemiology of cancer accessible to investigators at different stages of their scientific careers. Therefore, applicants should use the grant mechanism(s) appropriate to their career level and the type of program which they are proposing. Applicants are encouraged to propose programs to establish appropriate research training infrastructures, recruit students and other scientists into the field, and develop preceptor-student relationships in an environment with a peer-reviewed research base. Programs should provide students and junior scientists embarking on research careers in the genetic epidemiology of cancer with interdisciplinary training in such specialized areas as molecular genetics, biostatistics, epidemiology, behavioral science, and bioethics. Some examples of programs that would be responsive to this PAR are the following: A. Pre- and/or post-doctoral training in the genetic epidemiology of cancer within a cohesive interdepartmental and/or interinstitutional program providing a multidisciplinary exposure (T32, F32, and K08 Awards). B. Postdoctoral training in the development and/or experimental testing of the techniques of genetic epidemiology in human populations for cancer prevention and control (K07 Award) C. A 6 month to2 year training program or sabbatical for scientists at the middle or senior career level, to gain first-hand experience and exposure in the discipline(s) of interest (F33 Award). D. Short training courses (e.g. one to three weeks) in pertinent topics, to enable basic scientists and physicians to understand the principles of genetic epidemiology study design and analysis, and to equip epidemiologists and biostatisticians with an understanding of cutting edge laboratory techniques in molecular genetics (R25 Award). 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," 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, Volume 23, Number 11, March 18, 1994. APPLICATION PROCEDURES Applicants are strongly encouraged to call or E-mail NCI staff with any questions regarding whether or not their proposed program/project is within the scope of the programmatic area of emphasis described in this PAR (see INQUIRIES section). The research grant application form PHS 398 (rev. 5/95 or latest version) is to be used in applying for the Institutional Research Training Award (T32), the Mentored Clinical Scientist Development Award (K08), the Preventive Academic Oncology Award (K07), or the Cancer Education Award (R25). The fellowship application form PHS 416-1 (rev. 8/95 or latest version) is to be used in applying for the Postdoctoral Fellowship Award (F32) or the Senior Fellowship Award (F33). 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: [email protected]; and from the program administrator listed under INQUIRIES. "Just-in-Time" procedures must be followed for the Preventive Academic Oncology (K07) and the Mentored Clinical Scientist Development (K08) Awards. These procedures postpone the collection of certain information until just prior to making an award. Instructions for these procedures are provided in the following NIH Guide to Grants and Contracts notices: Volume 25, Number 10, March 29, 1996 and Volume 25, Number 16, May 17, 1996. An application that proposes research training and education within the programmatic areas described by this PAR must be identified by marking the "YES" box and typing the number and title of this PAR in section 2 of the face page of the PHS 398 application, or for fellowships by typing the number of this PAR in section 3 of the face page of the PHS 416-1 application. This will facilitate the assignment of the application by the Referral Office. However, the fundamental factor upon which the assignment will be based is the content of the proposed programs/projects. While the grant mechanisms for unsolicited applications described in this PAR have variable receipt dates, all applications submitted in response to this PAR will use a single receipt date for each review cycle as follows: September 15, 1997; January 15, 1998; May 15, 1998; and September 15, 1998. One exception is that just for the initial cycle, Fellowship (F32, F33) applications should be submitted beginning with the January 15, 1998 cycle since they will be reviewed with other applications from the September 15, 1997 cycle thus avoiding a long delay to review. Subsequently, Fellowship applications may be submitted on all other receipt dates. Submit a signed, typewritten, single-sided original of the application 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 Referral Officer Division of Extramural Activities National Cancer Institute National Institutes of Health Executive Plaza North, Room 636 Bethesda, MD 20892-7405 Rockville, MD 20852 (for express/courier service) REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the NIH Division of Research Grants. Incomplete applications will be returned to the applicant without further consideration. Applications for research training and education topics that are not within the areas described by this PAR will be assigned and reviewed according to standard procedure. Applications that are complete and responsive within the scope of this PAR will be evaluated for scientific and technical merit by an appropriate peer review group convened by NCI in accordance with the standard NIH peer review procedures. 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 or in the case of Fellowships, the NCI Secondary Fellowship Review Committee. Review Criteria The review criteria will vary for the different grant mechanisms. Guidelines containing specific review criteria for the respective grant mechanisms can be obtained from NCI program staff listed under INQUIRIES. Examples of general review criteria include the following: A. Institutional Training Grant (T32) o Scientific and administrative leadership qualifications and experience of the Principal Investigator. o Qualifications of faculty mentors: adequacy of peer-reviewed research projects, publications and training experience. o Recruitment and selection plans for appointees and the availability of high quality candidates. o Appropriateness of detailed plans for a comprehensive, multidisciplinary research training program. o Adequacy of facilities and other resources. B. Career Grant (K) o Quality of the candidate's academic or clinical record. o Potential to develop as an independent investigator. o Commitment to a research career. o Appropriateness of a career development plan that will contribute substantially to the scientific development of the candidate. o Scientific and technical merit of the research plan. o Appropriateness of the mentor's research qualifications in the area of the research plan. o Quality and extent of mentor's proposed role in providing guidance and advice to the candidate. o Previous experience of the mentor in fostering the development of researchers. o Adequacy of research facilities and training opportunities. C. Education Grant (R25) o Significance of the education program to cancer research and/or to the reduction of cancer incidence, mortality, and morbidity and the improvement of quality of life. o Quality of the program leadership and faculty. o Overall quality and adequacy of the design of the program to achieve its short-term objectives and long-term goals. o Adequacy of the program's plan to evaluate its effectiveness in achieving objectives. The initial review group will also examine the provisions for the protection of human and animal subjects and 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 Applications will compete for available funds with all other approved applications assigned to the NCI. Awards will be made based upon the following considerations: o Scientific merit as determined by peer review o Programmatic priority based on areas of emphasis described in this PA o Availability of funds o Geographic and scientific discipline balance among awards INQUIRIES Inquiries concerning this PAR are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues (guidelines, appropriate grant mechanism, eligibility, application procedures, review criteria, etc.) to: For the following states: ID, IL, IN, KY, MA, ME, MI, MN, MT, ND, NE, NH, NY, OH, PA, SD, VT, WI, WV, WY contact: Lester S. Gorelic, Ph.D. Program Director National Cancer Institute Executive Plaza North, Room 520 Bethesda, MD 20892-7390 Telephone: (301) 496-8580 FAX: (301) 402-4472 Email: [email protected] For the following states: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, KS, LA, MD, MO, MS, NC, NJ, NM, NV, OK, OR, RI, SC, TN, TX, UT, VA, WA and District of Columbia contact: Andrew Vargosko, Ph.D. Program Director National Cancer Institute Executive Plaza North, Room 520 Bethesda, MD 20892-7390 Telephone: (301) 496-8580 FAX: (301) 402-4472 Email: [email protected] Direct inquiries regarding scientific matters concerning the research area of genetic epidemiology to: Daniela Seminara, Ph.D., M.P.H. Extramural Epidemiology and Genetics Program Executive Plaza North, Room 535 Bethesda, MD 20892-7395 Telephone: 301 496-9600 FAX: 301 402-4279 Email: [email protected] Direct inquiries regarding scientific matters concerning behavioral research and bioethics to: Amy R. Sheon, Ph.D., M.P.H. Extramural Epidemiology and Genetics Program Executive Plaza North, Room 535 Bethesda, MD 20892-7395 Telephone: 301 496-9600 FAX: 301 402-4279 Email: [email protected] Direct inquiries regarding fiscal and administrative matters to: Ms. Michelle Burr NCI Grants Administration Branch Executive Plaza South, Room 243 6120 Executive Blvd. MSC 7150 Bethesda, MD 20892-7150 Telephone: 301/496-7800, ext. 231 FAX: 301/496-8601 Email: [email protected] AUTHORITY AND REGULATIONS 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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