Full Text CA-97-007 THE NCI SCHOLARS PROGRAM NIH GUIDE, Volume 26, Number 15, May 9, 1997 RFA: CA-97-007 P.T. 34 Keywords: Cancer/Carcinogenesis Biomedical Research, Multidiscipl National Cancer Institute Letter of Intent Receipt Date: June 27, 1997 Application Receipt Date: July 30, 1997 PURPOSE The purpose of the NCI Scholars Program is to provide outstanding new research investigators who are ready to initiate their first independent program in cancer research with an opportunity to develop their program in the supportive and uniquely interactive intramural environment of the National Cancer Institute (NCI). The overall goal is to facilitate their successful transition to an extramural environment as independent researchers. This program is also intended to continually enhance and invigorate the NCI intramural community by providing a cadre of new, creative scientists who will interact with and expand the collaborative research opportunities of NCI intramural scientists. This program will uniquely address the need of the NCI intramural laboratories to attract outstanding scientists, and of the extramural cancer research community to identify for staff appointments new investigators capable of sustaining a successful research program. 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 for the NCI Scholars Program is related to the priority area of human resource development. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 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 Individuals with a research or health professional doctoral level degree or equivalent, with no more than five years of postdoctoral research training at the time of application, and with demonstrated outstanding abilities in basic, clinical or population-based (e.g., epidemiological) research, are eligible to apply. This includes individuals with postdoctoral research experience in any environment (e.g., academic, industry, government). Individuals who have had more than five years of postdoctoral research training or who have held research or other professorship positions or equivalent in academe or elsewhere are NOT eligible to apply. However, years of clinical training will not count against the five years of relevant research experience. Individuals who have been principal investigators on either PHS research grants (e.g. R29, R01, P01 or its subprojects) or non-PHS peer reviewed research grants are NOT eligible to apply for this award. Postdoctoral fellows at the NCI who meet other eligibility requirements are eligible to apply, but will not be considered for placement in Laboratories/Branches where they have previously trained. Minorities and women are encouraged to apply. Candidates must be U.S. citizens or noncitizen nationals, or must have been lawfully admitted for permanent residence and possess an Alien Registration Card (I-151 or I-152) or some other verification of legal admission as a permanent U.S. resident, at the time of award. 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 to apply. All applicants are encouraged to contact the NCI regarding their eligibility for this award (see Inquiries Section). MECHANISM OF SUPPORT The NCI Scholars Program will use the National Institutes of Health (NIH) Career Transition Award (K22). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The NCI Scholars Program will consist of two phases: an intramural phase and an extramural phase. The maximum total period of combined intramural support at NCI and at the extramural institution for an NCI Scholar will be six years. Initially, up to four years of the Scholar's research program will be an Intramural Support Phase in which the salary and the research costs of the successful Scholar will be derived entirely from Intramural NCI resources. The budget cannot exceed $150,000 total costs per year or $600,000 total costs over a four-year period, which is the maximum duration of the Intramural Support Phase. The final two years of the Scholar's research program will be an Extramural Support Phase funded through the NIH Career Transition Award (K03) mechanism. The budget cannot exceed $125,000 plus fringe benefits in direct costs per year or $250,000 plus fringe benefits in direct costs over a two-year period which is the maximum duration of the Extramural Support Phase. Transition from the intramural phase of support to the extramural phase is not automatic. Approval of the transition will be based upon the success of the Scholar's research program, as determined by a formal NCI scientific progress review which will take place no later than the end of the third year of the Intramural Support Phase. Scholars who are approved to proceed with this second phase of support will receive notification of approval in writing from the NCI. Once approved for the Extramural Support Phase, the NCI will process the change in organization in response to a request from the sponsoring institution that has recruited the Scholar for the final two years of the award (see section on INQUIRIES). FUNDS AVAILABLE It is anticipated that applications to the NCI Scholar's Program will be solicited annually through the reissuance of this RFA. Each annual solicitation will indicate the general areas of research and the number of positions that will be sponsored in that year. For the Intramural Support Phase, approximately $1,500,000 per year for up to four years will be set aside to fund about 10 applications submitted in response to this RFA. However, this funding level is dependent upon the receipt of a sufficient number of applications of outstanding scientific merit as evaluated by peer review (see section on REVIEW CONSIDERATIONS). The number of Scholars who can be supported is based upon the availability of resources and space in each sponsoring intramural Division. For the Extramural Support Phase, approximately $1,250,000 per year in direct costs will be available to fund about 10 awards, providing support for salaries and partial operating costs. It is important to note that a sponsoring extramural institution may submit a noncompeting continuation application only after the Scholar has been notified in writing that the NCI Progress Review Committee has recommended approval of the transition to the extramural support phase of the award. The individuals noted in the section on INQUIRIES should be consulted for any clarifications of intent or content. 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 NCI, the support of research programs pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH TRAINING OBJECTIVES Background For decades, the intramural scientists and facilities of the National Cancer Institute have provided a research environment for the training of new scientists who have subsequently entered the extramural biomedical research community and have become leaders in their fields of investigation. This has been accomplished primarily through staff fellow and senior staff fellow programs that, to varying degrees, have afforded independent research opportunities to new scientists. With the continuing effort of the NCI to develop an intramural research environment of the highest scientific quality, there is a new opportunity to use the unique intramural environment of the NCI to effectively foster the research careers of individuals who will pursue their careers as extramural scientists. Goals and Scope The NCI Scholars Program is designed for promising new investigators in basic, clinical or population-based biomedical research (e.g., epidemiology) who have demonstrated outstanding scientific abilities during their training, to enable them to establish their first independent research program. The major objective of the program is to sustain and advance the early research careers of the most promising investigators while they consolidate and focus their independent research programs. NCI Scholars will independently design and pursue research projects in their area of interest for which they would be provided with facilities, operating budget, salary and personnel. NCI Scholars will be responsible for all aspects of their research program, including the progress of the research and the management of allocated resources. The participating NCI intramural divisions invite applications for the support of Scholars who wish to develop independent research programs in the following scientific areas: o The Division of Basic Sciences encourages applications from candidates with experience and interest in pursuing research in the general areas of cell biology, cancer genetics, and immunology. Specific areas of interest include: chromatin structure, gene regulation, signal transduction, cell transformation, cell cycle and apoptosis. o The Division of Epidemiology and Genetics encourages applications from candidates with experience and interest in pursuing epidemiologic or interdisciplinary research into the environmental and genetic determinants of cancer. Areas of specific research interest include: lifestyle and environmental risk factors, genetic susceptibility, occupational exposures, infectious agents, pharmacoepidemiology, radiation exposures, methodologic and statistical research, or interdisciplinary studies (molecular epidemiology). o The Division of Clinical Sciences encourages applications from candidates engaged in cancer genetics and cancer biology research. Specific topics of interest include: exploratory technologies in interrogating the human genome, in genetic instability, and the molecular biology of angiogenesis, and of the cell cycle. Consonant with the goals of the division, applicants should be interested in participating in the translation of basic findings to the clinical setting. ALLOWABLE COSTS Intramural Support Phase: The budget for the intramural support phase cannot exceed $150,000 per year in total costs excluding equipment. The final budget for this phase of the award will be negotiated with the sponsoring NCI intramural division and will depend upon the nature and scope of the research as recommended by the peer review process. o Salaries will be provided for the Scholar and no more than two additional positions (e.g. postdoctoral trainee and technician). Salaries of the Scholar and other personnel must be commensurate with the level of training and experience specified in the Federal pay schedule. o Up to $25,000 per person will be provided for annual operating expenses (e.g. supplies, disposables, copying, etc.). o Up to $50,000 in the first year will be provided for laboratory equipment. - Laboratory equipment purchased for the Scholar during the intramural phase will not be transferable to the extramural position. Extramural Support Phase: The budget for the two year extramural transition phase may not exceed $125,000 plus fringe benefits per year in direct costs. o Scholars will be provided salary support of up to $75,000 plus applicable fringe benefits commensurate with the applicant institution's salary structure for persons of equivalent qualifications, experience, and rank. The total salary requested must be based on a full-time, 12 month staff appointment and there should be no less than 75 percent effort devoted by the Scholar specifically to the proposed research program. 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, institutions may carry-over unexpended funds into the next budget period and rebudget funds within the total costs awarded but may not rebudget funds involving the salary component of the budget. The total salary requested must be based on a full-time 12 month staff appointment. o Up to $50,000 per year in direct costs will be provided to partially support ancillary personnel, supplies, equipment, travel, tuition, and other costs which are deemed essential for the individual's research program. o Indirect costs will be reimbursed at eight percent of modified total direct costs, or at the actual indirect cost rate, whichever is less. Special Restrictions: Acceptance into the NCI Scholar's Program does not convey any commitment or intent of the NCI to consider the Scholar for a tenure track position within the NCI. The NCI Scholars Program is specifically intended to help develop scientists who will pursue their careers in the extramural biomedical research community. However, NCI Scholars are not explicitly precluded from applying for available tenure track positions at the NIH. If a Scholar obtains an NIH position, the NCI Scholar's Career Transition Award (K22) will be terminated. 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 (Public Law 103-43) that added Section 492B of the Public Health Service Act. The new policy supersedes and strengthens the previous policies (Concerning the inclusion of Women in Study Populations) which have been in effect since 1990. Investigators proposing research involving human subjects should read the NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research which were 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. LETTER OF INTENT Prospective applicants are asked to submit, by June 27, 1997 a letter of intent that includes a descriptive title of the proposed research, the name, address, telephone and FAX numbers, E-mail address of the Principal Investigator, 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 a subsequent application, it 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 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. These forms 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, E-mail: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 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 6130 Executive Boulevard, Room 636 Bethesda, MD 20892-7407 (for U.S. Postal Service) Rockville, MD 20852 (for express/courier service) Applications must be received by July 30, 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. Supplemental Application Guidelines o The RFA title (NCI Scholar's Program) and the RFA number must be typed on line 2 of the face page of the application, and the YES box must be marked. o The applicant must provide her/his signature in item 15; a signature is not required for item 16. o Leave items 9-14 and 16 on the face page blank. o Enter in item 6 (Dates of Proposed Period of Support) the combined 6 years of support needed to complete the intramural and the extramural support phases of the NCI Scholars Program. o A Checklist Page should NOT be submitted. o The applicant must provide an official certified transcript covering medical school or the graduate school level of education. o Three sealed letters of reference from well-established basic or clinical scientists must be provided. One should be from the applicant's thesis advisor if applicable and one should be from the most recent mentor in a postdoctoral research setting. These letters should be attached to the face page of the original application. The letters should address the following issues: - The applicant's past contributions to scientific achievements; - The applicant's special potential to pursue and develop an independent research program; - The applicant's ability to work with other scientists in various interactive situations (e.g.. seminars, journal clubs, etc.), on collaborative research projects, and with support staff (e.g., technicians, secretaries). o Career Development Plan: - Applicants should describe their career goals and plans to achieve an independent research career, e.g. the need for any courses, research techniques or methods, etc. o Research Plan: - The scientific objectives and specific aims should describe research plans that are sufficient to justify up to four years of support. Applicants should also provide future research directions for the extramural support phase should be provided, i.e. what are the broad research goals and potential avenues of research that would be stimulated by your specific research project. o Budget: - The budget should span the proposed total duration of the award (maximum 6 years) including both the intramural and extramural phases (see section on ALLOWABLE COSTS). Using continuation pages as needed, provide in a detailed narrative format justification for the budgetary needs of the proposed research program, including personnel, consultants,equipment, supplies and travel. The narrative must be prepared carefully, as it will be a critical factor used by peer reviewers in evaluating the applicant's ability to manage the research program as proposed. Extramural (Transition) Support Phase After the Scholar/Awardee receives approval in writing for the transition to extramural support (See section on SELECTION PROCESS, Extramural Support Phase), the Scholar should contact NCI staff for change of institution procedures (see section on INQUIRIES). REVIEW CONSIDERATIONS Application Upon receipt, applications will be reviewed by the Division of Research Grants (DRG) staff for completeness. Incomplete applications will be returned to the applicant without further consideration. Applications also will be evaluated for responsiveness to this RFA. This will be done by program staff of the NCI, the main criteria being the applicant's eligibility and whether or not the research proposal is reasonably within the scientific areas of interest declared by the participating intramural divisions of the NCI (see section on RESEARCH TRAINING OBJECTIVES, Goals and Scope). Applications that are not responsive to the objectives of the RFA will be returned to the applicant. Applications which are complete and responsive to this RFA will be evaluated for scientific and technical merit in accordance with the review criteria stated below by an appropriate extramural initial peer review group (IRG) convened by the NCI Division of Extramural Activities. 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 The initial peer review criteria for applications submitted in response to this RFA will include the following: Candidate o Capacity to carry out independent research based on level of training, experience and competence commensurate with the purposes of this award. o Past and present research productivity, e.g. contributions to the scientific literature; success in obtaining fellowships. o Ability to conceptualize and organize a research approach that will make full use of the six years of support offered under this program. o The special qualities of the applicant to work in a scientifically interactive setting and collaborate with other scientists. This should be addressed in the letters of reference (see section on APPLICATION PROCEDURES). o Appropriateness of the applicant's career development plan and the likelihood that the award will contribute substantially to the continued scientific development and productivity of the candidate. o Potential to become an outstanding scientist who will make significant contributions to the field. Research Plan o Quality and innovativeness of the research plan, including appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research. o Potential of the research plan for contributing to the scientific literature. o Suitability of the proposed research plan for a six year research program. o Consistency of the research plan with the candidate's career goals. o Where appropriate, adequacy of plans to include both genders and minorities and their subgroups for the scientific goals of the research. Plans for recruitment and retention of subjects will also be evaluated. Budget o Justification of budget requests in relation to career development goals, research aims and plans. SELECTION PROCESS Intramural Support Phase The priority score assigned to the application and the critique of the IRG will be mailed to the applicant. The peer review-evaluated applications will be ranked according to priority score, and an NCI Selection Committee (NSC) consisting of Senior Scientists from the NCI Intramural Programs and the Chief of the NCI Cancer Training Branch will identify the pool of highly meritorious candidates to be invited to the NCI for interviews/seminars. Criteria for this recommendation will include the priority score of the candidate's application and programmatic needs. The recommendations of the NSC for each candidate will be reviewed for approval by the NCI Executive Committee. Following the interviews, a ranking and matching process by both the applicants and the sponsoring intramural departments will be used to determine the final awards. The Cancer Training Branch will coordinate the notification of the candidates about the status of their application. Extramural Support Phase The NCI will conduct a formal scientific progress review no later than the end of the third year of the intramural support phase to determine whether or not the Scholar will be recommended for the extramural phase of support. This review will be conducted by an NCI Progress Review Committee comprised of members of the NSC and other ad hoc intramural and extramural scientists. The results of the review will constitute a final progress report for the intramural phase and be presented in writing to the Scholar. Approval will result in eligibility for the extramural phase funding of the Career Transition Award and up to a fourth additional year of intramural support to facilitate the transition to an extramural laboratory. Disapproval will result in a terminal fourth year of intramural support with no transition funding. Approval for the transition of the Scholar to the extramural support phase could be made at any time prior to the third year of the intramural support phase. In such a case, the Scholar would remain eligible for up to one additional year of intramural support. However, the remaining unused portion of the intramural support phase will not be carried over into the two year extramural support phase. The Scholar must be accepted by an extramural institution which will request a change in institution by submitting a form PHS 398 noncompeting application which must include an updated research proposal and budget.. The application submitted by the Scholar and the extramural institution for activation of the extramural phase of the program will be evaluated by the NCI Cancer Training Branch and Grants Administration Branch for completeness and responsiveness to the RFA. 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 funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and programmatic priorities. All NSC recommendations will be forwarded to the NCAB as informational items. EVALUATION Intramural Support Phase Each Scholar's research program will be evaluated for progress on an annual basis like all other independent intramural scientific research programs. For this purpose, the Scholar will prepare on an annual basis a progress report, which will subsequently be evaluated by the corresponding laboratory/ branch chief and the appropriate NCI division director. Additionally, the NCI will conduct a formal scientific progress review (See section on SELECTION PROCESS, Extramural Support Phase) by no later than the end of the third year. Extramural (Transition) Support Phase The awardee will be required to submit a form PHS 2590 non-competing continuation application for the final year of extramural support. The application should provide a description of the research and career progress of the awardee, including: 1) Publications in press or submitted; 2) Current investigator-initiated research grant support, and 3) All applications submitted for investigator-initiated research grant support. These annual reports will be closely monitored by NCI staff to ensure that the awardee is achieving the goals of the NCI Scholars Program. The NCI may solicit information from the awardee after completion of the extramural transition support phase regarding their career progress, for the purpose of evaluating outcomes of the NCI Scholars Program.. INQUIRIES Inquiries concerning this RFA are encouraged, especially during the planning phase of the application to clarify any issues or questions from potential applicants. NCI contacts for specific areas of expertise are listed below: Direct inquiries regarding programmatic 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 fiscal/administrative matters. At least two months prior to transition to the extramural phase, contact the following official for information on application procedures for submitting a PHS 398 application from the new applicant organization: Ms. Sara Stone Office of Administrative Management National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: 301/496-7800 FAX: 301/496-8601 Email: STONES@GAB.NCI.NIH.GOV 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 78-41 0, 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 and 45 CFR Part 92. This program is not subject to the intergovernmental review requirements of Executive Order 123 72 or Health Systems Agency review. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of 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 for 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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