RFA-CA-01-007: THE NCI SCHOLARS PROGRAM

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THE NCI SCHOLARS PROGRAM Release Date: March 9, 2000 RFA: CA-01-007 National Cancer Institute Letter of Intent Receipt Date: May 8, 2000 Application Receipt Date: June 12, 2000 This Request for Applications (RFA) is a reissue of RFA CA-98-026 "The NCI Scholars Program" which was released in the NIH Guide on November 25, 1998. PURPOSE The purpose of the NCI Scholars Program is to provide an opportunity for outstanding new investigators to begin their independent research careers first within the special environment on the intramural campuses of the National Cancer Institute (NCI) and second to continue their careers at an institution of their choice. This program is designed to encourage exceptionally well qualified new investigators to establish themselves in the cancer research field by providing them with independent research funding. This is accomplished by providing through an NCI intramural funding mechanism for up to four years the necessary resources to initiate an independent research program at the NCI, followed by support for two years through an extramural funding mechanism (K22) of their research program at the extramural institution to which they are recruited. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA, The NCI Scholars Program, is related to the priority area of human resource development. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Individuals with a research or health professional doctoral level degree or equivalent, who are recognized by their peers and mentors as exceptional but with no more than five years of postdoctoral research training at the time of application, are eligible to apply. These individuals should possess outstanding abilities in basic biomedical, clinical or population-based (e.g., epidemiological, behavioral, prevention or control) research, mathematics, or in technology-based research. This includes individuals with research experience in any environment (e.g., academic, industry, government). Individuals who have had more than five years of postdoctoral research training at the time of application are NOT eligible to apply; however, clinical training does not count against the five years of research experience. Individuals who have been principal investigators on either Public Health Service (PHS) research grants (e.g., R29, R01, P01 or subprojects) or non-PHS peer reviewed research grants are NOT eligible to apply for this award. Postdoctoral fellows in intramural programs at the NCI who meet the Eligibility Requirements are eligible to apply, but will not be placed in Laboratories/Branches where they have previously trained. Minorities and women and persons with disabilities are encouraged to apply. Candidates must be U.S. citizens or non-citizen 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 the award. 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 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 consists of an Intramural Phase and an Extramural Phase. The program begins with up to four years of support for the Scholar's independent research initiative in the NCI's intramural research program. Salary and research costs for this phase will be derived exclusively from intramural NCI resources. There is no grant award associated with this phase. The final two years of the Scholar's research program are supported by the extramural institution to which the scholar is recruited and will be funded through an extramural, NIH Career Transition Award (K22) mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. FUNDS AVAILABLE It is anticipated that applications for the NCI Scholar's Program will be solicited annually. Each annual solicitation will indicate the general areas of research and the number of positions that will be sponsored. For the Intramural Phase, approximately $1,500,000 per year for up to four years will be set aside to fund about 10 awards. However, this funding level is dependent upon the receipt of a sufficient number of meritorious applications 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 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 an 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 Phase of the award. The individuals noted in the section on INQUIRIES should be consulted for any clarifications of intent or content. 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 OBJECTIVES Background For decades, the intramural research program of the National Cancer Institute has provided an extraordinary research environment for the training of new scientists who go on to become leaders in the extramural biomedical research community. In addition to enriching the NCI intramural research environment with new investigators, the Scholar’s Program is uniquely designed to facilitate the transition of the NCI Scholars to independent research careers in the extramural community. Goals and Scope The NCI Scholar's Program is designed to enable exceptional junior investigators in basic, clinical or population-based biomedical research to establish their first independent research program. This would include individuals with backgrounds in specialized fields such as mathematics, technology development, etc., who wish to initiate cancer research programs. The Program offers a novel opportunity for new investigators who are exceptionally talented to establish an independent research program early in their careers. NCI Scholars will independently design and pursue their research projects with facilities, and operating budget for salary and personnel provided by NCI. NCI Scholars will be responsible for all aspects of their research program, including the progress of the research and the management of allocated resources. While the Scholars will not have a formal research mentor, they will receive orientation and guidance into the NCI/NIH environment and other support necessary to carry out their research. The NCI intramural divisions invite applications for the NCI Scholars Program in the following scientific areas: o The Division of Basic Sciences encourages applications from candidates with an exceptional ability to identify key research problems and strong evidence of the ability to develop and run an independent, focused, hypothesis-driven research program. Applications are invited in the general research areas of cell biology, cancer genetics and immunology. For example, proposals could address problems relating to cellular transformation, oncogenes, tumor suppressor genes, apoptosis, signal transduction, regulation, chromatin structure, structural biology, cellular carcinogenesis, tumor biology, viral immunology, tumor immunology, developmental biology, and cell cycle regulation. o The Division of Cancer Epidemiology and Genetics encourages applications from candidates with experience and interest in pursuing epidemiologic or interdisciplinary research into environmental and genetic determinants of cancer in a highly integrative and collaborative research environment. Areas of special research interest include: lifestyle factors such as diet and nutrition; genetic and familial susceptibility; occupational exposures and environmental pollution; infectious agents; radiation exposures; pharmacoepidemiology; and methodologic research in biostatistics and bioinformatics, exposure assessment, and genetic and molecular epidemiology. o The Division of Clinical Sciences encourages applications from candidates with an interest in research that links the concepts of the clinic with the concepts of the laboratory. Candidates are expected to develop an independent and focused research program that will likely include collaborations with clinicians and basic scientists. Areas of research interest include angiogenesis, apoptosis, cancer biology, gene expression, gene therapy, developmental therapeutics and immunotherapy. The diseases studied include AIDS and AIDS related malignancies, breast cancer, childhood tumors, colorectal cancer, kidney cancer, lung cancer, lymphoma, melanoma, ovarian cancer, and prostrate cancer. Applications are encouraged from candidates with research experience in basic science and/or clinical science who want to develop their research programs in an exceptional environment where research findings impact directly on clinical practice. Individuals with training in mathematics or engineering are encouraged to propose programs where their unique backgrounds can interface with ongoing development of novel technologies. Allowable Costs Intramural Phase: The budget for the intramural support phase will be approximately $200,000 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. Salaries will be provided for the Scholar and up to two additional support positions (e.g., a Cancer Research Training Award (CRTA) fellow and a Cancer Research Training Award (CRTA) technical fellow.) The salary range for the Intramural Phase of the Scholar’s award is $46,000 to $60,000 per annum. The salary will be based upon the Scholar’s level of training and experience and will be determined through negotiation with the sponsor. Stipends for CRTA fellows and technical fellows are based on their highest degree(s) attained and years of experience and are posted in the CRTA guidelines. Up to $22,500 per person per year will be provided for research supplies and services, including chemicals, biologicals, etc. A Scholar with two CRTA fellows would have a supplies and services budget up to $67,500. Additional budget expenses, such as animal costs and required equipment, will be provided as necessary and negotiated with the NCI. Equipment purchased for the Scholar during the Intramural Phase will not be transferable to the extramural position. Extramural Phase: The budget for the two-year extramural transition phase may not exceed $125,000 plus fringe benefits per year in direct costs. At the extramural institution, 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. This grant is included under Expanded Authorities. However, funds available for the salary of the principal investigator will be restricted and may not be rebudgeted without the approval of the NCI. 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. Facilities and administrative (F&A) costs are now reimbursed at 8% modified total costs. During the Extramural Phase, the Scholar is encouraged to apply for additional support through investigator-initiated research grants, e.g., R01, R03, R21. The K22 and an R series grant may be held concurrently, but salary can only be provided through the K22 (and supplements as noted above) during the overlap years. 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. All 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, available on the web at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html Investigators may obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all applications submitted in response to this RFA. All investigators proposing research involving human subjects should read the "NIH Policy And Guidelines on The Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide For Grants And Contracts, March 6, 1998 and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. LETTER OF INTENT Prospective applicants are asked to submit, by May 8, 2000, a letter of intent that includes a descriptive title of the proposed research, the name, address, telephone and FAX numbers, and email address of the Principal Investigator, 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, 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 the program staff listed under INQUIRIES by the letter of intent receipt date listed in the heading of this RFA. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) 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 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: grantsinfo@nih.gov. For those applicants with internet access, the 398 kit may be found at http://grants.nih.gov/grants/forms.htm The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. 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. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed, typewritten original of the application and three signed photocopies in one package to: Center for Scientific Review 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 6116 Executive Boulevard, Room 8062, MSC 8239 Bethesda, MD 20892-8239 Rockville, MD 20852 (for express/courier service) Applications must be received by June 12, 2000. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) 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 CSR 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. The initial application for the NCI Scholars Program will not be processed through your current institution; therefore, follow the supplemental guidelines below. Supplemental Application Guidelines 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. The applicant must provide her/his signature in item 15; signature is not required for item 16. Leave items 9-14 and 16 on the face page blank. 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. A Checklist Page is NOT to be submitted. Applicants who are not U.S. citizens must provide an official certified transcript covering medical school or the graduate school level of education. A total of three sealed letters of reference from well-established basic or clinical scientists must be provided. One letter should be from the most recent mentor in either a postdoctoral research setting or from the applicant's thesis advisor. These letters are to 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). Career Development Plan: Applicants should describe their overall career goals and plans for continued scientific development in their research career, including the need for any courses, research techniques or methods, etc. 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, i.e., what are the broad research goals and potential avenues of research that would be stimulated by your specific research project. Budget: Do NOT provide any dollar figures in the application. The final budget will be negotiated when a selected applicant accepts a position and will be within the allowable costs specified above as well as consistent with the peer-reviewed recommended scope of the research program. Using continuation pages as needed, provide in a detailed narrative format justification for the budgetary needs of the proposed research program, e.g. personnel, consultants, equipment, animals, patient populations, databases, supplies and travel. This justification should be prepared carefully, since it will be a critical factor used by peer reviewers in evaluating the applicant's knowledge and ability to manage the proposed research project. Extramural (Transition) Phase: After the Scholar/Awardee receives approval in writing for the transition to extramural support (See section on SELECTION PROCESS, Extramural Phase), the Scholar should contact NCI staff for change of institution procedures (see section on INQUIRIES). REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the Center for Scientific Review (CSR) 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 OBJECTIVES, Goals and Scope). Applications that are not responsive to the objectives of the RFA will be returned to the applicant without review. Applications that 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, generally the top half of the applications under review, will be discussed and assigned a priority score and receive a second level of review by the National Cancer Advisory Board. Review Criteria: The peer review criteria for applications submitted in response to this RFA are: 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. The level of achievement will be judged relative to the number of years of training. 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 specific aims for the initial three to four year research program. o Appropriateness of proposed future directions and broad research goals. 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. The initial review group will also examine: the appropriateness of proposed project budget and duration; the adequacy of plans to include both genders and minorities in their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the adequacy of plans for including children as appropriate for the scientific goals of the research, or justification for exclusion; the provisions for the protection of human and animal subjects; and the safety of the research environment. Selection Process The priority score assigned to the application and the critique of the IRG will be mailed to the applicant. Intramural Phase A Scholars Selection Committee (SSC) consisting of extramural scientists, senior NCI scientists, and the Chief of the NCI Cancer Training Branch will identify the highly meritorious candidates to be invited to the NCI for interviews/ seminars. Criteria for this selection will include the priority score and recommendations of the initial peer review committee, and programmatic priorities. The recommendations of the SSC for each candidate will be reviewed for approval by the NCI Executive Committee. A ranking and matching process by both interviewees and the sponsoring intramural divisions will then be used to determine final intramural unit assignments. Candidates who are successfully matched with a host intramural unit as a result of the recruitment process will be offered Scholars Awards. The Cancer Training Branch will coordinate the notification of the candidates about the status of their application. The specific terms of the intramural phase will be finalized in a Scholars Agreement. The applicant indicates his/her acceptance of the Scholars Award and the specific intramural appointment terms by signing the Scholar’s Agreement. Extramural Phase Eligibility for the Extramural Phase funding of the Career Transition Award (K22) will be determined by a formal scientific progress review conducted by an NCI Progress Review Committee. This review can be conducted at any time prior to the end of the third year of intramural support. The results of the review will be presented in writing to the Scholar. Approval will result in eligibility for the Extramural Phase funding of the Career Transition Award (K22) and up to one 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. Regardless of when the approval for transition is obtained, the maximum duration of the Extramural Phase would remain at two years. Prior to activation of the Extramural Phase of the program, the Scholar must obtain a position as an independent researcher at an eligible sponsoring extramural institution. Application procedures for the non-competing NIH Career Transition Award (K22) will be provided by the NCI Grants Administration Branch (see section on INQUIRIES). AWARD CRITERIA Applications will compete for available positions/funds with all other scored applications submitted in response to this RFA. The following will be considered in making award decisions: Qualifications and potential of the applicant and quality of the proposed research project as determined by peer review; programmatic priorities; and availability of funds. EVALUATION Intramural 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 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) no later than the end of the third year. Extramural (Transition) Phase The awardee will follow the same procedure as all other extramural grantees by submitting a progress report as part of the non-competing continuation application. A description of the research and career progress will be provided including publications, current research grant support, and pending applications. 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 Phase regarding their career progress, for the purpose of evaluating outcomes of the NCI Scholars Program. SCHEDULE: Letter of Intent Receipt: May 8, 2000. Application Receipt: June 12, 2000. Review by NCAB: February, 2001. Earliest Anticipated Start Date: April 1, 2001. 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 eligibility and other programmatic issues to: Lester S. Gorelic, Ph.D. Office of the Deputy Director for Extramural Sciences National Cancer Institute Executive Plaza North, Room 520 Bethesda, MD 20892-7390 Telephone: (301) 496-8580 Fax: (301) 402-4472 Email: LG2H@NCI.GOV Direct inquiries regarding the following to: 1. Fiscal/administrative matters; and 2. At least two months prior to the transition from the Intramural Phase to the Extramural Phase, for information on procedures for submitting a non-competing application from the new applicant organization, using the PHS Form 398 and specifying change of grantee institution: Ms. Catherine Blount Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-3179 Fax: (301) 496-8601 Email: CB136G@NIH.GOV Direct inquiries regarding review issues to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8062, MSC-8239 Rockville, MD 20852 (express courier) Bethesda, MD 20892-8239 Telephone: (301) 496-3428 Fax: (301) 402-0275 Email: tf12w@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 Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. 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 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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