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THE NCI CAREER DEVELOPMENT AWARD FOR QUANTITATIVE SCIENTISTS RELEASE DATE: February 20, 2004 RFA Number: RFA-CA-04-016 EXPIRATION DATE: April 21, 2004 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Cancer Institute (NCI) (http://www.nci.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.398 LETTER OF INTENT RECEIPT DATE: March 22, 2004 APPLICATION RECEIPT DATE: April 20, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The purpose of this Request for Applications (RFA) is to solicit applications to encourage doctoral level quantitative scientists to develop and apply their skills to biomedical cancer research. This RFA is specifically intended for quantitative scientists, whose skills have not yet focused primarily on questions of health and disease and who wish to become cancer researchers as independent investigators and/or as leaders or co-leaders of interdisciplinary cancer research teams. Examples of scientific and technical backgrounds considered appropriate, but not all inclusive, for this award are as follows: physics, mathematics, computer science, imaging science, informatics, statistics, economics, chemistry, engineering, and nanotechnology. This K25 award provides up to 5 years of salary and research support for a mentored research career development experience in biomedical cancer research. Quantitative scientists receiving an NCI K25 Award will become eligible to apply for the NCI Transition Career (K22) Award, which would provide 3 years of protected time after completion of the K25 Award to develop an independent research program in biomedical cancer research. The “NCI Career Development Award for Quantitative Scientists” is not intended to supersede participation of the National Cancer Institute (NCI) in the existing omnibus “NIH Mentored Quantitative Scientist Research Career Development Award” (http://grants.nih.gov/grants/guide/pa-files/PA-02-127.html). Instead, this RFA represents a pilot program that is intended to complement and expand on the objectives of the NIH omnibus K25 program. This is achieved by requiring (1) that the research career development experience takes place at institutions that are NCI-designated Cancer Centers (P30s) and/or are supported by NCI Integrative Cancer Biology Programs (ICBPs or P50s) and (2) that a Mentoring Committee is in place to ensure that the candidate is progressing successfully toward meeting his/her proposed career development objectives. NCI-designated Cancer Centers are responsible for broad-based coordination and integration of research in academic and free-standing institutions and are therefore in a unique position to match the background of a quantitative scientist to tailored didactic and multidisciplinary research experiences needed for a successful career in cancer research. Additionally, NCI-designated Cancer Centers are characterized by scientific excellence and the ability to integrate diverse research approaches that focus on the problem of cancer. Consequently, the Cancer Centers represent ideal environments for quantitative scientists to identify areas that will bring their novel perspectives to bear on basic, clinical, prevention, or behavioral research in, for example, the development of new tests, devices, software, analytical tools, and innovative methodologies. Finally, institutions that have successfully competed for Integrative Cancer Biology Program grants are the ideal sites to nurture career awardees in the kind of team science efforts that truly integrate the quantitative and computational sciences with the biomedical sciences. This initiative is consistent with the recommendations of the Bioengineering Education and Training Panel which was convened as part of the 1998 Bioengineering Consortium (BECON) Symposium (the symposium Report is available at http://www.becon.nih.gov/becon_symposia.htm). This initiative is also consistent with the recommendations of the 2002 BECON Symposium "Catalyzing Team Science" (http://www.becon.nih.gov/symposium2003.htm). PROGRAM OBJECTIVES Background Many of today’s health problems are too complex to be readily addressed using a single discipline or even a multi-disciplinary approach. It has become increasingly apparent that interdisciplinary approaches are needed that integrate biological, clinical, behavioral and population science research with the quantitative sciences in highly collaborative team research settings. In 1998, BECON convened a 2-day symposium at the NIH to identify scientific priorities in several categories of bioengineering research and to propose strategies for addressing these priorities. In the area of clinical medicine, the need to catalyze multidisciplinary teams, to develop and document models of translational research, and to provide incentives for translational research were among the scientific priorities identified. NIH support for new approaches to educate persons committed to translational research and to create the intellectual infrastructure necessary for productive translational research were recommended as strategies for addressing these priorities. In the areas of education and training, the need to increase the level of quantitative skills at all levels through K awards was identified as a scientific priority. In 1999, the NIH issued PA 99-087 titled “Mentored Quantitative Research Career Development (K25) Award." This K award was intended for quantitative scientists whose research careers have not yet focused primarily on issues of health and disease. The award was intended to provide quantitative scientists a mentored biomedical research experience that would allow them to conduct basic, clinical, behavioral, bioimaging, or bioengineering research, and to become independent investigators or play leading roles in multi-disciplinary research teams. The K25 PA encouraged but did not require that career development takes place in a multidisciplinary, translational team-oriented research environment. The NCI Quantitative Scientist Career Development Award will support career development exclusively within this type of research environment. The Cancer Centers Program of the NCI (see: http://cancer.gov/cancercenters) provides the infrastructure that supports the establishment of multidisciplinary and interdisciplinary research programs through Cancer Center Support Grants (CCSGs or P30s). NCI Integrative Cancer Biology Programs (ICBPs or P50s) are specifically designed to create team research settings that integrate the biomedical, quantitative, and computational sciences. Both NCI-designated Cancer Centers and ICBPs represent ideal environments for quantitative scientists to identify areas that will bring their novel perspectives to bear on the basic, clinical, prevention, and behavioral cancer research. Objectives The objectives of the NCI Career Development Award for Quantitative Scientists are to: o Encourage research-oriented quantitative scientists (e.g., physicists, mathematicians, computer scientists, imaging scientists, informaticians, statististians, economists, chemists, engineers, and nanotechnologists with little or no experience in biomedical or health-related research to pursue careers in biomedical cancer research; o Engage NCI-designated Cancer Centers and NCI ICBPs to not only serve as the sites for career development, but to take a proactive role in selecting the best candidates to submit applications, matching candidates to the most appropriate mentor(s) and research, and monitoring performance of the mentors and the progress of candidates in order to ensure successful career outcomes. o Develop a cadre of quantitative scientists who can conduct biomedical cancer research as independent investigators and/or as leaders or co- leaders of interdisciplinary cancer research teams. Because this career award will support the first experience of quantitative scientists in applying their skills to biomedical cancer research, these individuals may require an additional period of protected time after completion of the NCI K25 Award to develop a funding base for their research. To accommodate this potential need, the eligibility requirements of the NCI Career Transition Award (K22) (PAR-04-040 http://grants.nih.gov/grants/guide/pa-files/PAR-04-040.html), will be expanded to include quantitative scientists who have been supported by this K25 Award. MECHANISM OF SUPPORT This RFA will use the NIH K25 career development award mechanism. Planning, direction, and/or execution of the career development plan of the candidate according to the special requirements of this RFA will be the responsibility of the applicant institution as implemented by the mentor(s) and the Mentoring Committee. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary NIH peer review procedures. The anticipated award date is September, 2004. Applications that are not funded in the competition described in this RFA may be resubmitted as standard NIH K25 applications in response to PA-02-027 or subsequent reissuances using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. Applicants may request up to 5 years of support. Each award is non- renewable and non-transferable from one Principal Investigator to another. Funding beyond the first year is contingent upon satisfactory progress during the preceding year, as documented in the required progress report. NIH Grant policies apply to these awards. This RFA follows the Just-In-Time initiative for Career Awards published in the NIH Guide, Volume 25, Number 10, March 29, 1996. Applications submitted in accordance with PHS 398 (Rev. 05/2001), Section IV (Additional Instructions for Preparing Individual Research Career Award (RCA) Applications - "K" Series, are in compliance with the instructions provided in the 1996 Guide Notice (See Supplementary Instructions below). FUNDS AVAILABLE The NCI intends to commit approximately $700,000 in FY 2004 to fund four new grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget for direct costs of up to $115,000 per year (excluding fringe benefits), which includes costs for Salary of the candidate and Research Development Support (see section below on Allowable Costs). Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NCI provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS An institution may submit an application on behalf of the candidate if it has either of the following characteristics: o It is an NCI-designated Cancer Center and is supported by an NCI Cancer Center Support Grant (P30 grant) and/or o Has pending an NCI Integrative Cancer Biology Program (P50) application. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS: To be eligible to apply for this award, candidates must be: (1) doctorally-degreed individuals in the quantitative sciences (e.g., physics, mathematics, computer science, imaging science, informatics, statistics, economics, chemistry, engineering, nanotechnology);(2) experienced quantitative scientists, who have been committed to a research career at either the postdoctoral, junior faculty or senior faculty level at the sponsoring institution (these could be individuals from the industry who will be trained at the sponsoring institution with the intent of establishing collaborative research programs between the sponsoring institution and the industrial sponsor after completion of the program – see below); (3) quantitative scientists with little or no experience in applying their research to biomedical research; and (4) individuals, who will devote a minimum of 75 percent full-time professional effort to the Award. The remaining 25 percent can be divided among other research, clinical, and teaching activities only if these activities are consistent with the goals of the K25 Award, i.e., the candidate's career development as an independent cancer researcher and/or as a leader or co-leader of an interdisciplinary research team. If the candidate, who will be supported by the K25 award, is from industry, there must be assurances from both the sponsoring institution and the industrial sponsor guaranteeing protected time as required in (4) above and stating the mutual commitment to develop collaborative research in the future. Only U.S. citizens or non-citizen nationals, or an individual lawfully admitted for permanent residence who possesses an Alien Registration Card (I-151 or I551), or some other verification of legal admission as a permanent resident, are eligible for this award. Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S.; they are usually born in the lands that are not States but under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. A candidate for this K25 award may not simultaneously submit or have pending an application for any other PHS or non-Federal award that duplicates any of the provisions of this award. Former or current principal investigators on any NIH research grants (this does not include NIH R03 or R21 grants or their equivalents) or non-PHS peer reviewed research grants that are over $100,000 direct costs per year, or project leaders on sub-projects of program project (P01) grants or center grants (P50) are NOT eligible to apply. SPECIAL REQUIREMENTS Special Programmatic Requirements 1. The sponsoring institution, through the Cancer Center and/or ICBP, must use a selection process that is broadly inclusive in selecting the most motivated, highly qualified candidates representing the quantitative sciences in the sponsoring institution to apply for the K25 Award. 2. The Cancer Center and/or the pending ICBP must play a significant role in matching the selected candidate to the most appropriate mentor(s) and research environment. 3. The candidate must have a mentor(s) who is a member of the NCI- designated Cancer Center or a project leader of a pending ICBP. This mentor(s) must have a strong research and training track record in biomedical cancer research, experience in interdisciplinary team research settings, and currently active independent support for biomedical cancer research. 4. The candidate must have a Mentoring Committee (MC) appointed by the senior leadership of the NCI Cancer Center and/or the pending ICBP. The MC should be an appropriately qualified interdisciplinary group of internal and/or external experts responsible for monitoring both the performance of the mentor and progress of the candidate in achieving his/her career objectives and becoming an independent investigator and/or a leader or co-leader of a interdisciplinary research project. The MC should perform these responsibilities at least once-a-year and should make recommendations to the Mentor(s) and the Candidate for improving career outcomes. A brief written Annual Summary (AS) of the MC’s deliberations and any recommendations should be prepared each year. The AS and statements describing how the mentor and candidate responded to any recommendations should be included in the annual progress report submitted to the NCI. 5. The Career Development Plan should include both didactic and research requirements designed to enable the candidate to achieve his/her objectives during the K25 award. Budget and Related Issues 1. Allowable Costs: a. Salary: The NCI Career Development Award For Quantitative Scientists (K25) will provide salary up to $75,000, plus fringe benefits. The total salary requested must be based on a full-time, 12- month staff appointment requiring the candidate to devote a minimum of 75 percent of full-time professional effort to conducting cancer research. The remaining effort should be devoted to activities related to the development of a successful research career. The salary must be consistent both 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 in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. The sponsoring institution may supplement the NIH contribution up to a level consistent with the institution's salary scale. Supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. Because the salary amount provided by this award is based on the full-time institutional salary, no other NIH funds may be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with or detract from the purpose of the award. Effective for all competing research grant applications submitted for the February 1, 2004, deadlines and beyond, mentored career award recipients in the last 2 years of career award support may hold concurrent support from their career award and a competing NIH research grant when recognized as a Principal Investigator or subproject Director. This new policy can be found at the following website:http://grants.nih.gov/grants/guide/pa-files/PAR-04-040.html b. Research Development Support: Up to $40,000 per year will be provided for the following types of expenses: (a) research expenses, such as supplies, equipment, and technical personnel; (b) statistical services including personnel and computer time; (c) tuition, fees, and books related to career development of the PI; and (d) travel to research meetings or for training. The level of research development support may be negotiated downward with the acquisition of any independent grant support from any source. c. Ancillary Personnel Support: Salaries for mentors, secretarial and administrative assistance, etc. are NOT allowed. d. Facilities and Administrative Costs: These costs, which were formerly called indirect costs, will be reimbursed at eight percent of modified total direct costs. 2. Other Income: Fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and research- related activities of this award may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods: a. The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution. b. The funds may be used for health-related research purposes. c. The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks should be made payable to the Department of Health and Human Services, NIH, and forwarded to the Director, Office of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment. d. Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, or honoraria from other institutions for lectures or seminars and fees resulting from clinical practice, professional consultation or other comparable activities, provided these activities remain incidental, are not required by the research and research-related activities of this award, and provided that the retention of such pay is consistent with the policies and practices of the grantee institution. Usually, funds budgeted in an NIH supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted. The awarding component will give consideration to approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of a career award must receive prior written approval of the NIH awarding component. Special Administrative Requirements 1. Special Leave: Leave to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award. Only local institutional approval is required if such leave does not exceed 3 months. In general, leave without award support may not exceed 12-months, should be requested only in unusual situations and will require prior written approval of the NCI. Such leave does not reduce the number of months of program support for which an individual is eligible. To request prior NCI approval, the award recipient must submit a letter to NCI describing the plan, countersigned by his/her mentor and the appropriate institutional official. A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the career award will continue during such leave. Under unusual circumstances, an awardee may submit a written request to the awarding component requesting a reduction in professional effort below 75 percent. Such requests will be considered on a case-by-case basis during the award period. In no case will it be permissible to work at less than 50 percent effort. The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission to reduce the level of effort will not be approved to accommodate other sources of funding, job opportunities, clinical practice, or clinical training. In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the awardee. In addition, the awardee must submit assurance of his/her intention to return to full-time professional effort (at least 75 percent) as soon as possible. During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly. 2. Termination of Grant When a grantee institution plans to terminate an award, NCI must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The Director of the NIH may discontinue an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, the Director of the NIH shall notify the grantee institution and career award recipient in writing of this determination, the reasons therefore, the effective date, and the right to appeal the decision. 3. Change of Institution Due to the unique institutional environment requirements of this award, individuals may not make a change of sponsoring institution. 4. Changes in Research Program Individual awards are made for career development at a specific NCI- sponsored Cancer Center in a specific integrated research environment. Consequently, a change in the specified scientific area of the research component of the career development program may be allowed only under extremely extenuating circumstances. A scientific rationale must be provided for any proposed changes in the aims of the original peer- reviewed research plan. The new research plan will be evaluated by NCI staff to ensure that the plan remains within the scope of the original peer-reviewed research and career development program. If the new plan does not satisfy this requirement, the award could be terminated. A final progress report, invention statement, and Financial Status Report are required upon termination or after completion of award. 5. Changes in Mentor(s) Grantees may request a change in mentor(s). This request must be submitted in writing to NCI staff, cosigned by an appropriate institutional business official, and include from the grantee 1)justification for the change, 2) name(s) of the new mentor(s); 3) a description of how the research expertise of the new mentor(s) will contribute to the achievement of the research and career development objectives of the peer-reviewed grant application. This request must be accompanied by a letter from the proposed new mentor(s) 1) documenting agreement to the change, 2)listing the current active support for his/her/their research using the PHS Form 398 OTHER SUPPORT Format page, 3) a description of how his/her/their research expertise will contribute to the achievement of the research and career development objectives of the peer-reviewed grant application 4) if primary mentor, a mentoring plans for the K-awardee. 6. Evaluation In carrying out its stewardship of human resource related programs, the NIH may begin requesting information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Lester S. Gorelic, Ph.D. Cancer Training Branch National Cancer Institute 6116 Executive Boulevard, Suite 7025, MSC 8346 Bethesda, MD 20892-8346 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-8580 FAX: (301) 402-4472 Email: gorelicl@mail.nih.gov o Direct your questions about peer review issues to: Referral Officer National Cancer Institute Division of Extramural Activities 6116 Executive Boulevard, Room 8041, MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (express/courier service) Telephone: (301) 496-3428 FAX: (301) 402-0275 Email: ncirefof@dea.nci.nih.gov o Direct your questions about financial or grants management matters to: Ms. Kimmery B. Griffin Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, EPS Room 243 Bethesda, MD 20892-7150 Rockville, MD 20852 (express/courier service) Telephone: 301-496-3196 FAX: 301-496-8601 Email: griffink3@mail.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA 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 plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Lester S. Gorelic, Ph.D. Cancer Training Branch National Cancer Institute 6116 Executive Boulevard, Suite 7025, MSC 8346 Bethesda, MD 20892-8346 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-8580 FAX: (301) 402-4472 Email: gorelicl@mail.nih.gov SUBMITTING AN APPLICATION: Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone: (301) 435-0714, Email: GrantsInfo@nih.gov. SUPPLEMENTARY INSTRUCTIONS: In addition to the required information listed in the instructions for Research Career Awards in the PHS 398, all applications MUST include the following information in the respective sections: BIOGRAPHICAL SKETCH o Provide information on research projects completed and/or research grants participated in during the last 5 years that are relevant to the proposed project o Provide Biographical Sketches for all members of the Mentoring Committee. LETTERS OF REFERENCE Three letters of reference must be provided from established scientists familiar with the candidate's potential and capability to become a successful independent investigator. These letters should be provided in sealed envelopes attached to the front page of the application. PROCESS FOR SELECTING THE CANDIDATE o Describe the process (in the form of a self-contained document) that will be used by the Cancer Center and/or the ICBP to identify and select potential candidates to apply for the K25 award, and for matching the candidate(s) to the most appropriate mentor(s) and research environment. If candidate(s) from industry are being considered, describe the role of the industry in this process. This document should be signed by an institutional business official, and NCI Cancer Center Director and/or the Director of a pending ICBP. THE CANDIDATE o Describe your commitment to a research career in the application of the quantitative sciences to biomedical cancer research. o Describe your immediate and long-term career objectives, explaining how the award will contribute to their attainment. o Describe all activities and professional accomplishments in the quantitative sciences; and, if appropriate, in biomedical research. Include all research experiences and mentors, any pertinent didactic experiences and any other experiences designed to acquire critical skills, techniques and scientific perspectives for pursuing an independent research career in the chosen area of cancer biomedical research (e.g., basic research, clinical, or patient-oriented research, and prevention, control and population research). o Describe and document your past scientific productivity (e.g., publications, discoveries) o Describe and document your ability to interact and collaborate with other scientists. o Establish the ability to make a commitment of at least 75 percent effort to the career objectives of this award, including any current duties that you will relinquish to pursue this career development opportunity. o Document prior instruction in or proposed plans for instruction in the responsible conduct of research in terms of subject matter and duration of instruction. An award cannot be made if an application lacks this component. MENTORING COMMITTEE o Describe in detail the composition of the MC appointed by the Cancer Center and/or the pending ICBP if appropriate and the frequency of meetings (note: the MC must meet at least once a year) o Describe the process and the factors to be used in the process the MC will use in overseeing the performance of the mentor, the effectiveness of the mentoring plan, the progress of the candidate in meeting his/her career didactic and research objectives and progress in becoming an independent investigator and/or a leader or co-leader of a interdisciplinary cancer research project. o Describe how recommendations of the MC for midcourse corrections or changes in the mentoring plan or research plan will be implemented. RESEARCH PLAN o Describe the research plan in basic, clinical, cancer prevention or cancer control research; or in behavioral or population sciences research directly related to cancer. The research plan must be described as outlined in form PHS 398 including sections on the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, Research Design and Methods. o Describe how the proposed plan extends the prior research experience in the quantitative sciences (and, if applicable, biomedical research) into new concepts and ideas in biomedical cancer research. o Describe the equipment, specialized facilities and personnel resources that will be needed to conduct the proposed research. o Describe the plans for inclusion of women, minorities and children in any clinical or population research activities. o Describe the plans for protection of humans, animals, or the environment to the extent they may be adversely affected by activities proposed in the application. CAREER DEVELOPMENT PLAN o Describe a systematic multi-disciplinary plan incorporating consideration of the candidate's goals and prior experience to obtain the necessary theoretical and conceptual background and research experience to launch an independent research career involving the integration of the quantitative sciences and biomedical cancer research. The career development plan must be tailored to the needs of the individual candidate and the ultimate goal of achieving independence as a researcher integrating the quantitative sciences with biomedical cancer research. This plan should include a description of the core didactic, biomedical research and quantitative sciences requirements that each candidate will be expected to satisfy during the K25 award. STATEMENT(S) BY MENTOR/CO-MENTOR(S) o The application must include a statement from the mentor(s) providing information on his/her basic or clinical biomedical research qualifications in the research area proposed by the candidate; his/her research support relevant to the candidate’s research plan; experience conducting interdisciplinary cancer research in a team-oriented research environment; and experience as a research supervisor. The mentor must also provide a plan for mentoring the candidate that is tailored to integrating an individual in the quantitative sciences into biomedical research, and describe how this plan is likely to contribute to the achievement of the objectives of the K25 award. The mentor(s) must agree to provide annual evaluations of the trainee's progress to the MC and to make midcourse corrections based on the MC’s recommendations. Co-mentors may be employed in any sector of the biomedical research community (e.g., academia, industry, non-profit research institutions). o Similar information must be provided by each co-mentor. When more than one co-mentor is proposed, the respective areas of expertise and responsibility of each should be described and distinguished from each other as they relate to the Research Plan and the Career Development Plan of the candidate. STATEMENT(S) BY CONSULTANT(S), AND COLLABORATOR(S) Signed statements must be provided by each consultant/collaborator confirming his/her participation in the project and describing their specific roles. Collaborators and consultants generally do not need to provide their biosketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration. LETTERS OF REFERENCE Three sealed letters of recommendation addressing the candidate's potential for a research career in the quantitative sciences and biomedical cancer research. The mentor's statement should not be included as one of the letters of recommendation, although the mentor(s) may submit a separate letter(s) of recommendation. ENVIRONMENT AND INSTITUTIONAL COMMITMENT TO THE CANDIDATE o Describe the existing depth and breadth of the funded biomedical cancer research at the sponsoring institution, especially those environments that are multidisciplinary and interdisciplinary, that will meet, sustain and nurture the proposed Research Plan and the Career Development Plan of the candidate and effectively integrate the candidate into biomedical research. o If not an NCI Cancer Center, describe the pending ICBP and specifically how it will be linked to the career development of the K25 award candidate. o By the sponsoring institution, provide assurance that the candidate will be able to spend a minimum of 75 percent full professional effort on the proposed career development plan/research, with the remaining 25 percent effort devoted to activities related to the development of a successful research career. IF THE CANDIDATE COMES FROM INDUSTRY, statements from both the sponsoring institution and the industrial sponsor must be included AND there has to be a commitment to develop collaborative research together after the candidate completes his/her career development program. These statements must be signed by appropriate officials representing the sponsoring institution and/or the industrial partner. o Describe the steps the sponsoring institution will take to help career progression of the candidate (i.e., to help the candidate become funded as either an independent investigator or as a leader or co-leader of a interdisciplinary research program) after the K25 award is completed. TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH o Candidates must describe plans to receive instruction in the responsible conduct of research. These plans must detail the proposed subject matter, format, frequency, and duration of instruction. No award will be made if an application lacks this component. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 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 RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, 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 and all copies of the appendix material must be sent to: Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Room 8041, MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express/courier service) Appendices should be comprised of single-sided, unbound materials, with separators between documents. APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE WILL NO LONGER BE ACCEPTED. This policy does not apply to courier deliveries (i.e., FEDEX, UPS, DHL, etc.) (http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html) This policy is similar to and consistent with the policy for applications addressed to Centers for Scientific Review as published in the NIH Guide Notice http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html. APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. 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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by CSR and for responsiveness by the NCI. Incomplete and/or non-responsive applications will not be reviewed. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities of the NCI in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o 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 o Receive a written critique o Receive a second level review by the NCI National Advisory Board. REVIEW CRITERIA The following review criteria will be applied: Process for Selection Of Candidates And Matching With Mentor(s). o Adequacy of the process with regard to involving the Cancer Center and/or the pending ICBP (and industry, when appropriate) o Appropriateness and adequacy of the selection criteria for candidates o Adequacy of the criteria for matching the candidate to the appropriate mentor(s) and research environment o Likelihood that the process has selected the best potential candidate within the sponsoring institution and has matched the candidate to the most appropriate mentor(s) Candidate o Quality of the research and academic record. o Potential to develop as an independent researcher and/or become a leader or co-leader of interdisciplinary research teams. o Strength of candidate’s commitment to a career in interdisciplinary biomedical cancer research. Mentoring Committee o Qualifications of the members of the Mentoring Committee to monitor and provide advice to the candidate and the candidate’s mentor to ensure that the candidate achieves his/her career objectives o Adequacy of the factors that the Mentoring Committee will use in monitoring the mentor and the progress of the candidate and making recommendations Career Development Plan o Likelihood that the career development plan will contribute substantially to the candidate's scientific development o Appropriateness of the content and duration of the proposed didactic and research phases of the award. o Consistency of the career development plan with the candidate's career goals and prior research experience. o Adequacy of the career development plan for producing a quantitative scientist who can conduct biomedical cancer research as an independent investigator and/or as a leader or co-leader of a team-oriented interdisciplinary research project. o Presence of the requirement for training in the responsible conduct of research Research Plan Reviewers recognize that an individual with limited research experience is less likely to be able to prepare a research plan with the breadth and depth of that submitted by a more experienced investigator. Although it is understood that K25 applications do not require the level of detail necessary in regular research grant applications, a fundamentally sound research plan must be provided. These particular career award applications should reflect considerable input from the mentor(s), since the candidate is not familiar with biomedical research. In general, less detail is expected with regard to research planned for the later years of the award, but the application should outline the general goals and a timeline for achieving those goals over the grant period requested o Appropriateness of the research plan to the candidate's stage of research development and as a vehicle for developing the research skills as described in the career development plan. o Scientific and technical merit of the research question, design, and methodology. o Relevance of the proposed research to the candidate's career objectives. o Adequacy of the plans to include both genders, minorities, and children and their subgroups as appropriate for the scientific goals of the research when human subjects are used. Plans for the recruitment and retention of subjects will also be evaluated, when applicable. Mentor/Co-mentors o History of research productivity and support in biomedical cancer research. o Appropriateness of the mentor's research qualifications in the area of this application, particularly in interdisciplinary team-oriented research. o Quality and extent of the mentor(s)’ proposed role(s) in providing guidance and advice. o Adequacy of prior experience in fostering the development of researchers who can conduct research in a team-oriented research environment. Core Requirements o Merit of the proposed core requirements to successfully train a quantitative scientist who can conduct biomedical cancer research in a team-oriented interdisciplinary research environment. Institutional Environment and Commitment o Evidence that the institution is committed to the candidate's scientific development and professional development. Assurance that the institution intends for the candidate to be an integral part of its research program. o Adequacy of research facilities and training opportunities (including access to such facilities or opportunities in other institutions). o Quality and relevance of the environment for the candidate's goals and objectives for scientific and professional development. o Quality, strength and clarity of the Institution's commitment to the candidate for 75 percent full-time, professional effort while supported on this award. o If the candidate comes from industry, adequacy of the statements from both the sponsoring institution and the industrial sponsor to commit to the development of collaborative research together after the candidate completes his/her career development program. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: March 22, 2004 Application Receipt Date: April 20, 2004 Peer Review Date: June/July 2004 Council Review: September 2004 Earliest Anticipated Start Date: December 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. Additionally, for applications submitted through a pending ICBP, the ICBP must be awarded before the K25 application can be awarded. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. See http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html.) Clinical trials supported or performed by NCI require special considerations. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the principal investigator/project manager or NCI program staff or a Data and Safety Monitoring Board (DSMB). These monitoring activities are distinct from the requirement for study review and approval by an Institutional review Board (IRB). For details about the Policy for the NCI for Data and Safety Monitoring of Clinical trials see: http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. For Phase I and II clinical trials, investigators must submit a general description of the data and safety monitoring plan as part of the research application. See NIH Guide Notice on “Further Guidance on a Data and Safety Monitoring for Phase I and II Trials” for additional information: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. Information concerning essential elements of data safety monitoring plans for clinical trials funded by the NCI is available: http://www.cancer.gov/clinical_trials/. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub- populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating 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 clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH- defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. 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 is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the “Standards for Privacy of Individually Identifiable Health Information,” the “Privacy Rule,” on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as “covered entities”) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on “Am I a covered entity?” Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.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. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. 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 is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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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