INSTITUTIONAL CLINICAL ONCOLOGY RESEARCH CAREER DEVELOPMENT PROGRAM RELEASE DATE: March 20, 2003 PA NUMBER: PAR-03-083 (see replacement PAR-04-096) (see addendum NOT-CA-04-008) EXPIRATION DATE: April 1, 2004 (per addendum NOT-CA-04-008) National Cancer Institute (NCI) (http://www.nci.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANT NUMBER(S): 93.398 LETTER OF INTENT RECEIPT DATE: May 1 APPLICATION SUBMISSION DATE: June 1 This Program Announcement (PA) replaces PAR-00-063, Clinical Oncology Research Career Development Program, which was published in the NIH Guide on February 17, 2000. THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism of Support 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 Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE The purpose of the National Cancer Institute (NCI) Institutional Clinical Oncology Career Development Program, referred to in this PAR as the Program, is to increase the number of medical doctors (M.D.'s, D.O.'s) and Nurses who are motivated and properly trained to: (1) perform clinical oncology research that develops and tests scientific hypotheses based on fundamental findings; 2) design and test hypothesis-based clinical protocols and manage all phases (i.e., pilot/Phase I, Phase II, and Phase III) of cancer therapeutic clinical trials, and (3) communicate and collaborate with basic research scientists in order to expedite the translation of basic/behavioral research discoveries into patient- oriented therapeutic cancer research. The National Cancer Institute (NCI) Institutional Clinical Oncology Career Development Program is intended to train clinical researchers whose career focus will be on patient-oriented therapeutic research and not on laboratory-based research. Clinicians seeking a career development experience in laboratory-based research should refer to the NIH Mentored Clinical Scientist Career Development Award or K08. To achieve the purpose of this Program, awards are made to institutions for up to five years for the development and implementation of training programs providing clinicians with all of the necessary information and training that will enable them to design, implement and manage all phases of therapeutic cancer clinical trials research. For the purposes of this award patient-oriented research is defined as research conducted with human subjects for which an investigator directly interacts with human subjects. RESEARCH OBJECTIVES o Background: In 1991 the NCI recognized the need for establishing formal training programs that would prepare the next generation of clinical scientists to participate more effectively in translational research. The NCI embarked on a pilot program initiative that would prepare clinical oncologists to be effective scientific partners with basic/behavioral scientists in the movement of discoveries in the laboratory into patient research settings or the reverse process of taking observations in the clinic back into a laboratory research setting. These well-trained clinical oncology researchers would be expected to communicate, interact and collaborate with basic/behavioral scientists in the design and implementation of clinical trials that were hypothesis driven and based on an understanding of biological mechanisms. This pilot program initiative was implemented through two successive RFAs in 1992 and 1997 and was founded on the following principles: (1) unlike career awards to individuals, these would be awards to institutions and the institution would appoint individuals to a formal training Program; (2) rather than having a single mentor, the individuals on the program would likely have more than one mentor as they are exposed to the basic sciences and to the many disciplines critical to the clinical sciences; (3) the Program would provide individuals with all of the information and training needed to design, implement and manage all phases of clinical trials research. This initial pilot Program was highly successful and had generated considerable interest in the cancer research community. It became clear that advertising the Program every five years as an RFA would not provide sufficient opportunity for this community to submit applications. The conclusion was that NCI objectives would be better served by making this grant mechanism open to investigator-initiated applications on a regular basis using a Program Announcement (PA). As a result, the NCI decided to establish the Clinical Oncology Research Career Development Program(K12) as an ongoing PA with a once-a-year submission date. Additionally, due to the critical role of nursing in general and oncology nursing in particular, in clinical cancer research and care, the PA extended eligibility to include doctorally prepared Oncology Registered Nurses. The expectation of the NCI is that this kind of training program will greatly enhance and promote the multidisciplinary research approaches and team concepts needed for conducting clinical cancer research and for delivering optimum cancer patient care. In view of the continuing commitment of the NCI to increasing the participation of individuals from underrepresented minority groups in biomedical and behavioral research and the critical need for more underrepresented minorities in clinical oncology research, all competing applications for an Institutional Oncology Career Development Program (K12)Grant are required in this latest reannouncement of this Program to include a specific plan to recruit and retain underrepresented minorities as trainees. o Program: The award provides support to institutions for up to five consecutive 12-month periods. Appointments of clinical candidates to the program are provided in 12-month increments. The Program provides research career development opportunities in more than one clinical oncology research discipline (e.g., medical oncology, surgical oncology, radiation oncology, oncology nursing, etc.). Both the didactic and the research phases of the award are expected to develop the necessary knowledge and research skills in scientific areas relevant to the career goals of the candidate in clinical research. Candidates lacking skills in data management, statistics, epidemiology, study design, clinical trial design, hypothesis development, drug development, etc. will be provided the opportunity to participate in courses designed to overcome these deficiencies. MECHANISM OF SUPPORT This PA will use the NIH Mentored Clinical Scientist Development Program Award or K12 mechanism. Planning, direction and execution of the program will be the responsibility of the Program Leader/Principal Investigator and the Advisory Committee on behalf of the applicant institution. The project period is up to five years. Awards are renewable. Awards will be administered under NIH grants policy as stated in the National Institutes of Health Grants Policy Statement (Rev. 3/01) and described on http://grants.nih.gov/grants/policy/nihgps_2001/. However, the K12 award, as administered by the National Cancer Institute, is not subject to "Just-in-time" application procedures or to the Streamlined Noncompeting Application Process (SNAP). The K12 remains under "Expanded Authorities" except that carryover of funds from one fiscal year to the next requires approval by the NCI. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o Domestic o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories Foreign institutions are not eligible to apply. INDIVIDUALS ELIGIBLE TO BECOME PROGRAM LEADER The Program Leader is the Principal Investigator (PI), must be an established investigator in patient-oriented research and able to provide both administrative and scientific leadership to the Program. Minorities, women and individuals with disabilities are encouraged to apply as principal investigators. ELIGIBLE CLINICIAN CANDIDATES All candidates or trainees must currently be physicians holding the M.D. or D.O. degrees, or be nurses with a Ph.D. degree; and must have completed the necessary clinical training (i.e., completed residency and are board eligible) to engage in clinical oncology research. Candidates must be able to spend a minimum of 75 percent effort conducting research and research career development, which includes all relevant didactic activities during the period of the award. All clinician candidates must be citizens or non-citizen nationals of the United States, or must have been lawfully admitted to the United States for permanent residence (i.e., in possession of a currently valid Alien Registration Receipt Card I- 551, or other legal verification of such status). Non-citizen nationals are generally persons born in outlying possessions of the United States (i.e., American Samoa and Swains Island). Individuals on temporary visas are not eligible. Clinician candidates who were former or who are current principal investigators on NIH Small Grants (i.e., R03s) or Exploratory/Developmental Grants (i.e., R21s) remain ELIGIBLE. However, former or current principal investigators on NIH research project grants (i.e., R01s), FIRST Awards (i.e., R29s), sub- projects on Program Project Grants (i.e., P01s) or on center grants (i.e., P50s) and the equivalent are NOT ELIGIBLE. Candidates who have been supported on NIH or non-NIH career development awards are NOT ELIGIBLE unless approved by the NCI. SPECIAL REQUIREMENTS Special NCI Programmatic Requirements o Where there already exists an active Ruth L. Kirchstein (T32) National Research Service Award Program supporting a surgical or other clinical oncology research training program, the applicant must address the relationship between the existing T32 and proposed K12 programs. If there is significant overlap in the programs, the T32 award can be merged into the K12 program or modified to remove areas of substantial overlap. In those institutions with a Clinical Research Curriculum (K30) Award, the didactic component of this proposal should be linked with the K30 award. o Institution: The institution must have substantial peer-reviewed basic and clinical research support and faculty qualified in patient-oriented therapeutic cancer research to serve as mentors in the proposed Program. o Environment: The research environment should be one in which there are active basic/clinical research collaborations that exemplify a dynamic two-way exchange of information and ideas between basic and clinical scientists. o Program: 1. Program Management: The PI must use an Advisory Committee (AC) to provide an oversight function and annual evaluation of the Program as a whole. The committee's responsibilities should include but are not limited to: selecting physician and nurse candidates, assigning preceptors, approving each candidate's research development plan, evaluating each candidate's progress, monitoring the overall effectiveness of the program and recommending mid-course changes when needed. A detailed description should be provided of the committee's composition, function, and frequency of meetings. Plans for an annual evaluation of the program by the Advisory Committee should be described. 2. The Program must involve staff and clinical candidates representing at least two clinical oncology disciplines such as medical oncology, surgical oncology, radiation oncology, pediatric oncology, gynecologic oncology and oncology nursing. Clinical candidates from non-oncology medical subspecialties may also be represented in the Programs. However, these subspecialties should have direct relevance to cancer (e.g., thoracic surgery, pulmonology) and the individualized career development plans developed for these candidates must be focused on clinical oncology research. 3. The Program must motivate and train candidates to: 1) perform clinical oncology research that develops and tests scientific hypotheses based on fundamental and clinical research findings; 2) design and test hypothesis-based clinical protocols and manage all phases (i.e., pilot/Phase I, Phase II, and Phase III) of cancer therapeutic clinical trials, and (3) communicate and collaborate with basic research scientists in order to expedite the translation of basic research discoveries into patient-oriented therapeutic cancer research. 4. Programs should have the flexibility to accommodate clinical candidates with different levels of research experience and competence. 5. All competing applications for an Institutional Oncology Career Development Program (K12) Grant are now required to include a specific plan to recruit and retain underrepresented minorities in the Program. In addition, all future Non-competing Grant Progress Reports must include a report on the recruitment and retention of underrepresented minorities during the previous award period. 6. Appointments of clinical candidates to the program should be for a minimum of two years. As long as a K12 has been renewed, individual candidates can be supported for up to seven years. Clinical candidates must commit a minimum of 75 percent effort to the Program. The remaining 25 percent can be divided among other clinical and teaching activities only if they are consistent with the Program goals (i.e. the candidate's development into an independent clinical oncology researcher). 7. The Program should include Core Requirements that each candidate is expected to complete before meeting the Program's training objectives. All candidates graduating from the program must complete all of these requirements either directly or through combination with their past training experience. These requirements should include the following: a. A didactic core component (e.g. formal courses in clinical trial design, biostatistics, informed consent, Institutional Review Boards; lecture series, seminars, and journal clubs) based on the experience and needs of each candidate. b. A clinical research core component that provides "hands-on" experience (e.g., protocol development; preparation of IRB applications; clinical trials management including patient accrual, analysis of outcomes) in all aspects of Phase I, Phase II and where possible Phase III clinical trials. c. A basic research core component that provides a hands-on research experience that adequately prepares the trainee for communication, coordination and collaboration of clinical research activities with basic scientists. This experience should be linked to the core clinical research component. The expectation of the NCI is that candidates entering the Program with different backgrounds initially will satisfy many of the Core Requirements and that they will be provided with the additional didactic and research experiences over different periods of time in order to fully meet the objectives of the Program. Special Administrative Requirements o Special Leave: Leave of a trainee to another institution, including a foreign laboratory, may be permitted if directly related to the purpose of the award. Only local, institutional approval is required if such leave does not exceed 3 months. For longer periods up to one year, prior written approval of NCI staff is required. To obtain prior approval, the trainee must submit a letter to the NCI Grants Administration Branch with a copy to the NCI Program Director describing the plan, countersigned by his or her department head 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 for the leave and for the return of the trainee to the Program. Support from the award will continue during such leave. Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NCI and will be granted only in unusual situations. Support from other sources is permissible during the period of leave. Parental leave will be granted consistent with the policies of the grantee institution. o Termination: When a grantee institution plans to terminate an award, the NCI must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. 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 recipients in writing of this determination, the reasons therefore, the effective date, and the right to appeal the decision. o Change of Institution: The Clinical Oncology Career Development Program (K12) cannot be transferred from one institution to another. o Change of PI: If the PI moves to another institution or resigns from the position, support of the award may be continued with NCI prior approval provided: 1. The current PI or the awardee institution has submitted a written request for change of PI, countersigned by the appropriate institutional business official, to the NCI Grants Administration Branch with a copy to the NCI Program Director describing the reasons for the change. The biosketch of the proposed new PI, including a complete listing of active research grant support, is provided. The information in the request establishes that the specific aims of the original peer reviewed career development program to be conducted under the direction of the new PI will remain unchanged; and that the new PI has the appropriate research and administrative expertise to lead the program. 2. The request is submitted far enough in advance of the requested effective date to allow the necessary time for review. o Changes of Program: Awards are made to a specific institution for a specific program under the guidance of a particular PI. Changes in any of these parameters requires prior approval by the NCI. A scientific rationale must be provided for any proposed changes in the aims of the original peer reviewed program. The new program will be evaluated by NCI staff to ensure that the program remains within the scope of the original peer reviewed research program. If the new program does not satisfy this requirement, support could be withheld or the award could be suspended or terminated. Budget and Related Issues o Allowable costs: 1. Direct cost cap: No application may exceed $700,000 in direct costs per annum. Applicants do not need to request prior permission to submit the K12 application unless the application is in addition to another K12 application submitted by the same institution; in addition to another NCI K12 grant at the same institution; or the requested direct costs per annum in any year exceeds the current cap on NCI K12 grants. 2. Salary: Clinician research candidates may be provided salary support of up to $75,000 each year based on a full-time,12 month staff appointment; plus fringe benefits commensurate with the applicant institution's salary structure for persons of equivalent qualifications, experience, and rank. 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 NIH 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. The total salary requested must be based on a full-time, 12 month staff appointment. Salary support for the Program Leader/Principal Investigator and participating faculty is not allowed. 3. Research and Development Support: No more than $30,000 per individual candidate can be provided for the following types of expenses: (a) research expenses, such as supplies, equipment and technical personnel; (b) tuition, fees and books related to career development; (c) travel to research meetings or training; and (d) statistical services including personnel and computer time. These costs must be specifically documented for each individual candidate and must be specifically and directly related to the candidate's research activities. They cannot be pooled and used for advertising, recruiting or other programs unrelated or indirectly related to the research activities of individual candidates or trainees. It is anticipated that the K12 trainees will be working in a funded research environment. It will therefore be allowable to use the research and development support provided by the K12 grant to augment this support in order to be able to include the trainee in this research, but it will not be allowable to use this to pay substantially for funded basic research studies or clinical trials. 4. Ancillary Personnel Support: Salaries for mentors, secretaries, administrative assistants and other ancillary personnel are not allowed. 5. Facilities and Administrative Costs: These costs, which were formerly called indirect costs, will be reimbursed at 8 percent of modified total direct costs. 6. 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: 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. The funds may be used for health-related research purposes. 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. 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, provided these activities remain incidental and provided that the retention of such pay is consistent with the policies and practices of the grantee institution. Funds budgeted in an NIH-supported research or research training grant for the salaries and/or fringe benefits of individuals, but freed as a result of a K12 award, may not be rebudgeted and may not be used for any other purpose without prior NIH approval. 7. Carryover of unobligated balances: Although the K12 is subject to Expanded Authorities, the carryover of funds from one budget period to the next requires prior written approval by NCI. Special Reporting Requirements: o The K12 grant, as administered by the NCI, is not subject to the Streamlined Noncompeting Application Process (SNAP). In general this means that all reporting of budgetary information and program progress are provided in greater detail in an annual progress report. o Progress Reports: An Annual Progress Report for the grant is required. This report should provide information about changes in the Program, an evaluation of the Program made by the Advisory Committee, and a description of the research and career progress of each candidate. These Annual Reports will be closely monitored by NCI staff to ensure that the grant is achieving the goals of the K12 initiative. Progress reports are submitted using the Form PHS 2590, which can be obtained at the following website address: http://grants.nih.gov/grants/funding/2590/2590.htm. The procedure for obtaining the face page for the application is described on the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-066.html Since the Form PHS 2590 does not apply easily to the K12 grant, adapt the application for continuation to contain the following information: o Appropriate face page (Form Page 1) as instructed in the Form PHS 2590. o A budget page (Form Page 2) that provides the salary and fringe benefits for each candidate or trainee by name or by position if no individual is filling the position at the time of the application. Provide all other budgetary information (e.g., supplies, travel, technical help)by trainee name or by the position broken out specifically for each candidate and/or trainee up to the $30,000 limit. o A brief description of the Objectives and Goals of the Program o A brief summary listing by name delineating which faculty, mentors and Advisory Committee members have left the Program and which new individuals have been added or are taking their places. Include for each person their degree and department affiliation (or equivalent). o Biographical sketches of i. New faculty ii. New mentors iii. New Advisory Committee (AC) Members iv. New Trainees The biosketches for each trainee should include any Board Eligibilities or Certifications. The biosketches for new faculty/mentors/AC members should include a listing of all active research grant support for which they are the PI or co-investigator. o Progress of Individual Trainees: For each trainee, provide the start date (month/year) of the appointment to the Program and the cumulative number of years supported by the K12 grant; the names of the basic and clinical research mentors; and a brief paragraph for each candidate or trainee describing the basic laboratory and clinical research and didactic training experiences completed and ongoing, the relationship between the two research training experiences, and the specific future plans for satisfying the Core Requirements of the Program. The individual reports should also include: 1) A list of publications for the trainee resulting from their work in the Program; 2) Descriptive titles of clinical trials developed and/or implemented by each trainee and resulting from their work in the program, identifying the role of the trainee in each of the trials; and 3) A listing of all active research support for which a trainee is the PI, clearly showing the percent effort commitment of the trainee and addressing potential overlap issues with the research objectives of the K12-supported research. It is acceptable to describe all of the career-related activities in which the trainee participates during their appointment to the K12 program. However, it is important to differentiate progress made on activities directly relevant to the Program from progress made on other activities. o A Report from the AC that is separately attached summarizing the actions of the AC during the last year, evaluating the performance of the Program in meeting its objectives and the intent of the NCI, evaluating the effectiveness of recruitment strategies and providing recommendations for improving the Program (e.g., new mentors, changes in Core Requirements, changes in recruitment strategies etc.). o A separate report from the AC on progress made in recruiting underrepresented minorities into the Program. Information must be included on successful and unsuccessful recruitment strategies. The report should include the following information on underrepresented minorities: 1) Candidates who applied for admission within the participating department(s) relative to the Program; 2) Candidates who were offered admission to the Program; 3) Candidates who were appointed to the program. o Evaluation: In carrying out its stewardship of human resource related programs, the NCI may request information essential to an assessment of the effectiveness of this program. Accordingly, recipients (PI's, individual candidates/trainees) 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. o A final progress report, invention statement, and Financial Status Report are required upon either completion of an award or relinquishment of an award. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA 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. Office of Centers, Training and Resources Cancer Training Branch National Cancer Institute 6116 Executive Blvd., MSC 8346 Suite 7025 Bethesda, MD 20892-8346 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 Mail) 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. Catherine Blount Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 6120 Executive Blvd. Bethesda, MD 20892 Rockville, MD 20852 (Express Mail) Telephone: (301) 496-3179 FAX: (301) 496-8601 Email: blount@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 PA 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. Office of Centers, Training and Resources Cancer Training Branch National Cancer Institute 6116 Executive Blvd., MSC 8346 Suite 7025 Bethesda, MD 20892-8346 Rockville, MD 20852 (Express Mail) Telephone: (301) 496-8580 FAX: (301) 402-4472 Email: lg2h@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact Grants Info, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. The instructions in the Form PHS 398 do not fully apply to the special needs of this grant application. Therefore, follow the modified instructions below in preparing an application for an NCI Institutional Clinical Oncology Research Career Development Program (K12). These instructions have been adapted to accommodate the Form PHS 398 and the special needs of the K12 grant: 1. Face Page: Use Form Page 1 of the Form PHS 398. On Line 1, include the title that best represents the nature of the training program. On Line 2, provide the number of this Program Announcement beginning with PAR-03-083 , and the title "Institutional Clinical Oncology Research Career Development Program" of the Program Announcement. The Program Leader will be the principal investigator (PI) of the grant application. 2. The Description/ Performance site(s)/ Key personnel (Form Page 2 of Form PHS 398): Complete as directed in the Form PHS 398. The information provided should include the P.I., Advisory Committee members, mentors and other faculty participating in the program. 3. Table of Contents to be organized as follows: a. Face Page b. Description/Key Personnel c. Table of Contents d. Statement of Commitment e. Detailed Budget Page for First Year f. Budget for Entire Proposed Period of Support g. Biographical Sketches (not to exceed two pages per individual) - Principal Investigator - Advisory Committee Members - Mentors - Other Faculty - Trainees (if available) h. Other Support of the Principal Investigator and the Mentors that is specifically relevant to the purpose and objectives of this Program. This should include support from other training programs that relate to this application (e.g. other K12 grants, K30 Awards, T32 Awards, R25T Awards) i. Career Development/Training Plan (may exceed 25 pages; tables should be included in the text, not as appendices) (1) Introduction to Revised Application (when applicable, not to exceed 3 pages) (2) Purpose and Objectives (3) Description of Core Requirements (4) Research Base/Resources and Facilities(Suggested tabular formats for this information can be found under "Summary information on Program" on the following website: (http://cancertraining.nci.nih.gov/research/clinical/k12full.html#app) (5) Program Management - Principal Investigator - Recruitment Strategies (Including a separate plan for recruitment of underrepresented minorities) - Advisory Committee - Individual Training Plans j. Human Subjects k. Vertebrate Animals l. Checklist m. Appendices 4. Statement of Commitment: This statement should guarantee that all candidates participating in this Program will commit a minimum of 75% of full-time professional effort to research and research career development. 5. Detailed Budget for the Initial Budget Period: Use Form Page 4 of the PHS Form 398 and provide detailed budget information with regard to Salary and Fringe benefits, supplies, travel etc. specified for each trainee by name or by position, if there is no one available to fill the position. Note that there is an upper limit of salary of $75,000 plus fringe benefits, an upper limit for other costs of $30,000 per trainee; and a required minimum 75% effort. 6. Budget for the Entire Proposed Period of Support: Follow instructions as provided in the Form PHS 398. 7. Biographical Sketches: Provide biographical sketches using the Biographical Sketch Format Page of the Form PHS 398. Group the biosketches into the following five sections: (1)PI; (2) Advisory Committee Members; (3)Mentors; (4) Other Faculty; (5) Trainees (when available). 8. Career Development/Training Plan: a. Purpose and Objectives: Briefly describe the background, purpose and objectives of this career development Program. This description should identify two or more clinical oncology disciplines represented in the Program and a discussion of the strategies to be used to ensure that the representation in each discipline in the mentor population and the trainee population will satisfy the intent of this NCI requirement. The description should clearly show how the purpose and objectives of the Program will meet the broader objectives and intent of the NCI to prepare candidates who can design and implement all phases of clinical trials and who can effectively work with basic scientists on projects in patient-oriented therapeutic cancer research. b. Description of Core Requirements: Describe separately the core didactic, core clinical research and core basic research experiences that each clinician candidate or trainee must complete to satisfy the overall Core Requirements of the Program. If there is an existing institutional K30 program, explain how the K12 Program will link with and make use of the K30 program to meet the objectives of the K12 core didactic component. Using specific, real or hypothetical examples, describe how individualized trainee career development plans will be developed that take into account past experiences and competencies before providing new experiences and skills by the Program. Describe any certification, degree or other form of recognition, if any, that trainees will receive after completing the Core Requirements. c. Research Base/Resources and Facilities/Mentors (Refer to the following website for a suggested format for providing this information: http://cancertraining.nci.nih.gov/research/clinical/k12full.html) Research Base: Describe the existing funded laboratory and patient-oriented research activities and the interactive nature of the research environment that will meet and sustain needs of this Program. Include in this description the number and types of early to late phase clinical therapeutic clinical trials being conducted in the institution and the general range of activities in these trials. Resources and Facilities: Describe the research infrastructure, patient populations, facilities etc. that are available and accessible to this Program. Mentors: Describe the pertinent research experience and track record in training cancer clinician scientists of each mentor participating in the Program. d. Program Management: Principal Investigator: Describe the qualifications and role of the PI to provide scientific and administrative leadership and coordination of the Program. Recruitment Strategies: Describe the selection criteria for candidates recruited to this Program. Describe the various strategies that will be used to ensure that the different clinical oncology disciplines represented by the Program are included and to ensure an adequate candidate pool. Address the nature of any other competing institutional Programs that might limit the number of candidates and describe the strategies for addressing this competition. Plans for Recruitment of Underrepresented Minorities: Describe plans for recruitment of underrepresented minorities (e.g., African Americans, Hispanic Americans, Native Pacific Islanders, Native Americans and Alaskan Natives) and how these strategies will be implemented. Advisory Committee (AC): Describe how the AC will function in providing oversight of the development, implementation and evaluation of recruitment strategies in the recruitment and selection of candidates; in the evaluation of special curricula and/or links to curricula developed through a K30 grant (if present); in the monitoring and evaluation of each candidate's progress with recommendations for changes in the training plan, if necessary, or termination of a candidate who is not making adequate progress; and in monitoring and evaluation of the overall effectiveness of the Program. Individual Training Plans: Provide brief summaries/examples of individual training plans that the Program will employ or has been able to achieve (for competing renewal applications) in preparing candidates to design, implement and participate in patient-oriented therapeutic research and collaborate effectively with basic scientists in translating the discoveries of the basic scientists into therapeutic clinical trials. If relevant to your K12 program, provide examples of plans for short-term (2 years) appointments. 9. Human Subjects: Follow the instructions in Form PHS 398. You will need to follow current NIH policy on providing in your application information on data and safety monitoring. Refer to the following website for information on NCI policies on data and safety monitoring for training awards: http://www.cancer.gov/clinicaltrials/conducting/dsm-guidelines 10. Vertebrate Animals: Follow the instructions in Form PHS 398. 11. Appendices: Follow the instructions in Form PHS 398. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted by the receipt dates listed at the beginning of this program announcement. 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 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) APPLICATION PROCESSING: Applications must sent on or before the date(s) listed on the first page of this PAR. The CSR will not accept any application in response to this PA 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate knowledge of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and for adherence to the guidelines of this PA by the NCI program staff. Applications not adhering to the guidelines of this PA, and those applications that are incomplete as determined by CSR or by NCI program staff, will be returned to the applicant without review. Applications that are complete and adhere to the guidelines of this PA 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 Receive a written critique 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 second level review by the National Cancer Advisory Board. REVIEW CRITERIA PRINCIPAL INVESTIGATOR: Qualifications (and track record for competing renewal applications) of the PI to provide both scientific and administrative leadership of the Program. ADVISORY COMMITTEE: Quality (and track record for competing renewal applications) of the Advisory Committee and appropriateness for performing its critical functions in recruitment of candidates, assignment of mentors, establishment and monitoring of individual training plans, and evaluating and making mid-course corrections for the Program. Additionally, for competing renewal applications, adequacy of addressing any concerns expressed in the Summary Statement for the prior five year award. PROGRAM/CORE REQUIREMENTS: Merit of the Program (and track record for competing renewal applications), as defined in the didactic core requirements, basic research core requirements, and clinical core requirements, to train patient- oriented clinical scientists who can collaborate effectively with basic scientists in translational research and conduct all phases (e.g., Phase I, Phase II and Phase III) of hypothesis-driven, therapeutic cancer clinical trials. ENVIRONMENT: Quality, sufficiency and interactiveness of the basic and clinical research of the institution to provide the environment necessary for the Program to meet its goals and objectives. MENTORS: Experience and quality of the mentors to ensure a successful outcome of the Program. CANDIDATES: Adequacy of the plans for (and track record for competing renewal applications) recruiting high quality trainees, to ensure a supply of high quality trainees for the Program representing at least two oncology disciplines. Adequacy of the specific measures proposed or taken to recruit underrepresented minority candidates to the Program. This does not include Continuing Umbrella of Research Experiences (CURE) supplements to the K12 program. INSTITUTIONAL COMMITMENT: The strength of the institution's commitment to the Program, especially with regard to ensuring that each candidate will have protected time to commit 75% effort to research career development. OVERLAP: The potential of this Program to overlap with other existing training programs. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and 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. (Se 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 included in the section 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 CONSIDERATIONS TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH: The appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction. Every trainee supported by this grant must receive instruction in the responsible conduct of research. For more information on this provision, see the NIH Guide for Grants and Contracts, Volume 21, Number 43,November 27, 1992, see http://grants.nih.gov/grants/guide/notice- files/not92-236.html. Applications must include a description of a program to provide formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and will be returned to the applicant without review. o Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects. Within the context of training in scientific integrity, it is also beneficial to discuss the relationship and the specific responsibilities of the institution and the candidates appointed to the program. o Plans must address the subject matter of the instruction, the format of the instruction, the degree of faculty participation, trainee attendance, and the frequency of instruction. o The rationale for the proposed plan of instruction must be provided. o Program reports on the type of instruction provided, topics covered, and other relevant information, such as attendance by trainees and faculty participation, must be included in future competing continuation and noncompeting applications. The NIH encourages institutions to provide instruction in the responsible conduct of research to all graduate students, postdoctorates, and research staff regardless of their source of support. NCI initial review groups will assess the applicant's plans on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction. The plan will be discussed after the overall determination of merit, so that the review panel's evaluation of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. Staff within the NIH awarding component will judge the acceptability of the revised plan. MINORITY RECRUITMENT AND RETENTION PLAN: The NCI remains committed to increasing the participation of individuals from underrepresented minority groups in biomedical and behavioral research. All competing applications for this program must include a specific plan to recruit and retain underrepresented minorities in the training program. In addition, all competing continuation applications must include a report on the recruitment and retention of underrepresented minorities during the previous award period. If an application is received without a plan or without a report on the previous award period, the application will be considered incomplete and will be returned to the applicant without review. Competing continuation applications and Non-competing Grant Progress Reports must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period. Information must be included on successful and unsuccessful recruitment strategies. The report should provide information on the racial/ethnic distribution of: o All clinician candidates who applied for admission or positions within the department(s) participating in the Program o Clinician candidates who were offered admission to or a position within the participating department(s) o Clinician candidates actually enrolled in the participating departments o Clinician candidates who were appointed to the Program For those trainees who were enrolled in the Program, the report should include information about the duration of research training and whether those trainees finished their training in good standing. The success of efforts to recruit and retain minority trainees is a factor in the assessment of the quality of the trainee pool and thus will be included within the priority score. In addition, peer reviewers will separately evaluate the minority recruitment plan and report (for competing renewals) after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of minorities and whether the experience in recruitment during the previous award period has been incorporated into the formulation of the plan for the next award period. The review panel's evaluation will be included in an administrative note in the summary statement. If the plan or the record of minority recruitment and retention is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. Staff within the NCI will determine whether amended plans and reports submitted after the initial review are acceptable. BUDGET: Appropriateness of the budget and the requested period of support to achieve the stated goals and objectives of the Program. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to NCI priorities o Acceptability of the plan for minority recruitment o Acceptability of the proposal for instruction in the responsible conduct of research. 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. MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (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. Information concerning essential elements of data safety monitoring plans for clinical trials funded by the NCI is available: http://www.cancer.gov/clinicaltrials/conducting/dsm-guidelines. Please refer to the section titled "Training Grants" under Special Circumstances for specific guidelines on data and safety monitoring for K12 grants for the initial award. The Program must comply with all of the data and safety monitoring requirements of individual NCI career awards during the funded project period. 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. A continuing education program in the protection of human participants in research is available online at: http://cme.nci.nih.gov/ HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm 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 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. 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 PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.398 Cancer Research Manpower 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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Office of Extramural Research (OER) |
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National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
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Department of Health and Human Services (HHS) |
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