CANCER EDUCATION AND CAREER DEVELOPMENT PROGRAM Release Date: February 17, 2000 (see replacement PAR-03-148) PA NUMBER: PAR-00-064 National Cancer Institute This Program Announcement (PA) replaces PAR-99-095, Cancer Education and Career Development Program , which was published in the NIH Guide on May 4, 1999. PURPOSE The purpose of this specialized Cancer Education Program (R25) is to support the development and implementation of curriculum-dependent programs to train predoctoral and postdoctoral candidates in cancer research settings that are highly inter-disciplinary and collaborative. This Cancer Education and Career Development Program (R25) is particularly applicable to cancer prevention and control, epidemiology, nutrition, and the behavioral and population sciences; but should also be considered by other highly interdisciplinary areas of research such as imaging and molecular diagnosis that will require sustained leadership, dedicated faculty time, specialized curriculum development and implementation, interdisciplinary research environments, and more than one mentor per program participant to achieve their education and research career development objectives. Applicants whose programs cannot meet the Special Requirements stated in these guidelines should refer to the traditional National Research Service Award (NRSA) Institutional Training Grant (T32) as an alternative source of support. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Cancer Education and Career Development Program, is related to the priority areas of cancer and human resource development. Potential applicants may obtain a copy of "Healthy People 2000" at (http://odphp.osophs.dhhs.gov/pubs/hp2000). ELIGIBILITY Institution: Applications may be submitted on behalf of the principal investigator by domestic, non-Federal organizations, public or private, such as medical, dental, or nursing schools or other institutions of higher education. Applications may include more than one institution to create a Program through consortium agreements (refer to the following URL for guidelines on these agreements: http://grants.nih.gov/grants/policy/nihgps/part_iii_5.htm#Consortium) that includes all of the disciplines, research environments and mentors needed to accomplish the proposed educational and training objectives. However, only one of the participating institutions can be the recipient of an award. More than one application may be submitted by an institution to support programs in different areas of research. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Program Leader/Principal Investigator: The Program Leader/Principal Investigator must be an established investigator in a field relevant to the objectives and purpose of the Program and able to provide both administrative and scientific leadership to the Program. Predoctoral and postdoctoral candidates: Candidates may be at the predoctoral or postdoctoral stages of their career. They usually must be (see exception below) 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 normally are not eligible. Unlike other NCI grants that support career development and training, this grant does allow for the training of foreign nationals, who do not have the above residency certifications, under exceptional circumstances. These exceptions would require NCI approval of individuals on a case-by-case basis and would always depend upon the special international, collaborative nature of the research areas that the training and career development Program emphasizes. Individuals NOT eligible for appointment to the R25 program include former principal investigators on NIH research project (R01), FIRST Awards (R29), sub-projects of program project (P01) or center grants (P50), and the equivalent. Former principal investigators of NIH Small Grants (R03) or Exploratory/Developmental Grants (R21) remain eligible. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) R25 mechanism. Planning, direction and execution of the Program is the responsibility of the Program leader and the Advisory Committee on behalf of the institution(s). The total project period for an application submitted in response to this PA may not exceed five years. Awards are renewable. Awards will be administered under NIH grants policy as stated in the National Institutes of Health Grants Polity Statement, NIH Publication No. 99-8, October 1998. However, this specialized form of the R25 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 R25 remains under Expanded Authorities except that carryover of funds from one fiscal year to the next requires approval by the NCI. RESEARCH OBJECTIVES A. Background: In many developing and emerging fields of cancer research today, scientists must function within interdisciplinary teams rather than as isolated investigators or in simple collaborative settings. Preparing junior and more experienced basic research scientists and clinicians for this new type of research environment will require education and career development experiences in highly inter-disciplinary and collaborative cancer research settings that are integrated with a specialized curriculum. These education and career development experiences will have to provide wide access to multiple scientific disciplines and methodologies, involve mentors from more than one discipline, and will have to be tailored to the individual education and training needs of the investigator. Due to the likely breadth of the science involved, these experiences will frequently have to be facilitated and coordinated across departments, schools, centers and institutions. Management of programs with this kind of complexity and diversity will require concerted leadership and dedicated time of interdisciplinary faculty in order to sustain effective interactions within and coordination of the program. Furthermore, for clinicians lacking any prior research training, these experiences may have to include the completion of requirements for an additional degree, viz. M.P.H., and a number of years of research experience beyond the degree to prepare for conducting highly interdisciplinary collaborative research as an independent investigator. Prior NCI experience with other NIH training and career development funding mechanisms has shown that it takes a least 5 years of didactic and research training for clinicians to become competitive independent investigators, particularly in the highly interdisciplinary disciplines that are the focus of this grant mechanism. Recognizing these special issues and needs, in 1991 the NCI piloted its first "Education Programs in Cancer Prevention and Control", supported by the NIH Education Grant (R25) mechanism and based on the concept of interdisciplinary education and career development. These programs afforded institutions the flexibility needed in both program design and cost structure to allow for the development of complex, multi-disciplinary education and career development programs. These pilot programs proved to be extremely successful. In 1998, the NCI completed major external reviews of its cancer prevention and cancer control sciences. The scientific experts conducting these reviews noted a national shortage of cancer prevention and control researchers, and a pressing need for researchers educated in the new scientific paradigms that require collaborations with researchers in disparate disciplines (e.g., the quantitative sciences, cancer biology, genetics, molecular biology, nutrition, the social and behavioral sciences). These groups identified the need for a new approach to the training of prevention and control scientists requiring multi-disciplinary experiences with an interdisciplinary theme and including laboratory experiences. These groups recommended increasing the availability of support mechanisms, such as the R25 mechanism, to the cancer prevention, control and population sciences to address this need. More recently, the NCI Tobacco Research Implementation Group encouraged the increased development of training programs using interdisciplinary groups of researchers as trainers; and involving a special linkage between faculty leadership, curriculum development and training. The NCI Review Groups made a number of specific training recommendations that reflect the complexity of the cancer research tracks that will be needed in the future. For example, the NCI Cancer Control Review Group identified a need for Cancer Control researchers to understand the "vocabulary and utility" of cancer biology, quantitative methods, and social and behavioral science; and for basic and clinical scientists to obtain training in the basic behavioral sciences, epidemiology, health services and outcomes research, cost-effectiveness research, survivorship and Quality of Life research, screening and treatment, and adherence. Additionally, behavioral scientists interested in cancer control research should be trained in biomedical fields such as nutrition, pharmacology, genetics, and health services research. The NCI Cancer Prevention Review Group identified a need for cancer prevention researchers to acquire actual laboratory experience and for training in areas such as cancer biology, cancer genetics, molecular biology, carcinogenesis, pharmacologic interventions in prevention, biostatistics, epidemiology, health behavior, health policy, and the behavioral sciences. This same group also recommended that behavioral scientists should be trained to function in the new scientific paradigms including genetics, chemoprevention, and diet/nutrition. All of the above recommendations will facilitate the connectivity of and communication among disparate disciplines, and facilitate the preparation of investigators for effective participation in team research settings. Recent reports from other external NCI advisory groups have made similar recommendations regarding training needs. Breast Cancer scientists identified a need for new funding mechanisms for multidisciplinary training of individuals so that "they can participate effectively in multidisciplinary collaborations" in translational research. In the area of imaging sciences, advisors identified a need for postdoctoral training in molecular imaging; for interdisciplinary cross-training of senior investigators in diverse disciplines such as molecular genetics, molecular and cell biology, chemistry and clinical oncology; and for the development of multidisciplinary centers " providing the means for bringing researchers and teams with diverse backgrounds together". Similar needs for interdisciplinary training have been identified in the principal recommendations of a number of the latest national studies on science education and training and for emerging fields in the biomedical sciences (1-4). One report (4) pertaining to the emerging field of Modeling Biological Function notes the lack of programs for addressing training in the integration of molecular data to predict biological behavior, and points to the absence of training mechanisms and institutional environment for bringing together critical masses of interdisciplinary researchers in disparate fields (viz., biology and the computer sciences). Finally, a report from the NCI Imaging Sciences Working Group (5) notes that it is only at those few institutions where (imaging) programs "are conceived with an interdisciplinary goal in mind" that the communication gap between researchers in widely diverse areas of science can be successfully bridged. B. Program: The award provides support to institutions for up to 5 years for the principal investigator and an Advisory Committee to manage, coordinate and evaluate the program; for faculty to design, develop, implement and continually refine the program curriculum; for the salaries of predoctoral and postdoctoral trainees; and for other Program-related research costs. These Programs should provide curriculum-based, multi-disciplinary AND interdisciplinary didactic and cancer-related collaborative research training experiences for predoctoral and postdoctoral researchers. They should also provide the trainees with the research and communication skills to conduct cancer research in an inter-disciplinary and highly collaborative team research setting. C. Environment: The participating institution(s) must have well-established research programs and faculty qualified in curriculum development, implementation and program evaluation to serve as faculty for the program. The research environment should be team-oriented and highly collaborative with a strong potential for a dynamic two-way exchange of information and ideas within and across diverse and disparate disciplines such as the physical, biomedical, behavioral, population and quantitative (mathematics, computer sciences, etc.) sciences. The research environment should also be capable of promoting rapid translation of research outcomes into reductions in cancer incidence, morbidity and mortality. Finally, the institution must demonstrate a commitment to provide sustained leadership and dedicated faculty time to the development and implementation of the program; and commitment to the development of junior investigators as productive, independent investigators. D. Allowable costs: NO APPLICATION MAY EXCEED $500,000 IN DIRECT COSTS PER ANNUM WITHOUT WRITTEN APPROVAL FROM THE NCI. NIH Guide, March 20, 1998. 1. Salary: The principal investigator will be provided salary support for leadership, management, coordination and evaluation of the Program, in accordance with the percent effort commitment to the Program. Faculty critical to the design, development, implementation and refinement of the specialized curriculum essential to the training and didactic needs of the Program will be provided salary support in accordance with the percent effort commitment to the Program. Salary support may not be provided to program faculty for their service on the Advisory Committee (see SPECIAL REQUIREMENTS). The principal investigator and Program faculty may derive additional compensation from other Federal sources or awards provided the additional compensation does not exceed the maximum annual salary level for Federal employees (see INQUIRIES) and their total percent effort on all awards does not exceed 100 percent. Predoctoral appointees can be provided salaries of up to $20,000 per year plus fringe benefits commensurate with the institution's full-time salary scale for persons of equivalent qualifications, experience and rank. Postdoctoral appointees can be provided salaries of up to $75,000 per year plus fringe benefits commensurate with the institution's full-time salary scale for persons of equivalent qualifications, experience and rank. The institution may supplement the NIH contribution to an appointee's salary up to a level that is consistent with the institution's salary scale. Institutional supplementation of a salary must not require extra duties or responsibilities that would interfere with the purpose of the award. 2. Other Expenses: Up to $20,000 in direct costs per year per candidate/trainee adjusted to the actual percent effort 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. 3. Advertising and Recruitment Costs: A small proportion of the budget can be used for advertising and recruitment in order to attract the best possible candidates to the Program. It is assumed that to effect this kind of multi- disciplinary, multi-departmental, multi-institutional approach, a centralized fund for advertising and recruiting, NOT entertaining, will be needed. Consult INQUIRIES if there are questions about the use of funds for this purpose. 4. Ancillary Personnel Support: In general, 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 This specialized R25 grant, as administered by the NCI, is not subject to the Streamlined Non-competing Application Process (SNAP). In general, this means that all reporting of budgetary information and Program progress is provided in greater detail. While the R25 is subject to Expanded Authorities, the one exception is that carryover of funds from one fiscal year to the next must be approved by the NCI Grants Administration staff (see INQUIRIES). E. Special Leave: Leave to another institution of an appointee, 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, prior written approval of the NCI is required. To obtain prior approval, the trainee must submit a letter to the NCI 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. Support from the award will continue during such leave. NCI Program staff should be contacted prior to submitting the request for 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 NCI and the grantee institution. F. 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. G. Change of Institution: The Cancer Education and Career Development Program cannot be transferred from one institution to another. H. Change of Program Director: If the program director moves to another institution or resigns from the position, support of the award may be continued provided that the current program director or the awardee institution has submitted a written request for change of program director, countersigned by the appropriate institutional business official, to the NCI describing the reasons for the change. The biosketch of the proposed new program director, including a complete listing of active research grant support, must also be provided. The information provided must establish that the specific aims of the original peer reviewed research program to be conducted under the direction of the new program director will remain unchanged, and that the new program director has the appropriate research and administrative expertise to lead the program. NCI Program staff must approve of this change and should be contacted prior to submission of the letter (see INQUIRIES). I. Changes of Program: Awards are made to a specific institution for a specific program under the guidance of a particular program director. Changes in any of these parameters requires prior approval by 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, the award could be terminated. J. Progress Reports: An Annual Progress Report for the grant is required. This report should provide information about changes in the Program, a summary report of the evaluation of the Advisory Committee, and a description of the research and career progress of each candidate. These progress reports will be closely monitored by NCI staff to ensure that the Program is achieving its goals and meets the intent of the NCI for this specialized R25 grant mechanism. Progress report are to submitted using the Form PHS 2590, which should be available at most institutional offices of sponsored research or can be accessed directly at the following website address: http://grants.nih.gov/grants/funding/2590/2590.htm . Since the Form PHS 2590 does not easily apply to this specialized form of the R25 grant, adapt the application for continuation so it contains the following information: - Appropriate Face Page - A detailed budget page that provides all salaries and fringe benefits and other budgetary information (e.g., supplies, travel) specifically for each individual candidate by name or by position if the position is not occupied. - A brief description of the Objectives and Goals of the Program - A brief summary indicating which faculty, mentors and Advisory Committee members have left the Program and the names of the new individuals who are being added or taking their place. Include for each new person their degree and department (or equivalent) and, if a multi-institutional consortium, their institution. - Biographical Sketches of: i. New faculty ii. New mentors iii. New Advisory Committee members iv. New Trainees - Progress of Individual Trainees: A brief paragraph for each trainee describing the research and didactic experiences that they are engaged in or have completed as well as the specific future plans for each trainee in order to satisfy the Core Requirements of the Program. - List of publications for each trainee resulting from their training experiences in the Program. - For each postdoctoral candidate who completes training, a copy of his/her mock grant application and the critique of the application with the members of the review panel and their areas of expertise. - Summary Information of the Program. A sample table can be obtained from NCI program staff (see INQUIRIES below) - A Report from the Advisory Committee that is separately attached and evaluates the following: the effectiveness of the specialized curriculum developed for the Program and recommended changes; the effectiveness of the overall performance of the Program in satisfying its training and career development objectives with recommendations for changes that might improve the Program (e.g., modifications in Core Requirements, addition of new mentors, improved recruitment strategies) and the effectiveness of the minority recruitment efforts. A final progress report, invention statement, and Financial Status Report are required upon termination of an award. K. 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 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. SPECIAL REQUIREMENTS 1. The application must include a Statement of applicability clearly noting why the R25 grant mechanism, in contrast to more traditional training mechanisms such as the NRSA Institutional Training Grant (T32) grant mechanism, is essential for accomplishing the proposed educational and research career development needs of the program. Applicants should refer to the following website address for information on T32 grants: http://grants.nih.gov/grants/guide/pa-files/PA-02-109.html 2. A specialized curriculum, not otherwise available at the institution or other participating institutions, must be developed and linked in an essential manner to the training goals and objectives of the Program. 3. The principal investigator must assemble and chair a permanent multidisciplinary Advisory Committee (AC) representing all of the disciplines, departments, schools, institutions etc. involved in this education and training program. The AC would be responsible for the recruitment and selection of candidates for the Program; the establishment and review of effectiveness of specialized curriculum; the approval of the education and training plans (e.g., curriculum, research experiences, mentors) for each candidate; interim monitoring and evaluation of each candidate's progress with recommendations for changes in the plan, if necessary, or termination of a candidate who is not making adequate progress; and monitoring and evaluation of the overall effectiveness of the Program. The AC would provide a summary report with each annual progress report that describes the committee's actions, and discusses progress of the program including evaluation of areas of strengths and weaknesses. 4. A large majority of mentors must be involved in cancer research or research methodologies clearly important to the cancer focus and objectives of the proposed education and career development Program. 5. Trainees are expected to have more than one mentor during the course of their multi-disciplinary research training. 6. Trainees are expected to engage in multi-year, long-term research experiences. This is not a grant that should be used for short-term experiences in research. 7. The Program must have the flexibility to accommodate multiple disciplines and candidates with different levels of didactic and research experience (see 8. below on Core Requirements). 8. The Program should include Core Requirements that each candidate is expected to complete before meeting the program’s training objectives. These requirements should include the following: a. A core didactic component (the Specialized Curriculum, and other formal courses such biostatistics, informed consent, lecture and seminar series). b. A core research component defining the different kinds of disciplinary research experiences each candidate must complete to meet the requirements of the Program. 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 additional didactic and research experiences over different periods of time in order to fully meet the overall training objectives of the Program and be able to conduct research in a highly collaborative research team setting. 9. A separate plan should be included for recruiting individuals from under- served and under-represented minority and ethnic groups in biomedical research. 10. As part of the research and career development experience, each postdoctoral trainee who is near the end of his/her tenure must prepare a mock application to the NIH, following the instructions provided in the PHS Form 398. The faculty must provide a mock peer review. 11. An evaluation plan must be provided for determining the performance of the processes and outcomes of the Program. This plan should include the parameters and criteria that will be used to evaluate the Program. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research" which have been published in the Federal register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. It is also available electronically at URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. Investigators may obtain copies from these sources or from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by NIH, unless there are clear and compelling 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 was published in the NIH GUIDE FOR GRANTS AND CONTRACTS, March 6, 1998 and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) using the modified instruction provided below, and will be accepted on February 1, June 1 and October 1. Application kits are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, Email: grantsinfo@nih.gov. Application kits can be accessed directly at the following website address: http://grants.nih.gov/grants/funding/phs398/forms_toc.html. 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 Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-004.html). The completed original application and three legible copies must be sent to or delivered 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 must also be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8062 MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (express/courier service) If the application submitted in response to this PA is substantially similar to a grant application already submitted to the NIH for review but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of essentially identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. An application, therefore, cannot be submitted in response to this PA which is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Instructions for Preparing a Cancer Education and Career Development Program Grant Application: Applications for Cancer Education and Career Development Programs(R25) should use the Form PHS 398 and the modified instructions below, which take into account all of the special features and requirements of this grant. 1. Face Page: Use page AA of the form PHS 398. On Line 1 include the title that best represents the nature of your education and career development program. On line 2, provide the number (i.e., PAR.....) and the title (i.e., NCI Cancer Education and Career Development Program)of this NCI Program Announcement. 2. Description, Performance Site(s), Key Personnel: ((Page BB) of the form PHS 398): Complete as directed in the form PHS 398 instruction package; this should include the program leader, Advisory Committee Members, Mentors and other faculty participating in the program. Please make sure that you denote each individual’s degree and departmental affiliation (or equivalent) AND, if a consortia of institutions, institutional affiliation. 3. Table of Contents to be organized as follows: Page Number a. Face Page b. Description, Performance Site(s), Key Personnel c. Table of Contents d. Detailed Budget Page for First Year e. Budget for Entire Proposed Period of Support f. Budgets pertaining to Consortium/Contractual Arrangements g. Other sources of Institutional Training, Education, and Career Development Support. h. Biographical Sketches ( not to exceed 2 pages per individual): - Program Leader/Principal Investigator - Advisory Committee Members - Mentors - Other Participating Faculty - Trainees (if known at the time of application) i. Other Research Support of the "Principal Investigator and the Mentors" that is specifically relevant to this Education and Career Development Program j. Statement of Applicability k. Education and Career Development Plan (Not to exceed 25 pages, excluding tables) i. (If applicable) Introduction to Revised Application (Not to exceed 3 pages) ii. Purpose and Objectives iii. Core Requirements -specialized curriculum -other didactic experiences -research experiences iv. Research Base/Resources and Facilities/Mentors v. Program Leadership/Management - Program Leader - Advisory Committee - Recruitment Strategies - for candidates in general - for minority candidates - Individual Candidate Training Plans - Evaluation Plan vi. (For competing renewal applications only) Progress Report** i. Human Subjects j. Vertebrate Animals k. Checklist l. Appendices ** Suggested tabular formats for presenting data on trainees can be obtained from NCI program staff (see INQUIRIES) 4. Detailed Budget for the First Year: Use Form Page 4 (or DD) of the Form PHS 398. Under PERSONNEL break out the individuals as follows with percent effort, salary and fringe benefits: A. The Program Leader B. The Faculty being paid from the Grant C. Predoctoral Candidates by: i. Name ii. Position (when position is not filled) D. Postdoctoral Candidates by: i. Name ii. Position (when position is not filled) For Research and Development Costs, maintain a separation between predoctoral and postdoctoral candidates and specifically identify the requested costs under each budget category (e.g., supplies, travel) for each trainee by name or position (if the position is not filled), remembering that total for each individual cannot exceed $20,000. If costs are requested for Advertising and Recruitment, make sure that these costs are identified under each budget category. 5. Budget for the Entire Proposed Project Period of Support: Use Form Page 5 (or EE) of the Form PHS 398 and provide projected future year budgets as instructed in the Form PHS 398. 6. In a table, list all current and pending institutional cancer-related training, education and career development support available to the participating faculty, department(s), institution(s). Examples could include T32, R25 or K12 grants. Include funding source, complete identifying number, title of the program, name of the program director, project period, number of training positions (predoctoral, postdoctoral), and the amount of the award. For each grant listed, name only those participating faculty members who are also named in this application, and indicate their percent effort in those programs. 7. Biographical Sketches and Other Support: Provide biographical sketches using the forms provided in the PHS Form 398 package for the Program Leader, Advisory Committee Members, Mentors, other participating faculty, and trainees (for those that are available). Immediately following the biographical sketch for an individual, provide a listing of their OTHER SUPPORT, using Form Page GG and the corresponding instructions on page 14 of Form PHS 398. 8. Statement of Applicability: Provide a clear, substantive statement indicating why the use of this specialized form of the R25 grant mechanism, in contrast to the other education/ training support mechanisms (viz., NRSA Institutional Training Grants) uniquely allows for the success of the proposed education and training program. 9. Education and Career Development Plan: a. (If applicable) Introduction to Revised Application: If this is a revised application, in no more that three pages summarize how you have addressed the previous concerns of the reviewers and what new information is available that might be important for the reviewers to evaluate. Additionally, highlight (bold, italics, etc.) in the text of the plan changes made in response to the concerns of the previous review of the application. b. Purpose and Objectives: In this section provide background, purpose and objectives of the Program. c. Core Requirements. Describe the core requirements of this Program that each candidate is expected to complete based on prior experience and the training experiences to be provided within this Program in the following areas: 1. Specialized Curriculum: Describe the proposed core education curriculum. Explain how the development and implementation of this curriculum is critically linked to the purpose and objectives of the Program and to the research career development of individual candidates. Explain how this curriculum is distinguished from other curricula within the existing educational infrastructure and framework of the applicant/participating institution(s); 2. Other Didactic Experiences: utilization of any existing curriculum within the institution(s). 3. Research Experiences: Outline briefly the kinds of research experiences each candidate should have, either from prior experience, or from the mentors of this Program that will prepare them as independent scientists who can function in complex team settings and highly multidisciplinary team research settings. d. Research Base/Resources and Facilities/Mentors: Research: Generally describe the funded research activities and methodologies offered by the mentors participating in the Program and how the interactive nature of the research environment will meet and sustain the needs and objectives of this Program. Resources and Facilities: Briefly describe the research infrastructure, access to patient populations, community populations etc., and facilities that are available and accessible to this Program. Mentors: Describe the track record in training cancer scientists of each mentor participating in the Program. e. Program Leadership/Management: 1. Program Leader: Describe the qualifications and role of the Program Leader to provide leadership and coordination of the Program. 2. Recruitment Strategies: Within the multi-disciplinary research environments of this education and career development Program, describe the characteristics of candidates who will be selected for participation at the predoctoral level and placed in the existing degree awarding units of the institution(s) (e.g., Ph.Ds , DPHs) and how the mix of postdoctoral candidates (e.g., Ph.D.s, M.D.s and DPHs) will be prioritized to achieve the multi-disciplinary education and career development objectives of the Program. Describe any advertising strategies. Comment on the size of the candidate pool expected, note any other institutional programs that might compete for this pool, and describe strategies for addressing this competition. Separately describe the strategies for recruiting minority candidates. 3. Advisory Committee: Describe how the AC will function in providing oversight of the development, implementation and evaluation of recruitment strategies; recruitment and selection of candidates for the Program; establishment, implementation and evaluation of the core/specialized curriculum; approval of individual education and career development plans (e.g., curriculum, research/methodology experiences, mentors); interim monitoring and evaluation of each candidate’s progress, including a determination of when a candidate has successfully completed the program, with recommendations for changes in the plan and, if necessary, termination of a candidate not making adequate progress; review of mock grant applications; and monitoring of the overall effectiveness of the Program; 4. Individual Candidate Training Plans: Provide actual or examples of individual plans that the Program will employ or has been able to achieve that allow it to provide a unique education and career development experience for candidates, preparing them to design, implement and participate in highly inter-disciplinary, collaborative cancer research. Provide plans for conducting the required mock grant application and review process for each postdoctoral candidate; 5. Evaluation Plan: Describe the information that will be used in, the periods for, and criteria to be used in evaluating this Program g. Progress Report (for competing renewal applications): Describe progress made toward achieving the objectives of this program and the intent of the NCI. 10. Human Subjects: follow instructions provided in the PHS Form 398 application package; 11. Vertebrate Animals: follow instructions provided in the PHS Form 398 application package; 12. Consortium/Contractual Arrangements: Refer to the following the following website for guidelines on these agreements: http://grants.nih.gov/grants/policy/nihgps/part_iii_5.htm#Consortium. 13. Appendices: follow instructions provided in the PHS Form 398 application package. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review (CSR); and by the NCI program staff for adherence to the guidelines in two areas: 1) Eligibility criteria; 2) Special Requirements. Applications not responsive to this PA WILL BE RETURNED to the applicant without review. Applications that are complete and responsive to the PA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities in NCI in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board. All applications in response to this announcement will be evaluated for scientific and technical merit using the criteria noted below: Review Criteria 1. Adequacy of the Statement of Applicability justifying the unique use of this specialized R25 mechanism instead of traditional education/training mechanisms such as the NRSA Institutional Training Grant, for achieving the education and career development objectives of the proposed program. 2. Adequacy of the justification provided of the need for the proposed Program relative to other ongoing education, and training/career development activities being sponsored within the institution(s). 3. Education Career Development Plan: a. (If applicable) the degree to which the revisions of the Program take into account the weakness identified during the previous peer review evaluation. b. Purpose and Objectives: - clarity and importance of the Program’s purpose and objectives - adequacy in meeting the NCI’s intent of supporting education and career development programs that prepare candidates to participate as independent investigators in highly multidisciplinary, collaborative, team research. c. Core Requirements: - degree to which all of the core requirements combined satisfy the training and career development objectives of the Program - quality of the process for evaluating each candidate’s needs relative to the core requirements of the Program. - adequacy of the subject matter and design of specialized curriculum; adequacy of the linkage of the specialized curriculum to the research training of the candidates; uniqueness of the specialized curriculum relative to other curriculum available at the institution (s); adequacy of the faculty responsible for the specialized curriculum - strength and availability of other didactic experiences available for each candidate’s education and career development - adequacy of the breadth and depth of research experiences available to candidates to achieve their multidisciplinary training objectives. d. Research Base/Resources and Facilities/Mentors: - Adequacy of the funded research environments in the Program to support the proposed education and career development. - Adequacy of the multidisciplinary interactions present in the institution (s) to set the appropriate example for the training of candidates expected to function well in highly multidisciplinary, team research settings. - Adequacy of the availability of the research infrastructure, patients, populations etc. to support the Program - Quality of the mentors research experience and productivity and their track records in training cancer scientists. e. Program Leadership/Management: - Adequacy of the Program Leader’s experience and qualifications to lead and coordinate the Program. - Recruitment: - Adequacy of the pool of candidates - Adequacy of the criteria for selecting high quality candidates. - Adequacy of the strategies for recruiting minorities to the Program. - Advisory Committee: - Appropriateness and experience of the membership - Adequacy of the AC’s involvement as a quality control in - selecting candidates for the Program - establishing appropriate training plans for each candidate based on their individual needs and the Program Core Requirements - monitoring the progress of candidates and making midcourse corrections to improve the quality and effectiveness of each candidate’s experiences. - participation in mock reviews - terminating candidates for evident lack of performance or potential - monitoring and evaluating the overall performance and effectiveness of the Program - Individual Candidate Training Plans: Quality and completeness of the individual training plans relative to the purpose and objectives and core requirements of the Program. - Evaluation Plan: Adequacy of the criteria and process for evaluating the performance of the Program. g. Progress: Based on previous objectives and past performance, adequacy of the progress in achieving the objectives of this Program and meeting the intent of the NCI. AWARD CRITERIA Applications will compete for available funds with all other scored applications submitted in response to this PA. Following the initial peer review for scientific and technical merit, the initial review must be concurred with by the National Cancer Advisory Board (NCAB). The NCI will notify the applicant of the National Cancer Advisory Board's (NCAB) action. Final funding decisions are made by the NCI based on the quality of the proposed Program, as determined by peer review, the availability of funds and priorities of the NCI. NON-COMPETING RENEWAL APPLICATIONS The procedures for submission of a new or a competing renewal application are not applicable to applications for a non-competing renewal of an award. Non- competing renewal applications for this specialized R25 grant, as administered by the NCI, are not subject to the Streamlined Noncompeting Award Process (SNAP) and require detailed reporting of budgets and progress. The general requirements for reporting progress annually are outlined in this PA in RESEARCH OBJECTIVES under the part of section D (Allowable Costs) that refers to Progress Reports. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Brian W. Kimes Cancer Training Branch Office of Centers, Training and Resources National Cancer Institute 6116 Executive Blvd, Suite 7001 MSC 8346 Bethesda, MD 20892-8345 FAX: (301) 402-0181 Email: bk34t@nih.gov For inquiries about fiscal matters, please contact: Ms. Catherine Blount Grants Administration Branch National Cancer Institute 6120 Executive Blvd, Room 243 Bethesda, MD 20892-4500 FAX: (301) 496-3179 Email: cb136g@nih.gov Direct inquiries regarding review issues to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Room 8062, MSC 8239 Bethesda, MD 20892-8239 Rockville, MD 20852 (for express/courier service) Telephone (301) 496-3428 Fax: (301) 402-0275 Email: tf12w@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.398 Cancer Research Manpower. Awards are made under authorization of the Sections 301 and 405 of the Public Health Service Act as amended ( 42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities ( or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. REFERENCES 1. National Institute for Science education. (1998). Descriptions of programs and strategies for change: Strengthening graduate education in science and engineering. Promising practices and strategies for implementation from the Graduate Education Forum Madison: University of Wisconsin: Madison. 2. National Research Council, Committee on Dimensions, Causes, and Implications of Recent Trends in the Careers of Life Scientists. Trends in the Early Careers of Life Scientists. Washington, D.C.: National Academy Press; 1998. 3. The Association of American Universities, Committee on Postdoctoral Education. Report and Recommendations, March 31, 1998. Washington, D.C.: The Association of American Universities; 1998. 8p. Available from: URL: http://www.aau.edu/. 4. Brent, R. "Raising the Next generation of Scientific Pioneers," J NIH Res., 9, 37-39 (1997). 5. The NCI Imaging Sciences Working Group, Meeting of the In Vivo Molecular/Functional Imaging Subgroup, February 18-19, 1998. Available from: URL: http://wwwosp.nci.nih.gov/.


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