THE NCI TRANSITION CAREER DEVELOPMENT AWARD RELEASE DATE: December 16, 2003 PA NUMBER: PAR-04-040 EXPIRATION DATE: March 2, 2006 Updates: -June 12, 2006 (PAR-06-455) - This PAR has been reissued, see PAR-06-455 -See extension of expiration date NOT-CA-06-010 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Cancer Institute (NCI) (http://www.nci.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.398 This Program Announcement (PA) replaces PAR-01-134, which was published in the NIH Guide on September 4, 2001. 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 Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The purpose of the NCI Transition Career Development (K22) Award is to facilitate the transition of investigators from the mentored stage of career development in academic cancer research to the independent stage. This is achieved by providing protected time through salary and research support for up to three years to: 1) postdoctoral individuals (who are not required to have a sponsoring institution at the time of application) transitioning into their first independent position, and 2) investigators within the first two years of their first independent cancer research position, to develop and initiate their first independently-supported cancer research programs. The award targets clinicians pursuing basic science cancer research careers, careers in patient-oriented cancer research, or careers in cancer prevention, control, behavioral or population sciences; and doctorally degreed (e.g., Ph.D., D.Sc.) individuals pursuing research careers in cancer prevention, control, behavioral or population sciences. Federally employed doctorally degreed basic scientists are eligible candidates if they are working in research directly relevant to human cancer. The unique feature of this award is that eligible individuals may apply without a sponsoring institution while they are still in a "mentored" position. Successful postdoctoral applicants will be given up to 12 months to identify an independent, preferably tenure-track, position at a sponsoring institution before the award can be activated. For postdoctoral applicants, the sponsoring institution for this award can be their current institution. RESEARCH OBJECTIVES A critical mass of clinician cancer researchers, and researchers in cancer prevention, control, behavioral and the population sciences capable of working with basic science researchers is needed to ensure effective translation of basic research discoveries into patient and population research settings if there is to be optimal progress in reducing cancer incidence, mortality and morbidity. Many individuals in these fields need protected time to develop successful independent research programs. This is particularly true for medically trained individuals, in general, and for doctorally degreed and medically trained individuals pursuing cancer research careers in the prevention, control, behavioral and population sciences. Individuals in these research career tracks often require extended periods of mentored research training beyond their original doctoral degrees (e.g., M.D., Ph.D. s). As a result, upon completion of their mentored research training, these individuals are often at a competitive disadvantage in obtaining independent research support relative to their traditional basic science, Ph.D. counterparts, who generally have many more combined years of research training and experience in their field of expertise. Finally, the survival of clinician and Ph.D. researchers in these critical research areas is being threatened by the current economics of medical care, which is increasingly emphasizing revenue- generating clinical practice at the expense of clinical research; and by a corporate culture of many of the nation's academic institutions that does not provide academic homes and tenure-track positions for prevention, control, behavioral and population scientists in the beginning stages of the independent phase of their research careers. There is also a need for basic science researchers trained in human cancer research and who are capable of working with clinicians conducting cancer research and researchers in cancer prevention, control, behavioral, and population sciences. These individuals are generally trained in the basic or quantitative sciences and have a substantial number of combined years of training and accumulated expertise in these areas of research upon and shortly after completion of their doctoral degree requirements. However, these individuals need additional mentored training in order to be able to apply their training and expertise to human cancer and to initiate their first independent research programs in human cancer. Basic and quantitative postdoctoral scientists training in extramural (i.e., non-Federal) institutions have access to two NCI-supported programs, the NCI Howard Temin Award (K01) and the Mentored Quantitative Research Career Development Award (K25), for this purpose. These same opportunities are not available to postdoctoral scientists who are Federal Employees. In order to overcome this barrier, Federal Employees pursuing research directly relevant to human cancer may apply for the K22. Finally, the NCI Career Development Award for Quantitative Scientists (K25) will be providing quantitative scientists their first experience in applying their research and technical skills to biomedical cancer research. These scientists may therefore require an additional period of protected time after the completion of the NCI K25 award to develop their first independent program in biomedical cancer research. Consequently, quantitative scientists who have been supported by the NCI K25 may also apply for the NCI Transition Career Development Award. The major objectives of the NCI Transition Career Development awards are therefore to provide a mechanism for stabilizing the career tracks of the most promising of these investigators while they are establishing their first independent research programs; and to create equal access of postdoctoral scientists in basic human cancer research working as Federal employees to extramural career development opportunities. MECHANISM OF SUPPORT This PA will use the NIH Career Transition (K22) award mechanism. Planning, direction, and/or execution of the program will be the responsibility of the applicant. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. Applicants must request three years of support. Each award is non- renewable and non-transferable from one Principal Investigator to another. Funding beyond the first year is contingent upon satisfactory progress during the preceding year, as documented in the required progress report. NIH Grant policies apply to these awards. Funding in the third year is contingent upon submission of an R01 research grant application or equivalent for peer review and funding consideration prior to the end of the second year of support (see SPECIAL REQUIREMENTS) This PA follows the Just-In-Time initiative for Career Awards published in the NIH Guide, Volume 25, Number 10, March 29, 1996. Applications submitted in accordance with PHS 398 (Rev. 05/2001), Section IV (Additional Instructions for Preparing Individual Research Career Award (RCA) Applications - "K" Series, are in compliance with the instructions provided in the 1996 Guide Notice. ELIGIBLE INSTITUTIONS Applications with a sponsoring institution may be submitted and awards may be accepted on behalf of candidates by organizations with any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Domestic institutions/organizations o Foreign institutions are not eligible to apply. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS To be eligible to apply for this award, applicants must be: 1) clinicians (e.g., M.D.'s; individuals with a clinical doctoral degree such as doctorally degreed oncology nurses, clinical psychologists) pursuing basic science cancer research careers or careers in patient- oriented cancer research; or 2) doctorally degreed individuals (e.g., Ph.D.'s, M.D.'s, Dr.P.H.'s) educated as cancer prevention, control, behavioral or population scientists. Federally employed doctorally degreed (e.g., Ph.D. s) basic scientists are eligible candidates if they are working in research directly relevant to human cancer. (Extramural basic research scientists pursuing careers directly relevant to human cancer should apply for the Howard Temin Award [K01] after consulting the following websites: http://grants.nih.gov/grants/guide/pa-files/PAR-03-104.html. http://cancertraining.nci.nih.gov/research/basicphd/phdk01.html). Individuals who meet the requirements above must have completed a minimum of TWO YEARS of postdoctoral CANCER research training and be ready to pursue an independent career at the time of application OR be in an independent faculty position for LESS THAN TWO YEARS with continuous previous postdoctoral CANCER research training at the time of the application. To be eligible, you must also be able to devote a minimum of 75 percent of full-time professional effort to the Award. The remaining 25 percent can be divided among other research, clinical and teaching activities only if these activities are consistent with the goals of the K22 Award, i.e., the candidate's development into an independent investigator. Postdoctoral trainees may apply for this award WITHOUT an institutional affiliation. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. Only U.S. citizens or noncitizen nationals, or an individual lawfully admitted for permanent residence who possesses an Alien Registration Receipt Card (I-151 or I-551), or some other verification of legal admission as a permanent resident, are eligible for this award. Noncitizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible. A candidate for a K22 may not simultaneously submit or have pending an application for any other PHS or non-Federal award that duplicates any of the provisions of this award. Former or current principal investigators on any NIH research grants (this does not include NIH R03 or R21 grants or their equivalents) or non-PHS peer reviewed research grants that are over $100,000 direct costs per year, or project leaders on sub-projects of program project (P01) or center grants (P50) are NOT eligible to apply. SPECIAL REQUIREMENTS A. Program: Recipients of an NCI Transition Career Development Award (K22) must submit an R01 research grant application to the National Institutes of Health, or an R01 equivalent research grant application to an equivalent funding organization (for example, an American Cancer Society Research Project Grant) for peer review and funding consideration prior to the end of the second year of support. B. The sponsoring institution must have well-established research programs in basic, clinical, and/or cancer prevention/control/behavioral/population sciences. This research environment should be one in which there are active research collaborations that exemplify a dynamic two-way exchange of information and ideas between laboratory and clinical and/or population research settings. C. Allowable Costs: Salary: The Transition Career Development Award (K22) will provide salary up to $75,000, plus fringe benefits. The total salary requested must be based on a full-time, 12 month staff appointment requiring the candidate to devote a minimum of 75 percent of full-time professional effort to conducting cancer research with the remaining effort being devoted to activities related to the development of a successful research career. The salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. The sponsoring institution may supplement the NIH contribution up to a level consistent with the institution's salary scale. Supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. Because the salary amount provided by this award is based on the full-time institutional salary, no other NIH funds may be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with or detract from the purpose of the award. Effective for all competing research grants submitted for the February 1, 2004 deadlines and beyond, mentored career award recipients in the last two years of career award support may hold concurrent support from their career award and a competing NIH research grant when recognized as a Principal Investigator or subproject Director. This new policy can be found at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html. Research Development Support: Up to $50,000 per year will be provided for the following types of expenses: (a) research expenses, such as supplies, equipment, and technical personnel; (b) statistical services including personnel and computer time; (c) tuition, fees, and books related to career development; and (d) travel to research meetings or for training. Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc. is not allowed. Facilities and Administrative Costs: These costs, which were formerly called indirect costs, will be reimbursed at 8 percent of modified total direct costs. D. Evaluation: In carrying out its stewardship of human resource related programs, the NIH may begin requesting information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. E. 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: o 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. o The funds may be used for health-related research purposes. o 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. o 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. Usually, funds budgeted in an NIH supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted. The awarding component will give consideration to approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of a career award must receive prior written approval of the NIH awarding component. F. Special Leave: Leave to work at another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award. Only local institutional approval is required if such leave does not exceed three months. For longer periods, prior written approval of the NCI is required. To obtain prior approval, the award recipient must submit a letter to NCI describing the plan, countersigned by his/her mentor and the appropriate institutional official. A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the career award will continue during such leave. Leave without award support may not exceed 12 months. Such leave requires the prior written approval of NCI and will be granted only in unusual situations. Support from other sources is permissible during the period of leave. Such leave does not reduce the total number of months of program support for which an individual is eligible. Under unusual and pressing circumstances, an awardee may submit a written request to the awarding component requesting a reduction in full-time professional effort below 75 percent. Such requests will be considered on a case-by-case basis during the award period. In no case will it be permissible to work at less than 50 percent effort. The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission to reduce the level of effort will not be approved to accommodate other sources of funding, job opportunities, clinical practice, or clinical training. In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the awardee. In addition, the awardee must submit assurance of his/her intention to return to full-time professional effort (at least 75 percent) as soon as possible. During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly. G. Termination of Institution When a grantee institution plans to terminate an award, NCI must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The Director of the NIH may discontinue an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, the Director of the NIH shall notify the grantee institution and career award recipient in writing of this determination, the reasons therefore, the effective date, and the right to appeal the decision. H. Change of Institution Individuals planning a change of institution AFTER AN AWARD HAS BEEN INITIATED must submit to the NCI in advance of the change a written request for transfer countersigned by the appropriate institutional business official, describing the reasons for the change. The awardee must establish in this request that the specific aims of the research program to be conducted at the new institution are within the scope of the original peer reviewed research program. Staff within the NCI will review this request and may require a review by an initial review group and the appropriate National Cancer Advisory Board. Upon approval of this request, the new institution must follow all of the procedures outlined in the section on AWARD CRITERIA for submission and NCI approval of a "Statement of Environment and Institutional Commitment." Upon approval of the "Statement", a new career award application must be submitted by the new institution far enough in advance of the requested effective date to permit review. The period of support requested in the new application must be no more than the time remaining within the existing award period. A final progress report, invention statement, and Financial Status Report are required upon either termination of an award or relinquishment of an award in a change of institution situation. I. Changes in Research Program: Individual awards are made for career development at a specific institution in a specific research program. A change in the specified scientific area of the research component of the career development program requires prior approval of the NCI. A scientific rationale must be provided for any proposed changes in the aims of the original peer-reviewed research plan. The new research plan will be evaluated by NCI staff to ensure that the plan remains within the scope of the original peer-reviewed research program. If the new plan does not satisfy this requirement, the award could be terminated. 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: In the Basic Sciences: David Eckstein, Ph.D. Program Director, Cancer Training Branch National Cancer Institute 6116 Executive Boulevard, Suite 7023 Bethesda, MD 20892-8346 Rockville, MD 20852 (express/courier service) Telephone: (301) 496-8580 Fax: (301) 402-4472 Email: eckstein@mail.nih.gov In the Clinical Sciences: Lester S. Gorelic, Ph.D. Cancer Training Branch National Cancer Institute 6116 Executive Boulevard, Suite 7025, MSC 8346 Bethesda, MD 20892-7390 Rockville, MD 20852 (express/courier service) Telephone: (301) 496-8580 Fax: (301) 402-4472 Email: gorelicl@mail.nih.gov In Cancer Prevention, Control, Behavioral, Population Sciences: Mary Blehar, Ph.D. Cancer Training Branch National Cancer Institute 6116 Executive Boulevard, Suite 7021, MSC 8346 Bethesda, MD 20892-8346 Rockville, MD 20852 (express/courier service) Telephone: (301) 496-8580 Fax: (301) 402-0181 Email: mblehar@mail.nih.gov o Direct your questions about peer review issues to: Referral Officer National Cancer Institute Division of Extramural Activities 6116 Executive Boulevard, Room 8041, MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (express/courier service) Telephone: (301) 496-3428 Fax: (301) 402-0275 Email: ncirefof@dea.nci.nih.gov o Direct your questions about financial or grants management matters to: Ms. Kimery Griffin Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243 Bethesda, MD 20892-7150 Rockville, MD 20852 (express/courier service) Telephone: 301-496-3196 Fax: 301-496-8601 Email: griffink3@mail.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. The title and number of this program announcement must be typed on line 2 of the face page of the application form and the YES box must be checked. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SUPPLEMENTARY INSTRUCTIONS: In addition to the required information listed in the instructions for Research Career Awards in the PHS 398, all applications MUST include the following information in the respective sections: BUDGET FOR ENTIRE PROPOSED PERIOD OF SUPPORT o Within the limitation of $50,000 direct costs for research development support, provide a detailed description, with justification, for all equipment, supplies and personnel that will be used to help achieve the career development and research objectives of this award. BIOGRAPHICAL SKETCH o Provide information on research projects completed and/or research grants participated in during the last five years that are relevant to the proposed project. LETTERS OF REFERENCE Three letters of reference must be provided from established scientists familiar with the candidate's potential and capability to become a successful independent investigator. These letters should be provided in sealed envelopes attached to the front page of the application. THE CANDIDATE o (Only for applicants already in an independent position) Describe the current position in terms of its ability to enable the candidate to continue to pursue an INDEPENDENT career in CANCER research. o Identify whether you are a clinician pursuing a basic science career; a clinician pursuing a clinical research/translational research career; an individual pursuing a career in prevention, control, behavioral or population research; or a postdoctoral candidate working in basic research as a Federal employee. o Describe all activities during the "mentored" period (and, if applicable, during your first independent research position) of CANCER research training. Include all research experiences and mentors, any pertinent didactic experiences and any other experiences designed to acquire critical skills, techniques and scientific perspectives for pursuing an independent career in the chosen area of CANCER RESEARCH (e.g., basic research, clinical or patient-oriented research, and prevention, control, and population research). o Describe your scientific productivity during the mentored period of career development (and, if applicable, during your first independent position). o Establish your potential to manage an independent research program. o Establish your ability to become an independent investigator during the three year term of the award. o Describe your ability to interact and collaborate with other scientists. o Document your ability to make a commitment of at least 75 percent effort of full-time professional effort to the career objectives of this award. o Document your prior instruction in or proposed plans for instruction in the responsible conduct of research in terms of subject matter and duration of instruction. An award cannot be made if an application lacks this component. RESEARCH PLAN o Describe an original research plan in basic, clinical, cancer prevention or cancer control research; or in behavioral or population sciences research directly related to cancer. The research plan must be described as outlined in form PHS 398 including sections on the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, Research Design and Methods. o Describe how the proposed research extends the mentored research training (and, if applicable, the research conducted in your first independent research position) that has been completed into new concepts and ideas. The proposed research could consist of pilot studies. However, the applicant must clearly describe how these pilot studies would serve as a vehicle for meeting the Special Requirement of this K22 Award for submission of an investigator-initiated research grant application prior to the end of the second year of the award. o Describe the equipment, specialized facilities, and personnel resources that will be needed to conduct the proposed research. o Describe the plans for inclusion of women, minorities, and children in any clinical or population research activities. o Describe the plans for protection of humans, animals, or the environment to the extent they may be adversely affected by activities proposed in the application. STATEMENT(S) BY CONSULTANT(S), AND COLLABORATOR(S) o Consultant(s)/Collaborator(s): Signed statements must be provided by each consultant/collaborator confirming their participation in the project and describing their specific roles. Collaborators and consultants generally do not need to provide their biosketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration. ENVIRONMENT AND INSTITUTIONAL COMMITMENT TO THE CANDIDATE (Required at the time of application for candidates who have identified a sponsoring institution) o Describe the resources and facilities that will be available to the candidate. o Describe how the research environment of the institution is particularly suited for the development of the candidate's research career, as proposed in the research plan of the application. This should include a brief discussion (one paragraph) of the depth and breadth of cancer research being conducted at the institution. o Provide a clear statement by the sponsoring institution that the candidate will be able to spend a minimum of 75 percent of full-time professional effort on the proposed career development plan/research, with the remaining percent effort devoted to activities related to the development of a successful research career. o Provide a clear statement by the institution that describes the commitment to the career progression of the candidate (e.g., tenure track position). SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, three original sealed letters of reference, and three signed photocopies in one package to: Center for Scientific Review (CSR) National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to: Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Room 8041, MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express/courier service) Appendices should be comprised of single-sided, unbound materials, with separators between documents. APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE WILL NO LONGER BE ACCEPTED. This policy does not apply to courier deliveries (i.e. FEDEX, UPS, DHL, etc.) (http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html) This policy is similar to and consistent with the policy for applications addressed to Centers for Scientific Review as published in the NIH Guide Notice http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html. APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. 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 unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NCI. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Complete and responsive applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) by the Division of Extramural Activities at the NCI will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a written critique. o Receive a second level review by the National Cancer Advisory Board. REVIEW CRITERIA In the written comments, reviewers will be asked to evaluate the following aspects of the application: o Candidate o Letters of reference o Statements by former Mentor, Co-Mentor(s), Consultant(s), and Collaborator(s) o Environment and Institutional Commitment to the Candidate o Research Plan The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. The application does not need to be strong in all categories to deserve a high priority score. These criteria are listed in logical order and not in order of priority. CANDIDATE o (Only for candidates already in an independent position) Suitability of the position for the candidate to pursue an independent research career. o Quality of the mentored period of CANCER research training (or of the mentored period of training and current research if currently in your first independent research position) in terms of research experience(s), didactic experiences and other experiences (e.g., special skills, perspectives, techniques) that will enhance the candidate's ability to pursue an independent CANCER research career in the chosen area of research (e.g., basic research; clinical or patient oriented research; or prevention, control, behavioral, and population sciences research). o Scientific productivity during the mentored period (and, if applicable while in your first independent research position) of career development. o Potential ability to successfully manage an independent research project. o Ability to interact and collaborate with other scientists. o The potential to become a successful independent investigator during the 3-year term of this award. LETTER OF REFERENCE o Letters of reference on behalf of the candidate. STATEMENTS BY CONSULTANT(S) AND COLLABORATOR(S) o Appropriateness of the qualifications of the consultants/ collaborators in the area of the proposed research. ENVIRONMENT AND INSTITUTIONAL COMMITMENT TO THE CANDIDATE (Only for applicants with a sponsoring institution) o Quality of the environment for scientific and professional development. o Adequacy of research facilities. o Documentation of well-established research programs in basic, clinical and or cancer prevention/control/behavioral/population sciences. This research environment should be one in which there are active research collaborations that exemplify a dynamic two-way exchange of information and ideas between laboratory and clinical and/or population research settings. o Adequacy of the track record of the institution in the conduct of cancer research. o Adequacy and clarity of the applicant institution's assurance that the investigator will spend a minimum of 75 percent of full-time professional effort on the proposed career development plan/research, with the remaining percent effort devoted to activities related to the development of a successful research career. RESEARCH PLAN o The originality, innovativeness and scientific merit of the proposed Research Plan relative to the experience level of the applicant. o Extent to which the research plan goes beyond the mentored environment and will test new concepts and ideas. o The medical and/or health significance of the Research Plan to Cancer. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. 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 program priorities The NCI will notify candidates who have competed successfully for funding with a "Letter of Intent to Commit Funds." Candidates in a postdoctoral position will then have one year from the date of the letter to find an institution that offers a position, preferably tenure-track, suitable for enhancing a research career. For a candidate who already has a position in a sponsoring institution, negotiations with the institution will begin without delay. Negotiations will be initiated by asking the candidate's institution to submit a "Statement of Environment and Institutional Commitment" to the NCI. This statement will be evaluated by NCI staff using the following criteria: o Documentation of a strong, well-established research program related to the candidate's area of interest, including a high-quality research environment with staff capable of productive collaboration with the candidate; o Documentation of active research collaborations that exemplify a dynamic two-way exchange of information and ideas between laboratory and clinical and/or population research settings; o Agreement of the institution's statement of commitment of equipment, physical and personnel resources with the peer-reviewed recommendation of needs; o Adequacy of the institutional commitment to the required 75 percent of full-time professional effort requirement of this award for the development of an independently funded research program; o Adequacy of the arrangements with the candidate to provide a permanent, preferably tenure-track, position; adequate facilities for conducting a research program, and additional resources conducive to the development of a research project and establishment of a successful research career. For postdoctoral candidates, if the NCI approves the "Statement of Environment and Institutional Commitment" offered by the institution, the institution will be asked to submit a completed PHS Form 398 application. For candidates who already have a position in a sponsoring institution, the NCI only needs to approve the Statement. After NCI approval and subject to the availability of funds, the institution will receive an award. At the time of the award to the grantee institution in support of the K22, any current award held or other support provided for the mentored training of the candidate will be terminated. NON-COMPETING GRANT PROGRESS REPORTS Funding beyond the first year of the award is contingent upon satisfactory progress during the preceding year. Progress is documented on form PHS 2590 (rev. 5/2001 or subsequent revisions) and instructions found in Section IV. "Additional Instructions for Preparing Continuation Research Career Award (RCA) Progress Reports" under Table of Contents. The form PHS 2590 is available at http://grants.nih.gov/grants/funding/2590/2590.htm. Additionally, funding beyond the second year of the award is contingent upon submission of an R01 research grant application to the National Institutes of Health, or an R01 equivalent research grant application to an equivalent funding organization (for example, an American Cancer Society Research Project Grant) for peer review and funding consideration prior to the end of the second year of support. Documentation that the awardee has submitted an R01-type research grant application for funding should minimally be a copy of the face page of the application with all required institutional signatures. 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. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). Clinical trials supported or performed by NCI require special considerations. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the principal investigator/project manager or NCI program staff or a Data and Safety Monitoring Board (DSMB). These monitoring activities are distinct from the requirement for study review and approval by an Institutional review Board (IRB). For details about the Policy for the NCI for Data and Safety Monitoring of Clinical trials see: http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. For Phase I and II clinical trials, investigators must submit a general description of the data and safety monitoring plan as part of the research application. See NIH Guide Notice on "Further Guidance on a Data and Safety Monitoring for Phase I and II Trials" for additional information: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. Information concerning essential elements of data safety monitoring plans for clinical trials funded by the NCI is available: http://www.cancer.gov/clinical_trials/ INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This 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 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 authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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