and Human Services (HHS)
EXPIRED
NCI TRANSITION CAREER DEVELOPMENT AWARD FOR UNDERREPRESENTED MINORITIES (K22) RELEASE DATE: April 9, 2003 (replaced by PAR-05-011) PA NUMBER: PAR-03-101 EXPIRATION DATE: November 2, 2004 National Cancer Institute (NCI) (http://www.nci.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER (S): 93.398 This Program Announcement (PA) replaces PAR-01-074, which was published in the NIH Guide on March 30, 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 Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The Comprehensive Minority Biomedical Branch (CMBB), Office of Centers, Training and Resources (OCTR), Office of the Deputy Director for Extramural Sciences (ODDES), National Cancer Institute (NCI), invites transition career development award applications from recipients of the NCI Mentored Career Development Award for Underrepresented Minorities or from underrepresented minority individuals who are advanced postdoctoral and/or newly independent research scientists who have been in an independent position for less than two years at the time of the application. The purpose of the NCI Transition Career Development Award for Underrepresented Minorities (K22) is to provide "protected time" to develop and receive support for their initial cancer research program. This award is intended to facilitate the transition of a minority postdoctoral research scientist from the mentored to the independent stage of their careers in cancer research. The unique feature of this award is that the individuals may apply without a sponsoring institution while they are still in a mentored position. Successful candidates will be provided with special opportunities to enhance their knowledge and understanding of the NIH/NCI peer review system and to develop the skills required for preparing competitive research project grants. This award is a novel program that is intended to support and enhance the likelihood of success for underrepresented minority postdoctoral and newly independent investigators who have committed to basic, clinical, and prevention and population-based research careers in cancer. Awardees must apply for an R01 research grant or equivalent prior to the end of the second year of the award. RESEARCH OBJECTIVES Substantial national and local efforts have been made and are continuing to be made to reduce cancer morbidity and mortality in the general population. However, in spite of these efforts, projections made for 2002 indicated that 1,284,900 cancers were expected to be diagnosed in the United States and 555,500 Americans were expected to die of this disease. Past patterns of cancer incidence and mortality predict that a disproportionate share of this increase in U.S. cancer incidence and mortality will be borne by minorities. Specifically, past and current SEER data show that Hispanic Americans have excessive cancer incidences of the prostate, breast, lung and bronchus, colon and rectum, and cervix. Native Americans from New Mexico show excessive cancer rates for prostate, breast, colon and rectum, ovary, kidney, and renal pelvis cancers, with the incidence rate for gall bladder cancer being the highest of any racial group. Alaska Natives have the highest cancer incidence rates among any racial group for cancer of the colon and rectum. Finally, cancer mortality rates for all sites for African Americans are almost 1.4 times greater than for Caucasians. A reduction in the overall cancer mortality rate in minority populations would substantially impact known cancer statistics. A major obstacle to developing a stronger national minority cancer research effort has been the lack of significant strategic training programs for minority students and scientists in cancer research. Greater involvement of minority candidates, who possess the appropriate cultural perspectives, is integral to a successful national minority cancer research effort involving more minority patients and populations. Prior to 2000, progress in realizing a significant increase in the number of competitive minority cancer researchers had been disappointing. This K22 mechanism establishes a unique pathway of recruiting and retaining advanced postdoctoral student and new investigators into research fields that address problems pertinent to the biology, etiology, pathogenesis, prevention, diagnosis, control and treatment of human cancer and who can conduct independent competitive cancer programs. MECHANISM OF SUPPORT Awards in response to this program announcement will be made through the Transition Career Development Award (K22) mechanism. Planning, direction, and the execution of the proposed training program will be the responsibilities of the applicant on behalf of the applicant institution. The total project period for an application submitted in response to this PA may not exceed 3 years. Grants are not 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 (refer to "Non-Competing Renewals"). Awards are not renewable. ELIGIBLE INSTITUTIONS Although applications may be submitted for peer-review without institutional representation, if approved for funding, applications must be resubmitted on behalf of candidates by an institution that has 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 Units of State and local governments o Domestic The institution must be able to demonstrate a commitment to the development of the research careers of junior underrepresented minority research scientists in biomedical cancer research. Applications from foreign organizations are excluded from applying to this program announcement. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Applicants are encouraged to contact the NCI program staff listed under INQUIRIES regarding their eligibility for this award prior to the preparation of an application. Recipients of the NCI Mentored Career Development Award for Underrepresented Minorities and/or candidates who meet the following requirements are eligible to apply: o Qualify as an underrepresented minority individual defined as individuals belonging to particular ethnic, racial and other groups determined by the grantee institution to be underrepresented in biomedical, behavioral, clinical or social sciences, e.g., first generation college students/graduates, socio-economically disadvantaged. o Possess a research or health professional doctoral degree (or its equivalent) that is suitable preparation for a productive research career. o Have been in or currently in a "mentored" research postdoctoral position and have completed two years or more of research in this capacity at the time of the application, or be in a suitable independent position for less than two years with continuous previous postdoctoral research training at the time of the application. Exceptions to this condition will require explicit written permission from the NCI. o Intend to conduct a research project highly relevant to cancer biology, etiology, pathogenesis, prevention, diagnosis and treatment that has the potential for establishing an independent research program. o Candidates must be U.S. citizens or non-citizen nationals, or must have been lawfully admitted for permanent residence by the time of award. Individuals admitted for permanent residence must be able to produce documentation of their immigration status such as an Alien Registration Receipt Card (I-551) or some other verification of legal admission as a permanent resident. Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible for this award. Federal employees are ineligible for this program. Women and persons with disabilities are encouraged to apply as principal investigators. SPECIAL REQUIREMENTS A. Program The NCI Transition Career Development Award (K22) for Underrepresented Minorities can be used by more advanced postdoctoral and newly independent minority candidates who need protected time to establish their initial cancer research program. Accordingly, the award provides up to three consecutive 12-month appointments to recipients who must devote a minimum of 75 percent effort to the proposed basic, clinical or population science research program. The remaining 25 percent can be divided among other activities only if they are consistent with the program goals, i.e. the candidate's development into an independent investigator. Candidate: Candidates must devote at least 75 percent of their professional effort to cancer-related research and peer review activities consistent with the objectives of this award. The candidate must develop advanced knowledge in the basic, clinical, prevention or population-based sciences and the advanced research skills relevant to her/his cancer research field(s). Recipients of an NCI Transition Career Development Award for Underrepresented Minorities (K22) must submit a competitive research grant application to the NIH/NCI, 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. Environment: The sponsoring institution, once identified, must have well- established basic, clinical, and/or prevention and population-based cancer research programs. The candidate's proposed cancer research program should benefit from the relevant cancer research and educational resources that are available. The sponsoring institution must also demonstrate a commitment to the development of junior faculty as productive, independent investigators. B. Allowable Costs Salary: The NCI Transition Career Development Award for Underrepresented Minorities (K22) will provide salary up to $75,000 annually plus fringe benefits. The total salary requested must be based annually on a full-time, 12 month staff appointment requiring the candidate to spend a minimum of 75 percent effort 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 institution may supplement the NCI salary contribution up to a level that is consistent with the institution's salary scale; however, 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 PHS funds may be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K22. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. 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. The level of research development support may be negotiated downward with the acquisition of any independent grant support from any source. 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. C. Evaluation In carrying out its stewardship of human resource related programs, the NCI 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. D. 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, Division 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 a 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 NCI. E. Special Leave Leave to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award. Only local, institutional approval is required if such leave does not exceed 3 months. For longer periods, prior written approval of the NCI is required. To obtain prior approval, the award recipient 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 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 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 a rate of 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. Furthermore, the awardee must submit assurance of his or 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. F. Termination or Change of Institution When a grantee institution plans to terminate an award, the NCI must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The Director of the NCI 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 NCI 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. Awardees planning a change of institution are urged to contact the NCI Program Director (name listed in Notice of Grant Award) to discuss the transfer and obtain instructions. The required paperwork must be submitted by the new institution far enough in advance of the requested effective date to permit review. The period of support requested at the new institution 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. G. Reporting Requirements If the application is funded, additional reporting requirements for continuation of this project are listed in the section titled "Non-Competing Renewals". 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: Ms. Belinda M. Locke Program Director, Comprehensive Minority Biomedical Branch National Cancer Institute 6116 Executive Boulevard, Suite 7031 Bethesda, MD 20892-8350 Rockville, MD 20852 (express/courier service) Telephone: (301) 496-7344 FAX: 301-402-4551 Email: [email protected] 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 Telephone: (301) 496-3428 FAX: (301) 402-0275 Email: [email protected] o Direct your questions about financial or grants management matters to: Ms. Barbara Fisher Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243 Bethesda, MD 20892-7150 Rockville, MD 20852 (express/courier service) Telephone: 301-846-1015 FAX: 301-846-5720 Email: [email protected] SUBMITTING AN APPLICATION Potential candidates are strongly encouraged to contact the program staff person listed under INQUIRIES. Such contact should occur early in the planning phase of application preparation. Such contact will help ensure that applications are responsive to the goals and policies of this announcement. Applications must be prepared using Section IV, "Research Career Awards" (RCA), instructions to complete the PHS 398 research grant application (rev. 5/2001). The PHS 398 and Section IV instructions are 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: [email protected] Applicants who will be using the resources within a General Clinical Research Center (GCRC) during the course of the award should include a letter of agreement from either the GCRC program director or the principal investigator for the application. To identify the application as a response to this program announcement, check "YES" on item 2 of page one of the application and enter the title and number of this PA. 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. SPECIFIC INSTRUCTIONS: The application must address the following issues: Candidate For applicants already in an independent position: o Describe immediate and long-term career goals, explaining how the award will contribute to their attainment; o Describe the current position in terms of its ability to enable the candidate to pursue an independent career in cancer research; All Candidates o Describe immediate and long-term career goals, explaining how the award will contribute to their attainment; o Describe all activities during the "mentored" period (postdoctoral, previous K-award, etc.) 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 scientific productivity during the mentored period of career development; o Establish the potential to manage an independent research program; o Establish the ability to become an independent investigator during the three year term of the award; o Describe the ability to interact and collaborate with other scientists; o Establish the ability to make a commitment of at least 75 percent effort to the objectives of this award; o Submit three letters of recommendation from established scientists familiar with the candidate's potential and capability to become a successful independent investigator in which the following issues are addressed: - the adequacy of the candidate's scientific background for the proposed research and career goals; - the quality of the candidate's scientific productivity and achievements (e.g., publications, intellectual contributions to the research environment); - the candidate's ability to work with other scientists in various interactive situations (e.g., seminars, journal clubs), on collaborative research projects, and with support staff (e.g., technicians, nurses, secretaries etc.); - evidence of the candidate's originality and innovativeness in pursuing a research problem; - VERY IMPORTANTLY, the candidate's special potential to develop, establish and manage an independent research program. Research Plan o Describe the research plan using Form PHS 398 (rev. 5/2001 or subsequent revisions) following instructions for the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, Research Design and Methods. The research plan must be clearly relevant to cancer biology, etiology, pathogenesis, prevention, diagnosis, and/or treatment; o Describe how the proposed research extends the mentored research training that has been completed into new concepts and ideas; 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. Previous Mentor's Statement o Include a signed statement from the previous mentor(s) with information on potential and capability of the candidate to become a successful independent investigator in which the following issues are addressed: - The adequacy of the candidate's scientific background for the proposed research and career goals; - The quality of the candidate's scientific productivity and achievements (e.g., publications, intellectual contributions to the research environment); - The candidate's ability to work with other scientists in various interactive situations (e.g., seminars, journal clubs), on collaborative research projects, and with support staff (e.g., technicians, nurses, secretaries etc.); research qualifications and previous experience as a postdoctoral researcher. The application must also include information to describe the previous mentor's research support as related to the candidate's research plan. Environment and Institutional Commitment o Describe the resources and facilities 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 and the pursuit of the proposed research plan; o In a clear statement, provide assurances that the candidate will be able to spend a minimum of 75 percent effort in the conduct of his/her research activities, with the remaining percent effort devoted to activities related to the development of a research career. Biographical Sketch A biographical sketch is required for the candidate, including information on research projects completed and/or research grants participated in during the postdoctoral or mentored phase that are relevant to the proposed project. Training in the Responsible Conduct of Research Candidates must describe previous training in the responsible conduct of research or if the candidate has not had such training, must describe plans to receive instruction in the responsible conduct of research. These plans must detail the subject matter, format, frequency, and duration of instruction. No award will be made if an application lacks this component. Budget The total direct costs requested must be consistent with this K22 program announcement and the award limits of the NCI. Provide a detailed description, with justification, for all equipment, supplies and personnel that are required to achieve the research objectives of this award. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, and three signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Room 8041, MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express/courier service) APPLICATION PROCESSING: Applications must be received by or mailed before the receipt date(s) 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 application already reviewed, but such application must include an Introduction addressing the previous critique. 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 change in practice is effective immediately. 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. 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 for adherence to the guidelines of this PA by the NCI program staff. Applications not adhering to the guidelines of this PA, and those applications that are incomplete as determined by CSR or by NCI program staff, will be returned to the applicant without review. Applications that are complete and adhere to the guidelines of this PA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities of the NCI in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Those that receive a priority score will undergo a second level review by the National Cancer Advisory Board. REVIEW CRITERIA The following review criteria will be applied: Candidate (Principal Investigator) For candidates already in an independent position: o Suitability of the position for the candidate to pursue an independent research career; For all Candidates: o Quality of the mentored period of cancer research training 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 and population research); o Scientific productivity during the mentored period of cancer research training; o Commitment of the candidate to an independent cancer research career that will be focused on problems clearly relevant to cancer; o Potential ability to successfully manage an independent research project; o Ability of the candidate to interact and collaborate with other scientists; o Recommendations of three well-established scientists attesting to the special potential of the individual to pursue an independent career in cancer research. Research Plan o Adequacy of the proposed research plan for developing an independent cancer research program as it relates to the basic, clinical or patient-oriented and/or prevention control and population cancer research and commensurate with the candidate's level of research development; o The originality and quality of the research hypothesis/question, design and methodology, judged in the context of the candidate's previous training and experience; o Adequacy of plans for the protection of human and animal subjects and the safety of the research environment and conformance with the NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research and Inclusion of Children Participating in Research Involving Human Subjects. (See criteria included in the section on Federal Citations, below.) Previous Mentor/Co-Mentor o Adequacy and clarity of the previous mentor's statement describing the potential and capability of the candidate to become a successful independent investigator. Institutional Environment and Commitment o Clear commitment of the institution to ensure that a minimum of 75 percent of the candidate's effort will be devoted directly to research, with the remaining percent effort being devoted to activities related to the successful development of a independent research career; o Adequacy of research facilities and training opportunities; o Quality and relevance of the environment for scientific and professional development of the candidate. Training in the Responsible Conduct of Research Quality of the proposed/previous training in the responsible conduct Budget o Justification of the requested budget in relation to career development goals and research aims and plans; o Adequacy of the proposed budget items for the achievement of the career development and research objectives of the award. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, applications will also be reviewed with respect to the following: 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. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The NCI staff will notify the applicant of the National Cancer Advisory Board's action shortly after its meeting. 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 Candidates who have competed successfully for funding that do not have an institution at the time funding decisions are made will be notified by the NCI 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. Candidates who have already identified positions will not reveive the "Letter of Intent to Commit", but will be asked to submit the "Statement of Environment and Institutional Commitment" and to submit the Just-In-Time documents (detailed budget for first year, detailed budget for entire project period, other support and checklist). For candidates who already have a position in a sponsoring institution, negotiation 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 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 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. An award can be terminated prior to the end of the third year by the NCI if the candidate does not submit an R01 type grant application or equivalent for peer review before the end of the second year (See SPECIAL REQUIREMENTS). Non-Competing Renewals Funding beyond the first year of the award is contingent upon satisfactory progress during the preceding year, as documented in the required Progress Report. In addition to the information requested in the Application for Continuation Grant form PHS 2590 (Rev. 5/01), documentation must be provided with the Progress Report for the third year of the award showing that the awardee has submitted a competitive research grant (or equivalent) for funding. This documentation should minimally be a copy of the face page of the application with all required institutional signatures. The Progress Report (PHS form 2590) will be evaluated based upon and should include: o Demonstration of scientific progress toward the aims of the research. The candidate is responsible for a brief summary of the studies and results obtained during the prior funding period; o A list of accomplishments such as publications, inventions, or project- generated resources should be provided; o A brief explanation of plans to address the specific aims during the next year of support; o Description of similar activities for the next year of support with a clear indication of percent effort devoted to research/research training and other activities respectively; and REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and 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 AMENDMENT "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 in now available online at: http://cme.nci.nih.gov/ HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Guidance for investigators and institutional review boards regarding research involving human embryonic stem cells, germ cells, and stem cell-derived test articles can be found at http://grants.nih.gov/grants/guide/notice-files/NOT- OD-02-044.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. 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 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 by Public Law 99-158 (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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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