and Human Services (HHS)
EXPIRED
MENTORED PATIENT-ORIENTED RESEARCH FOR UNDERREPRESENTED MINORITIES (K23) RELEASE DATE: October 7, 2002 (see modification NOT-CA-03-024) PA NUMBER: PAR-03-006 EXPIRATION DATE: October 2, 2005, unless reissued. National Cancer Institute (NCI) (http://www.nci.nih.gov/) This Program Announcement (PA) replaces PAR-00-042, which was published in the NIH Guide January 14, 2000. THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) 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 Non-Competing Renewals 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), announces the availability of the "Mentored Patient-Oriented Research for Underrepresented Minorities" award for career development of underrepresented minorities in clinical oncology. This award provides specialized study for individuals with a health professional doctoral degree (e.g. M.D., D.D.S., D.O., O.D., D.V.M., D.N.Sc., N.D. [Doctor of Naturopathy], Pharm D.), who are committed to a career in patient-oriented cancer research. Individuals with a Ph.D. or other doctoral degrees in clinical disciplines such as clinical psychology, nursing, clinical genetics, speech-language pathology, audiology and rehabilitation are also eligible. Individuals holding the Ph.D. in a non- clinical discipline but certified to perform clinical duties should contact CMBB concerning their eligibility for a K23 award (SEE INQUIRIES). The purposes of this award are to: o Encourage research-oriented underrepresented minority clinicians to develop independent research skills and gain experience in advanced methods and experimental approaches needed to conduct patient-oriented research, o Capture those underrepresented minority health professionals with variable backgrounds in clinical practice and limited or no clinical research experience to re-direct their careers toward clinical cancer research by acquiring critical research skills in a mentored clinical research environment, o Provide an opportunity for minority clinicians engaged in other clinical research areas for less than two years, to re-direct their research focus to clinical cancer research, and o Increase the pool of underrepresented minority clinical researchers who can conduct patient-oriented studies, capitalizing on the discoveries of biomedical research and translating them to clinical settings. This award will support the career development of underrepresented minority investigators who have made a commitment to focus their research endeavors on patient-oriented research. This mechanism provides support for three to five years of supervised study and research experience that may integrate didactic studies with clinically based research. Candidates must be clinically trained professionals who have the potential to develop into productive, clinical investigators with a focus on patient-oriented cancer-related research. The proposed research must have intrinsic research importance as well as serve as a suitable vehicle for learning the methodology, theories, and conceptualizations necessary for a well-trained independent clinical investigator. The CMBB will provide successful candidates 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. For the purposes of this award, patient-oriented research is defined as research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator directly interacts with human subjects. This area of research includes: 1) mechanisms of human disease; 2) therapeutic interventions; 3) clinical trials; and 4) the development of new technologies. The NCI is especially interested in increasing the number of underrepresented minority clinicians trained to conduct high-quality, patient-oriented clinical research. Accordingly, this award forms an important part of the NCI initiative to attract talented underrepresented minority individuals to the challenges of clinical research. NCI intends to target a significant increase in funds for these entry-level career development awards. The K23 provides the awardee, through multidisciplinary didactic training, the opportunity to obtain both the knowledge and the research skills necessary to compete for independent support in patient-oriented research. This initiative is consistent with the recommendations of the NIH Director's Panel on Clinical Research, and from the CMBB MD Working Group and the Institute of Medicine Committee on Addressing Career Paths for Clinical Research. It is anticipated that candidates for this award may or may not have had a clinical research- intensive experience and will represent many different stages of career development. Because of this, the NCI "Mentored Patient- Oriented Research for Underrepresented Minorities" award places considerable emphasis on the experience and continued involvement and commitment of the mentor(s) during the candidate's development. To ensure progression to independence, the prospective candidate should propose a period of study in which the mentor(s) has carefully tailored the candidate's career development plan to build upon his/her previous training and background. For example, a candidate with limited experience in a given area of clinical research and/or a unique cultural background may find a phased 5-year developmental program that includes a designated period of specialized didactic training and a more intensely supervised clinical research experience to be the most efficient means of attaining independence. A candidate with substantial previous clinical research experience may require a shorter award period and less specialized attention from the mentor in order to facilitate the transition to independence. 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 1999 were that 1,221,800 cancers were expected to be diagnosed in the United States and 563,100 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 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 Whites. Contributing to the cancer mortality of U.S. minorities is their limited access for treatment by physicians with appropriate cultural sensitivities. This factor is largely due to the small numbers of U.S. minority patient- oriented clinical oncologists. Data from the American Medical Association for 1994 show that of 11,224 U.S. oncologists, only 184 (1.6 percent) were of African American descent, 336 (3.0 percent) were of Hispanic descent, and 3 (0.03 percent) were of Native American descent. Current statistics on medical specialties among U.S. medical school graduates do not portray a significant change in this situation. Specifically, of the total 1993 medical school graduates, only 0.9 percent had selected oncology as their area of specialization, and only 0.2 percent of graduates selecting an oncology specialization were underrepresented minorities. In 1994, only 11.2 percent of all medical school applicants were underrepresented minorities, a proportion that had not changed significantly from the value of 10.8 percent six years earlier. A reduction in the overall cancer mortality rate in minority populations would substantially impact known cancer statistics. Cultural barriers to cancer diagnosis/treatment and to advice regarding preventive health care will take on added importance as the techniques of molecular epidemiology are increasingly applied to identify minority individuals and family members at high risk for cancer. As a result of this new technology, physicians will increasingly be called upon to deal with culturally sensitive issues such as prophylactic surgery for family members, and/or major changes in lifestyle, possibly even including childbearing. It is therefore imperative that a sufficient number of minority clinical oncologists be available so that access to care is not limited by the number of oncologists sensitive to cultural issues. Additionally, the clinical oncologist must have an understanding of the new technologies being developed that will assist in the diagnosis/treatment of cancers and the predictions of cancer risk. This understanding can best be provided by a research and career development experience in the development and/or application of these technologies. MECHANISM OF SUPPORT Awards in response to this program announcement will be made through the Mentored Patient-Oriented Research (K23) mechanism. Planning, direction, and the execution of the proposed training program will be the responsibilities of the applicant and her/his co-mentors on behalf of the applicant institution. The career development award will be made for a period of up to 5 years. Each award is non-renewable and non-transferable from one Principal Investigator to another. Funding beyond the first year of the award is contingent upon satisfactory progress during the preceding year as documented in the required Progress Report (refer to "Non-Competing Renewals"). NIH Grant policies apply to these awards. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution 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 Eligible agencies of the Federal government or comparable institutions with well-established training programs in patient-oriented clinical oncology o Domestic Foreign organizations are excluded from submission to this announcement. Eligible institutions must also have active biomedical research programs in oncology, including clinical trials with adequate numbers of highly trained faculty in clinical and biomedical science areas as they relate to cancer. They must also demonstrate a commitment to the development of the research careers of junior underrepresented minority health professionals in clinical oncology. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS This award is designed to provide an intensive, supervised research experience for underrepresented minority health professionals. The award is intended for individuals with a health professional degree to acquire research experience in patient-oriented clinical oncology. Individuals with a Ph.D. or other doctoral degrees in clinical disciplines such as clinical psychology, nursing, clinical genetics, speech-language pathology, audiology and rehabilitation are also eligible. Individuals holding the Ph.D. in a non- clinical discipline but certified to perform clinical duties should contact CMBB concerning their eligibility for a K23 award (SEE INQUIRIES). Candidates must have completed their clinical training, including specialty and, if applicable, subspecialty training prior to receiving an award. However, candidates may submit an application prior to the completion of clinical training. Underrepresented minorities are defined as individuals belonging to a particular ethnic or racial group and determined by the grantee institution to be underrepresented in biomedical and behavioral research. NCI would like to point out that African Americans (Black), Hispanic Americans, Native Americans and Alaska Natives, and non-Asian Pacific Islanders are underrepresented in biomedical or behavioral research nationally. Awards will be limited to individuals who are citizens, non-citizen alien nationals, and permanent residents of the United States. Individuals on temporary or student visas are not eligible. Candidates for the award should have broad clinical training, must demonstrate competence in clinical activities, must document a serious intent for a research career in patient-oriented clinical oncology, and must document a sensitivity to cultural issues impinging upon the practice of medicine among the major U.S. ethnic populations. The candidates must be nominated by an institution on the basis of qualifications, interests, accomplishments, motivation, and their potential for a career in clinical oncology. Women and persons with disabilities are encouraged to apply as Principal Investigators. Evidence of the institution's commitment to the applicant's research development must be documented. Candidates must have at least two mentors. One who is recognized as an accomplished clinical investigator and at least one additional mentor or advisor who is recognized as an accomplished independent basic science investigator in the proposed research area. Candidates must be willing to devote a minimum of 75 percent full-time professional effort in conducting research career development and clinical research. Ineligible individuals include current and recent Principal Investigators on NIH research project grants (R01), and comparable career development awards (K01, K08, K07, K23). Individuals who have not been Principal Investigators on the above types of grants in the last five years are eligible. Former Principal Investigators of NIH Small Grants (R03) or Exploratory/Developmental Grants (R21), and sub-projects of a Program Project (P01), or Center Grant (P30), or Specialized Center Grant (P50) remain eligible. Current and former recipients of Clinical Associate Physician Award (CAP) support may apply for the K23 provided that they have had no more than 3 years of CAP support by the time a K23 award is made. The combined total of CAP plus K23 support must not exceed 6 years. A candidate for the K23 award may not have pending and may not concurrently apply for a CAP award or any other career development award. K23 recipients are encouraged to apply for independent research grant support during the period of this award. SPECIAL REQUIREMENTS A. Program: Up to five consecutive 12-month awards will be provided. At least 75 percent of the recipient's full-time professional effort must be devoted to the goals of this award. For the purposes of this award, full-time professional effort provides protected time away from normal activities (e.g. standard patient care and on-call duties, and administrative and teaching assignments). The 75 percent effort includes activities consistent with development of the minority candidate into a competitive independent clinical investigator (e.g. acquisition of clinical trials skills and didactic courses). The remainder (25 percent effort) may be devoted to clinical, teaching, or other research pursuits as long as they are consistent with the objectives of the award (i.e. to train a health professional to compete successfully for NIH support). Both the didactic and the research phases of an award period must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the career goals of the candidate. Under unusual and pressing circumstances, an awardee may submit to the awarding component a written request for 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. Further, 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. Because of the focus on progression to independence as clinical investigators, candidates for the K23 should propose, together with their mentor(s), a period of study and career development consistent with the previous research and clinical experience of the candidate. As appropriate, sensitivity to the candidate's needs related to his/her cultural, socioeconomic heritage should be considered. For example, a candidate with limited experience in a given field of patient-oriented research may find a 5-year phased developmental program that includes a designated period of specialized didactic training followed by a period of closely supervised training by the mentor necessary to insure that he/she will attain independence. A candidate with previous research experience and training may not require extensive additional didactic preparation, and may benefit from a program that focuses primarily on an intensive, supervised patient-oriented research experience. All programs must be tailored to meet the individual needs of each minority candidate to provide the opportunity for him/her to gain the skills and knowledge necessary to carry out high quality patient-oriented research. The candidate and the mentor are jointly responsible for the preparation of the plan for this program. The mentor must monitor the candidate's progress throughout the career development program and if necessary an advisory committee can be formed to assist with the development of a program that meets the candidates needs. The didactic and research components of both phases must develop new knowledge and research skills in scientific areas relevant to the career goals of the candidate. Whereas the focus of the career development program is on the conduct of patient-oriented research, complementary laboratory research studies can be directly related to the patient-oriented research proposed in the application. B. Mentor(s): Each applicant must name a primary mentor, who together with the candidate is responsible for the planning, direction, and execution of the clinical program. The mentor should be recognized as an accomplished clinical investigator. A second basic research mentor in the proposed research area should have a proven record of success in training independent investigators. The mentors should be sensitive to the individual needs of the minority candidate, have a proven record of success in training independent investigators, demonstrate a strong, continuous commitment to the candidate throughout the period of training and should have sufficient independent research support to absorb the costs of the proposed research project in excess of the allowable costs of this award. Applicants may also nominate co- mentors in each area as appropriate to the goals of the program. Where feasible, women, underrepresented minority individuals and individuals with disabilities should be involved as mentors to serve as role models. C. Allowable Costs: 1. Salary: The NCI will provide salary and fringe benefits for the career award recipient. The total salary requested must be based on a full-time, 12- month staff appointment. It 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 NCI will provide up to $75,000 annually plus fringe benefits to offset the full-time salary requirements of the candidate. 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. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K23 award. Under expanded authorities, however, institutions may re-budget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. 2. Research Development Support: NCI will provide generally up to $30,000 per year for the following expenses: (a) tuition, fees, and books related to career development; (b) research expenses, such as supplies, equipment and technical personnel; (c) travel to research meetings or training; (d) statistical services including personnel and computer time. In exceptional cases, the Research Development Support costs may be as high as $50,000, but such costs will only be awarded in those cases where the need for such higher costs is well documented and adequately justified. Prospective candidates should contact the NCI component to which the application is targeted to ascertain the maximum contribution for research and development support. 3. Ancillary Personnel Support: Salary for mentors, secretaries and administrative assistants is not allowed. 4. 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 NCI will request information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. 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 that these activities remain incidental and provided that the retention of such pay is consistent with the policies and practices of the grantee institution. o 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 re-budgeted. 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. F. 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 is required. To obtain prior approval, the award recipient must submit a letter countersigned by his or her department head and the appropriate institutional official to the NCI CMBB Program Director (see "Where To Send Inquiries") describing the plan. A copy of a letter or other evidence from the institution at which 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 prior written approval from the NIH Program Director 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. G. 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 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 NCI shall notify the grantee institution and career award recipient in writing of this determination, the reasons thereof, the effective date, and the right to appeal the decision. Awardees planning a change of institution must submit, in advance of the change, a written request for transfer to CMBB, countersigned by the appropriate institutional business official, describing the reasons for the change and including the new mentors' names and bio-sketches. 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. Additionally, the new mentors must have the appropriate research expertise to supervise the program and sufficient research support to ensure continuation of the research program to the end of the award (initial award). CMBB Program Directors will review this request and may require a review by an initial review group and/or the appropriate National Cancer Advisory Board. Upon approval of this request, 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 duration of support requested in the new application must be for no more than the time remaining within the existing award period. A final progress report, intervention statement, and Financial Status Report are required upon either termination of an award or relinquishment of an award in a change of institution situation. H. Change of Mentor: When a mentor at the grantee institution is to be replaced, the institution must submit a letter documenting the need for substitution, the new mentor's qualifications for supervising the program, the level of support for the candidate's career development and a detailed statement from the new mentor that convincingly demonstrates the candidate's development will continue successfully without delay. The letter must also document that the specific aims of the research program will remain within the scope of the original peer-reviewed research program. CMBB Program Directors will review the request and will notify the grantee institution of the results of the evaluation. I. Reporting Requirements: If an application is funded, additional reporting requirements for continuation of the project are listed in the section "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: Direct your questions about scientific/research issues to: Ms. Belinda M. Locke Program Director Comprehensive Minority Biomedical Branch National Cancer Institute, NIH 6116 Executive Boulevard, Room 7031, MSC 8350 Bethesda, Maryland 20892-8329 Rockville, Maryland 20852 (for express/courier service) Tel: 301-496-7344 FAX: 301-402-4551 Email: [email protected] 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, Maryland 20852 (for express/courier service) Telephone: (301) 496-3428 FAX: (301) 402-0275 Email: [email protected] Direct your questions about financial or grants management issues 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 "WHERE TO SEND 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. 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. 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]. 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. THE APPLICATION MUST ADDRESS THE FOLLOWING ISSUES: CANDIDATE o Describe the candidate's research background and note any cultural, socioeconomic, or ethnic issues, as appropriate, that have already effected or may effect the pace of the candidate's career development. o Describe the candidate's commitment to a career in patient-oriented research (candidates interested in field or laboratory-based research should consider the "Mentored Clinical Scientist Award for Underrepresented Minorities" (K08)). o Provide evidence of the candidate's potential to develop into an independent investigator. o Indicate a minimum commitment of at least 75 percent effort to the research program. The candidate should give a clear overall description of the types of research/research training activities that he/she will be involved in within the 75 percent effort versus an overall description of "other activities" and the percent effort involved. o Include three sealed letters of recommendation addressing the candidate's potential for a research career. Letters must be from individuals other than the designated mentors. CAREER DEVELOPMENT PLAN The career development plan should be a joint effort between the candidate and his/her mentor(s) and carefully tailored to the candidate's needs demonstrating an appreciation, as appropriate, of the candidate's cultural, socioeconomic and research background, and the particulars required to develop the candidate into an independent clinical investigator engaged in cancer research. The Plan must include a description and consideration of the candidate's goals and prior research experience. A systematic plan must be described for obtaining the necessary theoretical and conceptual background, in addition to the research experience and skills necessary to launch an independent career in clinical research. Candidates must describe the availability of courses such as research design, biostatistics, epidemiology, and ethical and regulatory issues at their institution and the integration of these studies into their career development plan. Less experienced candidates may require a phased development period in which the first year(s) of the award are largely of a didactic nature followed by a period of intense, supervised research experience. Candidates with more experience at the time of the application may require a shorter development period that includes mostly additional training in clinical research with little or no didactic component. In any case, the career development plan must be tailored to the needs of the candidate and the ultimate goal of the individual in achieving independence as a clinical researcher. TRAINING IN RESPONSIBLE CONDUCT Candidates must describe plans to receive instruction in the responsible conduct of research. These plans must detail the proposed subject matter, format, frequency, and duration of instruction. No award will be made if an application lacks this component. RESEARCH PLAN Must include: A description of the clinical research plan. The research plan must be described as outlined in PHS 398 form including sections on the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, Research Design and Methods. The candidate should consult with the mentors regarding the development of this section. MENTOR'S STATEMENT The application must include a statement from each mentor including information on their qualifications in the research area proposed by the candidate and previous experience as a research supervisor. The application must also include detailed information that describes the nature and extent of supervision that will occur during the proposed award period. This information must detail how the career plan will build upon the candidates unique research background, take into account the unique cultural, socioeconomic heritage of the candidate, as appropriate, and enhance the candidate's research development toward independence. Similar information must be provided by any co-mentor. If more than one clinical and one research mentor are proposed, the respective areas of expertise and responsibility should be described. ENVIRONMENT AND INSTITUTIONAL COMMITMENT The sponsoring institution must document a strong, well-established research and training program related to the candidate's area of interest and a high- quality research environment with staff capable of productive collaboration with the candidate. The sponsoring institution must provide a statement of commitment to the candidate's development into a productive independent investigator. The institutional statement also must commit to provision of release time from normal clinical, teaching or administrative duties as necessary to meet the 75 percent effort requirement of this award. The institutional statement should clearly indicate activities included within the 75 percent protected time. BUDGET The total direct costs requested must be consistent with this K23 program announcement and the award limits of the NCI. Requests for tuition and fees, books, travel, research development support, etc., must be justified and specified by category. Applicants seeking information on award limits should contact the fiscal representative listed in the INQUIRIES section at the end of this announcement. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines may also use revised or AIDS dates, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the reference letters, the checklist, and three signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Room 8041, MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express/courier service) APPLICATION PROCESSING: Applications must be received by or mailed 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 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 policy is similar to and consistent with the policy for applications addressed to Center for Scientific Review as published in the NIH Guide Notice http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html 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 o Quality of the underrepresented minority candidate's professional background that will represent an important addition to the cancer research community as a well-trained scientist; o Strength of the commitment of the underrepresented minority candidate to a patient-oriented cancer research career; o Appropriateness of the dedicated 75 percent effort to the successful development as a cancer researcher; o Strength of the letters of recommendation; CAREER DEVELOPMENT PLAN o Appropriateness of the content, phasing and duration of the underrepresented minority candidate's development plan in relation to his/her experience and background to become an independent investigator; o Conformity of the plan to 75 percent effort devoted to research/research training; o Adequacy of considerations in the plan that tailors it to the individual needs of the underrepresented minority candidate's experience and background, as well as to any important cultural, ethnic and/or socioeconomic factors, as appropriate, that could effect the pace of the candidate's successful development; and o Likelihood that the plan will contribute substantially to the achievement of scientific independence. RESEARCH PLAN Reviewers should recognize that underrepresented minority candidates are likely to have variable degrees of research experience and that an individual with limited research experience is less likely to be able to prepare a research plan with the breadth and depth of that submitted by a more experienced investigator unless the mentor plays a significant role. All plans must include fundamentally sound research approaches but reviewers should consider the applicant's research experience, cultural background, as appropriate, and evidence that the mentor is committed and involved (see Mentor/Co-mentor below). o Scientific and technical merit of the research question, design and methodology; o Relevance of the proposed research to the candidate's career objectives; o Appropriateness of the plan to the stage of research development of the candidate as a vehicle to assure that the candidate achieves his/her career goals and objectives towards developing into an independent scientist; and o Adequacy of the plan's attention to gender, children and minority issues associated with projects involving human subjects or justification for exclusion. MENTOR/CO-MENTOR o Evidence that the mentor(s) has participated in the development of the Career Plan, is sensitized to providing for the individual needs of the candidate and is willing personally to go beyond the traditional efforts that a mentor dedicates to a trainee in his/her research environment; o Appropriateness of the mentors' research qualifications in the area of this application; o Quality and extent of the mentors' proposed roles in providing guidance and advice to the candidate; o Previous experience in fostering the development of researchers; o Track record of research productivity and support; and o Adequacy of the research support to the mentor to ensure that the proposed project can be conducted unimpeded for the proposed research. ENVIRONMENT AND INSTITUTIONAL COMMITMENT o Adequacy of research facilities and the availability of appropriate educational opportunities; o Quality and relevance of the environment for scientific and professional development of the candidate; o Degree of evidence that the institution's commitment to the scientific development of the candidate is strong, as evidenced by it's willingness to ensure that individual needs of the underrepresented minority candidate are being provided and that the candidate will be integrated with care and sensitivity into the institution's research programs; and o Appropriateness of the applicant institution's commitment to ensuring that 75 percent of the candidate's time is dedicated to research career development and not to other activities unrelated to research, as evidenced by a clear listing of activities expected of the candidate within the 75 percent research effort, other activities that will be included in the remaining 25 percent effort, and activities that the applicant will not be responsible for in any way (i.e. administrative duties, patient care etc). TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH o Quality of the proposed training in the responsible conduct of research. BUDGET o Justification of the requested budget and duration in relation to the career development goals and research aims. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, applications will also be reviewed with respect to the following: PROTECTIONS: The adequacy of the proposed protection for humans (including data safety monitoring plan), animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) AWARD CRITERIA Applications submitted in response to this 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; and o Relevance to program priorities; 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. 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 A short description of candidate involvement in research/research training activities during the prior funding period in relation to the content, phasing and duration of the originally proposed Career Development Plan. This must also address how weaknesses in the plan, as identified by peer reviewers in the Summary Statement, have been addressed and corrected. Include formal coursework, informal instruction in specific research skills, scientific seminars, etc.. In addition, a concise description of the candidate's participation in "other activities" during the report period should be included. The percent effort devoted to research/research training and to "other activities", respectively, must be clearly stated; 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; o The mentor(s) report, briefly detailing the candidate's progress and performance during the prior year of support in terms of development into an independent investigator. Progress should be delineated in relation to the originally proposed Career Development Plan and Research Plan and, should describe how weaknesses in these plans, as identified by peer reviewers in the Summary Statement, have been addressed and corrected. The sponsor should clearly substantiate that the candidate has at least 75 percent protected time toward research/research training. REQUIRED FEDERAL CITATIONS 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. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/ AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.398 Cancer Research Manpower, 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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NIH Funding Opportunities and Notices
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