and Human Services (HHS)
EXPIRED
MENTORED PATIENT-ORIENTED RESEARCH FOR UNDERREPRESENTED MINORITIES (K23) Release Date: January 10, 2000 (see replacement PAR-03-006) PA NUMBER: PAR-00-042 National Cancer Institute PURPOSE 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 a patient-oriented research career development award for minorities in clinical oncology. The purposes of this award are to: o Encourage research-oriented minority clinicians to develop independent research skills and gain experience in advanced methods and experimental approaches needed to conduct patient-oriented research. o Increase the pool of 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 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 for clinically trained professionals who have the potential to develop into productive, clinical investigators focusing on patient-oriented research. Clinically trained professionals or individuals with clinical degrees who are interested in further career development in biomedical research that is not patient-oriented, should refer to the Minorities in Clinical Oncology Award (K08) (see http://grants.nih.gov/grants/guide/pa-files/PAR-00-040.html and http://deainfo.nci.nih.gov/cmbs/index.htm on the NCI website for details). 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 National Cancer Institute is especially interested in increasing the number of 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 minority individuals to the challenges of clinical research. NCI intends to target a significant increase in funds for these entry-level career development awards through 2003. 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 the recommendations from the Institute of Medicine Committee on Addressing Career Paths for Clinical Research. This PA will expire two years from the first receipt date. NIH Grants policies apply to these awards. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000", a PHS-led national activity for setting priority areas. This Program Announcement (PA) for Mentored Patient-Oriented Research Career Development Award for Underrepresented Minorities, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" or at http://odphp.osophs.dhhs.gov/pubs/hp2000. ELIGIBILITY REQUIREMENTS 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 (M.D., D.C., D.D.S., D.O., O.D., D.V.M., N.D. (Doctor of Naturopathy), Pharm.D. or its equivalent, or who are doctorally trained oncology nurses, 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 also 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. Candidates must identify a mentor with extensive research experience and must be willing to devote a minimum of 75 percent of full-time professional effort in conducting research career development and clinical research. 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. 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. Applications may be submitted by domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local government, and eligible agencies of the Federal government or comparable institutions with well-established training programs in patient-oriented clinical oncology. 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 physicians in clinical oncology. Women and persons with disabilities are encouraged to apply as Principal Investigators. Ineligible individuals include current and former Principal Investigators on NIH research project grants (R01), FIRST Awards (R29), comparable career development awards (K01, K08, K07, K23), sub-projects of program project (P01) or center (P30) grants, and the equivalent. Former principal investigators of NIH Small Grants (R03) or Exploratory/Developmental Grants (R21) 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. MECHANISM OF SUPPORT Awards in response to this program announcement will be made through the K23 mechanism. Planning, direction, and the execution of the proposed training program will be the responsibilities of the applicant and her/his mentors on behalf of the applicant institution. Awards are not renewable. 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. NIH Grant policies apply to these awards. RESEARCH OBJECTIVES A. Background: 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 are that 1,221,800 cancers are expected to be diagnosed in the United States and 563,100 Americans are 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/application of these technologies. B. Environment: The applicant institution must have a well-established research and clinical career development program. It must also have faculty to serve as mentors qualified in clinical research with an emphasis on patient- oriented research. The institution must be able to demonstrate a commitment to the development of the candidate as a productive, independent investigator. The candidate, mentor, and institution must be able to describe an in-depth, multidisciplinary career development program that will utilize the relevant research and educational resources. C. 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. The remainder may be devoted to clinical, teaching, or other research pursuits consistent with the objectives of the award. 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. Because of the focus on progression to independence as a researcher, candidates for the K23 should propose a period of study and career development consistent with her or his previous research and clinical experience. For example, a candidate with limited experience in a given field of research may find a phased developmental program lasting five years and including a designated period of didactic training followed by a period of closely supervised research experience as the most efficient means of attaining independence. A candidate with previous research experience and training may not require extensive additional didactic preparation, and a program that focuses on an intensive, supervised patient-oriented research experience may be appropriate. All programs must be tailored to meet the individual needs of the candidate to ensure that he/she will 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 may form an advisory committee to assist with the development of a program of study or to monitor the candidate's progress through the career development program. 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. D. Mentor(s): Each applicant must name a primary mentor, who together with the applicant 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 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. E. 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. Most NCI awarding components will provide up to $75,000 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. 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 K23 award. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. 2. Research Development Support: The NCI will provide generally up to $25,000 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. F. Evaluation: In carrying out its stewardship of human resource related programs, the NCI 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. G. 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. Usually, funds budgeted in an NIH-supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted. The awarding component will give consideration to approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of a career award must receive prior written approval. H. 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 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 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 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. I. 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 biosketches. 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). Staff within NCI 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. When a mentor at the grantee institution is to be replaced, the institution must submit from the proposed mentor a letter documenting the need for substitution, the new mentor's qualifications for supervising the program, and the level of support for the candidate's career development. 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. Staff within NCI will review the request and will notify the grantee institution of the results of the evaluation. 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. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects unless a clear and compelling rationale and justification is provided to indicate that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11 March 18, 1994 available on the web at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are clear and compelling scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES 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 the individual institute or center. 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 are to be submitted on the grant application form PHS 398 (rev. 4/98) according to the instructions in Section IV, Research Career Awards, of the application kit for "Just-In-Time" procedures. Applications will be accepted on the standard application receipt dates indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, Email: [email protected]. For those applicants with Internet access, the 398 kit may be found at http://grants.nih.gov/grants/forms.htm. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-004.html). To identify the application as a response to this program announcement, check YES on item 2 of page one of the application and to include the program announcement number and title. The application must address the following issues: Candidate o A description of the candidate's commitment to a career in patient-oriented research. Evidence of the candidate's potential to develop into status as an independent investigator. A commitment of at least 75 percent effort to the clinical research program. Three sealed letters of recommendation addressing the candidate's potential for a research career. The mentor's statement must not be included as one of the letters of recommendation. Career Development Plan o The career development 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 and may already have had an adequate basic science background. In any case, the career development plan must be tailored to the needs of the candidate and the ultimate goal of the individual's achieving independence as a clinical researcher. Training in the Responsible Conduct of Research o 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: o 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. Mentors' Statements o The application must include a statement from the mentors including information on their qualifications in the research area proposed by the candidate and previous experience as research supervisors. The application must also include information to describe the nature and extent of supervision that will occur during the proposed award period. o 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 o 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 necessary to meet the 75% effort requirement of this award. Budget The total direct costs requested must be consistent with this K23 program announcement and the award limits of the NCI. Applicants seeking information on award limits should contact the fiscal representative listed in the INQUIRIES section at the end of this announcement. Submit a signed, typewritten original of the application with Checklist, and five signed photocopies, in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 B MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) REVIEW CONSIDERATIONS At the same time of submission, submit two additional copies of the application to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Room 8062, MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express/courier service) If an application is received after the deadline, it will be returned to the applicant without review. If the application submitted in response to this PA is substantially similar to a grant application already submitted to NIH for review but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical application will not be allowed, nor will essentially identical applications be reviewed by different review committee. An application, therefore, cannot be submitted in response to this PA which is essentially identical to the one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications will be reviewed for completeness by the Center for Scientific Review. Incomplete applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the PA will be evaluated for scientific and technical merit by an appropriate NCI peer-review group in accordance with the standard NIH peer review procedures and the review criteria stated below. As part of the initial merit review, all applicants will receive a written critique. Applications may undergo a streamlined review process. In this process, only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board. The following review criteria will be applied: Candidate o Quality of the candidate's research, academic and clinical record in cancer; o Potential to develop as an independent clinical researcher focusing on patient-oriented research; o Commitment to a career in patient-oriented research in cancer. Career Development Plan o Likelihood that the career development plan will contribute to the scientific development of the candidate. o Appropriateness of the content, the phasing, and the proposed duration of the career development plan for achieving scientific independence; o Consistency of the career development plan with the candidate's career goals and prior research experience. o Training in the Responsible Conduct of Research. o Quality of the proposed training in the responsible conduct of research. Research Plan Reviewers recognize 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. Nevertheless, a fundamentally sound research plan must be provided. For candidates who require substantial didactic training as part of their program, the research plan may encompass less than the full period of the award. 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 research plan to the stage of research development and as a vehicle for developing the research skills described in the career development plan; o Adequacy of the plan's attention to gender and minority issues associated with projects involving human subjects; and o Adequacy of plans for including children, as appropriate, for the scientific goals of the research, or justification for exclusion. Mentor/Co-Mentor 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 History of research productivity and support; and o Adequacy of support for the proposed research project. 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 Applicant institution's commitment to the scientific development of the candidate and assurances that the institution intends the candidate to be an integral part of the research program; and o Applicant institution's commitment to an appropriate balance of research and clinical responsibilities, including the commitment of 75 percent of the candidate's effort to research and research-related activities. Budget o Justification of the requested budget and duration in relation to the career development goals and research aims. AWARD CRITERIA Funding decisions will be made on the basis of the recommendations of the initial review group and NCAB, program priorities, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this program announcement are strongly encouraged, especially during the planning phase of the application. Direct inquiries regarding programmatic issues to: Eric J. Bailey, Ph.D., M.P.H. Comprehensive Minority Biomedical Branch National Cancer Institute 6116 Executive Boulevard Bethesda, MD 20892-7405 Rockville, MD 20852 (express/courier service) Telephone: (301) 496-7344 FAX: (301) 402-4551 Email: [email protected] Direct inquiries regarding fiscal 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) 496-8626 FAX: (301) 496-8601 Email: [email protected] Direct inquiries regarding referral matters to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Room 8062, MSC 8239 Bethesda, MD 20892-8239 Rockville, MD 20852 (for express/courier service) telephone: (301) 496-3428 FAX: (301) 402-0275 Email: [email protected] AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.398 Cancer Research Manpower. Awards are made under authorization of the Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, The Pro-Children Act of 1994, prohibits smoking in certain facilities (or, in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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