Full Text PA-95-054 MENTORED CLINICAL SCIENTIST DEVELOPMENT PROGRAM AWARD NIH GUIDE, Volume 24, Number 15, April 28, 1995 PA NUMBER: PA-95-054 P.T. 34 Keywords: Biomedical Research, Multidiscipl Clinical Medicine, General National Institute on Aging National Institute of Dental Research Application Receipt Dates: February 1, June 1, and October 1 PURPOSE The Mentored Clinical Scientist Development Program Award (MCSDPA) is an award to an educational institution to support career development experiences for clinicians leading to research independence. Under this award, newly-trained clinicians are to be selected and appointed to this program award by the grantee institution. In other respects, the research experience of the candidates selected for support under this award should resemble those supported by the individual Mentored Clinical Scientist Development Award. Applications for this award should propose a research plan which has both intrinsic research importance and will also serve as a suitable vehicle for learning the methodology, theories, and conceptualizations necessary for a well trained independent researcher. The program should be designed to accommodate appointees with varying levels of experiences. For example, a prospective candidate with limited experience in a given field of research may find it appropriate to engage in a structured, phased developmental program, including a designated period of didactic training followed by a period of supervised research experience. The entire program should be comparable in scope and rigor to meeting the requirements for an advanced research degree. The NIH institutes and centers have modified this award to accommodate the career pathways of researchers in fields related to their missions. For example, the National Institute of Dental Research (NIDR) requires that all candidates must pursue a program that includes didactic and supervised basic or behavioral research experiences which result in the Ph.D. degree. The NIDR provides support under this program for the development of advanced clinical knowledge and skills in either a recognized clinical specialty or equivalent dental clinical discipline. Therefore, the prospective candidate must have a D.D.S. or an equivalent degree but need not have started postgraduate training, such as in a clinical specialty. Dentists who already posses advanced clinical knowledge and skills are eligible for the MCSDPA under special circumstances, but are encouraged to seek appointments to the Mentored Clinical Scientist Development Award (K08). All applicants and potential appointees are strongly advised to contact the prospective NIH awarding component for information about eligibility and the specific provisions of this award. This award replaces two comparable NIH career development program awards for clinicians. These are the Physician Scientist Program Award (K12) and the Dentist Scientist Program Award (K16). Institutions and departments that were eligible to apply for either of these program awards are now eligible to apply for the MCSDPA award. Therefore, this Program Announcement (PA) supersedes all previous K12 and K16 program announcements. The NIH will no longer accept competing applications for the old K12 and K16 awards. The new MCSDPA has been modified to incorporate the features of these career development programs. Existing policies and provisions will remain in effect for current K12 and K16 awards until completion of their non-competing years. The NIH recently reviewed its career awards (K) used to develop the research capabilities of clinicians and other scientists needed to carry out the nation's research mission in the biomedical and behavioral sciences. This evaluation resulted in several changes: (1) the total number of K mechanisms were reduced from 19 to six; (2) the review criteria were refined to clarify the career development goals of the K award; and (3) K award applications will be assigned to initial review groups managed by the prospective funding institute or center to which the application has been assigned. HEALTHY PEOPLE 2000 The Public Health Service is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Mentored Clinical Scientist Development Program Award, is related to the priority area of human resource development. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications will be accepted from departments or divisions from domestic, non-Federal organizations, such as medical, dental or nursing schools, or from comparable institutions of higher education that have strong, well-established research and training programs. The applicant institution must have adequate numbers of highly trained faculty in clinical and basic sciences who have the interest and capability to provide guidance to clinically-trained individuals in the development of research independence. The environment should be one which will stimulate and increase the interactions between basic scientists and clinical investigators. Institutions with a MCSPDA may recruit and select candidates into their programs on a local basis rather than submitting a separate application on behalf of each prospective candidate. In all aspects, the program awards are intended to provide support for the development of clinical scientists in the same manner and under the same conditions as the individual Mentored Clinical Scientist Development Award (K08). Therefore, candidates for support under this program award must have a clinical degree or its equivalent, must have initiated internship and residency training (or its equivalent), and must be provided with a mentor(s) who has extensive research experience and a record of providing the type of training required under this award. The candidate also must be willing to spend a minimum of 75 percent of full-time professional effort conducting research, career development, and/or research related activities. Minorities and women are encouraged to apply. Candidates appointed under this program award must be U.S. citizens or noncitizen nationals, or have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-551) or some other verification of legal admission as a permanent resident. Noncitizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states, but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible. Candidates who are or have been former principal investigators on NIH research projects (R01), FIRST Awards (R29), sub-projects of program project (P01) or center grants (P50), or the equivalent, are not eligible for appointment under this program. Candidates may not concurrently hold any other PHS award that duplicates the provisions of this award. MCSDPA candidates are encouraged to apply for independent research grant support during the period of support under this award. MECHANISM OF SUPPORT Awards in response to this PA will use the K12 mechanism. The program award provides five years of support and is renewable. Appointees may receive three to five years of support depending upon the number of years of prior research experience, the need for additional experiences to achieve independence, and the policy of the NIH awarding unit. Planning, direction, and execution of the program will be the responsibility of the appointee and her/his mentor and consistent with the goals of the program award. RESEARCH OBJECTIVES A. Environment: The institution must have well-established research and clinical career development program and qualified faculty in clinical and basic research to serve as mentors. The appointee, mentor and institution must develop innovative multi-disciplinary programs to maximize the available research and educational resources. B. Program Director: The proposed Program Director should possess the scientific expertise, leadership and administrative capabilities required to coordinate and supervise an interdisciplinary research and development program of this scope. The Director should also be experienced in the design and management of programs for developing investigators, and should be able to demonstrate a superior record of preparation of clinicians for independent research. In addition, a committee with representatives from the appropriate basic and clinical science departments should be established to advise the Program Director. C. Mentors: Each candidate appointed on the program award must have a primary sponsor who is recognized as an accomplished investigator and is actively involved in basic or clinical research and who has a successful record of providing the type of training required under this award. An assigned mentor will provide guidance for the development of each candidate assigned to the program. The mentor must be committed to continue this involvement throughout the appointee's total period of development under the award. D. Program: The program award provides five years of renewable support. The award is intended to support candidates who receive three to five years support consisting of consecutive 12 month appointments. The support is often divided into two distinct phases- -a basic science component and an intensive research experience under the general guidance of a qualified mentor. The basic science component must develop knowledge and research skills in scientific areas relevant to the career development goals of the candidate and must include relevant didactic and laboratory experiences. In all cases, the types of developmental experiences provided should be consistent with the candidate's prior experience and needs. At least 75 percent of the recipient's full-time professional effort must be devoted to the program and the remainder devoted to developing other clinical and teaching pursuits consonant with the objectives of the award. E. Allowable Costs: 1. Salary: The NIH will provide salary and fringe benefits for the candidate only. The salary limits on career awards are not uniform throughout the NIH and are determined independently by each component of the NIH. Therefore, prospective applicants should contact the component to which the application is targeted to ascertain the salary cap for appointees under the MCSDPA. No compensation is provided for the program director or the mentors. The institution may supplement the NIH 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. In no case, may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the MCSDA. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary requested for each candidate 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. 2. Research Development Support: Each appointee will be allowed up to $20,000 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. The NIDR will provide up to $15,000 for research development support for each candidate. 3. Indirect costs: Indirect costs will be reimbursed at 8 percent of modified total direct costs, or at the actual indirect cost rate, whichever is less. F. Evaluation: In carrying out its stewardship of human resource related programs, the NIH may begin requesting information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified, that candidates may be contacted after the completion of their career development experiences 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 candidate. Such fees must be assigned to the grantee institution for disposition by any of the following methods: 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. The funds may be used for health-related research purposes. The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks should be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Division of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment. Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, or honoraria from other institutions for lectures or seminars, provided these activities remain incidental and provided that the retention of such pay is consistent with the policies and practices of the grantee institution. Usually, funds budgeted in and institute-supported research or training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted. An institute will give consideration to approval for use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of an NIH career award must receive prior written approval of the institute awarding component. H. Special Leave: Candidates appointed to this program career award may engage in research experiences at another institution, including a foreign laboratory, may be permitted if directly related to the purpose of the award. Only local, institutional approval is required if such leave does not exceed three months. For longer periods, prior written approval of the NIH funding component is required. To obtain prior approval, the program director must submit a letter to the NIH describing the plan, countersigned by his or her department head and the appropriate institutional official. A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the career award will continue during such leave. Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NIH funding component 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. Parental leave will be granted consistent with the policies of the NIH and the grantee institution. The Director of the NIH may discontinue an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, the Director of the NIH shall notify the grantee institution and career award recipient in writing of this determination, the reasons therefor, the effective date, and the right to appeal the decision. A final progress report, invention statement, and Financial Status Report are required upon termination or relinquishment of an award. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. 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 of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES This is a generic program announcement for the NIH MCSDPA. Therefore, it is strongly recommended that prospective applicants contact the staff person in the relevant institute or center listed under "INQUIRIES" early in the planning phase of application preparation. Such contact will help ensure that applications are responsive to the career development goals of individual institutes and centers. It should be noted that not all NIH institutes and centers use the MCSDPA as a means of recruiting clinicians into research. Applications are to be submitted on form PHS 398 (rev. 9/91) and will be accepted on or before the receipt deadlines indicated in the application kit (February 1, June 1 and October 1). Forms are available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, NIH, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/710-0267. The application must address the following issues: (1) Provide information establishing the commitment of the applicant institution, the program director, and the faculty mentors to providing developmental experiences that lead to independence in biomedical, behavioral, or clinical research. (2) Summarize the immediate and long-term career objectives of the program, explaining how the program and the MCSDPA will contribute to their attainment. (3) Describe the career development plans for prospective candidates. Considering the program goals and the likely goals of prospective candidates, describe a plan to provide the necessary basic science background and research experiences considering the expected range of prior research training in the applicant pool. For example, candidates with little previous research experience may require a phased developmental period in which the first year or two of support under this program award are comprised largely of didactic training in the basic sciences. For these candidates, a second phase would be an intensive, supervised research experience to complete the five year developmental program. More experienced candidates may benefit from moving immediately to a mentored research environment and a shorter period of support under this program award. The application should contain a description of how the career development plan will be tailored to the needs of the prospective candidates. (4) Describe the pool of potential candidates including information about the types of prior clinical and research training. Also, describe how the appointments will be made to the MCSDPA. Describe the composition of the selection committee and the criteria to be used for selection. Describe plans to recruit candidates from racial or ethnic groups that are currently underrepresented in biomedical, behavioral, or clinical sciences. (5) Describe to the extent possible the types of research experiences available to the candidates. The research experiences may include either basic or clinical science approaches to biomedical or behavioral problems. Provide examples of potential experiences using the format described in form PHS 398, including Specific Aims, Background and Significance, Progress Report/ Preliminary Studies, Research Design and Methods. (6) Instructions in the responsible conduct of research. Applications must include plans for instruction in the responsible conduct of research, including the rationale, subject matter, appropriateness, format, frequency and duration of instruction; and the amount and nature of faculty participation. No award will be made if an application lacks this component. (7) Renewal applications must include a detailed account of the career outcomes of all candidates supported by this grant including positions held, research involvement, publications, and other evidence that this program award is meeting the objectives of the NIH awarding component Budget requests must be provided according to the instructions in form PHS 398. The request for tuition and fees, books, travel, research development expenses, etc., must be justified and specified by category. To identify the application as a response to this PA, check "YES" on item 2a of page 1 of the application and enter PA-95-054, Mentored Clinical Scientist Development Program Award" and the name of the NIH institute or center that you would like your application to be assigned. Submit a signed, typewritten original of the application with Checklist, and five signed photocopies, in one package to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be reviewed for completeness by the Division of Research Grants and responsiveness to the PA by the appropriate institute or center staff. Incomplete or nonresponsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by he appropriate national advisory council or board. The following review criteria will be applied: Program Director o The program director's experience in managing career development programs and success in preparing clinician investigators for independent research careers; Candidate(s) o Availability of high quality potential candidates, o Plans for recruiting and selecting candidates (including minorities and women); and o Plan to identify candidates with a commitment to research and the potential to develop as an independent researcher; o For renewal applications, the career success of candidates that have terminated support under this award within the past 10 years. Career Development Plan o Likelihood that the career development plan will contribute substantially to the scientific development of the candidates; o Appropriateness of the content, the phasing, and the proposed duration of the career development plan for achieving scientific independence for the prospective candidates; o Consistency of the career development plan with prospective candidate's career goals; and o Quality of the training in the responsible conduct of research. Research Plan o Usefulness of the research plans as a vehicle for developing the research skills as described in the career development plan; o Scientific and technical merit of the research questions, design and methodology; o Relevance of the proposed research to the career objectives of the potential candidate(s); and o Adequacy of the plan's attention to gender and minority issues. Mentor o Appropriateness of the faculty mentors research qualifications in the area of this application; o Quality and extent of the mentors proposed role in providing guidance and advice to candidates; o Previous experience of the mentors in fostering the development of researchers; and Environment o Applicant institution's commitment to the scientific development of the candidate(s) and assurances that the institution intends the program and the supported candidate(s) to be an integral part of its research program; o Adequacy of research facilities and training opportunities; o Quality of the environment for scientific and professional development; and o Applicant institution's commitment to the appropriate balance of research and clinical responsibilities. Budget o Justification of budget requests in relation to career development goals and research aims. AWARD CRITERIA The institute or center will notify the applicant of the board or council's action shortly after its meeting. Funding decisions will be made based on the recommendations of the initial review group and council/board, the need for research personnel in specific program areas, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this program announcement are encouraged especially during the planning phase of the application. Below is a listing of NIH contacts for this career development award: Dr. Robin A. Barr Office of Extramural Affairs National Institute on Aging 7201 Wisconsin Avenue, Room 2C218, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9322 Email: Barr@nihniagw.bitnet Dr. James A. Lipton Special Assistant for Training and Career Development National Institute of Dental Research Natcher Building, Room 4AN.18J Bethesda, MD 20892 Telephone: (301) 594-2618 Email: liptonj@de45.nidr.nih.gov Ms. Theresa Ringler Grants Management Office National Institute of Dental Research Natcher Building, Room 4AS-55 Bethesda, MD 20892 Telephone: (301) 594-4800 FAX: (301) 480-8301 AUTHORITY AND REGULATIONS The Mentored Clinical Scientist Development Program Awards are made under the authority of Title III, Section 301 of the Public Health Service (PHS) Act as amended (Public Law 78-410, as amended, 42 USC 241). The Code of Federal Regulations, Title 42 Part 52, and Title 45 part 74, are applicable to this program. This program is described in the Catalog of Federal Domestic Assistance No. 93.121. 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 routing 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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