MENTORED CLINICAL SCIENTIST DEVELOPMENT AWARD IN ANESTHESIOLOGY, CLINICAL PHARMACOLOGY, AND TRAUMA AND BURN INJURY Release Date: June 23, 1998 PA NUMBER: PAR-98-084 P.T. National Institute of General Medical Sciences PURPOSE The National Institute of General Medical Sciences (NIGMS) will accept applications for the Mentored Clinical Scientist Development Award (MCSDA) (K08) in the areas of anesthesiology, clinical pharmacology, and trauma and burn injury research. NIGMS will offer the K08 award to support the development of outstanding academic physician scientists. This mechanism provides support for a period of supervised research and study for clinically trained professionals who have the commitment and the potential to develop into productive, independent investigators. The award period will last three, four, or five years and must include a plan to obtain and integrate a fundamental and theoretical understanding of the chosen field with a period of intensive laboratory or clinically oriented research. The proposed research should have both intrinsic importance and be a suitable vehicle for learning the skills necessary to become an independent researcher. The scope and nature of the proposed research should also be suitable for potential development into an independently funded research endeavor. This award will support developmental experiences in either laboratory or clinical research. Because of the focus on a progression to independence as a researcher, the prospective candidate for the K08 award should propose a period of development consistent with this goal and his or her 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 for five years which includes a designated period of didactic training and closely supervised research experience the most efficient means of attaining independence. A candidate with substantial previous research experience may require a shorter award period appropriate for the transition to independence. In all cases, the candidate must provide evidence of attainment of a broad understanding of theoretical aspects of the relevant basic or clinical science, or s/he will attain the same during the course of this award. All applicants are strongly encouraged to contact NIGMS staff listed below to discuss issues of eligibility and the specific provisions of this award as it pertains to NIGMS programmatic interests. 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 PA, Mentored Clinical Scientist Development Award in Anesthesiology, Clinical Pharmacology, and Trauma and Burn Injury, 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) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS The candidate must have an M.D. degree or its equivalent, must have completed postgraduate clinical training and have secured a faculty appointment in an appropriate research-intensive environment, must identify a mentor with extensive research experience, and must be willing to spend a minimum of 75 percent of full-time professional effort conducting research and research career development. Applications may be submitted, on behalf of candidates, by domestic, non-Federal organizations, public or private, such as medical schools. Minorities and women are encouraged to apply. Candidates must be U.S. citizens or non-citizen nationals, or must have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-551) or some other verification of legal admission as a permanent resident. Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible. Former principal investigators on NIH research project (R01), FIRST Awards (R29), sub-projects of program project (P01) or center grants (P50), or the equivalent, are not eligible. A candidate for the K08 award may not concurrently apply for any other PHS award that duplicates the provisions of this award nor have another application pending award. K08 recipients are encouraged to apply for independent research grant support during the period of this award. The K08 recipient would be allowed to maintain the award if other PHS support is procured, as long as the new support does not interfere with the ability to meet the MCSDA requirements. MECHANISM OF SUPPORT Awards in response to this program announcement will use the K08 mechanism. Planning, direction, and execution of the program will be the responsibility of the candidate and her/his mentor on behalf of the applicant institution. The project period may be for three, four or five years and will depend upon the number of years of prior research experience, and the need for additional experiences to achieve independence. Awards are not renewable. RESEARCH OBJECTIVES A. Environment: The institution must have well-established research and clinical career development programs and qualified faculty in clinical and basic research to serve as mentors. The institution must be able to demonstrate a commitment to the development of the candidate as a productive, independent investigator. And, the candidate, mentor and institution must be able to describe an in-depth, multi-disciplinary career development program that will maximize the use of relevant research and educational resources. B. Program: The award provides three to five consecutive 12 month appointments. At least 75 percent of the recipient's full-time professional effort must be devoted to the program and the remainder devoted to other clinical and teaching pursuits consonant with the objectives of the award. Both the didactic and basic science components must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the career goals of the candidate. C. Mentor(s): The recipient must receive appropriate mentoring throughout the three to five year program. Where feasible, women and minority mentors should be involved as role models. D. Allowable Costs: 1. Salary: NIGMS will provide salary for the K08 recipient at a maximum of $75,000 per year. The institution may supplement the NIGMS 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 must be based on a 100%, 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: NIGMS will provide up to $20,000 per year for: (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. 3. Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc., is not allowed. 4. 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. E. Evaluation: In carrying out its stewardship of human resource related programs, the NIGMS may begin requesting information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. F. 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: 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 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. NIGMS will consider approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of a career award must receive prior written approval of NIGMS G. Special Leave: Leave to 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 3 months. For longer periods, prior written approval of NIGMS is required. To obtain prior approval, the award recipient must submit a letter to NIGMS 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 NIGMS 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. H. Termination or Change of Institution: When a grantee institution plans to terminate an award, NIGMS must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. If the individual is moving to another eligible institution, career award support may be continued provided: The new institution submits an application to transfer the award, complete with the requisite information concerning all aspects of the career development plan, mentoring, and institutional support (as described elsewhere in this notice); The period of support requested is no more than the time remaining within the existing project period; and The application to transfer an award is submitted at least 60 days prior to the requested start date at the new institution to allow time for review by NIGMS staff. 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 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 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 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 in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. NIH POLICY AND GUIDELINES ON THE 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 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://www.nih.gov/grants/guide/notice-files/not98-024.html 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 All candidates are strongly encouraged to contact the staff person in the relevant research area 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 career development goals and policies of NIGMS. Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted on the application receipt deadlines indicated in the application kit. Application kits are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, Office of Extramural Research, National Institutes of Health, 6701 Rockledge Drive, Room 6095, Bethesda, MD 20892-7910, Phone (301) 435-0714, FAX: (301) 480-0525, Email: GrantsInfo@nih.gov. Forms are also available on the NIH Website at: http://www.nih.gov/grants/oer.htm. The application must address the following issues: 1. Candidate Describe the candidate's commitment to a career in clinical or laboratory-based biomedical research. Establish the candidate's potential to develop into an independent investigator. Describe immediate and long-term career objectives, explaining how the award will contribute to their attainment. Letters of recommendation. Three sealed letters of recommendation addressing the candidate's potential for a research career must be included as part of the application. 2. Career Development Plan Describe the career development plan incorporating consideration of the candidate's goals and prior experience. Where necessary, it must describe a systematic plan to obtain both the necessary didactic training and research experience to launch an independent research career. Candidates interested in clinical research 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. Candidates with limited research training may require a phased developmental 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 application may need a shorter developmental period and may already have an adequate theoretical background. In any case, the career development plan must be tailored to the needs of the individual candidate and the ultimate goal of achieving independence as a researcher. 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. 3. Research Plan Describe the research plan and the use of a laboratory or clinical science approach to a biomedical problem. The research plan must be described as outlined in form PHS 398 including sections on the Specific Aims, Background and Significance, Progress Report/ Preliminary Studies, Research Design and Methods. The candidate should consult with the mentor regarding the development of this section, but the proposed research should derive from the candidate's own background, research interests, and career goals. The proposed research should also be suitable for development into a project capable of generating independent funding. 4. Mentor's Statement The application must include information on the mentor(s) including information on research qualifications and previous experience as a research supervisor. The applications must also include information to describe the nature and extent of supervision that will occur during the proposed award period. 5. 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 including a high-quality research environment with staff capable of productive collaboration with the candidate. The sponsoring institution also must provide a statement of commitment to the candidate's development into a productive, independent investigator. The statement should indicate that the candidate is in a tenure-track or analogous position. 6. Budget Budget requests must be provided according to the instructions in form PHS 398. The request for tuition and fees, books, travel, research development support, etc., must be justified and specified by category. To identify the application as a response to this program announcement, check "YES" on item 2 of page 1 of the application and enter "K08, Mentored Clinical Scientist Development Award" and NIGMS as the institute where you would like your application to be assigned for funding. 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 MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) 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 program announcement will be evaluated for scientific merit and training potential by an appropriate review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will be discussed, assigned a priority score, and receive a written critique. The applications will then receive a second level review by the National Advisory General Medical Sciences Council. The following review criteria will be applied: 1. Candidate Quality of the candidate's academic and clinical record, Potential to develop as an independent clinical or laboratory based researcher; and Commitment to a research career. 2. Career Development Plan Likelihood that the career development plan will contribute substantially to the scientific development of the candidate; Probability of development of a competitive independent research program; Appropriateness of the content and duration of the proposed didactic and research phases of the award; Consistency of the career development plan with the candidate's career goals and prior research experience; and, Quality of the proposed training in responsible conduct of research. 3. 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. Although it is understood that K08 applications do not require the level of detail necessary in regular research grant proposals, a fundamentally sound research plan must be provided. In general, less detail is expected with regard to research planned for the later years of the award, but the application should outline the general goals for these years. The following details should be provided: The significance of the area of research in which the candidate proposes to establish independence: Appropriateness of the research plan to the stage of research development and as a vehicle for developing the research skills as described in the career development plan; Scientific and technical merit of the research question, design and methodology; Relevance of the proposed research to the candidate's career objectives; and Adequacy of the plan's attention to gender and minority issues associated with projects involving human subjects. 4. Mentor Appropriateness of mentor's research qualifications; Quality and extent of mentor's proposed role in providing guidance and advice to the candidate; Previous experience in fostering the development of researchers; and History of research productivity and support. 5. Environment 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 its research program; Adequacy of research facilities and the availability of appropriate educational opportunities; Quality and relevance of the environment for scientific and professional development of the candidate; and Applicant institution's commitment to an appropriate balance of research and clinical responsibilities. 6. Budget Justification of the requested budget in relation to career development goals and research aims. AWARD CRITERIA Funding decisions will be made based on the merit of the proposal, the need for research personnel in specific program areas, 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: Alison E. Cole, Ph.D. Anesthesiology Program National Institute of General Medical Sciences 45 Center Drive, Room 2AS-49K, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-1826 FAX: (301) 480-2802 Email: colea@nigms.nih.gov Rochelle M. Long, Ph.D. Clinical Pharmacology Program National Institute of General Medical Sciences 45 Center Drive, Room 2AS-49A, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-1826 FAX: (301) 480-2802 Email: longr@nigms.nih.gov Scott D. Somers, Ph.D. Trauma and Burn Injury Program National Institute of General Medical Sciences 45 Center Drive, Room 2AS-49J, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-5560 FAX: (301) 480-2802 Email: somerss@nigms.nih.gov For questions about grants management, contact: Toni Holland Grants Management Officer National Institute of General Medical Sciences 45 Center Drive, Room 2AN.50B, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-5132 FAX: (301) 480-3423 Email: hollandt@nigms.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.859. 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 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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