MENTORED CLINICAL SCIENTIST DEVELOPMENT PROGRAM AWARD IN DENTAL, CRANIOFACIAL AND ORAL HEALTH RESEARCH (K12 AWARD) Release Date: September 22, 2000 PA NUMBER: PAR-00-140 National Institute of Dental and Craniofacial Research (http://www.nidcr.nih.gov) Application Receipt Date: June 1, 2001 Subsequent submissions will have a receipt date of October 1. PURPOSE The National Institute of Dental and Craniofacial Research (NIDCR) invites applications for the Mentored Clinical Scientist Development Program Award in Dental, Craniofacial and Oral Health Research. The award will be funded through the K12 Career Development Award mechanism. The NIDCR K12 is an institutional version of the NIDCR Individual Scholar Development and Faculty Transition Award (K22), as described in PAR-00-097. The NIDCR K12 is a five-year award to a consortium of educational institutions or health science centers and consists of two phases. In the first or Scholar Development phase, support is provided to outstanding new clinician researchers and scientists with a clinically relevant Ph.D. degree to obtain additional mentored postdoctoral research experience that leads to research independence. In the second or Faculty Transition phase, the individual is appointed to a tenure track line or equivalent position followed by funding for an independent research project. New clinician (e.g., DDS/DMD, MD) researchers who are eligible for appointment to the K12 must have completed at least two years of research training beyond their professional degree. Candidates may have an advanced degree (e.g., Ph.D., MS, MPH) beyond their professional training, although that is not a requirement. The maximum number of years of support for an appointee cannot exceed five. However, the actual duration of support for any appointee and the phase in which the person will start depends on her/his previous research training. The NIDCR issues this program announcement to help meet the need for highly skilled scientists with a clinical background (e.g., dentists, physicians) who can successfully address the increasing scientific opportunities in dental, oral and craniofacial research from a cross-disciplinary perspective. The expanding science base requires new research approaches which integrate various disciplines and levels of expertise in order to address effectively the increasing level of complexity in the interplay between biological, physical, environmental, behavioral and socioeconomic factors in human disease. These factors are of special importance to address research needs in areas such as health promotion, disease prevention, health disparities, and diagnosis and treatment, especially as related to the medically compromised patient. Scientists must become familiar with the knowledge base and the methods of a wide variety of disciplines and must develop a diverse set of competencies, including the ability to interact in cross-disciplinary research teams. This career development program should provide the opportunity to develop these skills and to create environments that prompt life-long learning, successful research career transitions and pathways, and strong collaborative and partnering skills. A secondary purpose for the NIDCR K12 is to help strengthen the research capacity in dental, craniofacial and oral health science areas of health professional institutions, especially U.S. dental schools. To do so, applications must be submitted by a regional consortium composed of at least one dental or medical institution that has a strong research grant portfolio in dental, craniofacial and oral health science areas, and at least one dental school that does not have an extensive portfolio. Another intent of the NIDCR K12 program award is for institutions to utilize this type of award, in conjunction with the NRSA Institutional Research Training Grants (PAR-00-116), to stimulate the creation of regional centers for excellence in research training and career development in dental, craniofacial and oral health research. This concept is based upon the recommendations from the recent report by the NIDCR Blue Ribbon Panel on Research Training to Meet the Scientific Opportunities of the 21st Century and the U.S. Surgeon General’s Report on Oral Health. It is suggested that staff from institutions responding to this PA should communicate with colleagues who will be preparing a submission to the PA for the Institutional T32 NRSA program. By obtaining a T32 and a K12 program, a regional consortium can structure a well-integrated, comprehensive, cross-disciplinary research career development pathway from the beginning of professional school through the mid-career and senior scientist stages of development. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS led national activity for setting priority areas. This Program Announcement (PA) is related to the priority objective of addressing diversity of the health professional pipeline. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Domestic non-profit, public or private academic research institutions are eligible to apply. Applicants for the K12 award must be a regional consortium composed of (1) at least one dental or medical institution that had NIDCR support of $2 million or greater in FY 1999, and (2) at least one dental school that had a research portfolio in FY 1999 of less than $2 million. A rank order listing of all U.S. dental schools according to NIDCR support in FY 1999 can be found at http://www.nidcr.nih.gov/research/schools99.htm. An institution in the first category should be primary in the application process. At least one applicant institution must be part of a comprehensive health science center that has a strong research program in the proposed areas of career development. The regional consortium must be able to provide cross-disciplinary career development opportunities through local collaborations with other professional or graduate schools. However, all institutional members of the consortium do not have to be equally strong in the entire range of research areas to be offered. At least one member of the consortium must have the requisite staff and facilities to carry out the proposed program. An appointee could obtain a tenure track line at any component institution of the consortium, not necessarily the one in which the career development experience occurred. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. APPOINTEE ELIGIBILITY REQUIREMENTS Individuals appointed to the institutional K12 must: (1) have either a health professional degree, such as the DDS/DMD or MD, or a Ph.D. (or equivalent degree) in a clinically applicable discipline such as clinical genetics, clinical psychology, clinical sociology, clinical social work, speech pathology, audiology or rehabilitation, (2) have completed at least two years of research training beyond their last doctoral degree, (3) be able to devote at least 75 percent of time to research-related activities, (4) not be or have been a principal investigator on an R01, R21, R29 or sub-project of a Program Project (P01) or Center (P50, P60) grant, and (5) be a U.S. citizen or noncitizen national, or must have been lawfully admitted for permanent residence and possess an Alien Registration Receipt card (I-151 or I- 155) or some other verification of legal admission as a permanent citizen. Individuals on temporary or student visas are not eligible. In addition, any individual initially appointed to the Scholar Development phase cannot have more than five years of research training experience beyond their last doctoral degree. Those individuals appointed directly to the Faculty Transition phase cannot have more than six years of research training experience beyond their last doctoral degree. The research training experience for either phase could have been obtained in a postdoctoral (e.g., T32 trainee, F32 grantee or similar fellowship awards) or equivalent postgraduate position (e.g., approved clinical residency or advanced specialty program, individual or program research career development K award funded by the NIH). Individuals appointed to the Faculty Development phase may presently be in a tenure track line or similar position for no more than four years at an institutional member of the applicant consortium. A maximum of five years support can be offered any appointee through the K12 award. The actual number of support years depends on the individual’s prior research experience and the need for additional career development to prepare a competitive application for an investigator-initiated research grant, such as the R01. For example, individuals having the minimum two years postdoctoral training could be provided with up to three additional years of didactics and mentored supervision before proceeding to the Faculty Transition phase of the award. Appointees may not concurrently hold any other PHS award that duplicates the provisions of this award. Appointees are encouraged to apply for investigator-initiated research grants (e.g., R01) during the period of support under this award. MECHANISM OF SUPPORT Support for this Program will be through the National Institutes of Health (NIH) Mentored Clinical Scientist Development Program award or K12 mechanism. Responsibility for the planning, direction, and execution of the proposed program will be solely that of the applicant institution(s). The program award provides five years of support and is renewable based on a successful competing continuation application, programmatic needs and the availability of funds. This PA is an on-going initiative. The first receipt date for applications will be June 1, 2001, with awards made in July 2002. Receipt date for subsequent applications is October 1, with award expected by July of the following year. The NIDCR intends to fund at least three K12 grants in the initial response to this PA. Although the financial plans of the NIDCR provide support for this program, awards pursuant to this PA are contingent upon the availability of funds and the receipt of a sufficient number of applications of outstanding scientific and technical merit. RESEARCH OBJECTIVES Background The NIDCR has expanded considerably its research programs in recent years. The expansion was highlighted in the Institute’s strategic plan, Shaping the Future, that was issued in 1997. This document can be found on the internet at http://www.nidcr.nih.gov/news/strat-plan/index.html. The programmatic organization of the NIDCR reflects this expansion and provides support for research in areas such as molecular medicine, bacterial genetics, oropharyngeal cancer and other neoplastic diseases of the head and neck, chronic disorders, the link between oral and systemic health, craniofacial anomalies and injuries, oral infectious diseases and AIDS, biomaterials, biomimetics, tissue engineering, oral manifestations of systemic diseases, and management of the medically compromised patient. In addition, growing efforts are being devoted to clinical, behavioral and health promotion activities and to the study of the factors responsible for the existence of health disparities among various segments of the population. It is now recognized that, in most diseases, a number of diverse genetic, environmental and socioeconomic factors converge to disrupt health and that new interdisciplinary research approaches which integrate various fields are required to effectively address the multifactorial nature of human disease. These new approaches require a different and more diverse set of core competencies of investigators who can interact in cross-disciplinary research teams to take advantage of the expanding opportunities in dental, craniofacial and oral health research. Cognizant of the various ideas and trends discussed above, the NIDCR recently initiated an in-depth review of its training and career development programs. A Blue Ribbon Panel was appointed in 1999 to examine the evolving scientific opportunities for the 21st century and to identify the investigator competencies that will be required of those pursuing these areas of biomedical research. The entire report can be accessed at the following internet address: http://www.nidcr.nih.gov/research/blueribbon/career_BRP.htm. The conclusions of the Blue Ribbon Panel were discussed by the National Advisory Dental and Craniofacial Research Council (NADCRC) at the September, 1999 and January, 2000 meetings. The NADCRC emphasized the need for multidisciplinary programs, partnering within the Academic Health Centers, multiple career paths and choices, flexibility in training and a life-long career development continuum. Based on the Blue Ribbon Panel report and NADCRC deliberations, an implementation plan was formulated. This plan can be accessed on the internet through the NIDCR Extramural Research Training and Career Development page at http://www.nidcr.nih.gov/research/blueribbon/impPlan_BRP.htm. General Requirements Applicant institutions are required to include the following elements in their proposal: O Structure of the Scholar Development phase: The application should include a description of the activities, including didactics, that will be incorporated into the mentored postdoctoral research experience of the Scholar Development phase. Opportunities must be provided for individuals to carry out supervised relevant research and further develop research skills in an area(s) related to dental, craniofacial and oral health and disease. Current areas of NIDCR research emphasis are found at the following internet address: http://www.nidcr.nih.gov/research/extramural/sciprog.htm. The proposed program should include: (A) an emphasis on opportunities for cross-disciplinary and interprofessional links and collaborations within and between the academic health professional sciences, and the integration of basic and clinical sciences in career development activities, (B) collaboration with community settings and public health programs and facilities, where possible, and (C) inquiry-based and experiential learning to "mine" the expanding and complex knowledge bases using such tools, where appropriate, as bioinformatics. Scholar Development in the basic sciences should give priority to research experiences in one or more of such areas as: genomics, molecular biology and molecular epidemiology, gene-mediated diagnostics and therapeutics, cell biology, neuroscience, computational biology (i.e., modeling, development of algorithms), bioinformatics (e.g., storage and analysis of genomic data), biomaterials, biomimetics, nanotechnology, tissue engineering, and bioimaging technology. Postdoctoral programs that focus on patient-oriented research should give priority to such areas as: clinical research and clinical trials design, diagnosis and management of the medically compromised patient, evidence-based care, clinical epidemiology, biostatistics, health services, public health and outcomes research, health promotion and disease prevention, health disparities among racial, ethnic and socioeconomic populations, behavioral and social science research, and research bioethics. Career development postdoctoral programs should provide some integration, wherever possible, of both basic science and patient-oriented/clinical research. The goal is for appointees to become knowledgeable about the cross-disciplinary approaches to research necessary to address most scientific opportunities, and to be aware of the processes that facilitate transfer of knowledge from the laboratory to clinical practice and community applications. Detailed information should be provided as to the recruitment and selection of candidates for the Scholar Development postdoctoral research experience, and evaluation of their progress. o Structure of the Faculty Transition Phase: Transition to the Faculty Transition phase should not be automatic. Detailed information should be presented about determination by the program that an appointee is ready for transition from the Scholar Development phase to the Faculty Transition independent research project phase. Among the factors that must be considered are (1) the success of the appointee’s mentored research experience, (2) the scholar’s obtaining a tenure track line or equivalent position, and (3) proposed peer-review procedure to evaluate the scientific merit of the proposed independent research project. The institution must demonstrate a commitment to the candidate by providing protected research time and space needed to perform the proposed research. Matching funds from the institution for equipment and supplies (and salary if needed) are encouraged. A candidate for appointment to the grant who already has a tenure track position must have her/his research proposal peer-reviewed by the process developed by the grantee institution prior to an appointment being made to the program. A copy of the written summary statement for all reviews of independent research projects must be forwarded to the Assistant Director, Office of Training and Career Development, Division of Extramural Research, NIDCR. o Plan for the recruitment and retention of underrepresented minorities, individuals with disabilities and women must be included in the proposal: The NIDCR remains committed to increasing the participation of women and individuals from racial or ethnic groups underrepresented in the biomedical, clinical and behavioral sciences. The following groups have been identified as underrepresented in biomedical and behavioral research nationally: African Americans, Hispanic Americans, Native Americans, Alaskan Natives, and Pacific Islanders. Use of the term "minority" in this announcement will refer to these groups. o Plan for on-going evaluation of the program: The application should include a plan for program evaluation in terms of recruitment and retention goals, completion success, overall outcome, the curriculum and program staff. For purposes of evaluating the impact of all research career development programs, awardees must agree to provide the NIDCR with information on career outcomes for those appointed to the program. This information will be supplied annually for 10 years subsequent to completion of the award. Program directors can satisfy this requirement by providing current curriculum vitae for each of their graduates, including information about current address and title, employment history, publications, and research grants and contracts received o Plan for an Advisory Oversight Board: Plans must be provided for the appointment of an advisory body to act as an oversight committee for the career development program. Composition, responsibilities, frequency of meetings and other relevant information should be included. An annual evaluation by the Advisory Board is recommended. o Plan for instruction in bioethics, scientific integrity and the responsible conduct of research: Every individual supported by a research career development award must receive instruction in the responsible conduct of research. Applications must include a description of a program to provide formal or informal instruction in bioethics, scientific integrity and the responsible conduct of research. Applications without such plans will be considered incomplete and will be returned to the applicant without review. Although the NIDCR does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, policies regarding the use of human and animal subjects, and security data management. Plans must address the subject matter of the instruction, the format of the instruction, the degree of faculty participation, trainee attendance, and the frequency of instruction. The rationale for the proposed plan of instruction must be provided. Program reports on the type of instruction provided, topics covered, and other relevant information, such as attendance by appointees and faculty participation, must be included in future competing continuation and noncompeting applications. The NIDCR encourages institutions to provide instruction in the responsible conduct of research to all graduate students and postdoctorates in a department, regardless of the source of support. o A plan for periodic research meetings and networking: Plans should be included for periodic, or at least twice per year, meetings of all program appointees and mentors in which research projects/results/directions are discussed and evaluated. Each application also must include plans to network with one or more similar programs in the same or other institutions, whether through joint meetings, electronic links or telemedicine interactions. The NIDCR plans to hold an annual meeting for appointees and relevant program personnel at the NIH. Other Requirements O Environment: At least the primary institution in a consortium must have well- established research and clinical career development programs and highly qualified faculty mentors in research areas to be offered. It is expected that one or more institutions in the consortium will be less involved at present in research. However, those institutions must make a financial and administrative commitment to develop the necessary infrastructure for a research program in coordination with the other consortial member(s). Appointees who complete an independent research project as part of the K12 must be offered a tenure track line at one institutional member of the consortium as part of the commitment. o Program Director: The proposed Program Director (PD) must possess the scientific expertise, leadership and administrative capabilities required to coordinate and supervise an interdisciplinary research and development program of this scope. The Director also must be experienced in the design and management of programs for developing independent scientists. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to serve as PD or co-directors. The PD (and any co-directors) is expected to participate in at least one annual meeting with the staff of the NIDCR. This meeting likely will be held in conjunction with the annual meeting of the American Association for Dental Research. o Mentors: Each appointee on the program award must have a primary sponsor/mentor who is recognized as an accomplished investigator, is actively involved in the area of research chosen by the appointee, and who has a successful record of providing the type of career development experience required under this award. Mentors can have appointments at any component of the academic centers to which the consortium institutions belong. An assigned mentor will provide guidance for the development of each of his/her appointees. The mentor must be committed to continue this involvement throughout the appointee’s total period of development under the award. The NIDCR strongly encourages multiple mentors for each appointee, in keeping with the cross-disciplinary research experience to be provided. o Number of appointee positions: The applicant can request support for up to two new appointees to enter the program each year, giving a total of ten during the five year project period. It is expected that all appointees will either hold or be offered a tenure track line or similar position either at the institution providing the career development experience, or at another component of the health science center, or at another institution(s) that is part of the regional consortium. Appointees cannot progress to the independent research project part of the K12 without the tenure track line being finalized. In planning appointments beyond the first year of the award, the PD should be aware that continued NIDCR support beyond the five-year project period is dependent upon the availability of appropriated funds and success in competition for renewed support. The applicant institution should have plans in place to provide such support in the event that funding from the NIDCR is not available. New appointments must occur within three months of the start of a new budget period, usually between July 1 and September 30. Unfilled positions resulting from either failure to make appointments within the prescribed period or due to termination of an appointee prior to completion of a five year program, will be eliminated from the program. The associated funds will not be available for carry over and will be deleted from future years. A "Statement of Appointment" form (PHS 2271) must be completed and sent to the NIDCR whenever an individual is appointed or reappointed to the program. ALLOWABLE COSTS Salary and Support During the Scholar Development phase, appointees may be provided support of up to $100,000 each year. For the independent research phase, appointees may receive support of up to $125,000. This amount includes (1) direct salary, not to exceed $75,000, that is commensurate with the applicant institution"s salary structure for persons of equivalent qualifications, experience, and rank, and (2) research and development support, which can include such expenses as supplies, equipment and technical personnel, tuition and fees, travel to research meetings or training, and statistical services including personnel and computer time. These costs must be specifically documented for each individual candidate and must be directly related to the candidate’s research activities. They cannot be pooled and used for advertising, recruiting or other things unrelated or indirectly related to the research activities of individual appointees. In addition, fringe benefits will be provided that are in keeping with the policies of the institution at which the majority of career development and independent research activities will take place. The institution may supplement the NIDCR contribution, 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 may not require extra duties or responsibilities that would interfere with the purpose of this award. The total salary requested must be based on a full-time, twelve month staff appointment. Up to ten percent of the PD"s salary plus fringe benefits will be allowed. A PD may serve as a mentor. Salary for other mentors, secretarial and administrative assistance, etc., is not allowed. The sponsoring institution is expected to provide these services. Facilities and Administrative Costs These costs, which were formerly called indirect costs, will be reimbursed at 8 percent of modified total direct costs. The K12 grant, as administered by the NIDCR, is not subject to the Streamlined Noncompeting Application Process (SNAP). In general this means that all reporting of budgetary information and program progress are provided in greater detail in an annual progress report. While the K12 is subject to Expanded Authorities, the one exception to this is that carryover of funds from one fiscal year to the next must be approved by the NIDCR Grants Administration staff (see INQUIRIES). LEAVE In general, appointees may receive salary during the normal periods of vacation and holidays observed by individuals in comparable positions at the grantee institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and is not considered to be a vacation or holiday. Appointees may receive salary for up to 15 calendar days of sick leave per year. Sick leave may be used for the medical conditions related to pregnancy and childbirth. Appointees also may receive stipends for up to 30 calendar days of parental leave per year for the adoption or the birth of a child when those in comparable positions at the grantee institution have access to paid leave for this purpose and the use of parental leave is approved by the program director. A period of terminal leave is not permitted and payment may not be made from grant funds for leave not taken. Individuals requiring periods of time away from their research career development experience longer than specified here must seek approval from the NIDCR for an unpaid leave of absence. PROGRESS REPORTS An Annual Progress Report for the grant is required. This report should provide information about changes in the Program, a summary of the evaluation by the Advisory Committee, and a description of the research and career progress of each candidate. These Annual Reports will be closely monitored by NIDCR staff to ensure that the grant is achieving the goals of this Research Career Development Program. Progress reports are submitted using the Form PHS 2590, which can be obtained at the following website address: http://grants.nih.gov/grants/funding/2590/2590.htm. Forms are also available at most institutional offices of sponsored research. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIDCR that women and members of minority groups and their sub-populations must be included in all NIDCR-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIDCR that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIDCR, 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://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators may also obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. APPLICATION PROCEDURES Applications are to be submitted on the grant application Form PHS 398 (rev. 4/98) using the modified instructions provided below. Application forms can be obtained directly at the following website address: http://grants.nih.gov/grants/funding/phs398/phs398.html. Forms are also available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892- 7910, Phone: (301) 435-0714, FAX: (301) 480-0525, E-mail: GrantsInfo@nih.gov. The instructions in the Form PHS 398 do not fully apply to the special needs of this grant application. Therefore, please follow the modified instructions below in preparing an application for an NIDCR MENTORED CLINICAL SCIENTIST DEVELOPMENT PROGRAM AWARD IN DENTAL, CRANIOFACIAL AND ORAL HEALTH RESEARCH. These instructions have been adapted to accommodate the Form PHS 398 and the special needs of the K12 grant: 1. Face Page: Use page AA of the PHS Form 398. On Line 1, include the title that best represents the nature of the career development program. On Line 2, provide the number of this Program Announcement beginning with PAR..., and the title of the Program Announcement. The Program Director will be the principal investigator (PI) of the grant application. 2. The Description/ Performance Sites/ Key personnel (page BB of Form PHS 398): List all sites involved, especially if a regional consortium is in place. Key Personnel should include the Program Director and any co-Directors, Advisory Oversight Board members, mentors and other faculty participating in the program. 3. Table of Contents (Page CC) to be organized as follows: Content Page Number a. Face Page b. Description, Performance Sites, Key Personnel c. Table of Contents d. Detailed Budget for First Year e. Budget for Entire Proposed Period of Support f. Budgets Pertaining to Consortium Arrangements (if applicable) h. Biographical Sketches (not to exceed three pages per individual) - Program Director (and co-Directors if applicable) - Advisory Board Members - Mentors - Other Faculty - Appointees (when available) i. Other Support of the Program Director and the Mentors j. Resources k. Career Development Plan (not to exceed 25 pages) i. Purpose and Objectives ii. Structure of Scholar Development Phase iii. Structure of Faculty Transition Phase iv. Research Environment, Resources and Facilities v. Program Management - Program Director/co-Directors - Recruitment Strategies - Advisory Oversight Board - Networking and Periodic Research Meetings - Evaluation plan - Bioethics, Scientific Integrity, Responsible Conduct of Research vi. Other l. Human Subjects m. Vertebrate Animals n. Consortium/Contractual Arrangements o. Checklist p. Appendices 4. Detailed Budget for the First Year: Use Page 4 (page DD) of the Form PHS 398 and provide detailed budget information with regard to Salary and Fringe benefits, supplies, travel, etc., specified for program director and any appointees identified or by position, if there is no one identified to fill the position. Note there is an upper salary limit of $75,000 plus fringe benefits and an upper limit for other costs of $25,000 per appointee to the Scholar Development phase. 6. Budget for the Entire Proposed Period of Support (page EE): Follow instructions as provided in the Form PHS 398. 7. Biographical Sketches (page FF): Divide into five sections as follows: (1) Program Director/co-Directors, (2) Advisory Oversight Board Members, (3) Mentors, (4) Other Faculty, (5) Appointees (when available). 8. Other Support (Page GG): Include research support that is specifically relevant to the purpose and objectives of this Program 9. Resources (Page HH) 10. Career Development Plan: a. Purpose and Objectives: Briefly describe the background, purpose and objectives of this career development Program. b. Structure of Scholar Development Phase: Address at least all of the points included above under General Requirements. c. Structure of Faculty Transition Phase: Address at least all of the points included above under General Requirements. d. Research Environment, Resources and Facilities: Include at least the following - ongoing basic biomedical and clinical research, availability of research support, equipment, facilities, and clinical resources, the past research and career development record of both the program director and the designated preceptors, as determined by the success of their former postdoctoral fellows. This can include a record of successful competition for research grants, receipt of special honors, a record of publications, receipt of patents, promotion to scientific positions, and any other measure of success consistent with the nature and duration of the training received. e. Program Management: Address at least all of the points included above under General Requirements for recruitment of underrepresented minorities and women, as well as the disabled and recruitment in general, ongoing evaluation of the program, Advisory Oversight Board, instruction in bioethics, scientific integrity and responsible conduct of research, and periodic research meetings and networking. In addition, address at least all of the points included above under Other Requirements for program director, mentors, and number of appointee positions. f. Other: Describe any other aspects of the proposed program which applicant feels the need to clarify. 11. Human Subjects: Follow instructions in Form PHS 398 application kit. 12. Vertebrate Animals: Follow instruction in Form PHS 398 application kit. 13. Consortium/Contractual Arrangements: A Statement of Institutional Commitment must be included for each institution participating in the consortium. Any plans for enhancing the research infrastructure of a regional consortium member should be described here. 14. Checklist: (Page II) 15. Appendices: Follow instructions in Form PHS 398 application kit. NIH requires that applicants for any grant who are planning to submit an investigator-initiated new (type 1) or competing continuation (type 2) application requesting $500,000 or more in direct costs for any year must contact the NIDCR program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the application must obtain agreement from the NIDCR staff that the Institute will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the NIDCR staff member who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of both any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at http://grants.nih.gov/grants/guide/notice-files/not98-030.html. The completed original application and three legible copies must be sent to or delivered to: CENTER FOR SCIENTIFIC RESEARCH NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (For express/courier service) At the time of submission, two additional copies must also be sent to: Dr. George Hausch Chief, Scientific Review Branch DER, NIDCR 45 Center Drive Bethesda, MD 20892-6402 Applications for the initial submission in response to this PA must be received by June 1, 2001. Applications received later than that date will be returned without review. For the future duration of this PA, the receipt date will be October 1 of each year. REVIEW CONSIDERATIONS Applications will be assigned to NIDCR. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened by NIDCR 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 the appropriate national advisory council or board. Review Criteria All applications are evaluated for merit based on the following criteria: o Research Career Development Environment. Evidence of: institutional commitment from all member institutions of the regional consortium, ongoing basic and clinical research, availability of research support, equipment, facilities, and clinical resources. o Program Director and co-Directors. Demonstration of: scientific and administrative expertise, experience in or potential for managing research career development programs and development of research skills, time commitment, other research support, assignment of mentors and projects, and evaluation of progress. Assessment of past research career development record of both the program director and the designated mentors/preceptors as determined by the success of former trainees in seeking further career development (evidence of further career development can include receipt of fellowships, career awards, additional career development and training appointments, and similar accomplishment) and in establishing productive scientific careers (evidence of a productive scientific career can include a record of successful competition for research grants, receipt of special honors, a record of publications, receipt of patents, promotion to scientific positions, and any other measure of success consistent with the nature and duration of the career development and training received). o Mentors. Evidence for their roles and time commitment now and for the duration of the program, accomplishments in basic and/or clinical research, current and pending research grants, and mentoring experience of graduate researchers and dental clinicians. O Advisory Oversight Board. Demonstration of high quality individuals on Board, procedures for selection, specific role of the Board. O Networking and Periodic Research Meetings. Evidence for development of networks with other career development programs within the health science center and institutions in the consortium, and for periodic meetings to discuss research areas being pursued by the appointees. o Methods for recruitment, selection and retention of trainees. Demonstration of well-defined recruitment procedures (including potential sources of high-quality candidates), candidate selection criteria and retention strategies. o Scholar Development and Faculty Transition requirements. Evidence for the development and implementation of the didactic and postgraduate research experience for the Scholar Development phase, organization and quality of cross-disciplinary and interprofessional research career development of all appointees, criteria for receipt of tenure track line and for progression to the Faculty Transition phase of the grant, including peer-review of independent research project, quality of the plan for evaluating the program. ADDITIONAL REVIEW CONSIDERATIONS FOR ALL APPLICATIONS Recruitment Plan for Underrepresented Minorities: After the overall educational and scientific merit of an application has been assessed, peer reviewers will examine and evaluate the minority recruitment plan. The findings of the panel will be included in an administrative note in the summary statement. If the minority recruitment plan or if the record of recruitment and retention of minorities is judged to be unacceptable, funding will be withheld until a revised plan that addresses the deficiencies is received. Staff within the NIDCR, with guidance from the NADCRC, will determine whether amended plans and reports submitted after the initial review are acceptable. Training in the Responsible Conduct of Research: The applicant’s plans for providing experience in the responsible conduct of research will be assessed on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction. The plan will be discussed after the overall determination of scientific, educational and administrative merit, so that the quality of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be considered for funding until the applicant provides a revised, acceptable plan. NIDCR staff will judge the acceptability of the revised plan. Notification Shortly after the review meeting, each applicant will be sent notification of the Review Group’s recommendation and the name and phone number of the NIDCR official responsible for the application. When the NIDCR official receives the summary statement of the review, prepared by the Scientific Review Administrator after the review meeting, a copy will be forwarded to the applicant. Following Council Review, the NIDCR program official will notify each applicant of the final disposition of the application. AWARD CRITERIA Applications are selected for funding primarily on the basis of scientific and educational merit and sound administrative organization. However, other factors are considered, such as: availability of funds, research program priorities, the balance among types of research training and career development supported by the NIDCR, the acceptability of the plan for minority recruitment, and the acceptability of the proposal for instruction in the responsible conduct of research. The NIDCR will notify the applicant of the final action shortly after advisory council review. The earliest award date will be July 1, 2002. The NIDCR appreciates the value of complementary funding from other public and private sources, including foundations and industrial concerns, for activities that will complement and expand those supported by the NIDCR. INQUIRIES Inquiries concerning this PA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. James A. Lipton Assistant Director, Office of Training and Career Development Division of Extramural Research, NIDCR Natcher Building, Room 4AN-18J Bethesda, MD 20892-6402 Telephone: (301) 594-2618, FAX: 301-480-8318 Email: James_Lipton@nih.gov Direct inquiries regarding fiscal matters to: Mr. Martin R. Rubinstein Grants Management Officer Division of Extramural Research, NIDCR Natcher Building, Room 4AS-55 Bethesda, MD 20892-6402 Telephone: (301) 594-4800, FAX: (301) 480-8301 Email: Martin_Rubinstein@nih.gov AUTHORITY AND REGULATIONS Awards are made under the authority of Section 487 of the Public Health Service Act as amended (42 USC 288). Title 42 of the Code of Federal Regulations, Part 66, is applicable to this program. This program is also described under section 93.121 in the Catalog of Federal Domestic Assistance. 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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