Mentored Clinical & Translational Research Scholars Program
Application Information
NIH Supported KL2 Program
Purpose
The goal of the ACTSI RETCD KL2-Mentored Clinical and Translational Research Scholars (MCTRS) program is to support career development for junior faculty (MD, PhD, or MD/PhD) from a wide variety of disciplines at Emory University, Morehouse School of Medicine (MSM), and Georgia Institute of Technology (GA Tech) to become independent, established, and ethical clinical and/or translational research investigators. Trainees accepted into the program will receive salary support to enable them to spend at least 75% of their professional time (50% is allowed for trainees from surgery or surgical subspecialties) on clinical and/or translational research and research training; a technical budget; and some salary support for their lead mentor. Didactic research training is provided through the Master of Science in Clinical Research (MSCR) program and mentored research training under the direction of an established, federally-funded clinical investigator at one of the collaborating institutions. Support in the program for junior faculty trainees will be provided for up to two years and is based on performance in the program. The KL2-MCTRS represents an expansion of the previously funded K12 program at Emory.
A limitation for many junior faculty with high potential to become clinical and/or translational research investigators is the lack of salary support and protected time to pursue research training including didactic training provided by the MSCR. The MCTRS program provides additional opportunities and support to train junior faculty members to enter careers in clinical investigation. The MCTRS program provides the opportunity to build upon the resources of the ACTSI and other established programs in supporting junior faculty members who want to establish a successful clinical and/or translational research career. The MCTRS program provides the opportunity for didactic training (in large part through the MSCR program) and also requires that the trainee have an established and successful lead mentor who could provide further guidance and training for those pursuing careers in clinical and/or translational investigation.
Source of Support
Funding for the KL2-MCTRS comes from the Atlanta Clinical & Translational Science Institute (ACTSI) through a National Institutes of Health (NIH) funded Clinical and Translational Science Award (CTSA) received by Emory University (in collaboration with MSM and GA Tech).
Background
The KL2-MCTRS responds to national efforts to support the training and development of junior faculty members who will become well trained, successful, and independent clinical and/or translational investigators. There is an urgent need to develop well trained clinical and/or translational investigators who can assure that the findings of basic research are translated to clinical settings and from clinical settings into the community. These investigators need to be able to conceptualize and implement cutting edge clinical and translational research. The KL2-MCTRS builds on the successful Emory K12 and K30-MSCR programs, the MSM MSCR program, and the considerable strengths and outstanding resources in Atlanta and at Emory, MSM, and GA Tech.
The KL2-MCTRS addresses the recommendations of the National Research Council Report, Addressing the Nation's Changing Needs for Biomedical and Behavioral Sciences, which recommends the need to intensify efforts to train and retain clinical and translational researchers in order to reverse the dramatic decline of clinical and/or translational investigators entering the research workforce. The rationale for the education and training program includes the expanding need for high-quality clinical and translational research; the necessity for integration of the analytic sciences and clinical and translational research; the need to translate research findings from the bench to the bedside and from the bedside to the community; the importance of interdisciplinary education and training in clinical and translational research; and the extensive expertise in and record of clinical investigation represented by the faculty at the collaborating institutions (i.e., Emory, MSM, and GA Tech). The KL2-MCTRS program will provide opportunities for junior faculty trainees to have 75% protected time to pursue clinical and/or translational research and research training. This includes both didactic and mentored training in clinical and/or translational investigation from an outstanding faculty mentor for up to two years.
The Emory MSCR and MSM MSCR programs provide didactic training needed by those pursuing careers in clinical and/or translational research. The MSCR program at either Emory or MSM provide didactic training for those applicants from the respective institutions accepted into the KL2-MCTRS. All applicants accepted into the ACTSI KL2-MCTRS program will be required to enroll in the MSCR program (either at Emory or MSM), although students can take courses in either program and there are some joint courses. The Emory MSCR program is offered by the James T. Laney School of Graduate Studies and is presented by the Emory University School of Medicine (EUSOM) and Rollins School of Public Health (RSPH).
The Emory MSCR program requires a minimum of 28 hours of academic credit that include in-class didactic coursework and a written research thesis. Generally, three semesters of didactic study (10-12 months minimum for full-time students) are required and an optimal time of 18-24 months to complete the program (including the mentored thesis). For most investigators, the period of two years is appropriate to accomplish both the didactic work (one year) and completion of an appropriate investigative research thesis. The MSM MSCR program is a broad-based multidisciplinary graduate level program in clinical research designed to prepare clinical and translational research faculty for a career in clinical investigation. The program provides training in the principles and methods of biostatistics; epidemiology, including genetics and clinical trials; and outcomes research, including health services research.
The CORE REQUIREMENTS of the MSCR degree program include:
1) Introduction to Clinical and Translational Research
2) Clinical Decision Analysis, focusing on evidence-based analytic techniques for clinical trials
3) Data Collection, Management and Analysis, focusing on the biases and problems encountered in data analysis and on the computer skills that are needed to facilitate such work
4) Analytic Epidemiology, focusing on the use of the tools of this science in clinical and translational research
5) Biostatistics for Clinical and Translational Research, focusing on the techniques and analytic strategies involved in probability issues and population distributions involved in clinical investigation
6) Clinical Trial Design, focusing on the development of clinical protocols for both interventional and observational studies
7) Fundamentals of Bioinformatics
8) Scientific and Grant Writing
9) Clinical Research Colloquium
10) Community Engagement and Health Disparities in Clinical Research
11) Bioethics, Legal and Social Issues of Clinical Investigation
12) Clinical Investigation Network and Institutional Review Board (IRB) Rotations
13) A Mentored THESIS PROJECT
Training Support
Junior faculty trainees accepted into the KL2-MCTRS must devote a minimum of 75% professional effort to clinical and/or translational research training (the only exception to this is a minimum of 50% effort for trainees from surgery or the surgical subspecialties). Salary support reflecting effort will be provided by the KL2-MCTRS (as well as the costs to cover fringe benefits on that salary). Salary support is based on the trainee's current institutional salary. The maximum salary support that the MCTRS program can provide is $120,000 per year (plus fringe benefits). The salary support provides protected time for trainees to obtain clinical and/or translational research training. Support will be provided for up to two years. Ongoing support is contingent upon the trainee making adequate progress in the program. In addition to salary support, up to $25,000 per year will be provided to each trainee for a technical budget. These funds must be used to pay for MSCR tuition while the trainee is in the KL2-MCTRS program and can also be used for other research related needs including research supplies, equipment, non-faculty research staff salary support, and travel to national meetings or to receive additional specialized training. Salary support for the lead mentor (2.5% plus fringe benefits support on that salary) is also provided.
Mentors
Each junior faculty trainee must identify a lead mentor who is an established clinical and/or translational investigator at one of the collaborating institutions (Emory, MSM, GA Tech). Lead mentors should be established and successful clinical and/or translational investigators. Generally this means that the lead investigator must be a federally-funded investigator (e.g., NIH and/or CDC). Lead mentors may only act as such for one KL2 trainee at a time.
A letter of support from the lead mentor indicating their willingness and desire to serve as the trainee's lead mentor should be included in the candidate's application. All KL2-MCTRS trainees must have mentored clinical and/or translational research training under the direction of their lead mentor. The lead mentor will provide guidance and mentoring to the trainee while they are in the KL2-MCTRS. Additional co-mentors or Advisory Committee members are permitted; however, there must be a single lead mentor that is identified. Multidisciplinary mentoring teams are strongly encouraged as is having representation from at least two of the ACTSI partners on the mentoring team or Advisory Committee (Emory, MSM, or GA Tech).
Additional Information
An investigator initiated, hypothesis driven proposal with specific aims will be developed by each trainee. This will be initially outlined in the application submitted by candidates for the program and will be further refined after enrollment in the KL2-MCTRS. Progress towards those aims will be updated in required semi-annual reports. It is anticipated that the clinical or translational research project that the trainee is working on under the guidance of their Lead Mentor will provide the data to be analyzed for their mentored thesis which is required to receive the MSCR degree. Clinical and/or translational research will begin during the first year of the program. Much of the trainee's time in the first year will be devoted to didactic studies (i.e., first year of MSCR curriculum). In the second year of the KL2-MCTRS program, a large portion of the trainee's time will be devoted to working on their clinical and/or translational research project under the guidance of their mentor and the MSCR thesis. The KL2-MCTRS program will provide additional support as well through ongoing functions such as journal club, colloquiums, and special seminars (often in collaboration with the MSCR program or other ACTSI components). The importance of interdisciplinary research will be emphasized in these additional colloquiums and seminars. Each KL2 scholar accepted into the KL2-MCTRS program must submit an NIH K23 Mentored Patient-Oriented Research Career Development Award or equivalent NIH K award (e.g., K01, K08) grant application by the end of their first year (12 months) of KL2 funding.
Eligibility
Junior faculty with a doctorate (MD, PhD, MD/PhD or equivalent) at the rank of Instructor or Assistant Professor at Emory, MSM, or GA Tech are eligible to apply to the program. Individuals who have accepted a faculty appointment at any of the three collaborating institutions may also apply if they will be on the Emory, MSM, or GA Tech faculty at the date of receipt of the award (e.g., June 1 or July 1). Faculty appointments cannot be dependent upon receipt of this award. Junior faculty physician candidates should have completed training in a specialty or subspecialty and be board eligible or certified. Non-physician candidates must have a PhD.
Candidates must be committed to a career in clinical investigation (clinical and/or translational research) and be willing to commit in writing to serve on the faculty of an academic institution pursuing clinical and/or translational research for each year of support received through the KL2-MCTRS.
As per NIH guidelines, candidates must be a U.S. citizen or permanent U.S. resident at the time they submit the application.
Individuals on temporary or student visas are not eligible. Candidates who are or have been former principal investigators on any NIH research project grant (this does not include NIH Small Grants [R03] or Exploratory/Developmental [R21] grants or their equivalents) or equivalent non-PHS peer reviewed research grants that are over $100,000 direct costs per year, or project leaders on sub-projects of program project (P01) or center grants (P50) are NOT eligible to participate as KL2 scholars. Minorities and women are encouraged to apply to the KL2-MCTRS.
Requirements of the applicants and awardees accepted into the program are as follows. The candidate must:
1) Be a full time junior faculty member at Emory University, Morehouse School of Medicine, or Georgia Institute of Technology (Instructor or Assistant Professor or equivalent level) at the time of receipt of the award.
2) Indicate a strong interest in pursuing an academic career in clinical and/or translational research.
3) Agree to commit in writing to serve at least one year on the faculty at an academic institution pursuing clinical and/or translational investigation for each year of support provided by the KL2: MCTRS (the goal would be for the trainee to spend a career in clinical investigation but this pledge emphasizes the importance of identifying persons interested in pursuing a career as a clinical investigator).
4) Be nominated by the candidate's Department Chair (and Division Director if applicable); the Chair must guarantee in writing in the nomination letter that a minimum of 75% of the junior faculty's professional time will be protected to pursue clinical and/or translational research training if the candidate is accepted into the KL2: MCTRS (an exception is made for a minimum of 50% effort for trainees from surgery or the surgical subspecialties).
5) Identify an established Emory, MSM, or GA Tech faculty lead mentor who meets approval criteria discussed above. Additional faculty members may serve as co-mentors or Advisory Committee members but there must be a single lead mentor.
6) Submit a completed application by e-mail to Cheryl Sroka (csroka@emory.edu) that includes (mentor and department chair letters of support should be submitted separately directly from the writers):
a. Cover Page - Click on the link to view the cover page required, which includes signature pages.
b. Abstract – one page (maximum) summary of the proposed research project and clinical and/or translational research training goals and activities
c. Research and Training Plan (15 pages maximum), single spaced, one inch margins. This section should include the candidate’s specific aims and goals in the KL2 program, including a hypothesis driven clinical and/or translational research proposal that they would develop under the guidance of their lead mentor (Research Plan) as well as plans for didactic and mentored clinical and/or translational research training (Training Plan). The Training Plan should indicate the candidate’s background and career goals and should also describe the faculty member who will serve as the lead mentor as well as a planned schedule of interactions between the trainee and mentor (be specific and indicate frequency of meetings, types of interactions, etc.). The Training Plan should also include a description of the didactic training that is planned and may include electives in the second year. The lead mentor should be an established and successful clinical and/or translational investigator and be described in the Research and Training Plan. Applicants should also include detailed information on what portion of their time would be devoted to clinical activities and what their clinical activities and responsibilities would be if accepted into the KL2 program.
The entire Research and Training Plan should be a maximum of 15 pages with one inch margins and it is suggested that the NIH PHS 398 format be used, including a section on Hypothesis and Specific Aims; Background and Significance; Preliminary Data (if any, but not required); Research Design and Methods; Biostatistics (can be included in the Methods section); and Data Safety and Monitoring Plan (if applicable). A suggested format for the Research and Training Plan is five pages devoted to the training component and 10 pages for the research plan.
d. Literature citations should be listed on a separate page in a standard bibliographic format following the research and training plan and does not count toward the 15-page maximum.
e. Budget may be submitted on the NIH PHS 398 forms or can be a line item listing and should include applicant’s salary (show salary as well as 75% requested) along with fringe benefits at the current rate (see OSP website). The current rate, effective 9/1/2009 is 26.1%. Also include a technical budget of $25,000 (which should include $13,000 for MSCR tuition), and a budget justification of no more than two pages. Do not include items not allowed on Federal Grants such as computers, software, books, administrative support staff (ask if uncertain).
f. Letters of Support from the lead mentor and Department Chair. The letter from the Department Chair must guarantee that the applicant will have protected time (equivalent to the salary support provided by the program) to carry out clinical research training if accepted into the KL2 program. The lead mentor’s letter should reflect willingness to serve as mentor for the candidate, their assessment of the candidate, prior trainees they have mentored, a brief summary of the applicant’s research proposal and a brief summary of plans for mentoring and enhancing the research capabilities of the applicant. Letters should be sent by e-mail to Cheryl Sroka (csroka@emory.edu) directly from the writers.
g. Cover letter from applicant should indicate the applicant’s rank (e.g. Senior Associate, Instructor, Assistant Professor, etc.) as well as the name of the applicant’s lead mentor. The candidate should indicate their interest in pursuing a career in clinical and/or translational investigation and agree to serve at least one year on the faculty of an academic institution pursuing clinical and/or translational research for each year of support from the KL2 program. The applicant should also state they will:
- agree to the rules of the KL2 program,
- meet with the program director(s) at least once every 6 months to review progress,
- submit semi-annual progress reports,
- keep the program office updated on publications and grant submissions/awards during AND AFTER completion of the program,
- complete the MSCR program
- submit a NIH K23 or other appropriate NIH application (e.g. K01, K08) during their first year of the KL2 program.
h. NIH Biosketch and Other Support Page of candidate and lead mentor as well as co-mentor (if applicable).
Selection/Review Criteria
The selection process will be carried out under the direction of the Atlanta Clinical and Translational Science Institute (ACTSI)/Research Education, Training and Career Development Program (RETCD) KL2 Advisory Committee, which has established the rules and regulations for the KL2 program. The goal of the KL2 program is to select candidates who, with proper career development and clinical and/or translational research training, have potential to become independently funded, successful and ethical clinical investigators. Decisions will be based on the strength of the application submitted by the prospective trainee, the potential of the applicant, the success and track record of the Lead Mentor in mentoring previous junior faculty members and other trainees, and diversity issues. Decisions of the KL2 Advisory Committee are final. Applications will be scored using the new NIH scoring system (1 to 9 point scale). Potential applicants are encouraged to contact or meet with the Program Director (Henry M. Blumberg, MD) and/or Co-Program Director, (Thomas Ziegler, MD) before submitting an application.
Plan for Recruitment and Retention of Underrepresented Minorities, Women and those with Disabilities
The KL2 program is committed to meeting the NIH/NCRR goal and that of Emory University to increase the participation of women and individuals from ethnic or racial groups underrepresented in the biomedical and behavioral sciences. Such groups include American Indian or Alaska native, Asian, Black or African-American, Hispanic or Latino, and Native Hawaiian or Other Pacific Islander. Applications from women and minority candidates are encouraged. In addition, accommodations will be made to assist any individuals with disabilities so those persons who are qualified applicants can complete the program.
Acknowledgements
All publications derived from work supported by the KL2 award must acknowledge the ACTSI KL2-Mentored Clinical and Translational Research Program and NIH KL2 support (NIH NCRR KL2 RR025009 ).
Note: The Research and Training Plan DOES NOT have to be routed through the Office of Sponsored Programs as this is an internal application.
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