We will recruit qualified KL2 scholars who have recently completed doctoral-level training (PhD or MD) or postdoctoral fellowships; who are appointed to the Penn State faculty or are qualified to be appointed to the faculty; who are U.S. citizens or permanent residents and who are commencing translational, behavioral, clinical, and/or health services research. Approximately 10 scholars will be trained over the 5-year program period, half with clinical doctorates and half with PhD or equivalent research doctorates. Recruitment efforts will focus both on internal candidates at Penn State and external candidates.
Candidates holding an MD, doctoral degree in nursing or other clinical or scientific doctoral degree, who are committed to focusing their career on clinical and translational research, and who have demonstrated excellence in scholarship will qualify to apply to become CTSI KL2 Scholars. Each candidate will submit an application cover page, along with a current curriculum vitae, three letters of recommendation, and an 8-12 page proposal that summarizes his/her research and training plan. In the future, applicants will be encouraged to familiarize themselves with the CTSI’s translational research clusters via the CTSI website and identify candidate clusters of interest.
Admissions criteria and selection process. 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 multidisciplinarity of the training environment, the success and track record of the Lead Mentor in mentoring previous junior faculty members and other trainees, and diversity issues. The candidates will be evaluated by the Education and Training Internal Advisory Committee (IAC). Candidates whose written statements and letters of recommendation indicate overall scholarly excellence, clearly delineated career/research goals, and a strong commitment to interdisciplinary research preferably within one of the translational research cluster research areas will be selected for personal interviews. Interviews will be conducted by members of the IAC, who will rate each candidate using a standard evaluation form addressing the applicant’s background qualifications, research accomplishments and plans for a career in clinical and translational research. The interviewed candidates will be evaluated with regard to the scientific merit and feasibility of their research proposal, the suitability of the applicant for a career in clinical and translational research, the strengths of their mentors and the maturity of the associated translational research cluster. Applicants will be graded using the NIH scale of 1-9 and discussed by the IAC with the final recommendation to accept made by majority vote of the committee. The formal offer of a position in the program will depend upon an identified primary mentor for the candidate and on a letter from the candidate’s department chair committing to protecting 75% effort for research during the course of the scholar’s career development program. The decisions regarding duration of the award will be made by the Mentoring and Career Development Advisory Panel (MCDAP) based on the applicants progress after the first year.
KL2 Review Process
Applications will be reviewed using an NIH style with the 1-9 scale below. Each application will have a primary and secondary reviewer who will be asked to write a one page review and complete a scoring sheet in advance of the meeting. All reviews will be submitted a minimum of one week in advance of the meeting so that they may be available to all committee members. Each KL2 reviewer will review no more than 3 applications total. A list of applicants will be circulated in advance of the meeting to allow reviewers to identify any applications in conflict (See below).
CORE REVIEW CRITERIA
There will be five core review criteria each scored (1-9) and weighed separately on the score sheet. An application does not need to be strong in all areas to have scientific and career development impact. The criteria are:
- Training/Career Development Plan
- Research Plan
- Qualifications of Mentor and Co-mentor(s)
Does the candidate have the potential to develop as an independent researcher focusing on patient oriented research?
Is the candidate’s academic, clinical and research (if relevant) record of high quality?
Is there evidence of the candidate’s commitment to meeting the program objectives to become an independent researcher focusing on patient oriented research?
Do the letters of reference attest to the ability of the applicant to become an independent investigator?
Career Development Plan
What is the likelihood that the plan will contribute substantially to the scientific development of the candidate leading to scientific independence?
Is the candidate’s prior training and research experience appropriate for this award?
Are the goals and scope of the training plan and the stated training and research objectives appropriate in view of the candidate’s prior experience?
Are the content and duration of didactic research activities during the award clearly stated and appropriate?
Are there adequate plans for evaluating the candidate’s research and career development progress?
Are the proposed research question, design, and methodology of significant scientific and technical merit?
Is the research plan relevant to the candidate’s research career objectives focusing on patient-oriented research?
Is the plan for developing and enhancing the candidate’s research skills appropriate and adequate?
If applicable are there adequate plans for data and safety monitoring of clinical trials?
Are the mentor’s research qualifications in the area of the proposed patient-oriented research appropriate?
Is there adequate description of the quality of the extent of the mentor’s proposed role in providing guidance and advice to the candidate?
Is there evidence of the mentor’s previous experience in fostering the development of independent investigators?
Is there evidence of previous research productivity and peer-reviewed support focusing on patient oriented (clinical/translational) research?
Is there active/pending support that is appropriate and adequate for the proposed research project?
Environment and Departmental/Institutional Commitment
Is there clear commitment of the sponsoring department/division to ensure that a minimum of 75% of the candidate’s efforts will be directly devoted to the research described in the application with the remaining per cent effort devoted to an appropriate balance of teaching, administrative and clinical responsibilities (as applicable).
Is the departmental/divisional commitment to the career development of the applicant particularly strong?
Are the research facilities, resources (including faculty capable of productive collaboration with the applicant), and training opportunities adequate and appropriate?
Is the environment for scientific and professional development of the candidate of high quality?
Additional review criteria (not scored)
Protection of Human Subjects. For research that involves human subjects that does not meet one of the 6 exemption criteria listed under 45 CFR Part 46, the committee will evaluate the justification for the use of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risks to human subjects; 2) adequacy of protection against risk; 3) potential benefit to the subjects and others; 4) importance of the knowledge to be gained and, 5) data and safety monitoring for clinical trials.
Inclusion of Underrepresented Minorities/Gender/Children. For research that involves human subjects: Does the proposal include plans for inclusion of underrepresented minorities, both sexes, as well as the inclusion of children as participants, justified in terms of the proposed scientific goals and research strategy?
ENHANCED REVIEW CRITERIA
Overall impact. Reviewers will provide an OVERALL IMPACT SCORE to reflect their overall assessment of the application and enthusiasm for the application. Please base your overall impact score on the following criteria with the weights as follows:
a) Potential of the candidate to become a successful and externally funded clinical investigator (~25% weight)
b) Qualifications and commitment of the lead mentor (~25% weight): successful investigator, externally funded, prior successful history of trainees)
Strength of the Research and Training proposal (~50%). The training plan should describe didactic work and mentored clinical research training. The hypothesis-driven research proposal can be evaluated using the NIH scale for the areas of Significance, Innovation and Approach. Keep in mind that the Candidate, Mentor and Environment are graded separately as above. PLEASE NOTE THAT THE OVERALL IMPACT SCORE IS NOT NECESSARILY AN AVERAGE OF THE SCORES FOR THE 5 CORE CRITERIA. The overall impact score will be used to compare the applications.
In keeping with the desire of the Penn State CTSI to foster multidisciplinary approaches to team science through the development of translational research clusters, each reviewer will be asked to meet with or phone the proposed mentor for each of his/her assigned applicants to gather standardized information regarding the research environment.
CONFLICT OF INTEREST IN REVIEW
The KL2 reviewers will not review an application or participate in the ranking of any proposal in which the applicant or mentor is in their department or for any application in which the reviewer would serve as a mentor, advisor or collaborator. For submissions from the Departments of Medicine, Pediatrics or Surgery we are using the same criteria but based on Division rather than Department.
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 Pennsylvania State 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.