Early-Stage Investigator Training Program (KL2)

• Full-time Penn State junior faculty with a research or practice doctorate (MD, DO, PhD, MD/PhD, PharmD, DrPH, DO/PhD or comparable doctoral-level degree) at the rank of assistant professor.

• Research focus on translational science or translational research.

• In rare cases (following consultations with KL2 program directors), associate professors whose career trajectory has changed to focus on translational research.

• Research associates at either Penn State University Park or Penn State College of Medicine.

• Faculty appointments cannot be dependent upon receipt of this award.

• Must be a U.S. citizen or permanent U.S. residents at the time of application.

• Individuals on temporary or student visas are not eligible.

• Current and former program directors or principal investigators on an NIH research project (RO1), program project (P01), center grants (P50), other career development awards (K awards), or the equivalent are not eligible.

• Current and former program directors or principal investigators of an NIH Small Grant (R03), Exploratory/Developmental Grant (R21), Dissertation Award (R36), or SBIR/STTR (R41, R42, R43, R44) are eligible.

• Appointed KL2 scholars may apply for an individual K award from the NIH and, if successful, will be transferred to that K award.

KL2 scholars are required to commit a minimum of 75% full-time professional effort (i.e., a minimum of nine person-months) or 50% effort for surgery or surgical specialties to their career development and research training during the mentored phase. Candidates may engage in other duties (clinical, research, or teaching) as part of the remaining 25% of their full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development plan. Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full-time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant institute or center before preparing an application to discuss their eligibility.

Applicants must be nominated by their department chair who must guarantee in writing in the nomination letter that a minimum of 75% of the applicant’s professional time will be protected to pursue clinical and/or translational research training if the candidate is accepted into the KL2 (50% for clinicians from surgery or surgical specialties). The nomination (chair’s letter) is included as part of the application (see table below) as well as the letter of intent.

Candidates will be evaluated by a review committee selected by Penn State CTSI's Executive Committee. Criteria include overall scholarly excellence as defined by written statements, letters of recommendation, and record of productivity. Clear delineation of career/research goals and a strong commitment to translational and interdisciplinary research are essential.

Each application will have three reviewers who will be asked to write a review and complete a scoring sheet, in accordance with the NIH system of 1 to 9, to establish the score for each application. A list of applicants will be circulated in advance of the meeting to allow reviewers to identify any applications in conflict. Applicants will be discussed by the review committee and preliminary scores will be updated into final scores.

Recommendations for funding will be made to the CTSI Executive Committee, who will make the final decisions. The formal offer of a position in the program will depend upon the candidate’s department chair committing to protecting 75% effort for research (50% for clinicians from surgical specialties or subspecialties) and $25,810 for direct research costs and $2500 for travel during the course of the scholar’s support by the KL2 award.

There will be five core review criteria following the NIH review process (i.e., each scored 1 to 9 and weighed separately on the score sheet. See K23 instructions, under “Section V. Application Review Information 1. Criteria”. Questions that will be considered by reviewers, under each section, are noted below. These are:

• Candidate

• Training/Career Development Plan

• Research Plan

• Qualifications of Mentor and Co-Mentor(s)

• Environment

Details for each category are below.

Reviewers will provide their assessment of the likelihood that all proposed career development and research plan will enhance the candidate’s potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact score.

Candidate

• Does the candidate have the potential to develop as an independent and productive researcher?

• Are the candidate's prior training and research experience appropriate for this award?

• Is the candidate’s academic, clinical (if relevant), and research record of high quality?

• Is there evidence of the candidate’s commitment to meeting the program objectives to become an independent investigator in research?

• Do the reference letters address the above review criteria, and do they provide evidence that the candidate has a high potential for becoming an independent investigator?

• Does the candidate have the potential to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study?

• Does the candidate have training (or plans to receive training) in data management and statistics including those relevant to clinical trials?

Career Development Plan/Career Goals and Objectives

• What is the likelihood that the plan will contribute substantially to the scientific development of the candidate and lead to scientific independence?

• Are the candidate's prior training and research experience appropriate for this award?

• Are the content, scope, phasing, and duration of the career development plan appropriate when considered in the context of prior training/research experience and the stated training and research objectives for achieving research independence?

• Are there adequate plans for monitoring and evaluating the candidate’s research and career development progress?

Timeline and Milestones

A timeline that includes tasks and activities to meet milestones is required. It may include elements such as, but not limited to, manuscript submissions, grant submissions, IRB approval, enrollment of first participant and planned enrollment timeline, completion of specific experiments.

Research Plan

• Are the proposed research questions, design, and methodology of significant scientific and technical merit?

• Is the prior research that serves as the key support for the proposed project rigorous?

• Has the candidate included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project?

• Has the candidate presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?

• Has the candidate presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

• Is the research plan relevant to the candidate's research career objectives?

• Is the research plan appropriate to the candidate's stage of research development and as a vehicle for developing the research skills described in the career development plan?

• Are the scientific rationale and need for a clinical trial, feasibility or ancillary study well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms?

• If proposing a small feasibility study, is the study warranted and will it contribute to planning and preliminary data needed for design of future larger scale clinical trials?

• Is the clinical trial or ancillary study necessary for testing the safety, efficacy or effectiveness of an intervention, or in the case of a feasibility study necessary to establish feasibility of future clinical trial?

• Is the study design justified and relevant to the clinical, biological, and statistical hypothesis(es) being tested?

• Are the plans to standardize, assure quality of, and monitor adherence to, the protocol and data collection or distribution guidelines appropriate?

• Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions, if interventions are delivered?

• For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Mentor, Secondary Mentor(s)

• Are the qualifications of the mentor(s) in the area of the proposed research appropriate?

• Does the mentor(s) adequately address the candidate's potential and his/her strengths and areas needing improvement?

• Is there adequate description of the quality and extent of the mentor's proposed role in providing guidance and advice to the candidate?

• Is the mentor's description of the elements of the research career development activities, including formal course work adequate?

• Is there evidence of the mentor's, consultant's, and/or collaborator's previous experience in fostering the development of independent investigators?

• Is there evidence of the mentor's current research productivity and peer-reviewed support?

• Is active/pending support for the proposed research project appropriate and adequate?

• Are there adequate plans for monitoring and evaluating the career development awardee's progress toward independence?

• Does the mentor or mentoring team have the expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed clinical trial, ancillary, or feasibility study and help him/her to meet timelines?

Environment and Institutional Commitment to the Candidate

• Is there clear commitment of the sponsoring institution to ensure that the required minimum of the candidate's effort will be devoted directly to the research described in the application, with the remaining percent effort being devoted to an appropriate balance of research, teaching, administrative, and clinical responsibilities?

• Is the institutional commitment to the career development of the candidate appropriately strong?

• Are the research facilities, resources and training opportunities, including faculty capable of productive collaboration with the candidate adequate and appropriate?

• Is the environment for scientific and professional development of the candidate of high quality?

• Is there assurance that the institution intends the candidate to be an integral part of its research program as an independent investigator?

• Are the administrative, data coordinating, enrollment and laboratory/testing centers appropriate for the trial proposed?

• Does the application adequately address the capability and ability to conduct the trial feasibility or ancillary study at the proposed site(s) or centers? If applicable, are there plans to add or drop enrollment centers, as needed, appropriate?

• If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

Scholars are also expected to comply with all program and grant reporting requirements through provision of progress reports and to cite the KL2 grant in all publications completed during the KL2 period. KL2 scholars are required to complete a progress report every six months during the program, then yearly following completion of the program. Session evaluations are also mandatory. Mentors are expected to participate in quarterly meetings with KL2 leadership, to review scholar progress in meeting expectations described in the timelines and milestones (including Individualized Development Plan) laid out in the application.

KL2 scholars can select from graduate courses offered at the University, including clinical and translational science and public health sciences. Educational funds can be included in the applicant’s KL2 budget. The career development plan for KL2 scholars will provide time for scholars to earn either a 30-credit Master of Science in Public Health Sciences or a 15-credit graduate certificate in translational science, depending upon their prior level of training. Neither of these is mandatory. Scholars may enroll in one or more courses, as needed, without earning a certificate or degree. Most courses are offered in designated time slots, two to three evenings per week or a designated early morning session, to facilitate attendance by both clinicians and non-clinicians, including individuals based at University Park. Several courses are available via videoconference between Hershey and University Park for those who cannot travel for course sessions.

Currently, KL2 scholars are expected to participate in all planned trainings and workshops. Details of the schedule will be confirmed closer to the funding start date. In general, scholars and co-directors will meet weekly, via video or in-person (where practicable), to discuss and solve current problems that scholars are experiencing with either their career development or research activities. These sessions will continue year-round, including summer, and are considered mandatory. Additional half-day (monthly) curricular sessions will also be scheduled. The location of these sessions alternates between Penn State University Park and Penn State College of Medicine in Hershey; in-person attendance is expected.

After being notified of funding, KL2 scholars and their mentors sign a memorandum of understanding that serves as an agreement on the part of the mentor and mentee to follow best practices for mentoring relationships. A sample memorandum is available for use.

All scholars will be required to complete a rural health translational practicum, in which scholars will be expected to partner with a rural health stakeholder (e.g., researcher, hospital, community organization, care provider) to collaborate on a small-scale project to work with the stakeholder in understanding and/or addressing the health and healthcare needs of rural populations. KL2 scholars will meet a range of rural health stakeholders and are encouraged to design or collaborate on a clinical translational project that helps them better understand the health and health care needs, resources and outcomes of rural populations.

Each year, generally in the winter, Penn State CTSI’s external advisory board meets with the leadership, and KL2 and TL1 scholars within the institute. Scholar attendance is required at this meeting, typically in Hershey, and select scholars may be asked to give a brief presentation on their research. In addition, there may be additional mandatory CTSI programmatic activities each year.

Provost Endorsement Program

The KL2 program provides a supportive environment for junior faculty scholars to acquire the skills and experience needed to become successful, independent clinical and translational scientists. This is accomplished through coursework, mentored research, workshops, and career development programs. There are 8 scholars per year selected from a competitive pool of applicants submitted by junior faculty across the University. You must be a current KL2 Scholar to be eligible to participate in this .