Early-Stage Investigator Training Program (KL2)

The Clinical and Translational Science Institute’s Early-Stage Investigator Training Program (KL2) provides a supportive interdisciplinary 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 and career development programs.

KL2 funding provides 75 percent protected time for research; funds for research supplies; tuition support for up to three courses per semester; and travel.

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KL2 Program Details

Scholar Eligibility Expand answer
  • Full-time Penn State junior faculty with a doctorate (MD, DO, PhD, MD/PhD, DO/PhD or equivalent) at the rank of assistant professor
  • Research focus on translational science
  • 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
  • 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
  • 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 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
Level of Effort Expand answer

KL2 scholars are required to commit a minimum of 75 percent full-time professional effort (i.e., a minimum of nine person-months) 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 percent 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.

Department Nomination Expand answer

Applicants must be nominated by their department chair (and division director if applicable). The chair must guarantee in writing in the nomination letter that a minimum of 75 percent 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 percent for trainees from surgery or surgical specialties).

The remaining percent of the junior faculty member’s professional time may not be funded by other federal (NIH) funds. The nomination (chair’s letter) is included as part of the application.

Application Process Expand answer

KL2 awards are for two years with the option to competitively renew (from among the current pool of scholars) for a third year based on satisfactory performance in the program and a demonstrated need for additional research training. The KL2 grant application should be written for research and training to be conducted over two years.

KL2 awards that were made in January 2018 provide funding through Dec. 31, 2019.

Letter of Intent

A letter of intent should be submitted before applying to begin to identify potential reviewers for your grant. Include your name, title, department, contact information, project title, a paragraph describing your research, and the name, title and department of your mentor(s). Letters of Intent should be sent to Karen Shields, education strategy and planning manager, at kshields@psu.edu.

Application

The table here details required application information. Deadlines will be posted here when applications are being accepted.

Preparation of the CTSI KL2 application for the most part follows the guidance for preparation of a general NIH K grant, with a few exceptions. Equal weight is placed on the candidate/training plan and the research plan. It is recommended that each section be as fully developed as possible with commensurate representation by the number of pages within the application, i.e. about half to candidate/mentor statement and half to research plan.

Having specific aims for training and career development within the candidate information is suggested, as well as a description of how each training aim will be addressed and the role that each mentor or member of the research team will play in supporting each aim of the training plan, as well as any additional courses to be taken to meet the training aims. See coursework details here.

To assemble the application, compile documents in the order indicated below. Save it as a single PDF file and email it to Karen Shields at kshields@psu.edu.

Application Resources

The following resources are available to help you in preparing your application. Email requests to Karen Shields at kshields@psu.edu.

  • Examples of successful K grant applications
  • Example of a training plan
  • A sample training table for mentors and co-mentors to attach to their biosketch

Several NIH resources also exist.

Program Directors Expand answer
KL2 Awardee Profiles Expand answer

Selection Process

The goal of the KL2 Training 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 and translational investigators.

Decisions will be based on the strength of the research and career development training plan 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 or co-mentor in mentoring previous junior faculty members and other trainees, and diversity issues.

Emphasis is placed heavily upon a fully developed training plan including training goal, procedures, description of the roles of each mentor and plans for mentoring interactions.

Review Process Expand answer

The candidates will be evaluated by a review committee selected by the Penn State Clinical and Translational Science Institute Executive Committee.

Criteria include overall scholarly excellence as defined by written statements, and letters of recommendation and record of productivity. Clear delineation of career/research goals and a strong commitment to interdisciplinary research are essential.

Applicants will be discussed by the review committee and scored in accordance with the NIH system of 1 to 9. A list of applicants will be circulated in advance of the meeting to allow reviewers to identify any applications in conflict.

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 will be available to all committee members. Recommendations for funding will be made to the 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 percent effort for research during the course of the scholar’s support by the KL2 award.

Core Review Criteria Expand answer

There will be five core review criteria, each scored 1 to 9 and weighed separately on the score sheet. These are:

  • Candidate
  • Training/Career Development Plan
  • Research Plan
  • Qualifications of Mentor and Co-Mentor(s)
  • Environment
Overall Impact Expand answer

Reviewers should 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.

Scored Review Criteria Expand answer

Reviewers will consider each of the review criteria listed here in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

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

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?

Research Plan

  • Are the proposed research questions, design, and methodology of significant scientific and technical merit?
  • Is there a strong scientific premise for the 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?

Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(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 their 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 coursework, 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?

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?
Additional Review Criteria Expand answer

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria:

  • Risk to subjects
  • Adequacy of protection against risks
  • Potential benefits to the subjects and others
  • Importance of the knowledge to be gained
  • Data and safety monitoring for clinical trials

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate:

  • The justification for the exemption
  • Human subjects involvement and characteristics
  • Sources of materials

For additional information on review of the Human Subjects section, refer to the NIH Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities and Children

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race and ethnicity, as well as the inclusion (or exclusion) of children, to determine if it is justified in terms of the scientific goals and research strategy proposed.

For additional information on review of the Inclusion section, refer to the NIH Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria:

  • Description of proposed procedures involving animals, including species, strains, ages, sex and total number to be used
  • Justifications for the use of animals versus alternative models and for the appropriateness of the species proposed
  • Interventions to minimize discomfort, distress, pain and injury
  • Justification for euthanasia method if not consistent with the AVMA Guidelines for the Euthanasia of Animals

Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals.

For additional information on review of the Vertebrate Animals section, refer to the NIH Worksheet for Review of the Vertebrate Animal Section.

Additional Review Considerations Expand answer

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Training in the Responsible Conduct of Research

All applications for support must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the level of experience of the applicant, including any prior instruction or participation in RCR as appropriate for the applicant’s career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components:

  • Format: The required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only online instruction is not acceptable)
  • Subject matter: The breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics
  • Faculty participation: The role of the mentor(s) and other faculty involvement in the scholar’s instruction
  • Duration of instruction: The number of contact hours of instruction (at least eight contact hours are required)
  • Frequency of instruction: Instruction must occur during each career stage and at least once every four years.

Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee. See details via NIH.

Enhanced Review Criteria Expand answer

Overall Impact

Reviewers will provide an overall impact score to reflect their overall assessment of the application. The overall impact score will be based on the following criteria with the weights as follows:

  • Potential of the candidate to become a successful and externally funded clinical investigator (25 percent weight)
  • Qualifications and commitment of the lead mentor/mentoring team (25 percent weight)
    • Is each mentor a successful investigator, externally funded, with prior successful history of trainees? In keeping with the desire of Penn State Clinical and Translational Science Institute to foster multidisciplinary approaches to team science through the development of translational research clusters, it is important to convey sufficient information regarding the research environment.
  • Strength of the Research and Training plans (each 25 percent weight). 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.

The overall impact score is not necessarily an average of the scores for the five core criteria. The overall impact score will be used to compare the applications.

Conflict of Interest in Review Expand answer

The KL2 reviewers will not review an application or participate in the ranking of any proposal in which the following is true:

  • The applicant or mentor is in their department
  • The reviewer would serve as a mentor, advisor or collaborator
  • The reviewer has a conflict or potential conflict of interest with the proposed primary or secondary mentors of the applicant
  • The reviewer has provided advice for the applicant in preparing the application

For submissions from the departments of Medicine, Pediatrics or Surgery, the same criteria apply but are based on division rather than department.

Plan for Recruitment and Retention of Underrepresented Minorities, Women and those with Disabilities Expand answer

The KL2 program is committed to meeting the NIH/NCATS goal and that of Penn State 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.

Scholar and Mentor Expectations

Unlike individual K awards or other types of awards, the KL2 program is an institutional research and career development program. As such, there is mandatory participation in our activities designed to accelerate your transition to independent R01 funding.

Coursework Expand answer

KL2 students select from graduate courses offered at the University, including in clinical and translational science and public health sciences.

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.

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 in order 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.

Training Day Expand answer

A training day is usually held 10 a.m. to 3 p.m. on the first Monday of the month, year-round. The day consists of a seminar, career development activities, lectures and peer-to-peer presentations and mentoring activities. The location alternates between Penn State University Park and Penn State College of Medicine in Hershey.

These are held in person only because face-to-face interaction promotes development of collaborations between scholars (such as joint grant submissions and publications) as well as increased opportunities for networking and sharing of best practices.

All scholars are expected to attend each training day and should build their schedule to accommodate these training days.

If a training day will be missed because of a special circumstance, the KL2 program directors must be notified in advance.

Mentor Memorandum of Understanding Expand answer

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

Mentor Workshop Expand answer

Optimal mentoring is key to the success in the transition of junior faculty from K to R01 funding. The KL2 program requires that the primary mentors for each KL2 scholar participate in the Best Practices in Mentoring Workshop.

This workshop consists of completion of online case studies (approximately two hours) and a face-to-face two-hour workshop. Mentors must participate in the workshop during their scholar’s first year in KL2. The workshop is offered at both Penn State University Park and Penn State College of Medicine in Hershey.

KL2 Scholar Mentoring Experience Expand answer

KL2 scholars will be asked to attend a session to interact with students in Penn State’s summer programs for undergraduates.

Mentoring and Career Development Advisory Panel Expand answer

Each KL2 scholar will be assigned a Penn State Clinical and Translational Science Institute Mentoring and Career Development Advisory Panel mentor who is a senior faculty member. The mentor serves as a resource to help address issues that could arise with regard to mentoring. The KL2 scholar can provide input on the selection of their advisory panel mentor. The panel of mentors also evaluates the progress of KL2 scholars twice a year.

Individualized Development Plan Expand answer

As part of the ongoing review process, KL2 scholars will be required to work with their mentors to develop an individualized development plan that states their short- and long-term goals and the milestones needed to achieve them. A sample plan will be provided.

The percentage of effort devoted to training activities for each KL2 scholar is flexible and individualized. Scholars who have already completed research coursework, and have a well-defined area of research and pilot data, will be ready to begin submitting applications for external research funding early in the KL2 funding period. Scholars at that stage will likely need only two years of support to become successfully funded independent scientists, while others may need up to three years of training and research experience.

The needs of each scholar will be evaluated yearly by the Mentoring and Career Development Advisory Panel.

KL2 Progress Reporting Expand answer

KL2 scholars are required to complete a progress report every six months during the program, then yearly following completion of the program. Progress reports are reviewed by the scholar’s primary mentor, the Mentoring and Career Development Advisory Panel mentor and the panel mentor.

In addition, a short summary of the progress report is sent to the NIH each year.

Institute External Advisory Board Meeting Expand answer

Each year, generally in the fall, Penn State Clinical and Translational Science Institute’s external advisory board meets with the leadership, members and KL2 and TL1 scholars within the institute. Scholar attendance is required at this meeting and select scholars may be asked to give a brief presentation on their research.

In addition, there may be an additional one or two mandatory institute programmatic activities each year.

Supplemental Opportunities Expand answer

A number of opportunities are available to but not required of KL2 scholars.

Junior Faculty Development Program

KL2 scholars at Penn State College of Medicine in Hershey can participate in the Junior Faculty Development Program (JFDP), which runs from September through May of each year and includes a comprehensive curriculum delivered through a series of weekly lessons as well as an individual project completed under the guidance of a senior faculty mentor.

Learn more about JFDP

Grants Academy

KL2 scholars at Penn State College of Medicine in Hershey can participate in Grants Academy, which is a structured, non-credit workshop intended to assist participants with preparation and submission of an independent investigator-initiated grant application.

Learn more about Grants Academy

Seminar Series

Penn State Clinical and Translational Science Institute offers several seminar series devoted to aspects of translational research.

Learn more about CTSI seminar series