Early-Stage Investigator Training Program (KL2)

• 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 board-certified.
• Non-physician candidates must have a PhD
• Must be a U.S. citizen or permanent U.S. resident 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

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.

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.

Time Period

The KL2 grant application should be written for research and training to be conducted over two years. 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. Productivity in submitting external grants will be a key factor in competitive renewal applications.

• Webinars about KL2 application: 9 a.m. Sept. 10, 2021, and noon Sept. 16, 2021
• Letter of Intent due: Oct. 15, 2021
• Application due: Nov. 22, 2021
• Funding begins: April 2022

Webinars to review KL2 application and process

Did you miss the information sessions?

Potential applicants can access recorded information sessions by registering on Zoom using the links below.

Letter of Intent

A letter of intent should be submitted before applying to begin to identify potential reviewers for the grant. These letters will not be used to make award decisions, and all who submit a letter of intent should plan to submit a full proposal.

Letters of intent must include name, title, department, contact information, project title, NIH biosketch, a paragraph describing the research, how it is translational, and the name, title and department of the applicant’s mentor(s). Letters of intent need to include a statement that the candidate will commit at least nine person-months (75 percent of full-time professional effort) to the career development program and related career development activities.

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. Once the program has received your letter of intent, you will be sent a link to use to complete a cover page and upload your completed application. The link will provide details on submission of required letters of nomination and reference letters.

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.

Instructions for sections below will be the same as those for the NIH K23 program, as for many scholars the goal of the KL2 award will be to provide them support for them to submit a successful individual K23 or other NIH-funded career development award if the KL2 is not funded. Instructions for how to submit the full proposal will be provided to individuals who submit a letter of intent.

Application Resources

The following resources are available to help applicants who are preparing an 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

The NIH has published detailed instructions for career development awards, which this funding announcement largely follows. See NIH SF424 instructions here.

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 translational and interdisciplinary research are essential.

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 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 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.

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

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.

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. See K23 instructions, under “Section V. Application Review Information 1. Criteria.” Questions that will be considered by reviewers, under each section, are noted below.

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?
• 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?

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(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?
• 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 them 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?

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

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 Individuals Across the Lifespan

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 on the Inclusion of Women and Minorities as Participants in Research Involving Human Subjects.

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.

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.

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.

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, adviser 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

The KL2 program is committed to meeting the NIH/NCATS goal to increase the participation of Underrepresented Populations in the U.S. Biomedical, Clinical, Behavioral and Social Sciences Research Enterprise.

In 2019 the NIH changed its guidance and approach. The revised notice can be found here.

The revised guidance encourages applications from the following groups:

• Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis.
• Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended.
• Individuals from disadvantaged backgrounds, including individuals who were homeless, in foster care, were eligible for the Federal Free and Reduced Lunch Program, etc. Detailed definitions can be found here.

In addition, literature shows that women from the above backgrounds (categories A, B, and C) face particular challenges at the graduate level and beyond in scientific fields. As such, NIH encourages institutions to consider women for faculty-level, diversity-targeted programs to address faculty recruitment, appointment, retention or advancement.

A specific aim of this KL2 is to leverage the strengths of Penn State Clinical and Translational Science Institute’s rural environment, partnerships and technologies.

To that end, while the program anticipates most scholars will not focus on rural health research, preference will be given to candidates with a focus on rural health research.

In addition, all scholars will be required to complete a rural health translational micro-project, in which scholars will expected to partner with a rural health stakeholder (e.g., researcher, hospital, community organization, care provider) to complete a small-scale project to work with the stakeholder in understanding and/or addressing the health and health care needs of rural populations.

KL2 scholars will meet a range of rural health stakeholders and are encouraged to design a clinical translational micro-project that helps them better understand the health and health care needs, resources and outcomes of rural populations. This should take no more than 5 percent of the scholar’s time.

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.

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 will continue year-round, including summer, and are considered mandatory.

Each month, each scholar will meet individually with the KL2 co-directors to discuss progress toward meeting timelines and milestones and any specific problems they are experiencing with either their career development or research activities.

These will continue year-round, including summer, and are considered mandatory.

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. These meetings will continue year-round, including during the summer.

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.

After being notified of funding, 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.

KL2 scholars are required to complete a progress report every six months during the program, then yearly following completion of the program.

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

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.

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

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

Mock Review of Grants (MoRe) Program

Penn State College of Medicine’s Mock Review of Grants (MoRe) Program offers support in advance of proposal submission. The four-stage program uses a review process similar to that of an NIH study section, but in which the reviewing team interacts with the applicant to help strengthen the proposal.

The MoRe program is offered in three cycles annually, preceding each NIH grant cycle; investigators preparing non-NIH proposals are welcomed to use the program as well.

Learn more about MoRe