NIH

KL2 Scholar Selection Process

**Calls for applications to the KL2 Scholar Program generally occur every 2 to 3 years. Please refer to the CTSI website homepage for announcements.**

Candidates holding an MD, DO, 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 competitively apply to become CTSI KL2 Scholars. Each candidate will submit an application format for individual K awards. Instructions can be found on this website under KL2 Application Process page.

Selection Criteria
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 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. Of note is that this is a career development award and 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.

KL2 Review Process
The candidates will be evaluated by a review committee selected by the CTSI 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 is essential. Applicants will be discussed by the review committee and scored in accordance with the NIH system of 1-9. A list of applicants will be circulated in advance of the meeting to allow reviewers to identify any applications in conflict (see 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. 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 during the course of the scholar’s support by the KL2 award. In general, two years of funding will be awarded and a competitive application process is followed to apply for an additional year three if needed by the scholar.

Applications will be reviewed using an NIH style with the 1-9 scale below.

 

 

 

 

 

 

 

 

 

Core Review Criteria
There will be five core review criteria each scored (1-9) and weighed separately on the score sheet. The criteria are:

  1. Candidate
  2. Training/Career Development Plan
  3. Research Plan
  4. Qualifications of Mentor and Co-Mentor(s)
  5. Environment

Overall Impact
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
Reviewers will consider each of the review criteria below 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 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?

Environment & 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

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: (1) risk to subjects, (2) adequacy of protection against risks, (3) potential benefits to the subjects and others, (4) importance of the knowledge to be gained, and (5) 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: (1) the justification for the exemption, (2) human subjects involvement and characteristics, and (3) sources of materials. For additional information on review of the Human Subjects section, please refer to the 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, please refer to the 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: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) 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, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Additional Review Considerations

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: 1) Format – the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) 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; 3) Faculty Participation – the role of the mentor(s) and other faculty involvement in the fellow’s instruction; 4) Duration of Instruction – the number of contact hours of instruction (at least eight contact hours are required); and 5) 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 also: NOT-OD-10-019.

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.  The overall impact score will be based on the following criteria with the weights as follows:

  1. Potential of the candidate to become a successful and externally funded clinical investigator (~25% weight)
  2. Qualifications and commitment of the lead mentor/mentoring team (~25% weight): successful investigator, externally funded, prior successful history of trainees). In keeping with the desire of the Penn State CTSI 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 (25%) and Training (25%) Plans)  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.   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.

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 or if the reviewer has a conflict or potential conflict of interest with the proposed primary or secondary mentors of the applicant or if the reviewer has provided advice for the applicant in preparing the application.  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/NCATS 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.