KL2 Mentored Career Development Program

Data Safety and Monitoring of Clinical Trials

In accordance with the NIH’s policy on data and safety monitoring of clinical trials NIH Grants Policy Statement (Part II, Chapter 4), the grantee must submit a data and safety monitoring plan for review and approval.

Prior Approval of Delayed Onset Research Involving Human Subjects and Live Vertebrate Animal Subjects

Prior to the start of the KL2 award period, all scholars that conduct research involving human subjects and/or live vertebrate animal research are required to obtain prior approval from the National Institutes of Health. The NCATS Prior Approval process requires that all regulatory approvals be in place before the study may begin and may take 30 days or more. For more information, visit the NCATS website.

Human Subject Projects Documentation Required:

• Completed the NCATS Prior Approval Human Subjects Form (form to be provided)
• IRB-approved research protocol (eProtocol application is not considered a research protocol)
• IRB-approved informed consent, verbal consent transcript, assent and parental permissions documents, or documentation of IRB waiver, if applicable
• Summary of request, line item budget and detailed budget justification for the specific aspects of the proposed study that will be supported by NCATS funds
• Summary of parent study, if applicable
• NIH Biosketches for KL2 Scholar, Research Mentor, and each Key Personnel involved in the proposed study
• Institutional letter attesting to Human Subjects Protection Training (i.e., CITI Training Record – Group 7: IRB BioMed/GCP Research for All Medical Investigators and Staff) completed by the KL2 Scholar, Research Mentor and study Key Personnel
   

Animal Projects Documentation Required:

• Completed NCATS Prior Approval Live Vertebrate Animals Form (form to be provided)
• Research/scientific protocol
• APLAC/IACUC approval letter
• NIH Biosketches for the KL2 Scholar and Research Mentor

Restrictions

• No clinical trials as defined by NIH (https://grants.nih.gov/policy/clinical-trials/definition.htm)
• No foreign components as defined in the NIH Grants Policy Statement
  • No non-domestic (non-U.S.) entities (foreign institutions)
  • No non-domestic (non-U.S.) components of U.S. organizations

The Stanford Center for Clinical and Translational Research and Education (Spectrum) is committed to increasing the participation of women and individuals from underrepresented ethnic or racial groups – 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.

• A Cover Sheet with the:
• • Applicant Name, Title, and Department;
  • Mentor Name and Title; and
  • Title of Research Project

• Candidate Personal Statement: Please address the following:
  • Education, career experience, short- and long-term goals, reasons for applying to the KL2 program and how it will further professional objectives. Limit your response to 800 words.
  • Educational and mentoring plan (description of planned didactic activities, including nature and frequency of interactions with primary research mentor; and how this will enhance your research project) Limit to 400 words.
    

• Research Plan (Limit the total of the following subsections, excluding references, to 1,600 words):
  • Structured Abstract (title, background, research question, study design, methods, outcome measures, potential implications of work and innovation)
  • Overall Research Question(s) and Specific Aims
  • Background / Significance
  • Preliminary Data (if relevant) and feasibility assessment: If the project is in the early stages of development, describe any strategy to assess feasibility, and address the management of any high-risk aspects of the proposed work.
  • Approach / Methods (including key measurements, primary outcome measures and analytic plan)
  • Nature of Originality / Innovation
  • Potential Implications / Contribution of Work
  • Research Timeline, with key progress benchmarks
  • References (not included in the word count)
    


• Applicant's Current Curriculum Vitae and NIH Biosketch
  

• Research Mentor’s NIH Biosketch


• Signed Letters of Support/Recommendation
  • Signed Letter of Recommendation from the prospective research mentor (description of the mentor’s anticipated interactions with the trainee, the research environment, their qualifications to serve in this role, and list of mentees within 3 years, with their current positions).
  • Two Additional Letters of Recommendation from colleagues with whom the candidate has worked. (One letter could be substituted for the one from the proposed mentor above if the mentor has worked with the applicant before.)
  • Signed Letter of Support from the department chair or division chief guaranteeing 75% protected time (or 50% for surgeons) to pursue the educational and research goals of the KL2 program. If the proposed training period is longer than the guaranteed funding period of 2 years, an additional letter of support is required from the department chair or division chief assuring continued funding support for the years that are not supported by the KL2 award. The divisional/departmental letter of support must specifically attest that the trainee is able to accept KL2 funds toward the entire 75% (or 50% for surgeons) of their research effort and that they do not hold any concomitant federal support.


• Other Support
  • Other support includes all financial resources, whether non-Federal, commercial or institutional, available in direct support of an individual's research endeavors, including but not limited to research grants, cooperative agreements, contracts, and/or institutional awards.
  • Please note that you must not be or have been a principal investigator on an NIH R01, or a project leader on a sub-project of a Program Project (P01), Center (P50, P60, U54), mentored career development grant (K23, K08, K01, etc.) and must not have a current application for another mentored K award (e.g. K23, KO8) submitted or under review.


• OrcID (Open Researcher and Contributor Identification) is a unique digital identifier meant to connect researchers with their science contributions over time and across changes of name, location and institutional affiliation. There is no cost to register. This ID will be linked to our eRA Commons profile. https://orcid.org

Applications are reviewed, ranked and interviewed by the KL2 Selection Committee. Two to three rounds of interviews will begin within one month of application deadline and awards announced two-months later. The number of scholars funded each cycle is dependent on the availability of funds.

Review criteria include:

• Candidate’s prior accomplishments and stated commitment to pursue a career in clinical and or translational research
• Quality, relevance, and likelihood of success of the proposed research project
• Quality and appropriateness of the didactic training plans, career development activities, and commitment and expertise of mentors
• Commitment of the home department
• All applicants must be eligible to receive NIH support (i.e., US citizen or hold a permanent resident card)
   

Scholar Support

• Up to $120,000 annual base salary support (plus fringe benefits) for 75% of total professional effort for non-surgeons (9 calendar months of total effort), 50% for surgeons and other procedural-based specialties (6 calendar months of total effort).
• Up to $20,000 per year to support education and career development programs, research project-related costs and other related activities.
• An additional $2,000 per year for travel in support of the objectives of the award.

ORCID (Open Researcher and Contributor Identification) is a unique digital identifier meant to connect researchers with their science contributions over time and across changes of name, location and institutional affiliation. It has many benefits and there is no cost to register.

Benefits of ORCID

OrcID is required by NIH and the KL2 Mentored Career Development Program.

For more information and to register, visit http:///orcid.org.