Fact Sheet: NHLBI K99 Awards

(NIH Pathway to Independence, PI, Award)
Transitioning to R00 Phase

Overview

As indicated in the K99/R00 program announcement, transition from the mentored phase (K99) to the independent scientist phase (R00) is NOT automatic. Transition to the independent phase is subject to NHLBI’s review of your research progress and training/career development accomplishments during the K99 award, evaluation of your research plan, and proof of commitment from the sponsoring institution to which you have been recruited. Transition is intended to be continuous in time. An important transition resource can be found on the NIH webpage “New Investigators Program/Pathway to Independence Award, Questions and Answers”. All applicants should be aware that:

• It is expected that the awardee will complete at least one full year of mentored training under the K99 phase before transitioning to the R00 phase.
• K99 awardees must submit their R00 transition package to NHLBI by June 30 if they plan to transition to the R00 phase before September 30.
• R00 transition awards will not be issued in October or November.

Before the R00 transition application deadline, you need to (1) find a suitable position as a tenure-track, full-time assistant professor (or equivalent) at an eligible institution, and once that is accomplished, (2) provide us with the required documentation to initiate the R00 phase of the award. When you are ready to prepare the R00 application, please use the following instructions and notify your NHLBI Program Official and Grants Management Specialist of your intentions.

Transition to R00 Instructions:

During the final year of the K99 phase and no later than 3 months before its anticipated end date, send the application by email in PDF format to the NHLBI Grants Management Specialist listed in the eRA Commons account for your grant, and one copy to your NHLBI Program Official (PO):

1. A copy of the official offer letter for a faculty position and any additional correspondence from the Chairperson or Dean of the institution where you have been recruited that addresses the following issues:
   • Independent position: Your status as a tenure-track, full-time Assistant Professor (or equivalent). The appointment must NOT be contingent on the transition (or continuation) of the R00 award to the sponsoring institution.
   • Level of effort: Documentation that you will have a minimum of 9 person-months/year (75% full-time professional effort) devoted to research as required by the R00 award for its entire duration, and a description of your level of effort spent on teaching, clinical and/or administrative duties. Teaching, clinical and/or administrative duties should be minimal during the R00 phase. Please specify the amount of hours per week in preparation and contact time for teaching duties.
   • Institutional Commitment: The institution’s plans for providing start-up funding, technical personnel, research resources and facilities, and/or paying your salary. The start-up package and other institutional support must be similar to that which is typically offered to new faculty members at that institution, and the institutional letter should state whether this is the case.
   • Research and Office Space: Describe the laboratory and office space (size and whether you will share equipment with others, be charged for use of equipment, etc.) that will be provided to you for conducting the proposed research.
   • Clinical Space: For patient-oriented research projects, describe the clinic space that will be accessible to you for conducting the proposed research. Include details of other research support services (e.g. core facilities, research coordinators, statistical support, nurse coordinators, etc.). For clinical projects performed within an institutional General Clinical Research Center (GCRC) or Clinical and Translational Science Award (CTSA), submit a letter from the GCRC or CTSA Director indicating support of your R00 research project.
   • Plan to independence: If the applicant intends to stay at the mentored phase institution during the independent phase, this letter should describe the plan by which the applicant will separate from the postdoctoral mentor and advance to independence.
   • Grant application submission plan: Include a plan and timeline for submitting an independent research grant application in a research area relevant to the mission of an NIH awarding component.
     
     

2. New NIH Grant application from your proposed R00 grantee institution:
   
   
   • Cover Letter: A co-signed Institutional Cover Letter should be included in application.
   • Face page with the appropriate institutional signatures.
   • Budget pages: detailed budget page (PHS 398 Form Page 4) required for the first year of the R00 award, and categorical budget (PHS 398 Form Page 5) for the entire project period. The budget may include salary to support your research effort on the R00 award. However, the portion of your base salary provided by the hiring institution must be consistent with that provided routinely to newly appointed, independent faculty members.
   • Budget Justification: include your level of effort on the R00 project and the portion of the required 75% research effort to be supported by institutional funds.
   • New Resources Format Page.
   • Biographical sketches: Include updated Biosketch of Candidate, and biosketches for any Key Personnel. Publication citations must show the PCMID numbers when applicable.
   • Progress report, and K99 mentor’s final evaluation statement, describing the research accomplishments and training and career development during the K99 award. We expect you to have accomplished all training and career development goals. Please describe how the training and career development goals/objectives were met during the K99 award including proposed coursework and training in responsible conduct of research, or if all the goals/objectives were not accomplished, how you plan to meet them during the R00 award.
   • Updated Project Summary page (Form Page 2).
   • Updated research plan (less than 5 pages). Identify any changes from the original research project described in your K99/R00 application.
   • Current Other Support page for the candidate.
   • Human Subjects: If the research will use human subjects, provide:
   • A complete updated Human Subjects section, including an "Inclusion Enrollment Report".
   • Current IRB approval.
   • Vertebrate Animals: If the research will use vertebrate animals, provide:
     • A complete updated Vertebrate Animals section.
     • Current IACUC approval.
   • Data and Safety Monitoring Plan (DSMP) for clinical studies in human subjects that involve more than minimal risk. The DSMP needs to be approved by the IRB and details of the NHLBI requirements are available on the NHLBI website.
   • Copy of a sharing plan for any new model organisms that you propose to generate: All NIH applications and proposals that will produce new, genetically modified variants of model organisms and related resources are expected to include a sharing plan or to state why such sharing is restricted or not possible. Examples of Plans for Sharing of Model Organisms and Related Resources are available on the NIH website.
   • New Checklist Form Page from the PHS 398.
     
     

3. The following information is needed from the K99 grantee institution for those R00 grants transferring to a new institution:
   • Final Invention Statement and Certification (Form HHS 568). See NIH Grant Forms, Grant Close Out.
   • Final Financial Status Report, Form SF- 269 (within 90 days of terminating the K99 grant). See NIH Grant Forms, Grant Close Out.

Revised October 2010