Slots: Each eligible institution (defined as having a unique UEI number or NIH IPF number) may submit up to a combined total of four applications (one in Cancer Data Science, one in Cancer Control Science, one in Molecular/Precision Cancer Prevention, and one in Other Cancer Research) to any companion NOFO or any combination of companion NOFOs (PAR-23-286, PAR-23-287, and/or PAR-23-288).
Deadlines
Internal Deadline: Friday, November 15th, 2024, 5pm PT
LOI: N/A
External Deadline: February 14, 2025
Recurring Deadlines: June 16, 2025; October 14, 2025; February 17, 2026; June 15, 2026; October 14, 2026
Award Information
Award Type: Grant
Estimated Number of Awards: The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Anticipated Award Amount: Award budgets are composed of salary and other program-related expenses, as described in “Other Award Budget Information” of the RFA.
Who May Serve as PI:
NOTE: Candidates for this NOFO are strongly encouraged to obtain confirmation of their eligibility from NCI before seeking institutional nomination. It is incumbent upon the candidate to provide evidence that all eligibility criteria have been met.
Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to seek institutional nomination and work with his/her mentor and organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. See, Reminder: Notice of NIH’s Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019. Multiple PDs/PIs are not allowed.
K99/R00 candidates must have no more than 2 years of postdoctoral research experience as of the relevant application due date. Individuals must be in mentored, postdoctoral training positions to be eligible for support under to the K99/R00 program. If a candidate achieves independence (i.e., any faculty or non-mentored research position) before a K99 award is made, neither the K99 award, nor the R00 award, will be issued.
Consistent with the NIH Extension Policy for Early Stage Investigator Status (ESI), NIH will approve an extension of one year for childbirth within the 2 year K99 eligibility window. Applicants with candidates who will be PD/PIs on a K99 application must provide the child’s date of birth in the extension request justification submitted to IC program officials and/or scientific/research contacts listed in the NOFO at least 12 weeks before submitting an application.
In addition, parental, medical, military, or other well-justified leave for personal or family situations of generally less than 12 months duration is typically not included in the 2-year eligibility limit, nor is clinical training with no research involvement (e.g., full-time residency training). Only time dedicated to research activities counts toward the 2-year limit. Part-time postdoctoral research training, related to personal or family situations or occurring during a research residency or fellowship, will be pro-rated accordingly.
Additional clarifications are provided under Frequently Asked Questions. Potential candidates are encouraged to discuss their individual situation with an NCI Scientific Program Contact before applying.
There is no citizenship requirement for K99 applicants. An applicant may be a citizen or a non-citizen national of the United States, have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status), or be a non-U.S. citizen.
For applications submitted on behalf of non-U.S. citizens with temporary U.S. visas, visa status during each phase of the K99/R00 award must allow the PD/PI to conduct the proposed research at the applicant institution. For the K99 phase of the award, the applicant institution is responsible for determining and documenting, in the K99 application, that the candidate’s visa will allow him or her to remain in the U.S. long enough to complete the K99 phase of the award. For the R00 phase of the award, the U.S. institution at which the R00 phase of the award will be conducted is responsible for determining and documenting, in the R00 application, that the PD/PI’s visa will allow the PD/PI to remain in the U.S. for the duration of the R00 award.
Candidates for the K99/R00 award must have a clinical or research doctorate (including PhD, MD, DO, DC, ND, DDS, DMD, DVM, ScD, DNS, PharmD or equivalent doctoral degrees). Clinicians (including those with MD, DDS, DVM and other licensed health professionals) in a clinical faculty position that denotes independence in clinical responsibilities but not in research may also be eligible for the K99/R00 award.
Individuals are NOT eligible if they:
- Have currently or previously held an independent research faculty or tenure-track faculty position, or its equivalent, in academia, industry or elsewhere; or
- Have more than 2 years of related postdoctoral research training at the time of initial application or resubmission; or
- Have been an independent PD/PI on NIH research grants (e.g. R01, R03, R21), NIH career development awards (e.g., K01, K07, K08, K23, K25), or other peer-reviewed NIH or non-NIH research grants over $100,000 direct costs per year, or Project Leaders on sub-projects of program project (P01) or center (P50) grants or the equivalent.
Ph.D. (or equivalent research doctorate degree) candidates in positions other than postdoctoral fellow positions: It is recognized that some institutions appoint postdoctoral fellows in positions with other titles although they are still in non-independent, mentored training positions. Candidates in such positions are encouraged to obtain confirmation of their eligibility from the relevant IC before they begin to prepare their applications. It is incumbent upon the candidate to provide evidence that their position complies with the intent of this eligibility requirement. If a potential applicant is in a position that is not clearly identifiable as a postdoctoral training position, candidate should provide the relevant NIH Institute or Center an official statement of the institution’s policy (e.g. published position description in an official institutional document) which documents the position as a mentored, postdoctoral training position.
Clinicians (including those with M.D., D.D.S, D.V.M. and other licensed professionals) in positions not designated as postdoctoral positions: Following clinical training or fellowship training periods, clinicians often obtain a clinical faculty position that denotes independence in clinical responsibilities but not in research. A clinical faculty member who does not hold an independent research faculty position may be eligible for the K99/R00 award, and should contact a Program Director at the relevant NIH Institute for guidance. Clinicians in such positions are encouraged to obtain confirmation of their eligibility before they begin to prepare their applications. Such individuals may also wish to consider other career awards (see K Kiosk) available for junior faculty development.
The following is provided as an aid to distinguish independent from non-independent positions: However, it is not sufficient merely to cite one or more of the following items to document eligibility.
Evidence for non-independence may include:
- The candidate’s research is entirely funded by another investigator’s grants.
- The candidate’s research is conducted entirely in another investigator’s assigned space.
- According to institutional policy, the candidate cannot hire postdoctoral fellows or technical staff or be the responsible supervisor of graduate students.
- According to institutional policy, the candidate is not allowed to submit an application as the PD/PI of an NIH research grant application (e.g., R01).
- The candidate lacks other rights and privileges of faculty, such as attendance at faculty meetings.
Conversely, evidence for independence, and therefore lack of eligibility, includes:
- The candidate has a full-time faculty position.
- The candidate received a start-up package for support of their independent research.
- The candidate has research space dedicated to their own research.
- The candidate may attend faculty meetings, be the responsible supervisor for graduate students, and/or hire technical support or postdoctoral fellows.
- The candidate is eligible to apply for independent research funding as the PD/PI of an NIH research grant.
Link to Award: https://grants.nih.gov/grants/guide/pa-files/PAR-23-288.html
Process for Limited Submissions
PIs must submit their application as a Limited Submission through the Research Initiatives and Infrastructure (RII) Application Portal: https://rii.usc.edu/oor-portal/. Use the template provided here: RII Limited Submission Applicant Template
Materials to submit include:
- (1) Two-Page Proposal Summary (1” margins; single-spaced; standard font type, e.g. Arial, Helvetica, Times New Roman, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 2-page limit will be excluded from review. You must use the template linked above.
- (2) CV – (5 pages maximum)
Note: The portal requires information about the PIs in addition to department and contact information, including the 10-digit USC ID#, Gender, and Ethnicity. Please have this material prepared before beginning this application.
Purpose
The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation’s biomedical, behavioral, and clinical research needs. NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.
The objective of the NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers (K99/R00) is to help postdoctoral researchers complete needed, mentored training and transition in a timely manner to independent tenure-track (or equivalent) faculty positions. The K99/R00 award is intended to foster the development of a creative, independent research program that will be competitive for subsequent independent funding and that will help advance the mission of the NCI.
This program is designed for postdoctoral fellows with research and/or clinical doctoral degrees who do not require extended periods of mentored research training beyond their original doctoral degrees before transitioning to research independence, which is common for those working in cancer control, cancer prevention and cancer data sciences, as defined in Section III. 3. Additional Information on Eligibility. Therefore, researchers from these disciplines are particularly encouraged to work with their institutions to apply.
This K99/R00 award is intended to support individuals who require no more than 2 additional years of mentored research training and career development (K99 phase) before transitioning to the independent stage (R00 phase) of the program. Consequently, the strongest applicants will require and will propose, a well-conceived plan for 1 2 years of substantive mentored research training and career development that will help their investigators become competitive candidates for tenure-track faculty positions and prepare them to launch robust, independent research programs.
Individuals must be in mentored, postdoctoral training positions to be eligible for support under the K99/R00 program. If an applicant’s candidate achieves independence (any faculty or non-mentored research position) before a K99 award is made, neither the K99 award, nor the R00 award, will be made. The K99/R00 award will provide up to 5 years of support in two phases. The initial (K99) phase will support up to 2 years of mentored postdoctoral research training and career development. The second (R00) phase will provide up to 3 years of independent research support, which is contingent on satisfactory progress during the K99 phase and an approved, independent tenure-track (or equivalent) faculty position. The two award phases are intended to be continuous in time. Therefore, although exceptions may be possible in limited circumstances, R00 awards will generally only be made to those applicants’ K99 PDs/PIs who accept independent, tenure-track (or equivalent) faculty positions by the end of the K99 award period.
Pre-Application Webinar: The NCI anticipates holding a pre-application webinar to which all interested prospective candidates, mentors, administrators, and grant managers are invited. An NCI program director will explain the goals and objectives of the NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers, discuss the eligibility and nomination requirements, explain the peer review process, and answer questions. For details on the nomination letter see Sections III and IV. Information about the pre-application webinar will be available after the publication of the NOFO under the “NCI Early K99 Award” tab of the NCI Cancer Training Branch website.
Note: This Notice of Funding Opportunity (NOFO) is designed specifically for candidates proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary clinical trial, as part of their research and career development. Those not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion NOFO (PAR-23-286).
All applications submitted to this Notice of Funding Opportunity must propose basic science experimental studies involving humans, otherwise referred to in NOT-OD-18-212 as prospective basic science studies involving human participants, that fall within the NIH definition of a clinical trial and also meet the definition of basic research.
NIH defines basic research consistent with the definition of basic research in federal code, the systematic study directed toward greater knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications towards processes or products in mind. (32 CFR 272.3).
NIH defines a clinical trial as “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” (NOT-OD-15-015).
Types of studies that should submit under this NOFO include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind.
For the purposes of this NOFO, specific application towards processes or products refers to the application of biomedical or behavioral products, procedures, or services intended to affect a health-related outcome of the individual or a group of individuals either by better understanding the mechanism of action of an intervention or a measurable improvement in health.
Basic experimental studies in which participants are prospectively assigned to experimental conditions and receive an intervention or experimental manipulation where the effect will be assessed for the purpose of understanding fundamental aspects of phenomena may submit under this NOFO.
Please refer to the table comparing Funding Opportunity Types by Clinical Trial Allowability for additional guidance on the most appropriate NOFO for the type of study.
Prospective studies with humans conducted with specific applications towards processes or products in mind, including FDA Phase 0 or 1 studies, mechanistic clinical trials (e.g., those that examine the mechanisms by which an intervention works or the processes that account for an intervention’s effects on clinical outcome), and safety and efficacy studies should submit under the a ‘Clinical Trials Required’ companion NOFO (PAR-23-287), but not under this NOFO.
Observational studies involving humans should submit under the Clinical Trials Not Allowed companion NOFO (PAR-23-286).
Scientific Areas
- (A) Cancer Data Science: For the purposes of this K99/R00 award, cancer data science is defined as an interdisciplinary field of inquiry in which quantitative and analytical approaches, processes, and systems are both developed and used to extract knowledge and insights from increasingly large and/or complex sets of data. This includes cancer-focused data integration and visualization, systems biology, artificial intelligence, machine learning, informatics, genomics, precision oncology, and developing analytics for epidemiological or biostatistical studies.
- (B) Cancer Control Science: For the purposes of this K99/R00 award, cancer control science is defined as basic and applied research in the behavioral, social, and population sciences to create or enhance interventions that, independently or in combination with biomedical approaches reduce cancer risk, incidence, morbidity, and mortality, and improve quality of life. This includes research in epidemiology, behavioral sciences, health services, surveillance, cancer survivorship, and healthcare policy.
- (C) Molecular/Precision Cancer Prevention: For the purpose of this K99/R00 award, early translational research in cancer prevention is defined as basic research to understand mechanisms of cancer formation, development and progression of cancer precursors, and to translate basic biological knowledge into novel human interventions and human-centered adaption of current interventions with the potential to reduce cancer risk, incidence, and mortality, and improve quality of life. This includes but is not limited to research in molecular and systems biology, diagnostics, vaccine and drug development, pharmacology, and biomedical engineering.
- (D) Other Cancer Research: For the purposes of this K99/R00 award, “Other Cancer Research” includes all scientific fields supported by the NCI that are not included in (A), (B) or (C). Applicants proposing research in (D) “Other Cancer Research” may apply only if it is reasonable to expect their candidates to transition to independence with an abbreviated period of mentored research training beyond their original doctoral degrees.”
Visit our Institutionally Limited Submission webpage for more updates and other announcements.