NIH Pathway to Independence Award (Parent K99/R00 Independent Clinical Trial Required)

---

Description

This opportunity provides a two-phase NIH career development award (K99/R00) to facilitate the transition of exceptional postdoctoral researchers to independent, tenure-track (or equivalent) faculty positions. The program is specifically for candidates proposing to lead an independent clinical trial, a clinical trial feasibility study, or an ancillary study to an existing trial. The K99 phase supports mentored postdoctoral research and career development, while the R00 phase provides independent research support as a new faculty member. The goal is to help launch competitive, independent research careers in areas aligned with the missions of participating NIH Institutes and Centers (ICs).

---

Due Dates

• Standard NIH due dates apply for new, renewal, resubmission, and AIDS-related applications.
• Upcoming deadlines include:
  • June 12, 2024 (New)
  • July 12, 2024 (Renewal/Resubmission/Revision)
  • September 7, 2024 (AIDS)
  • October 12, 2024 (New)
  • November 12, 2024 (Renewal/Resubmission/Revision)
  • January 7, 2025 (AIDS)
  • February 12, 2025 (New)
  • ...and continue on a similar cycle through May 7, 2027.
• All applications are due by 5:00 PM local time of the applicant organization.

Full schedule of NIH due dates

---

Funding Amount

• K99 Phase (mentored): Up to 2 years of support; salary and research costs as per the awarding IC’s policy (consult IC-specific budget info).
• R00 Phase (independent): Up to 3 years; maximum $249,000/year (total costs, including salary, fringe, research, and indirect costs).
• Indirect costs: 8% of modified total direct costs for K99 phase; full institutional rate for R00 phase.
• No cost sharing required.
• Number of awards depends on NIH appropriations and the number of meritorious applications.

---

Eligibility

• Eligible applicants: U.S. public/private higher education institutions, nonprofits, for-profits (including small businesses), state/local/tribal governments, and certain other organizations. See full eligibility list.
• Individuals: Must have a clinical or research doctorate (e.g., PhD, MD, DO, DDS, DVM, etc.).
• Postdoctoral experience: No more than 4 years of postdoctoral research experience at the time of application (extensions possible for certain life events).
• Position: Must be in a mentored, postdoctoral training position at the time of application and award.
• Not eligible: Those who have held independent research or tenure-track faculty positions, or have been PI on major NIH or equivalent grants.
• Citizenship: No U.S. citizenship or permanent residency requirement, but visa status must allow completion of the award phases in the U.S.
• Clinical trial requirement: Applicants must propose to lead an independent clinical trial (not just participate in one led by another investigator).
• Institutional eligibility: Non-U.S. organizations are not eligible to apply; foreign components are allowed as defined by NIH policy.

---

Application Process

• Consult IC-specific requirements: Not all NIH ICs participate; review IC-specific guidance and contacts before preparing your application.
• Submission: Applications must be submitted electronically via Grants.gov, NIH ASSIST, or institutional S2S systems.
• Required registrations: Applicant organizations must be registered in SAM, eRA Commons, and Grants.gov; PIs must have eRA Commons and ORCID IDs.
• Application format: Follow the NIH Career Development (K) Application Guide and the specific instructions in the funding announcement.
• Reference letters: Required and must be submitted via eRA Commons.
• Mentor(s): A primary mentor (and optionally a mentoring team) must be identified and provide a detailed mentoring plan.
• Transition to R00 phase: Requires securing an independent, tenure-track (or equivalent) faculty position and NIH approval.

---

Additional Information

• Limited submission: Only one application per candidate per cycle; no concurrent competing NIH career development applications.
• Effort requirement: Minimum 75% full-time professional effort (9 person-months/year) during both K99 and R00 phases.
• Clinical trial definition: Only applications proposing an independent clinical trial (or feasibility/ancillary study) are eligible for this announcement.
• Review criteria: Emphasize candidate’s potential for independence, quality of research/training plan, mentor’s track record, and institutional environment.
• Transition: R00 phase must be activated within the K99 period; exceptions are rare.
• Data management: All applications must include a Data Management and Sharing Plan.
• Recent updates: The opportunity was updated March 31, 2025; review the full announcement for any changes.

---

External Links

• NIH Funding Announcement & Full Details
• IC-Specific Information, Requirements, and Staff Contacts
• NIH K99/R00 Program Overview
• Apply via Grants.gov
• NIH Application Guide for Career Development (K) Awards
• NIH Clinical Trial Definition & Resources

---

Contact Information

---