Mentored Patient-Oriented Research Career Development Award (Parent K23 Independent Clinical Trial Required)

The Mentored Patient-Oriented Research Career Development Award (Parent K23 – Independent Clinical Trial Required) is a career development initiative offered by the National Institutes of Health (NIH), specifically tailored for early-career clinician-scientists who intend to lead independent clinical trials. This funding opportunity aims to enhance the pipeline of patient-oriented researchers by providing a sustained period of support for those with a clinical doctoral degree. It supports the development of advanced research skills needed to translate biomedical research findings into clinical practice. Multiple NIH Institutes and Centers participate, including the National Heart, Lung, and Blood Institute, National Institute on Aging, and National Institute of Mental Health, among others, ensuring broad relevance and applicability across health disciplines. The overarching goal of the K23 program is to provide 3 to 5 years of "protected time" with financial support to facilitate the transition from mentored research to independent investigation. It specifically supports research involving direct interaction with human subjects or material of human origin requiring identifiable patient data. The award is restricted to individuals proposing to lead independent clinical trials, feasibility studies, or ancillary studies to existing trials. It is not intended for those aiming to gain clinical trial experience under another investigator. Applications must align with the mission and priorities of the participating Institutes or Centers, and early consultation with NIH staff is highly encouraged to ensure alignment and responsiveness to specific IC expectations. Award budgets under the K23 mechanism cover salary and fringe benefits in addition to other research-related expenses such as tuition, equipment, technical personnel, travel to scientific meetings, and statistical services. Salary for mentors and administrative staff is not allowed. Indirect costs are reimbursed at 8% of modified total direct costs. The total project period must not exceed five years. While the number of awards is contingent on appropriations and merit, the support ensures robust investment in promising clinician-researchers across a variety of health fields. Eligible applicants include a wide spectrum of U.S.-based organizations such as public and private higher education institutions, nonprofits, for-profits (including small businesses), and local/state/tribal governments. The individual applying must be a U.S. citizen or permanent resident and hold a health-professional doctoral degree such as an MD, DO, DDS, or equivalent. Candidates must also have completed all clinical training by the time of award and commit a minimum of 75% of their full-time professional effort to the career development program. Applications must be submitted electronically via Grants.gov, NIH ASSIST, or institutional system-to-system platforms. Applicants must comply with NIH’s submission and registration requirements, including having a unique entity identifier (UEI), SAM registration, and eRA Commons credentials. The program does not require a letter of intent. NIH follows standard due dates for submission: February 12, June 12, and October 12 annually, each followed by a respective review and award cycle. The program is recurring with the current expiration date set for May 8, 2027. Given its long-term structure, applicants must plan ahead to meet review deadlines and track changes to application instructions or IC participation. Applications are reviewed for overall impact based on the candidate’s potential, career development plan, research plan, mentoring, and institutional environment. For clinical trial applicants, reviewers also assess the necessity and design of the proposed trial, its feasibility, and potential impact. NIH expects that successful candidates will transition to independent research careers and contribute meaningfully to improving patient care and health outcomes. Further contact and application information are provided through the NIH grants portal and Table of IC-Specific Information and Staff Contacts.

Consult the Table of IC-Specific Information to tailor submission; ensure protected time and strong mentor support; address clinical trial requirements directly; follow new NIH review criteria changes effective January 2025.