The NIH Pathway to Independence Award (Parent K99/R00 – Independent Clinical Trial Required) aims to support outstanding postdoctoral researchers in transitioning from mentored postdoctoral research positions to independent, tenure-track faculty roles. The program offers a dual-phase funding mechanism designed to facilitate the development of independent research programs and support postdoctoral researchers who will serve as principal investigators on independent clinical trials, feasibility studies, or ancillary studies to existing clinical trials. Candidates interested in gaining experience in clinical trials led by other investigators should consider the companion funding opportunity (PA-24-194).

The award includes two phases: the K99 phase, providing up to two years of mentored training, followed by the R00 phase, which offers up to three years of independent research support. The K99 phase focuses on the candidate’s mentored research and career development to prepare for a tenure-track faculty position, while the R00 phase supports the candidate’s independent research program at a new institution. The transition to the R00 phase is contingent on securing a tenure-track or equivalent faculty position by the end of the K99 phase. The award is intended to be continuous between the two phases unless exceptional circumstances arise.

Eligibility for the K99/R00 award requires no more than four years of postdoctoral research experience by the application deadline. Candidates must be in mentored, non-independent positions and have a clinical or research doctorate (e.g., PhD, MD). The program welcomes applications from diverse backgrounds, including individuals from underrepresented groups. There is no citizenship requirement, but visa status must permit the candidate to remain in the U.S. during the K99 phase and complete the R00 phase. Applicants with prior independent research positions or substantial independent funding are not eligible.

The funding for the K99 phase includes salary and research-related costs as allowed by the sponsoring institution’s policies. The R00 phase provides up to $249,000 annually, covering salary, fringe benefits, research costs, and indirect costs at the institution's negotiated rate. Applicants must detail their plans for both phases, demonstrating how the K99 period will prepare them for independent research and outlining a viable research program for the R00 phase. The mentor’s support, including a plan for the candidate’s transition to independence, is also essential.

Applications are evaluated based on the candidate’s potential for independence, the quality of the career development plan, the significance and innovation of the proposed research, and the mentor’s commitment to the candidate’s development. The application must address all NIH requirements for clinical trial registration, human subjects research protections, and inclusion plans for diverse populations.

Prospective applicants should contact NIH staff to ensure their proposals align with specific Institute or Center requirements. Multiple submission dates are available yearly, with standard NIH due dates applying for new and resubmission applications. The program aims to equip researchers with the skills necessary for independent, impactful research careers that contribute significantly to biomedical and clinical science.