The NIH Mentored Research Scientist Development Award (Parent K01 - Independent Clinical Trial Required) is a reissue of PA-20-176, aimed at fostering the transition of promising researchers to independent careers in health-related fields. This funding opportunity is specifically for candidates who will serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary clinical study. The program provides three to five years of “protected time” for intensive, mentored career development in biomedical, behavioral, or clinical sciences, with the expectation that recipients will become competitive for independent research grants, such as NIH R01 awards.

The primary goal is to enhance the capacity of highly trained scientists in critical areas of health research. Each candidate must propose a research plan that fits the mission and scientific interest of one or more of the participating NIH Institutes and Centers (ICs). While most ICs use the K01 to support a path toward research independence, some may target individuals changing fields or returning after a hiatus. Candidates are required to serve as lead investigators in a clinical trial as part of their proposal and must meet detailed eligibility and registration requirements to apply.

Funding is composed of salary support and research development costs, with budgets defined by individual ICs. Support covers tuition, supplies, travel, statistical services, and more, but excludes salary support for mentors or administrative staff. The maximum project period is five years, and indirect costs are capped at 8% of modified total direct costs. Applicants must be U.S. citizens or permanent residents and hold a research or health-professional doctoral degree. Multiple applications from the same organization are allowed if scientifically distinct and from different candidates.

Applications must follow a detailed submission format using one of NIH’s electronic platforms, such as ASSIST, an institutional system, or Grants.gov Workspace. The candidate, mentor(s), institution, and environment must be well-documented and demonstrate readiness for rigorous research training. Applicants must commit a minimum of 75% full-time effort to the program, with the institution assuring support in terms of space, resources, and mentor time.

Evaluation will consider the candidate’s potential for independence, the quality and relevance of the research and career development plans, mentor qualifications, and institutional support. The proposed clinical trial must be well-justified and feasible, with clear milestones and contingency planning. Reviewers will assess compliance with NIH policies including data sharing, responsible conduct of research, inclusion policies, and protections for human subjects.

Applications are accepted multiple times per year on NIH standard due dates. The earliest open date is May 12, 2024, and applications will be accepted through May 8, 2027. Applicants are advised to consult the Table of IC-Specific Information to align their proposals with IC priorities. Consultation with NIH staff is strongly encouraged before applying.