The Mentored Research Scientist Development Award (Parent K01 - Independent Basic Experimental Studies with Humans Required) provides early-career researchers with an opportunity to develop their skills in biomedical, behavioral, or clinical research through a mentored career development experience. This funding supports three to five years of "protected time" for intensive research training, with the goal of leading recipients toward research independence and enhancing their competitiveness for future independent research grants, such as the NIH R01. The K01 award is suitable for those conducting basic science studies involving humans, where participants are prospectively assigned to conditions to assess biomedical or behavioral outcomes in order to understand fundamental aspects of phenomena without immediate practical application.

Applicants must propose basic experimental studies that involve human participants and meet the NIH definition of a clinical trial. These studies are characterized by the prospective assignment of participants to interventions to evaluate the effects on health-related outcomes, which qualifies as basic research. Proposals must not aim to lead clinical trials or studies that focus on specific applications, such as drug development or intervention efficacy. The research project should align with the programmatic interests of the participating NIH Institutes and Centers (ICs), and applicants are encouraged to consult with NIH program staff to ensure alignment with IC requirements.

The K01 award covers salary support, fringe benefits, and other program-related expenses such as research supplies, travel for training or meetings, tuition, and technical support. The total project period can be up to five years, and the applicant must commit at least 75% of their full-time professional effort to the research and career development activities supported by the award. Applicants may have other responsibilities during the remaining 25% of their time, provided these duties do not detract from the K01 program's objectives.

Eligibility is open to individuals with a research or health-professional doctoral degree, such as PhD or MD, who demonstrate a commitment to pursuing a research career in health-related fields. Eligible organizations include higher education institutions, nonprofits, government entities, and certain tribal organizations. While foreign institutions are not eligible to apply directly, foreign components can be part of the research proposal.

Candidates must work closely with a primary mentor who has a strong track record in research supervision. The mentor's role is to guide the candidate's career progression, assist in the development of research skills, and ensure the project's feasibility. Institutions must demonstrate a commitment to the candidate's development by providing a supportive research environment and adequate resources.

Applications are reviewed based on criteria such as the candidate's potential for independence, the quality and significance of the proposed research, and the strength of the mentoring plan. Standard submission deadlines apply, with multiple annual cycles for new, resubmission, or renewal applications.