Mentored Career Development Program (K01) for Early Stage Investigators Using Nonhuman Primate Research Models (K01 Independent Clinical Trial Not Allowed) | PAR 20 258

Opportunity Information: Apply for PAR 20 258

The NIH Mentored Career Development Program (K01) for Early Stage Investigators Using Nonhuman Primate Research Models (PAR-20-258) is a career development grant designed to help early-stage investigators build the skills, publication record, and scientific independence needed to become competitive for major independent research funding, such as an R01. The award provides substantial protected time and support for an intensive, research-focused career development plan lasting up to five years, with the work carried out under a structured mentorship team. A central goal of the program is to grow the pipeline of highly trained scientists who can use nonhuman primate (NHP) models in rigorous preclinical research and effectively translate those findings toward clinical application, especially for complex biomedical questions where NHP models offer unique value.

The program is built around mentored training and research in NHP-based translational science. Applicants are expected to propose a coherent career development strategy that combines a well-justified research project using NHP models with deliberate training activities (for example, skill development in study design, advanced methods, bioinformatics, statistics, reproducibility, ethical use and welfare considerations for NHP research, regulatory knowledge, and translational planning). The mentorship structure is a core feature: the candidate should be guided by an experienced primary mentor and, when appropriate, co-mentors who collectively cover both deep expertise in NHP model implementation and a demonstrated ability to move preclinical insights toward clinical relevance. The underlying expectation is that, by the end of the K01 period, the awardee will be positioned to transition to research independence with a strong track record of outputs and a clear pathway to competing successfully for independent NIH research project grants.

A key boundary of this specific K01 FOA is its clinical trial limitation: it is for candidates whose proposed research does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary study to a clinical trial. In other words, the award supports mentored development and research activities that are not centered on the applicant serving as the responsible leader of a clinical trial. At the same time, the FOA allows candidates to gain experience in a clinical trial setting if the trial is led by a mentor or co-mentor, which can be useful for investigators aiming to strengthen translational perspectives without taking on the formal leadership role that would make the application noncompliant.

Eligibility for applicant organizations is broad and includes many U.S.-based entities such as public and private institutions of higher education, nonprofits (including those with and without 501(c)(3) status), for-profit organizations (other than small businesses), small businesses, and various levels of government (state, county, city/township, special districts), as well as Native American tribal governments and tribal organizations (including federally recognized tribal governments and other tribal entities). The FOA also explicitly highlights eligibility for a range of institution types and community-linked organizations, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), along with faith-based or community-based organizations, eligible federal agencies, and U.S. territories or possessions. However, foreign participation is tightly restricted: non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as NIH defines them in its Grants Policy Statement) are not allowed.

Administratively, this is a discretionary NIH grant opportunity in the health area, tied to multiple CFDA assistance listings (93.213, 93.273, 93.351, 93.855, 93.866). The FOA was created on August 24, 2020, and the original closing date listed is January 7, 2023. The opportunity does not specify an award ceiling or expected number of awards in the provided details, so applicants typically need to rely on NIH institute-specific guidance and the FOA text for budget structure, allowable costs, effort requirements, and review expectations. Overall, the program is best understood as a mentored bridge to independence for early-stage scientists committed to translational research that leverages NHP models, with strong emphasis on structured mentorship, protected time, and a clear trajectory toward independent funding.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Mentored Career Development Program (K01) for Early Stage Investigators Using Nonhuman Primate Research Models (K01 Independent Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.213, 93.273, 93.351, 93.855, 93.866.
• This funding opportunity was created on 2020-08-24.
• Applicants must submit their applications by 2023-01-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 20 258

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