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NIH Exploratory/Developmental Research Project Grant (Parent R21 Basic Experimental Studies with Humans Required)

US · US National Institutes of Health (NIH) grant open #PA-25-307
Response due May 24, 2026 · 00:00 UTC

Summary

The National Institutes of Health (NIH) is soliciting applications for the Parent R21 grant mechanism to support exploratory and developmental biomedical research projects. This specific opportunity requires that proposed research involve Basic Experimental Studies with Humans (BESH), meaning studies that prospectively assign human participants to conditions to evaluate causal relationships. The R21 mechanism is intended for novel, innovative, or high-risk/high-reward research that may lack sufficient preliminary data for a traditional R01 application. Funding supports early-stage investigations across a wide range of NIH mission areas.

What they want

Applicants must propose exploratory or developmental research projects that: (1) involve Basic Experimental Studies with Humans (BESH) as defined by NIH; (2) are innovative or high-risk/high-reward in nature; (3) fit within the mission of one or more participating NIH institutes or centers. The R21 grant mechanism supports up to two years of funding. Applications must comply with NIH human subjects research requirements given the BESH designation, including registration in ClinicalTrials.gov.
Technical requirements
  • Research must qualify as Basic Experimental Studies with Humans (BESH) per NIH policy
  • Studies must prospectively assign human participants to conditions to evaluate causal relationships
  • Registration in ClinicalTrials.gov required for BESH studies
  • R21 mechanism supports a maximum of two years of project period
  • Must align with the mission of at least one participating NIH institute or center

How they evaluate

  • Scientific and technical merit (innovation, approach, significance)
  • Investigators' qualifications and experience
  • Environment and institutional support
  • Human subjects protections and BESH compliance
  • Alignment with NIH institute/center priorities
Submission: Electronic submission via Grants.gov and NIH ASSIST or institutional systems-to-systems portal

Eligibility & certifications

SAM.gov registration (for institutional applicants)Compliance with NIH human subjects research requirementsInstitutional assurance (IRB/HRPP approval required)ClinicalTrials.gov registration

Risks & flags

  • BESH designation narrows eligibility to studies involving prospective human experimentation, excluding purely observational or animal studies
  • No specific dollar cap stated — budget limits must be inferred from NIH R21 standard guidelines (typically $275,000 direct costs over two years)
  • Rolling deadline with multiple submission windows across a multi-year period may disadvantage applicants unfamiliar with NIH standard due dates

Market context

inferred from NAICS
Professional, Scientific & Technical Services
NAICS 541711
US market size
$2.0T
Typical award
$25K – $50M
Typical buyers
All federal civilianDoDStates
Commonly required
8(a)WOSBSDVOSBPE/PMP

Sector-level estimate — full code lookup not yet in catalog.

NIH Exploratory/Developmental Research Pro…
Due May 24
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