NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)
Funding Agency:
- National Institutes of Health
The NIH Research Project Grant (R01) supports a discrete, specified, circumscribed project in scientific areas that represent the investigators' specific interests and competencies and that fall within the mission of the participating NIH Institutes and Centers (ICs). The R01 is the original, and historically the oldest, grant mechanism used by the NIH to support health-related research and development.
Research grant applications are assigned to participating ICs based on receipt and referral guidelines, and many applications are assigned to multiple participating ICs with related research interests. Applicants are strongly encouraged to identify a participating IC that supports their area of research and contact Scientific/Research staff from relevant ICs to inquire about their interest in supporting the proposed research project. For specific information about the mission of each NIH IC, visit the List of NIH Institutes, Centers, and Offices website.
All applications submitted to this Parent Notice of Funding Opportunity must propose basic science experimental studies involving humans, otherwise referred to in NOT-OD-18-212 as prospective basic science studies involving human participants, that fall within the NIH definition of a clinical trial and also meet the definition of basic research.
NIH defines basic research consistent with the definition of basic research in federal code, the systematic study directed toward greater knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications towards processes or products in mind. (32 CFR 272.3).
NIH defines a clinical trial as "A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes." (NOT-OD-15-015).
Types of studies that should submit under this NOFO include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind.
For the purposes of this NOFO, specific application towards processes or products refers to the application of biomedical or behavioral products, procedures, or services intended to affect a health-related outcome of the individual or a group of individuals either by better understanding the mechanism of action of an intervention or a measurable improvement in health.
Basic experimental studies in which participants are prospectively assigned to experimental conditions and receive an intervention or experimental manipulation where the effect will be assessed for the purpose of understanding fundamental aspects of phenomena may be submitted under this parent NOFO.
Please refer to the table comparing Funding Opportunity Types by Clinical Trial Allowability for additional guidance on the most appropriate NOFO for the type of study.
Prospective studies with humans conducted with specific applications towards processes or products in mind, including FDA Phase 0 or 1 studies, mechanistic clinical trials (e.g., those that examine the mechanisms by which an intervention works or the processes that account for an intervention's effects on clinical outcome), and safety and efficacy studies should submit under the parent Clinical Trial Required NOFO, or other 'Clinical Trial Required' or Clinical Trial Optional NOFOs, but not under this NOFO.
Observational studies involving humans should submit under the Clinical Trial Not Allowed NOFO.
Applicants are strongly advised to contact relevant Scientific/Research staff to discuss the most appropriate mechanisms of support for their studies.
Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.
Application budgets are not limited but need to reflect the actual needs of the proposed project.
February 05, 2025; June 05, 2025
Participating NIH Institutes and Centers are listed in "Components of Participating Organizations" in Part 1. Overview. Scientific/Research Contact information is listed on R01 Basic Experimental Studies with Humans Required IC-Specific Scientific Interests and Contact website.