July 2025

The National Institutes of Health (NIH) is expanding its support for New Approach Methodologies (NAMs) as part of a broader initiative to prioritize human-based research and reduce reliance on animal models. While current NIH Notice of Funding Opportunities (NOFOs) do no include specific language that NAMs must be addressed in the application, future NOFOs may include such expectations. See guidance on recent NIH policy changes.

We strongly encourage you to carefully read both current and upcoming NOFOs for updated or revised criteria. Please note that the inclusion of NAMs is likely to strengthen grant applications, particularly those reviewed by study sections with a disease or translation/clinical focus.

The Division of Research, Innovation & Impact will soon add web content highlighting NAMs-related resources and support services available to Mizzou researchers.
 

What are NAMs?

NAMs are innovative, human-relevant research models and technologies that include:

  • Ex vivo human tissue and organs
  • Organoids
  • Organs-on-chip / microphysiological systems (MPS)
  • In vitro human cell-based assays
  • High-throughput screening methods
  • Computational modeling and AI-driven approaches
     

When integrating NAMs into NIH grant applications that use animal models, consider the following key areas:

  1. Justification and integration
    • Clearly explain why the selected NAMs are relevant and scientifically appropriate.
    • Describe how the selected NAMs accurately model human biology.
    • Describe how these methodologies complement or enhance traditional animal models or reduce the use of animal models.
    • Emphasize how the selected NAMs improve reproducibility and translatability of your research.
       
  2. Experimental design and validation
    • Describe the specific NAMs technologies and experimental protocols.
    • Describe validation criteria, expected outcomes and performance benchmarks.
    • Address any limitations and how they will be mitigated.
    • Discuss how selected NAMs support experimental rigor and reproducibility.
       
  3. Feasibility and expertise
    • Highlight previous experience or preliminary data supporting successful implementation of NAMs.
    • Reference prior validation studies or published evidence.
    • Note any multidisciplinary collaborations with NAMs-experienced laboratories or industry partners with appropriate supporting documentation.
    • If your team lacks NAMs experience, consider including training plans or collaborations with experts as part of your strategy.
       
  4. Training and compliance
    • Document investigator and research team expertise or relevant training in proposed NAMs.
    • Confirm compliance with NIH standards for rigorous methodological standards and reproducibility.
    • Describe compliance with NIH ethical requirements for human-based research components.
       
  5. Budget and resources
    • Budget appropriately for NAMs, including costs for technologies, necessary equipment, reagents, computational resources, human tissue or cell procurement, cross-validation studies and personnel.
    • Clearly justify these expenses in your budget narrative.
       
  6. Impacts on animal use
    • Assess how your project may reduce, refine or replace animal use through NAMs integration.
       
  7. Review criteria alignment
    • Align your proposal closely with NIH review criteria emphasizing:
      • Importance of the research
      • Rigor and feasibility
      • Expertise and resources related to NAMs
         

More information from NIH: