Selecting the Right Models for Your Research: A Focus on New Approach Methodologies (NAMs)

NIH supports a wide range of scientifically sound approaches to advance our understanding of human health and disease. As we continue to encourage approaches that enhance human relevance and translational potential, investigators should still select the models most appropriate for their specific research questions.

Here we focus on the use of New Approach Methodologies (NAMs) either alone or in combination with other models, including laboratory animals. These methodologies may include human-based in vitro systems, computational models, and real-world data as a few examples. 

If interested in using these methods, investigators are encouraged to consider the following when planning and applying for NIH funding.

When planning your study:

• Select models based on their scientific suitability for the research question
• Consider human relevance, translatability, and context of use
• Avoid justifying the use of model systems based solely on their current or historical use in the scientific field of interest.
• Understand how different approaches may be used together to strengthen the study design
• Focus on the development and use of well-characterized methods and protocols to ensure reliable and reproducible results
• Understand the alternative method’s approach, benefits, and limitations
• Leverage available infrastructure and resources (see the Resources section below for more)
• Consult with colleagues to identify integrative approaches and collaborative opportunities that best align with your scientific aims
• Contact appropriate NIH staff to discuss your approach and available options

When applying for funding: 

NIH is designing funding opportunities to expand the range of options available to investigators and to promote the use of models that enhance scientific rigor, reproducibility, and relevance to human biology. We continue to support scientifically meritorious research ideas that employ the approaches best suited to the scientific question. 

Applicants may propose any model or combination of models that is well-justified and appropriate for their research aims. Some funding opportunities may also indicate exclusive use of human-based science or NAMs.

Peruse NIH's Highlighted Topics to understand areas where NIH seeks research ideas. 

Highlighted Topics identify priority areas of scientific interest and support innovation through investigator-initiated research. NIH Institutes and Centers may prioritize or dedicate funding to applications aligned with these areas.  

Examples relevant to NAMs include:

• Leveraging New Approach Methodologies and Non-Animal Technologies to Accelerate Osteoarthritis Research
• Advancing the Use of 3D Technologies Using Human Auditory, Vestibular and Chemosensory Organoids to Create New Approach Models (NAMs) for Treatments
• Advancing Autoimmune Disease Research: Integrating Genetic, Environmental, and Immunological Factors to Improve Diagnosis and Treatment
• Research on Short-Lived and Long-Lived Plasma Cells in Humans

Please remember these topics are not specific funding opportunities. Rather, they represent priority areas that may be supported through broad funding opportunities like parent announcements. Applicants are encouraged to consult NIH program staff to determine fit, refine their approach, and identify the most appropriate funding pathway.

Resources:

• When Are Alternatives to Animals Used in Research? 

NIH Resources:

• NIH Common Fund: Complement Animal Research in Experimentation (Complement-ARIE) Program’s Validation and Qualification Network
• National Center for Advancing Translational Sciences: Assay Guidance Manual Program
• NIH: Standardized Organoid Modeling Center
• National Institute of Environmental Health Sciences: Bibliography on Alternatives to the Use of Live Vertebrates in Biomedical Research and Testing
• National Institute of Environmental Health Sciences: Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies

 Others:

• Research Resource Identification Portal
• Biomedical Models Hub
• Organization for Economic Cooperation and Development: Guidance Document on Good In Vitro Method Practices