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New Approach Methodologies (NAMs)

NAMs, or New Approach Methodologies, is a term defined by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM)—a federal committee under the U.S. Department of Health and Human Services (HHS) and coordinated by the National Institutes of Health (NIH):

The formal definition—originally emphasized by current NIH leadership during their oversight of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM)—describes “any technology, methodology, approach, or combination thereof that can be used to provide information on chemical hazard and risk assessment that replaces, reduces, or refines the use of animals.” Our broader interpretation remains compatible with that definition, while expanding its application to include any approach that advances scientific understanding, including in fields such as biomedical research, drug development, and safety assessment, in a way that replaces, reduces, or refines the use of animals.

But depending on who you’re talking to, NAMs can also refer to:

Novel Alternative Methodologies

Non-Animal Models (which are a subset of NAMs, falling under the Replacement principle of the 3Rs)

Across all interpretations, the focus is clear: NAMs are tools and strategies that support innovation, improve translational science, and reduce reliance on animals.

NAMs are not new – you’re probably already doing a lot.

Let’s Move Progress Forward—Together

You may have noticed that some recent Notices of Funding Opportunities (NOFOs) now reference non-animal models or New Approach Methodologies (NAMs). This does not mean that proposals must include NAMs or exclude animal research.

In fact, proposals may fall into any of the following categories:

  • Animal research only
  • Animal research combined with NAMs
  • NAMs-only approaches

What’s changing is the scope of the NOFO, not the requirement for each individual grant.

Previously, many NOFOs were written to support only animal-based models.

The new language reflects a broader, more inclusive framework—encouraging innovation across the 3Rs: Replacement, Reduction, and Refinement.

Wondering What’s Going On With NAMs?

You’re not alone. With NAMs in the spotlight—featured in federal initiatives, public discussions, and policy shifts—it’s natural to have questions:

What exactly counts as a NAM?

  • How are NAMs being used in research right now?
  • How do NAMs fit into the 3Rs (Replacement, Reduction, Refinement)?
  • And what do they mean for the future of biomedical science?

This space is designed to help.

Here, we’ll share:

✨ Trusted definitions and updates

🔬 Examples of how NAMs are already in use

📚 Resources to explore

🧭 Opportunities for innovation—and ways we’re already making progress

The Bottom Line?

We are proud of our ongoing efforts to advance ethical, high-quality science—and we’re committed to continual progress. NAMs aren’t just future concepts. They’re active tools in today’s research landscape, helping us move toward more humane, predictive, and innovative science.

Stay tuned for more updates and examples. Let’s explore NAMs together.

Calling All 3Rs Innovators

Are you advancing Replacement, Reduction, or Refinement in your research?

Whether you’re:

  • Developing a non-animal model (Replacement)
  • Designing studies that use fewer animals more effectively (Reduction)
  • Enhancing animal welfare through improved procedures or technology (Refinement)

—We want to hear from you!

Contact aco3rs@uw.edu.

UW’s 3Rs & NAMs Innovator Survey

Feature Your Work

We’re building a showcase of real-world 3Rs innovation, and we’d love to highlight your project. Share how your research is driving ethical, efficient, and forward-thinking science. From early-stage pilots to published programs, we welcome a wide range of work.

Need Help Framing the 3Rs in Your Proposal?

Describing the 3Rs—and NAMs—clearly in grants, protocols, or outreach can be challenging. We can help you:

  • Identify how your work supports the 3Rs.
  • Use trusted definitions and ICCVAM-aligned language.
  • Connect your project to emerging trends and expectations.
  • Reach out today to collaborate, get feedback, or be featured.

Not Sure if Your Work Qualifies as a NAM?

We can help.

You may already be doing things that count—and we’re here to support you in describing, framing, and highlighting those efforts.

Reach out to us if you’d like help aligning your proposal with current language or showcasing your innovative approach.

3Rs Certificate Course

This fully virtual, self-paced training is designed to elevate understanding and application of the 3Rs—Replacement, Reduction, and Refinement—across your organization.

CITI Program Course

NIH-How Does the NIH Initiative to Prioritize Human-Based Research Affect Research Proposing the Use of Laboratory Animals? (July 18, 2025)

NIH-Director’s Desk” The Future of Animal Testing (YouTube PodCast) (July 10, 2025)

FDA-NIH Workshop: Reducing Animal Testing (July 7, 2025)

Letter to NIH/FDA (July 14,2025)

NIH to prioritize human-based research technologies (April 29, 2025)

3Rs certificate course

Driving Progress Through the 3Rs and NAMs

3rs with nams

New Approach Methodologies: Complement Animal Research In Experimentation (ARIE)

Read the full article: Complement-ARIE: Catalyzing the development and adoption of new approach methodologies DirectScience.com.

Abstract:

NAM journal coverNew approach methodologies (NAMs) are proving to be invaluable tools in basic and clinical research to better understand human health and disease, elucidate mechanisms, and study the efficacy and toxicity of novel therapeutics that can improve upon and complement animal-based methodologies.

Over the last 15 years, the National Institutes of Health (NIH) has increased investment in NAMs, including in chemico, in silico, and in vitro approaches, such as cell-free assay systems, digital twins, and microphysiological systems (MPS). To further catalyze and innovate the use of NAMs, the NIH Common Fund has initiated a new program, Complement Animal Research In Experimentation (Complement-ARIE), which aims to pioneer the development, standardization, validation, and regulatory use of combinatorial NAMs that will more accurately model human biology and disease states.

This program specifically aims to 1) better model human health and disease differences in outcomes across populations, 2) develop NAMs that can provide insights into specific biological processes or disease states, 3) validate mature NAMs to support regulatory use and standardization, and 4) complement traditional animal models to make research more efficient and effective.

To inform the implementation of Complement-ARIE, the NIH organized strategic planning activities including an inter-agency retreat, public listening sessions, scientific literature landscape analysis, and a challenge prize. Here we discuss the goals and findings of these activities, and how these results helped identify and address scientific and operational opportunities and roadblocks for implementation of the program towards broader acceptance and impact of NAMs. We anticipate these new methods and approaches could transform the way we do basic, translational, and clinical sciences.

3D-printed device advances human tissue modeling

Stomp device
Institute for Stem Cell and Regenerative Medicine
The tiny Suspended Tissue Open Microfluidic Patterning, or STOMP device, for tissue engineering studies.

The device is small enough to fit on a fingertip and can work with existing tissue-engineering technology.

A new, easily adopted, 3D-printed device will enable scientists to create models of human tissue with even greater control and complexity. An interdisciplinary group of researchers at UW Medicine and the University of Washington led the development of the device.
3D tissue engineering, which recently has undergone other major advances in speed and accuracy, helps biomedical researchers design and test therapies for a range of diseases.

One goal of tissue engineering is to create lab-made environments that recreate the natural habitats of cells.

Read the full article…

Brain Computer Interface with Scott Imbrie

In this video, Scott Imbrie shares his experience being part of a study on spinal cord injuries and the use of brain computer interfaces. These important components were developed with academic researchers who first created the technology working with non-human primates.

Please note, this video contains content that includes photos of living brain and surgical appliances.

2024 3Rs Symposium

Thursday, November 21, 2024
11:30am PST – 2:00pm PST
Location: HUB 214 + zoom option.
3Rs Symposium

Join us for an engaging session with Dr. Lisa Levin, a leading advocate for the 3Rs: replacement, reduction, and refinement. Dr. Levin will discuss key steps in promoting the adoption of non-animal research models.

The event will also feature lighting talks by the 2024 3Rs Pilot Award recipients, showcasing their innovative work in advancing the 3Rs principles.

This event is open to the UW community and the public. Registration is required. A free networking lunch will be provided (limited to the first 40 attendees; registration for lunch is now full).

Register today to attend this session.

Learn more

The 3rs Centre Utrecht

This animation of the 3Rs Centre Utrecht shows the differences, but also the similarities, between the 3Rs approach and the NAMs approach.

August 22 Webinar: “Making the 3Rs More Than a Checkbox” Presented by Dr. Sally Thompson-Iritani

Dr Sally Thompson Iritani
Dr. Sally Thompson-Iritani

Thursday, August 22, 2024
8:00 AM – 9:00 AM  Pacific Time.

On Thursday, August 22, the Allentown educational webinar will feature guest presenter, Dr. Thompson-Iritani serves as AVP, Animal Care, Outreach, & 3Rs at the University of Washington (UW).

The 3Rs—Replacement, Reduction, and Refinement—are fundamental principles in animal research aimed at enhancing ethical standards and scientific quality. However, their implementation often becomes a perfunctory task, failing to fully realize their potential.

UW challenged themselves to make the 3Rs more than a checkbox through strategic initiatives. Key approaches included fostering a culture of ethical responsibility, enhancing awareness, providing pilot funding for 3Rs-focused initiatives, and partnering with the 3Rs Collaborative (3RsC).

By prioritizing innovative methodologies and technologies, promoting interdisciplinary collaboration, and ensuring transparent communication of 3R advancements, UW researchers are working together to significantly improve animal welfare and research outcomes.

The goal is to embed the 3Rs into the scientific ethos, making them a continuous and dynamic process that enhances both ethical standards and scientific integrity. This commitment is leading to a transformative impact, positioning UW as a leader in ethical animal research practices.

Attend this session to gain valuable insights and discover practical strategies to empower your organization to embrace the 3Rs, ultimately enhancing animal welfare, improving research outcomes, and positioning you at the forefront of ethical research practices.

Cindy A. Buckmaster, PhD, CMAR, RLATG, will moderate this session.

This webinar meets AALAS and CALAS requirements for 1.00 hour of Continuing Education (CE) and may be used elsewhere where accepted.

Register for the Webinar.

Registration for this event will close at 5:00 PM Eastern on Wednesday, August 21.

Learn about other webinars hosted by Allentown.

NCATS Tissue Chips in Space-The UW Kidney Chip Experiences

In this “Behind the Papers” post, Edward Kelly, Associate Professor of Pharmaceutics, describes the challenges faced to modify the kidney MPS perfusion system from a terrestrial lab to the ISS-NL for two successful launches in 2019 (CRS-17) and 2022 (CRS-22) as well as the experimental results from CRS-17.

Read the Post

Changes to WaNPRC protocols, procedures following recent incidents

The University of Washington’s Institutional Animal Care and Use Committee (IACUC) was informed on Thursday of recent incidents at the Washington National Primate Research Center (WaNPRC), which have prompted changes to protocols and procedures to ensure high standards of animal welfare and research integrity.

  1. Pausing of incoming shipments – As of May, incoming shipments of non-human primates were paused after an April 25 shipment of four geriatric pig-tail macaques raised compliance concerns. Issues included unlisted source institutions, prior surgery on an animal that was not described in protocols, and non-compliance with shipping standard operating procedures. These concerns prompted a thorough review by a high-level animal care leadership team. Immediate actions included halting shipments, enhancing standard operating procedures with better documentation and real-time monitoring, and clarifying primary investigator protocol approval requirements. Despite procedural issues, the transport care was adequate. One geriatric macaque was euthanized due to health condition and decline after arrival. Veterinary staff were not able to identify any evidence that the shipping caused the animal’s condition.
  2. Water withholding incident (November 2022): An animal inadvertently had water withheld for over 24 hours and improvements were made in water provision documentation. This was reported to the IACUC at the time of the initial occurrence. The animal later developed acute interstitial nephritis. We cannot definitively say that withholding water in 2022 directly caused this animal’s chronic kidney pathology but felt that it was important to notify the IACUC of the animal’s current condition. The animal remains on ad-lib water to prevent further complications.
  3. Intracranial injection complications (August 2023): A 22-year-old macaque experienced complications during intracranial injections. Upon recovery from the procedure the animal was treated for a grand mal seizure and partial paralysis. After a recovery period the animal was approved for a second surgery which was performed without incident, but the macaque did not revive from anesthesia and was euthanized. Necropsy revealed significant hemorrhage likely secondary to the injections. This was consistent with the IACUC protocol, identifying bleeding as a potential rare risk of the procedure. These incidents were reported to the attending veterinarian by WaNPRC veterinary staff in May 2024. It is unclear why there was a delay in reporting this incident to the IACUC or the attending veterinarian, who acknowledged that the complications and severity of the outcome from the first procedure warranted immediate notification to the IACUC.

The UW is committed to transparency and accountability in the use and care of animals for academic research, and is developing clearer guidelines, enhancing oversight, and continually evaluating practices to ensure compliance and animal welfare. The IACUC was apprised of these incidents, and they will continue to be updated as other investigations proceed. Each of these incidents has been reported to the appropriate regulatory authorities.

The Washington National Primate Research Center (WaNPRC) is dedicated to advancing scientific knowledge while ensuring the ethical and humane treatment of non-human primates in research. Our mission is to foster innovative research and maintain the highest standards of animal welfare.

For more information about the Animal Care Program at the UW, visit the Animal Care, Outreach, and 3Rs Program (ACO3Rs) website.