AMP News: Decoding Gold Standard Science: Anticipating and Responding to AR Groups’ Spin

Last Friday (August 22, 2025), NIH released its Gold Standard Science (GSS) Implementation Plan, laying out nine guiding tenets for ensuring high-quality science:

• Reproducible
• Transparent
• Communicative of Error and Uncertainty
• Collaborative and Interdisciplinary
• Skeptical of its Findings and Assumptions
• Structured for Falsifiability of Hypotheses
• Subject to Unbiased Peer Review
• Accepting of Negative Results as Positive Outcomes
• Without Conflicts of Interest

Together, these principles aim to build a framework for strengthening research practices across the agency.

Animal Research and NAMs Highlighted in GSS Plan

The plan does not ignore animal research or the role of New Approach Methodologies (NAMs). For example, under the transparency tenet, NIH signals that the Animal Research: Reporting of In Vivo Experiments (ARRIVE) Essential 10 guidelines—which help readers of scientific publications assess study reliability and design—will no longer be just “encouraged” (as is current policy, per NOT-OD-23-057), but expected.

It’s worth noting for our own understanding that while many journals already require the use of the ARRIVE Essential 10, their true power lies earlier in the process: guiding scientists as they design studies, not just as a box-checking exercise at publication. That’s a gap the research community can work together to address.

Expanding ICCVAM

But perhaps the most significant signal in the plan is NIH’s intent to expand the role of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). ICCVAM has long been central to validating NAMs, but primarily in the toxicology space. It is also important to note that earlier this year, the FDA’s Roadmap to Reducing Animal Testing in Preclinical Safety Studies emphasized ICCVAM as a key driver of progress (page 8). 

When two of the most influential biomedical agencies point to ICCVAM, it’s a clue worth paying close attention to.

What could expansion look like? While details are sparse, one logical step would be to fold ICCVAM into the new NIH Office of Research Innovation, Validation, and Application (ORIVA), elevating its authority from a committee within the National Institute of Environmental Health Sciences (NIEHS) to a body tied directly to the NIH Director’s Office. That would give ICCVAM greater influence over agency-wide policy and guidance on NAMs and animal research.

But even if ORIVA isn’t the final destination, the message is clear: ICCVAM will have a larger stage, and the animal research community must be ready to engage.

Questions and Gaps Persist

This expansion also raises a critical point. ICCVAM’s expertise lies in toxicology, where NAMs have delivered strong alternatives, such as skin and eye irritation tests that no longer require animals because robust and validated NAMs have been developed.

However, toxicology is only a small part of biomedical science. Copy-and-paste policymaking that assumes the same frameworks will apply to neuroscience, oncology, pediatrics, or infectious disease would be shortsighted and irresponsible.

For ICCVAM to be truly successful, there needs to be a federal recognition that the scientific and ethical balance between NAMs and animal models differs across disciplines.

For the research community, this means emphasizing to NIH that any ICCVAM expansion:

• Broadens its lens beyond toxicology to include diverse biomedical fields.
• Includes laboratory animal veterinarians, IACUC experts, and basic and translational researchers alongside toxicologists.
• Coordinates closely with the Office of Laboratory Animal Welfare (OLAW) to harmonize oversight and animal welfare policies.
• Engages stakeholders from across the ecosystem (not just activist voices).
• Communicates the complementary, not competitive, relationship between NAMs and animal models.

To learn more and stay informed, stay connected with Americans for Medical Progress.