HEARTS Act of 2025
- Sponsor
- Rep. Calvert, Ken [R-CA-41]
- Committees
- Energy and Commerce Committee (primary)
- Last action
- Feb 13, 2025
Bottom line
This bill seeks to significantly shift federally funded biomedical research towards nonanimal methods by establishing new NIH mandates, creating a dedicated center, and requiring transparent reporting on animal use.
What it actually does
The HEARTS Act of 2025 amends the Public Health Service Act to mandate that the National Institutes of Health (NIH) prioritize nonanimal research methods where applicable and feasible. It requires NIH to establish a system of incentives for nonanimal methods, ensure full evaluation of nonanimal alternatives before animal research is approved, and establish a new National Center for Alternatives to Animals in Research and Testing. The bill also mandates biennial reporting by federally funded research entities on animal usage and plans for reduction.
Proponents argue
Proponents argue that the bill will accelerate biomedical research by promoting more human-relevant models, citing high failure rates of drugs tested on animals in human clinical trials. They also emphasize the ethical imperative to reduce animal suffering and improve transparency regarding animal use in research, fulfilling the original intent of the National Institutes of Health Revitalization Act of 1993.
Opponents contend
Opponents, or those cautious about rapid shifts, might argue that while nonanimal methods are promising, they are not yet sufficiently developed or validated to replace all animal research, particularly for complex systemic interactions. They might express concerns that overly strict mandates could hinder critical research, slow scientific progress, or divert resources from established, effective animal models before alternatives are fully robust.
The bill is concise and relatively easy to read, allowing an informed reader to grasp its core provisions quickly.
Section 3, amending Section 495(a) of the Public Health Service Act.
Mandate for Prioritizing Nonanimal Research Methods
This provision requires the NIH, for all research it conducts or supports, to ensure that scientifically satisfactory nonanimal methods are fully evaluated before any animal research is approved. It also mandates establishing a system of incentives for using existing nonanimal methods and guidelines for thorough searches for such alternatives.
Supporters argue
Supporters argue this provision is crucial for modernizing research, reducing animal suffering, and improving the relevance of preclinical studies to human health outcomes by pushing for human-focused biology.
Critics contend
Some researchers might express concern that this could add bureaucratic hurdles and potentially delay research if nonanimal methods are not yet fully developed or validated for specific research questions, or if the review process becomes overly stringent.
Tradeoffs
Balances the ethical imperative to reduce animal use with the practical needs of ongoing biomedical research and the current limitations of nonanimal models for all research types.
Section 3, amending Section 495(a) of the Public Health Service Act by adding paragraph (4).
Enhanced Review Process for Nonanimal Alternatives
This provision requires that research proposals be reviewed by at least one person with expertise in nonanimal research methods. Additionally, reviewers must have access to a reference librarian skilled in evaluating the adequacy of searches for nonanimal methods described in proposals.
Section 4, amending Section 401(b) and adding new Subpart 6 (Section 485E) to Part E of title IV of the Public Health Service Act.
Creation of a Dedicated National Center
This provision establishes a new National Center for Alternatives to Animals in Research and Testing within the NIH, to be headed by a director appointed by the Secretary. Its purpose is to develop, promote, and fund alternatives to animal research and testing, and to create a plan for reducing animal use in federally funded research.
Section 4, new Section 485E(c) of the Public Health Service Act.
Mandated Activities of the New Center
The Director of the National Center is tasked with providing funding and assistance to researchers for developing nonanimal methods (e.g., organoids, AI), training scientists in these methods, establishing collaborations among research institutions, and collecting and publicly disseminating data on animal use in federally funded research.
Section 5.
Biennial Reporting and Reduction Plans for Animal Use
This section requires all federally funded research entities and federal departments/agencies that use animals in research to report biennially to the National Center (and make public) the number of animals used, disaggregated by species, and the number bred/acquired. They must also submit a plan for reducing these numbers every two years.
The bill defines "animal" for the purpose of reporting requirements to include "any live, nonhuman vertebrate animal or cephalopod used or intended for use in research, research training, experimentation, or biological testing, or for related purposes."
Section 5(c)(1)
Why it matters:This is standard legislative practice to place definitions at the end of a section or bill. However, the inclusion of "cephalopod" is a specific expansion beyond typical vertebrate definitions in some animal welfare contexts, making it noteworthy.
Case for: Proponents would argue that including cephalopods reflects growing scientific understanding of their sentience and cognitive abilities, ensuring their protection and inclusion in efforts to reduce animal use.
Case against: Some researchers might argue that expanding the definition to include invertebrates like cephalopods could significantly broaden the scope of reporting and regulatory burden, potentially without equivalent scientific justification for all research contexts.
Estimated impact: Expands the scope of animals covered by reporting requirements, potentially increasing the reported numbers and the administrative burden for facilities that use cephalopods.