HEARTS Act of 2025

Bill Number

H.R. 1291

Origin Chamber

House

Congress

119th Congress, Session 1

Policy Area

Health

Status

Introduced

Latest Action

2025-02-13: Referred to the House Committee on Energy and Commerce.

Last Updated

2026-06-24T08:09:10Z

AI-Generated Summary

Purpose of the Legislation

The Humane and Existing Alternatives in Research and Testing Sciences Act of 2025 (HEARTS Act) seeks to reduce the use of animals in biomedical research funded by the National Institutes of Health (NIH). It promotes the prioritization of nonanimal methods—such as advanced cell cultures, computer modeling, and artificial intelligence—where these methods are practical and effective. The bill also establishes a dedicated center within NIH to support these alternatives and improves transparency about animal use in federally funded research.

Key Provisions

• Prioritization of Nonanimal Methods in NIH Research:
• Requires NIH to create guidelines that encourage the use of existing nonanimal alternatives in research proposals through incentives like funding or recognition.
• Mandates that before approving any animal-based research, all suitable nonanimal options must be fully evaluated.
• Ensures research proposals are reviewed by at least one expert in nonanimal methods and provides access to librarians skilled in assessing searches for alternatives.
• Adds requirements for grant applications to include a statement confirming no suitable nonanimal method exists for the research goals.

• Establishment of the National Center for Alternatives to Animals in Research and Testing:
• Creates a new center within NIH, to be established within one year of the bill's enactment, led by a director appointed by the Secretary of Health and Human Services.
• The center's duties include:
• Funding and assisting researchers in developing nonanimal tools (e.g., 3D organ models, stem cell-based systems, and AI-driven simulations).
• Training scientists on these methods and fostering collaborations between institutions to share resources like advanced equipment.
• Developing a plan to reduce animal use in federally funded research.
• Collecting and publicly reporting data on the number of animals used in such research.

• Reporting Requirements for Animal Use:
• Federally funded entities that use animals (including universities, research labs, and federal agencies) must report every two years to the new center on:
• The number of animals used in research and testing, broken down by species (e.g., mice, rats, primates).
• The number of animals bred or acquired for these purposes, also by species.
• Entities must also submit and update public plans to reduce animal numbers.
• The center will create a standardized process for these reports to ensure consistency and public access.
• Defines "animal" as any live nonhuman vertebrate (e.g., mammals, birds, fish) or cephalopod (e.g., octopus) used in research.

Significant Changes to Existing Law

• Amendments to the Public Health Service Act (Section 495): Expands NIH's responsibilities beyond current animal care guidelines to actively enforce the consideration of nonanimal alternatives. This builds on the 1993 NIH Revitalization Act, which called for research into animal reduction methods but lacked strong implementation, and the Animal Welfare Act, which requires exploring alternatives but has weak oversight.
• Addition to NIH Structure: Inserts the new National Center as the 25th institute or center under NIH (increasing the total from 27 to 28), formalizing support for nonanimal research that was previously under-resourced.
• New Transparency Measures: Introduces mandatory, species-specific public reporting on animal use, addressing the current lack of precise data (estimated 17–100 million animals used annually in the U.S., with no exact tracking).

Potential Impacts

• On Government Agencies: NIH will face increased administrative duties, including guideline development, expert reviews, and data collection, potentially raising costs but enabling better oversight and more efficient resource allocation toward human-relevant research. Other federal agencies using animals (e.g., Department of Defense) must comply with reporting.
• On Citizens: Enhances public access to information on animal use, addressing ethical concerns and promoting humane research. It could lead to faster development of treatments by reducing drug failures (noted as 30% due to toxicity and 60% due to inefficacy in animal models), benefiting public health.
• On International Relations: May set a U.S. standard for ethical research, influencing global collaborations and encouraging other countries to adopt nonanimal methods, potentially improving the U.S.'s leadership in biomedical innovation without direct foreign policy effects.

Main Stakeholders Affected

• NIH and Federal Research Funders: Directly responsible for implementing changes, including the new center and review processes.
• Researchers and Institutions: Universities, labs, and companies receiving NIH grants must evaluate alternatives, include expert reviews, and report animal data, which may shift workflows but provide new funding opportunities.
• Animal Welfare Organizations: Benefit from reduced animal use and greater transparency, aligning with advocacy for ethical standards.
• Biomedical and Pharmaceutical Industries: Could see improved research accuracy and cost savings from nonanimal methods, though initial adaptation may require investment.
• The General Public: Gains from ethical advancements and potential health benefits, with access to data on animal use in taxpayer-funded research.

Notable Legal, Constitutional, or Political Implications

• Legal Implications: Strengthens enforcement of existing laws like the Animal Welfare Act by adding specific incentives and reporting, reducing reliance on self-regulation. It ensures research approvals include documented justification for animal use, potentially leading to fewer legal challenges over unnecessary testing.
• Constitutional Implications: No direct conflicts; the bill supports First Amendment transparency by mandating public data disclosure and due process in research funding decisions without infringing on scientific freedoms.
• Political Implications: Reflects bipartisan support (introduced by representatives from both parties) and responds to public concerns about animal welfare and research efficacy. It fulfills unmet goals from 1993 legislation, potentially reducing political pressure on NIH while promoting innovation in a field with growing ethical scrutiny.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Rep. Calvert, Ken [R-CA-41]

Cosponsors (18)

Rep. Pappas, Chris [D-NH-1], Rep. Malliotakis, Nicole [R-NY-11], Rep. Scholten, Hillary J. [D-MI-3], Rep. Goldman, Daniel S. [D-NY-10], Rep. Davis, Donald G. [D-NC-1], Rep. Thanedar, Shri [D-MI-13], Rep. Harder, Josh [D-CA-9], Rep. Tokuda, Jill N. [D-HI-2], Rep. Himes, James A. [D-CT-4], Rep. Gottheimer, Josh [D-NJ-5], Rep. Titus, Dina [D-NV-1], Rep. Vindman, Eugene Simon [D-VA-7], Rep. Lee, Susie [D-NV-3], Rep. Fitzpatrick, Brian K. [R-PA-1], Rep. Buchanan, Vern [R-FL-16], Rep. Foushee, Valerie P. [D-NC-4], Rep. Figures, Shomari [D-AL-2], Rep. Carson, André [D-IN-7]

Recent Actions

• 2025-02-13: Referred to the House Committee on Energy and Commerce.
• 2025-02-13: Introduced in House
• 2025-02-13: Introduced in House

Bill Versions

• Humane and Existing Alternatives in Research and Testing Sciences Act of 2025 — issued 2025-02-13 — PDF (11 pages)