General Summary

The proposed bill, H.R. 1291, known as the “Humane and Existing Alternatives in Research and Testing Sciences Act of 2025” or the “HEARTS Act of 2025,” seeks to amend the Public Health Service Act. It aims to prioritize the use of nonanimal methods in research conducted or funded by the National Institutes of Health (NIH). The bill also proposes establishing a National Center for Alternatives to Animals in Research and Testing within the NIH. This Center would develop and promote nonanimal research methods, fund researchers to use these methods, and reduce animal use in research.

Summary of Significant Issues

A recurring theme in the bill is the lack of specific details in several critical areas:

• Funding and Resources: While the bill emphasizes using nonanimal research methods, it does not specify how these efforts will be financed or resourced. This omission could hinder the achievement of its objectives.

• Director Appointment and Oversight: There is a lack of clear criteria or processes for appointing the director of the proposed National Center. This raises concerns about potential favoritism or a lack of transparency.

• Reporting and Compliance: The bill mandates reporting on the number of animals used in research but lacks specific penalties for non-compliance. This could lead to ineffective enforcement.

• Ambiguity in Definitions: Including cephalopods in the definition of ‘animal’ is atypical and may create confusion given current research standards.

• Execution and Responsibilities: The broad scope of responsibilities assigned to the National Center may lead to unclear execution or overly broad interpretations of its duties.

Impact on the Public

The bill has the potential to drive innovation in biomedical research by promoting nonanimal testing methods. This could lead to more efficient and effective research that better mimics human biology, potentially expediting the development of new treatments for diseases. However, without clear funding, the progress might be slowed, leaving the public without the intended benefits.

Additionally, increased transparency about the use of animals in research, as required by the reporting stipulations, could lead to greater public awareness and dialogue regarding ethical research practices.

Impact on Stakeholders

Researchers and Institutions: They may face both challenges and opportunities. On one hand, the bill provides incentives and resources for developing nonanimal research methods, which could lead to scientific advancements. On the other hand, compliance with stricter reporting requirements and the potential for resource allocation shifts could impose burdens without clear funding routes.

Animal Rights Advocates: These groups are likely to view the bill positively as it aligns with their goals of reducing animal use in research. The establishment of the National Center could also signal a governmental commitment to alternative research methods.

Federal Agencies and Legislators: They might face challenges in allocating appropriate funding and resources to the initiatives proposed by the bill. Additionally, ensuring adequate oversight to prevent favoritism or inefficient use of funds is a concern they will need to address.

Industry and Healthcare: The long-term benefits could be significant for pharmaceutical and healthcare industries, as more effective nonanimal testing models could streamline drug development and approval processes. However, transitioning to new models may involve upfront costs and adjustments in established research practices.

Conclusion

The HEARTS Act represents a significant step toward evolving the landscape of research to prioritize humane and potentially more effective testing methods over traditional animal models. However, its success hinges on how well the issues of funding, oversight, and compliance enforcement are addressed. Without clarity and support in these areas, the bill's envisioned transformation of research practices might face obstacles that could delay its potential benefits.