H.R. 1291 — HEARTS Act of 2025

This section provides the short title of the Act as the “Humane and Existing Alternatives in Research and Testing Sciences Act of 2025” or the “HEARTS Act of 2025.”

This section provides findings that the National Institutes of Health (NIH) has supported life-saving research, that an estimated 17,000,000 to 100,000,000 animals are used annually in the United States in research, education, and testing, and that approximately 30 percent of promising medications fail in human clinical trials because of toxicity and about 60 percent fail because of lack of efficacy. It also finds that publicly available NIH data on animal use are limited, that alternatives such as organoid cell cultures, multiphysiological systems, genomics, induced pluripotent adult stem cells, 3D modeling with human cells, molecular imaging, computer models, in silico trials, digital imaging, and artificial intelligence are expanding, and that a dedicated center with resources, funding, and training is needed to advance humane, cost-effective, and scientifically suitable nonanimal methods.

This section revises the animal research provisions of the Public Health Service Act under 42 U.S.C. § 289d by reorganizing subsection (a), requiring the National Institutes of Health (NIH) to establish and maintain animal care guidelines for all NIH-conducted or NIH-supported research, and adding new requirements to promote nonanimal research methods. It renumbers the existing animal care provisions so that the current paragraphs become subparagraphs and clauses, and it changes the introductory text to specify that NIH must act “with respect to all research conducted or supported by the National Institutes of Health.” The section also adds four new requirements: (1) NIH must establish a system of meaningful incentives to encourage the use of existing humane and scientifically satisfactory nonanimal methods in research proposals; (2) before any animal research is approved or performed, all scientifically satisfactory nonanimal methods for obtaining the desired results must be fully evaluated; (3) research proposals must be reviewed by at least one person with expertise in nonanimal research methods, and reviewers must have access to a reference librarian with expertise in evaluating searches for nonanimal methods; and (4) NIH must establish and maintain research proposal guidelines for conducting thorough searches for nonanimal alternatives to animal use in biomedical and behavioral research. In addition, the section makes conforming changes to the animal care committee provision by updating the cross-reference from subsection (a)(3) to subsection (a)(1)(C), and it amends the assurance requirements for research applications and contract proposals to require a statement that a scientifically satisfactory nonanimal method of obtaining the desired result is not available.

This section adds the National Center for Alternatives to Animals in Research and Testing to the list of National Institutes of Health (NIH) national research institutes and national centers under 42 U.S.C. § 281(b), redesignates the existing catchall provision as paragraph (26) from paragraph (25), and makes a conforming change to increase the total number of NIH institutes and centers to 28 from 27. It also establishes, not later than 1 year after enactment of the Humane and Existing Alternatives in Research and Testing Sciences Act of 2025, a new National Center for Alternatives to Animals in Research and Testing within NIH, headed by a director appointed by the Secretary of Health and Human Services. As background, NIH is the primary federal biomedical research agency, and this new center would focus on developing, promoting, and funding alternatives to animal research and testing and on developing a plan to reduce the number of animals used in federally funded research and testing. The center’s director would be required to provide assistance, including funding, to federally funded researchers to develop and qualify nonanimal methods (e.g., advanced cell cultures, 3D organoids, microphysiological systems, induced pluripotent adult stem cell models, in silico modeling, advanced imaging systems, and artificial intelligence), train scientists on those methods, facilitate collaborations among research institutions, and collect and publicly report information on the number of animals used in federally funded research and testing.

This section requires covered reporting entities, beginning not later than 2 years after enactment and every 2 years thereafter, to report and publicly disclose the number of animals used in federally funded research and testing at their facilities, disaggregated by species, as well as the total number of animals bred or acquired for those purposes, also disaggregated by species. It also requires each entity to update its prior report every 2 years to measure progress in reducing animal use and to submit and publicly disclose a plan for reducing those numbers. As background, the reports would cover any live, nonhuman vertebrate animal or cephalopod used or intended for use in research, research training, experimentation, biological testing, or related purposes, and would apply to any entity receiving Federal research or testing funds that uses animals, as well as any Federal department or agency that uses animals in research or testing. This section further directs the Director of the National Center for Alternatives to Animals in Research and Testing to establish a standardized process for submitting, updating, and publicly posting the required reports and plans.