More than a Guideline: Why Compliance with the PHS Policy is not Optional

By Akosua Dufie| June 11th, 2026

The Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy) is a key legal framework for animal welfare and ethical treatment of research animals. However, unlike the Animal Welfare Act, it is uniquely enforced through funding allocation decisions, not adjudication, fines or imprisonment. The question therefore arises, how effective is the PHS’ enforcement mechanism? Does the PHS merely constitute a policy guideline for desirable conduct? Could animal research institutions refuse to comply with the PHS Policy? What would be the consequence, if any, for such non-compliance? The answers to these questions are important to determine what legal and regulatory status to ascribe to the PHS Policy.  

What is the legal basis for the PHS Policy? 

The PHS Policy derives its mandate from the Health Research Extension Act (HREA). The HREA is a federal statute which requires the National Institutes of Health (NIH) through the Office of the Laboratory Animal Welfare (OLAW) to administer the humane care and treatment of research animals. Thus, the PHS Policy implements the HREA. The PHS Policy also requires each PHS funded research activity to comply with federal animal laws such as the Animal Welfare Act, the Guide for the Care and Use of Laboratory Animals (the Guide) and the US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training. 

Who should comply and how to comply with PHS Policy?

PHS agencies and federally funded animal research institutions must comply with the PHS Policy.  Compliance is the condition precedent for receiving funds for research involving live vertebrates. The PHS Policy even extends to institutions in foreign countries receiving PHS support for animal research. Such a foreign institution must at least provide evidence that humane standards will be observed.  

To comply, a research institution must: i) obtain and maintain Assurance documents, with OLAW, of compliance with humane animal research practices. ii) Through its Institutional Official, promptly report to OLAW, any suspension, serious or persistent violation of this Policy or the Guide. iii) Establish an IACUC to review and approve animal research protocols. This review entails access to a veterinarian, trained personnel on humane animal care and experimentation, adequate housing and sanitation, the use of methods that limit animals use or reduce animal pain and a statement to justify the use of animals in the research. 

Thus, the 3Rs principles of animal Replacement, Reduction and Refinement seem to be indirectly built into the PHS framework. As science advances, a better way to ensure regulatory efficiency is to amend the PHS Policy, to mandate the use of more human centric New Approach Methodologies for biomedical research whenever available instead of animals. 

Is the PHS Policy Legally Enforceable?

Yes, the PHS Policy is legally enforceable, because it derives its mandate from a federal statute, the HREA.  Also, it is legally enforced through the quiet but potent power of funding allocation. An Animal Research institution that complies with the PHS Policy can receive NIH funding, and those who do not comply may lose money. 

Those who hold that PHS Policy is not law but policy, can point to its very nomenclature, as a ‘policy’ document despite being federal law. This oxymoronic description of a law as policy makes it counterintuitive to accept the PHS Policy as law. Also, the use of funding as the PHS Policy’s enforcement mechanism is nonconventional and a major reason for dismissing the PHS Policy’s legal efficacy. However, nonconventional does not imply ineffective. The PHS Policy is enforced through administrative channels, not judicially. It reasonably follows that administrative sanctions are preferred for violations and not court remedies. For research institutions, being deprived of funds is akin to being deprived of oxygen. Research survives on funding. The impact of a withdrawal of research funding to a research institution is arguably as effective as jail term is to individuals.   

The challenge here lies in the practical shortfalls of this policy. If every defaulting institution will be given ample time to remedy their breach, will the policy ever actually bite? The Policy should serve as an inherent notice of accepted standards for animal use in research. Instead of issuing additional notices anytime noncompliance occurs, defaulters should rather be called upon to account for their failure to comply. If the Policy should ever be meaningfully enforced, it should suffice as clear notice of recognized animal research standards with ensuing consequences.  

How is the PHS Policy Enforced?

The PHS Policy is enforced via: 

• Funding Decisions: Noncompliance with the PHS Policy means forfeiture or suspension of funding. 

• Assurance Withdrawal: The OLAW can withdraw an accepted Assurance upon a violation. 

• Corrective Measures: Research institutions may be given opportunity to take remedial steps.  

• IACUC Reports: An IACUC must report uncorrected noncompliance, any temporary suspension of animal activity and any corrective steps taken to OLAW. 

• Site Visits: PHS staff or advisors may visit research sites to evaluate compliance with the PHS Policy 

Is the PHS Policy Soft Law or Hard Law?

The PHS Policy can be considered “Soft Law’’ because it is enforced through federal grant allocation, instead of “Hard Law”, involving adjudication and criminal sanctions. Its enforcement mechanism is like many enforcement regimes under international law; monetary sanctions are imposed. Predictably, many eminent jurists have similarly argued that international law is not law because it uses Soft Law instead of Hard Law for enforcement. However, those who believe in international law can attest to money’s efficacious power in driving desired global change.  

Conclusion

For an animal research institution seeking federal dollars, compliance with the PHS Policy is not optional. Even though the PHS Policy is not enforced through punitive measures, it is still enforceable through the quiet but potent power of funding. This makes the PHS Policy uniquely enforceable, unlike many laws, and yet highly enforceable just like any other law. 

The views expressed do not necessarily reflect the official policy or position of Johns Hopkins University or Johns Hopkins Bloomberg School of Public Health.