Animal Welfare

Applicable laws and policies

Animal research is subject to a complex network of federal and state regulations and guidelines implemented through each institution’s animal care committee. In addition, researchers, institutional veterinarians, and animal care staff are guided by ethical principles for the proper care and use of animals.

The federal agencies that oversee animal research in the United States include the U.S. Department of Agriculture (USDA), which enforces the Animal Welfare Act, and the National Institutes of Health’s Office of Laboratory Animal Welfare through its Public Health Service Policy on Humane Care and Use of Laboratory Animals.

The Animal Welfare Act generally regulates the use for research purposes of warm-blooded animals, including non-human primates, dogs, cats, guinea pigs, hamsters, and rabbits. Institutions that conduct research with these USDA-covered species must register with the USDA and are subject to periodic reporting and inspections to ensure compliance with the rule of law.

Not all animal research is subject to USDA oversight. Which laws apply depends, in part, on the type of animal. For example, research that involves fruit flies, worms, or fish is not subject to USDA oversight, nor is research involving all birds, mice, or rats. However, research funded by federal dollars that involves any vertebrate animal, including rats, mice, and birds, is subject to oversight by the NIH or the National Science Foundation.

Oversight at HMS

Animal research conducted at the basic science departments that make up Harvard Medical School falls under the purview of the Institutional Animal Care and Use Committee, or IACUC, a federally mandated body charged with ensuring that federal regulations and ethical principles and guidelines are strictly followed in the use, handling, and care of research animals. The committee was founded in 1907, nearly 60 years before passage of the Animal Welfare Act, the federal law that made such oversight bodies mandatory.

The committee reviews animal research proposals and protocols, animal care and use programs, and monitors animal facilities to ensure compliance with standards and regulatory requirements. It is composed of a veterinarian and scientists experienced in animal research and includes a non-scientist and a community member not affiliated with the institution. The latter two represent community interests and values in the proper care, use, and treatment of animals.

The use of animals in research is a privilege, not a right, and society demands that animal use in scientific research be both justified and humane. This core belief informs our policies on animal care and research at HMS.

In addition to our ongoing efforts to replace, reduce, and refine the use of animals in research whenever possible, there are many ways our faculty, staff, and trainees ensure that research animals are protected and well cared for.

IACUC responsibilities

The Harvard medical area IACUC has the following federally mandated oversight responsibilities:

• Review animal use protocols to achieve the following:
  • Ensure that the use of animals is justified, and the aims of the study cannot be achieved with alternative models.
  • Evaluate the potential relevance and value of the research.
  • Ensure proper research procedures and proper animal monitoring during the research.
  • Ensure that research is not unnecessarily duplicative and does not repeat past research studies involving animal models.
• Review significant changes to protocols.
• Evaluate institutional compliance with PHS policy, USDA animal welfare regulations, and institutional policies.
• Monitor institutional animal care and use programs, including inspecting animal facilities.
• Review concerns about animal care or use.
• Report noncompliance and suspensions to the Office of Laboratory Animal Welfare.

While the responsibility for scientific merit review normally lies outside the IACUC, the committee will evaluate scientific elements of the protocol as they relate to the welfare and use of the animals. The veterinary review focuses on all clinical aspects of the work to ensure that pain and distress are minimized.

IACUC protocols

All proposals must include a scientific justification for why the selected species is the most appropriate for the study and to justify the number of animals to be used. Principal investigators must also justify why non-animal models would not meet the study objectives. Investigators are encouraged to consult statisticians and bioinformatics specialists in determining the number of animals necessary for a project.

Investigators must demonstrate that they are using the smallest number of animals that would allow them to achieve their scientific objectives. All protocols must provide for acceptable monitoring and humane care for the animals relative to the procedures being conducted and the acceptable regulatory and veterinary standards governing such procedures. Protocols with the potential to cause pain or distress are reviewed under the auspices of the 3Rs (replace, reduce, refine), and consideration is given to whether there are reasonable and scientifically acceptable alternatives to the proposed procedures.

IACUC’s core principle in approving the use of research animals stipulates that unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in animals.

The IACUC conducts semiannual reviews of HMS facilities and programs. Researchers must submit protocols to the IACUC and receive approval before they can embark on research involving animals. All protocols are reviewed every three years.

IACUC Staff

We also employ highly trained and compassionate animal care staff, including specialists in veterinary medical care and in environment, housing, and management.

These staff members are key players in:

• Providing veterinary care to research animals.
• Training personnel on animal welfare and proper animal care and handling.
• Planning for emergencies and disasters.
• Handling physical plant issues.
• Our occupational health and safety program.
• Daily animal welfare checks.

When the HMS campus ramped down many activities at the beginning of the COVID-19 pandemic, animal care staff remained on site to make sure that lab animals critical for research were kept healthy.

Our scientists and research staff are required to complete special training and are involved in developing animal research policies, maintaining compliance, and reaching out to community members and legislators.

Finally, even with all the safeguards in place, any community member who believes animals are not being treated properly in an HMS lab is encouraged to report their concerns; this protocol includes the ability to file a report anonymously.

Beyond IACUC

In addition to Harvard’s own Institutional Animal Care and Use Committee, animal research conducted at HMS is subject to numerous policies, regulations, and oversight regarding the use of lab animals. These include:

• Animal Welfare Act, which sets standards for the humane care and treatment of certain animals, including those used in research. Established in 1966, the act has been amended multiple times over the years in an effort to refine standards of care and extend coverage.
• Public Health Service Policy on the Humane Care and Use of Animals, which stipulates that federally funded researchers can be required to give back funds from their NIH grants or even lose their grants if they do not comply with this policy
• AAALAC International, which endorses the ethical and humane use of animals to advance medicine and science in the absence of non-animal alternatives. The organization applies more stringent guidelines than the Animal Welfare Act. Like the National Institutes of Health and Public Health Service, AAALAC follows the Guide for the Care and Use of Laboratory Animals as a standard of care.
• Massachusetts Department of Public Health
• Massachusetts Division of Fisheries and Wildlife
• U.S. and Massachusetts Drug Enforcement Administrations

Additional information can be found at:

• Harvard University
• HMS and the Harvard medical area
• Harvard Catalyst

Note: Animal research conducted at the Harvard-affiliated hospitals is generally outside of the purview of IACUC and under the purview of hospital-based animal care committees. This is because Harvard Medical School neither owns, nor operationally controls, its affiliated hospitals.