Laboratory animal research in clinical trials is essential for the life sciences industry, enabling advancements in pharmaceuticals and medical device research. However, studies using laboratory animals must adhere to stringent regulations to ensure ethical treatment of animals and compliance with regulatory standards. Understanding these regulations is key to maintaining a high standard of care, avoiding non-compliance and fostering public trust.
The Animal Welfare Act (AWA) is the primary federal law governing the care and use of laboratory animals in the United States [1]. It is administered by the USDA and mandates humane treatment for a wide variety of species [1]. Interestingly, it does not include rats, mice, and birds bred for research [1]. Some requirements include adequate housing, veterinary care, and training for personnel that come in contact with animals. Another relevant regulation is the public health service (PHS) policy, which protects all vertebrate animals used in federally funded research. PHS is overseen by the Office of Laboratory Animal Welfare (OLAW), which requires institutions to follow the standards outlined in the Guide for the Care and Use of Laboratory Animals. Institutions must also establish an Institutional Animal Care and Use Committee (IACUC) to oversee compliance and review proposed research protocols. Good Laboratory Practices (GLP), are enforced by the FDA and EPA, ensure that data from studies are reliable and support product approval. These guidelines emphasize proper documentation, training, and oversight, ensuring that laboratory animal care and handling meet ethical and scientific standards
Compliance with laboratory animal regulations is a critical responsibility for life sciences professionals. By getting ahead of regulations and implementing best practices, organizations can have an easier time upholding ethical standards, ensuring research integrity, and driving innovation.
EMMA International provides full-circle solutions for all aspects of clinical research, with and without laboratory animal research. Give us a call at 248-987-4497 or email us at info@emmainternational.com to learn more about how EMMA International can take the stress out of quality and regulatory compliance!
[1] USDA (2024) Animal Welfare Act, Retrieved on 19 December from: https://www.nal.usda.gov/animal-health-and-welfare/animal-welfare-act
