Blog article by Ben Wyman, M.A., Ashlie Reker, Ph.D.
In vivo research is a crux of the drug discovery and treatment development process to get novel therapeutics to patients. Several governing bodies serve to guide in vivo researchers to achieve the highest degree of animal welfare during this process. While the overall principles are the same across the globe, centering around the 3 Rs¹ (see our earlier post on this here), requirements do vary by country and region.
In the United States, animal research must adhere to directives defined by the USDA, IACUC, and AWA, while the European Union follows regulations put forth in the European Directive 2010/63/EU. The EU requirements for animal research embody exceptional international standards and are considered one of the strictest in the world.²
Compared to the US, EU and UK regulations are often considered more progressive and broader in their exigencies for the proper treatment of laboratory research animals, applying stricter regulations to a wider range of species such as the recent recognition of sentience for crustaceans and cephalopods by the UK³.
In addition the EU federally regulates the use of mice and rats just as strictly as higher order animals such as pigs and non-human primates, while in the US, rats, mice, and birds, are not protected by federal regulation. Where the animals come from also matters in EU regulations as all animals included need to be bred specifically for research purposes.
These animals include:
Mice
Rabbits
Rats
Cats
Zebrafish
Dogs
Frogs
Non-Human Primates5
The directive also requires comprehensive reporting to include, for example, number and severity of procedures per year, the type of research, and the number of times an animal has been used for experiments.6
No matter where your research lab is located, it’s easy to use Climb’s comprehensive audit trail and reporting to adhere to your local animal research regulations. Using the animal and study management functionality, researchers can query and report on an animal’s history, including housing history, experiments it was enrolled on, procedures done to the animal, and the animal’s clinical records.
Climb also keeps your study data associated both with the research animal and the individual who collected that data, stored in the cloud for future reference.
[1] Barley, J. (2005) Balancing the needs of animals and science. School Science Review, 87(319) https://speakingofresearch.com/facts/animal-welfare-the-3rs/
[2] Tomaselli, P.M. (2003). Overview of International Comparative Animal Cruelty Laws. Michigan State University College of Law. https://www.animallaw.info/article/overview-international-comparative-animal-cruelty-laws
[3]Aridi, R. (2021) Lobsters, Crabs and Octopuses Will Now Receive Welfare Protection as ‘Sentient Beings’ in the UK. Smithsonian Magazine. https://www.smithsonianmag.com/smart-news/lobsters-crabs-and-octopuses-will-be-recognized-as-sentient-beings-in-the-uk-warranting-welfare-protections-180979113/
[4] National Research Council (US) Committee to Update Science, Medicine, and Animals. Washington (DC). Science, Medicine, and Animals (2004). https://www.ncbi.nlm.nih.gov/books/NBK24650/
[5] EU Regulations on Animal Research. European Animal Research Association (2022). https://www.eara.eu/animal-research-law
[6] Vasbinder, M.A. & Locke, P. (2016). Introduction: Global Laws, Regulations, and Standards for Animals in Research. ILAR Journal, 57(3) https://academic.oup.com/ilarjournal/article/57/3/261/3796595
