Currently, the oversight of laboratory animal research in Ukraine does not involve the national government. Instead, this responsibility is delegated to local Ethics Committees. At BIENTA Ltd., the local Animal Care and Use Committee (BACUC) is entrusted with monitoring all animal research activities. The committee carries out several important tasks to ensure compliance with international animal welfare regulations and ethical standards (which one).
One of the main responsibilities of the BACUC is to review and approve Animal Use Protocols (AUPs) for studies involving laboratory rodents. They also ensure that researchers adhere to animal welfare regulations by conducting regular assessments, especially with the arrival of new projects. Additionally, the committee performs post-approval research monitoring on a regular basis.
Primary BACUC functions include:
- Monitoring compliance with sanitary standards in all areas of the animal facility.
- Initial training upon employment and subsequent regular training every year. The Committee also provides training to personnel engaged in the research and testing of rodents, either upon approval of new AUPs for new methods or regularly every three years for routine methods.
- Reviewing, approving, and suggesting corrections to each AUP according to the requirements.
The commitment of the BACUC and its members to upholding the highest standards of animal welfare and research ethics is essential for the successful implementation of animal research at BIENTA Ltd. If you have questions, please contact bacuc@bienta.net
BACUC Policies are based on
several international regulatory documents and guidelines that govern the use of laboratory animals for scientific research. Here are some of the key ones:
- The Guide for the Care and Use of Laboratory Animals (Guide): Published by the National Research Council (NRC). https://grants.nih.gov/grants/olaw/guide-for-the-care-and-use-of-laboratory-animals.pdf
- European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes (ETS 123). https://rm.coe.int/168007a67b
- Directive 2010/63/EU on the protection of animals used for scientific purposes: This European Union directive provides a framework for the protection of animals used in scientific research. https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:276:0033:0079:en:PDF
- International Council for Laboratory Animal Science (ICLAS) publications: ICLAS produces various publications and guidelines related to laboratory animal science. https://iclas.org/membership-iclas/
- International Standards Organization (ISO) standards: ISO 10993 for biological evaluation of medical devices and ISO 10993-2 for animal welfare requirements. https://nhiso.com/wp-content/uploads/2018/05/ISO-10993-2-2006.pdf
- OECD Guidance Document on the Recognition, Assessment, and Use of Clinical Signs as Humane End Points for Experimental Animals Used in Safety Evaluation, Series on Testing and Assessment, N°19, ENV/JM/MONO (2000)7, OECD, Paris. (2000). https://read.oecd-ilibrary.org/environment/guidance-document-on-the-recognition-assessment-and-use-of-clinical-signs-as-human-endpoints-for-experimental-animals-used-in-safety-evaluation_9789264078376-en#page1
- WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
- DIRECTIVE 2010/63/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 September 2010 on the protection of animals used for scientific purposes https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:276:0033:0079:en:PDF
- Law of Ukraine “On the Protection of Animals from Cruelty.” https://zakon.rada.gov.ua/laws/show/3447-15#Text