CCAC Training Module on: the Ethical Use and Care of Farm Animals in Biomedical Research

1. CCAC Training Module on: the Ethical Use and Care of Farm Animalsin Biomedical Research www.ccac.ca

2. Species Applicability • This training module applies to all farm animals used in biomedical research including: • dairy and beef cattle • sheep • goats • swine • poultry • horses • farmed wildlife

3. Training Module Goals • Provide an overview of the special care requirements of farm animals in biomedical research • Establish methodology for selecting appropriate farm animal models, as well as endpoints which address animal welfare while achieving scientific goals • Provide investigators with references and resources for the use of farm animals in biomedical research Basic principles of farm animal welfare, fundamental needs, acquisition, routine handling and specialized procedures and termination of scientific use are covered in the CCAC training module on: the ethical use and care of farm animals in science (2010)

4. Training Module Outline • Biomedical research and other applications • Special considerations and challenges • Model selection • Meeting animal needs • Facility and disease control considerations • Example of biomedical application: Medical devices

5. Farm Animals in Biomedical Research • The purpose of utilizing farm animals in biomedical research and science is to address questions concerning human health • Many applications exist, e.g.: • neurological research • development and testing of pharmaceuticals and medical devices • reconstructive surgery research • medical education

6. Farm Animals in Biomedical Research Photo courtesy of M. Smit Photo courtesy of UBC Animal Welfare Program Photo courtesy of O. Zobel • Swine • e.g., skin grafts or skin testing; reconstructive surgery • Calves • e.g., ventricular assist devices • Chickens • e.g., production of antibodies in eggs

7. Challenges of Using Farm Animals in Biomedical Research • Consider that agricultural performance and scientific biomedical outcomes may have no relation • Animal selection and management must be flexible, and made on a case-by-case basis Good animal welfare Scientifically relevant outcomes + GOAL:

8. Consideration for The Three Rs Replacement • is it possible to use non-animal models? Reduction • what is the minimum number of animals needed in order to achieve statistically relevant results? Refinement • have replacement and reduction alternatives been considered? • has pain and distress been minimized as much as possible?

9. Selecting an Appropriate Farm Animal Model • Husbandry and housing requirements • Availability of information (anatomy, physiology, behaviour) • Suitability to research objectives and experimental conditions • Applicability of resulting data to human physiology • Sentience • Lifespan • Availability in captivity • Tolerance to humans Photo courtesy of M. Smit

10. Appropriate Models in Relation to Study Duration • Consider growth and life stage in relation to study requirements • Adult human models • need physiological, anatomical or biochemical criteria match • issues: maturity, size, long-term studies difficult • Pediatric Models • shorter time course to adulthood useful for answering questions in research timeframe

11. Other Considerations • Genetic variability • farm animals have greater genetic variability than conventional laboratory animals • consequence: increased Photo courtesy of UBC Animal Welfare Program • variability in treatment response, may require increased number of animals for scientific significance • Animal Acquisition • similar requirements to conventional research animals with additional regulations in some cases

12. Meeting Animal Needs in Confinement • Understanding the needs of animals is necessary to choose an appropriate animal model • experimental design should address the infrastructure needed to meet animal needs • provide exercise every 7 days (minimum) • habituate to handling before study commencement Photo courtesy of M. Smit

13. Facilities & Disease Control Considerations • Species-specific husbandry • Sanitation and hygiene program to address animal and human health issues • dedicated equipment • medical management according to standard veterinary practices • necropsy facilities address zoosanitary issues • Zoonoses infection control • particularly important for “cross-over” agents

14. Example of a Biomedical Application: Medical Devices • Two types of devices • external: may require animal restraint and confinement • internal: require on-going short and long-term assessment strategies • Size and physiological similarities make farm animals good candidates for testing medical devices such as: • ventricular assist devices (cardiovascular research) • bone implants (endosseous research) • implanted cerebral stimulators (neural research) • The testing of medical devices requires careful attention to potential welfare impacts, special care, and endpoint determination

15. Medical Devices How do in vivo medical devices impact the animal?

16. Medical Device Testing • Prior to in vivo, test in vitro to ensure intended use is appropriate for target species • devices must be designed in the context of intended use and the target species • during design refinement, could use non-survival, anesthetized animal models

17. Medical Device Failure & Endpoints • Protocol should include device performance reliability, biocompatibility, device failure and repair strategies • Endpoints should balance the scientific goals and animal welfare, and detail the procedures needed to handle device failure and malfunction • minor component – replacement might be an option • if repair/replacement of component involves major surgery – euthanasia may be the most humane endpoint For further information on endpoints: CCAC guidelines on: choosing an appropriateendpoint in experimentsusinganimals for research, teaching and testing(1998) CCAC training module on: pain, distress and endpoints

18. Summary • Farm animals are useful in some biomedical research, as long as the correct model is used • Careful consideration must be given to: • balancing animal needs and achieving scientific goals • understanding animal welfare impacts on the specific biomedical research • Investigators should strive to achieve their scientific goals in line with the best possible animal welfare standards