Refining animal models in fracture research: seeking consensus in optimising both animal welfare and scientific validity for appropriate biomedical use
1 Equine Hospital, Vetsuisse Faculty University of Zurich, Winterthurerstrasse 260, CH-8057 Zurich, Switzerland
2 Royal Veterinary College and Institute of Orthopaedics and Musculoskeletal Science, University College, London, UK
3 College of Veterinary Medicine, Michigan State University, East Lansing, MI, 48824, USA
4 AO Research Institute, AO Foundation, Clavadelerstrasse 8, CH-7270 Davos, Switzerland
5 Institut für Unfallchirurgische Forschung und Biomechanik, Universitätsklinikum Ulm, Germany
6 MatSearch, Ch. Jean Pavillard 14, CH-1009 Pully, Switzerland
7 Institut für Öffentliches Recht, Universität Bonn, Germany
8 European Academy for the Study of Scientific and Technological Advance, Bad Neuenahr-Ahrweiler, Germany
9 Ethik im Diskurs, University of Zurich, Zurich, Switzerland
10 Department of Pharmaceutics and Pharmaceutical Chemistry, University of Utah, Salt Lake City, UT 84112-5820, USA
BMC Musculoskeletal Disorders 2007, 8:72 doi:10.1186/1471-2474-8-72Published: 1 August 2007
In an attempt to establish some consensus on the proper use and design of experimental animal models in musculoskeletal research, AOVET (the veterinary specialty group of the AO Foundation) in concert with the AO Research Institute (ARI), and the European Academy for the Study of Scientific and Technological Advance, convened a group of musculoskeletal researchers, veterinarians, legal experts, and ethicists to discuss, in a frank and open forum, the use of animals in musculoskeletal research.
The group narrowed the field to fracture research. The consensus opinion resulting from this workshop can be summarized as follows:
Results & Conclusion
Anaesthesia and pain management protocols for research animals should follow standard protocols applied in clinical work for the species involved. This will improve morbidity and mortality outcomes. A database should be established to facilitate selection of anaesthesia and pain management protocols for specific experimental surgical procedures and adopted as an International Standard (IS) according to animal species selected. A list of 10 golden rules and requirements for conduction of animal experiments in musculoskeletal research was drawn up comprising 1) Intelligent study designs to receive appropriate answers; 2) Minimal complication rates (5 to max. 10%); 3) Defined end-points for both welfare and scientific outputs analogous to quality assessment (QA) audit of protocols in GLP studies; 4) Sufficient details for materials and methods applied; 5) Potentially confounding variables (genetic background, seasonal, hormonal, size, histological, and biomechanical differences); 6) Post-operative management with emphasis on analgesia and follow-up examinations; 7) Study protocols to satisfy criteria established for a "justified animal study"; 8) Surgical expertise to conduct surgery on animals; 9) Pilot studies as a critical part of model validation and powering of the definitive study design; 10) Criteria for funding agencies to include requirements related to animal experiments as part of the overall scientific proposal review protocols. Such agencies are also encouraged to seriously consider and adopt the recommendations described here when awarding funds for specific projects. Specific new requirements and mandates related both to improving the welfare and scientific rigour of animal-based research models are urgently needed as part of international harmonization of standards.