4.2.2 Protocol Submission and the 3Rs Principle

Every proposed study must be submitted to the IAEC as a complete protocol specifying the scientific justification for the chosen species, the number of...

Every proposed study must be submitted to the IAEC as a complete protocol specifying the scientific justification for the chosen species, the number of animals to be used (justified statistically, as discussed in Phase 6), the experimental procedures, the anaesthesia and analgesia plan, and clearly defined humane endpoints. Underlying all such protocols is the internationally accepted 3Rs principle: Replacement (using non-animal alternatives such as in-vitro or in-silico methods wherever scientifically valid), Reduction (using the minimum number of animals statistically consistent with a reliable result), and Refinement (minimising pain, distress, and suffering through improved technique, analgesia, and humane endpoints). Justification against each of the 3Rs is a mandatory component of every IAEC protocol submission.