Differentiation between acts of research and acts of veterinary treatment
The Panel has developed these criteria to assist Animal Care and Ethics Committees in deciding whether activities are acts of research as defined by the Animal Research Act 1985 or acts of veterinary treatment as exempted by the Act. These criteria relate to the use of therapeutic goods.
The questions to be considered are:
1. Is the procedure intended to protect the welfare of that animal; i.e. to alleviate disease or injury or symptoms thereof in the interests of maintenance of animal welfare principals, to minimise unnecessary pain, distress, or suffering. If yes, this would help establish that the act is within the definition of veterinary treatment.
2. Is the primary purpose of the procedure to establish the efficacy of the therapeutic or prophylactic agent rather than minimise pain, distress or suffering? If yes, this would assist in establishing that the act falls within the definition of animal research.
Features that would strengthen the presumption that it is an act of research, and help to rebut the presumption that it is an act of veterinary treatment.
(a) Results are to be recorded.(b) The disease has been induced specifically for this prophylactic or therapeutic regime to be evaluated.
(c) Animals suffering from the condition have been specifically located and isolated merely for establishing the efficacy of this regime.
(d) It involves the testing of new products or products for a new purpose.
(e) It is original research.
(f) the activity constitutes phase 1, 2 or 3 of an evaluation of a new product or a product for a new purpose where:
Phase 1 - the development or isolation of a new active agent
Phase 2 - determination of mode of action, sites and spectrum of activity.
Phase 3 - Accumulation of data to meet regulatory requirements for safety or efficacy, public health, or activity in most animals; for the purpose of product registration.
Activities in any of these phases are acts of research.
Features that would strengthen the presumption that it is an act of veterinary treatment, and would help to rebut the presumption that it is an act of research.
(a) There is a real risk of disease or injury or continuation thereof if the treatment is not administered.(b) The treatment or prophylaxis is a generally accepted clinical practice for treatment or prevention of this condition.
(c) The decision is one of clinical judgement rather than experimentation.
(d) The treatment or prophylaxis for that purpose is supported by the existence of published data or other evidence that it is a recognised, albeit new, form of treatment or prophylaxis for that condition.
(e) This activity is a recognised use of the compound or procedure proven by fact of existing registration for that purpose or authority of publication.