Implementation in research

In the design of a research protocol, thought must be given to the implementation of humane endpoints. Information pertaining to this issue should be laid down in the protocol and should include the following points of consideration:

• the clinical course, including any critical aspects thereof, and any anticipated discomfort/pain;
• observation frequency and registration of findings;
• the humane endpoint and the parameters underlying the establishment of this humane endpoint;
• the responsibilities with respect to observation and treatment/euthanasia;
• the type of treatment/euthanasia;
• autopsy. 

Should there be any doubt as to the (clinical) progression of the illness or about the parameters for determining the humane endpoint, then conducting a pilot study with a limited number of animals is recommended.

Responsibility

Prior to the start of an animal experiment, all staff directly involved need to be accurately informed about the critical periods in the experiment. In this matter, the initiative lies with the principal investigator. All personnel must be knowledgeable about the following aspects:

• normal behavior and physiology of the animal;
• anticipated deviations from the norm in the proposed procedure;
• the moment at which a humane endpoint will be decided;
• awareness of their role and responsibility;
• the consultant in the event of unanticipated clinical effects;
• facilities and options for postmortem examination to establish the cause of death;
• a scoring system to facilitate decision making.

In case of uncertainty, expert advice must be obtained, either from the attending veterinarian, a laboratory animal specialist or a pathologist. It is important that all responsible personnel be reachable at all times for consultation, should questions arise concerning the implementation of a humane endpoint for an animal.

Pilot studies

Pilot studies are carried out prior to the main experiment to allow definition of various elements or parameters of the study. Pilot studies for setting humane endpoints in an experiment are needed when:

• the effects of the treatment are unknown, so that morbidity, time course of effects, and appropriate observation frequency still have to be more narrowly defined;
• identification of humane endpoints may be possible on the basis of specific parameters (e.g. telemetrically obtained data);
• the pathological changes observed in an animal will later be used to set humane endpoints.