Download Section 10 – Endpoints

Section 10 – Endpoints
Principal Investigator
AUP #
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Experiment Title
Principal Investigators are advised to look carefully at this section which is a joint effort to comply with the CCAC Endpoint
Guideline (www.ccac.ca). It may require refinement as a project progresses if unforeseen complications arise. Compliance
with the CCAC Endpoint Guideline clearly places responsibility on everyone involved in the care and use of animals to ensure
that to the best of our ability, animals do not undergo “unnecessary pain and suffering”. The Principal Investigator, research
staff and students have a primary responsibility to ensure that required monitoring and records are in place. The animal care
staff and veterinarians are to assist the researchers with this task as may be required. Ultimate responsibility to deal with
situations of pain and distress lies with the veterinary staff under authority of the Animal Research Ethics Board (AREB)—see
AREB Terms of Reference. Because of the large numbers of individual animals being housed in our many facilities,
veterinary staff will usually delegate first contact with Principal Investigators to trained animal care staff to ensure open
communication and awareness of endpoint issues that may exist with research animals. In the final instance, the decision to
alleviate or terminate pain in an animal rests with the veterinary staff under the authority of AREB.
A Request for Services form must be submitted to CAF 48 hours in advance of the commencement of an experimental
procedure where endpoints apply to assist animal care staff in monitoring.
Prepare and attach an observation checklist/monitoring documentation sheet (generic monitoring sheet available at
http://www.fhs.mcmaster.ca/csd/ethics/areb/forms.htm).
A)
What is the planned time course for this experiment for an individual animal, and at what point in that timeframe could
you start to expect the animal to experience sickness, pain, distress, suffering or death?
Animal Research Ethics Board – McMaster University
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Section 10 – Endpoints
B)
What are the clinical symptoms that an animal might be expected to demonstrate? Once one or more of the following
symptoms are observed, CAF Veterinary Staff must be contacted.
Body Condition
Blue and cold extremities (ears, paws)
Decreased body condition (SOP CAF073)
Decreased body weight compared to control
Hunched posture
Lack of grooming (porphyrin staining)
Lethargic
No peer interaction (isolated)
Not responsive
Ocular discharge
Ruffled hair coat
Skin lesions (alopecia, redness, ulceration)
Tumours/Neoplasia
Indicators per Tumour Endpoints SOP CAF075
Multiple tumours
Palpable mass internal
Ulceration/infection of tumour site
Tumour location interferes with normal bodily function
Tumour size
Urogenital
Prolapsed penis
Prolapsed vulva
Demeanor (pain)
Aggressive
Restless (circling)
Vocalizing
Oral / GI / Liver
Constipation
Decreased food/water intake, anorexia
Diarrhea
Feces altered in volume, color, consistency (black with blood, pale)
Fluid accumulation in body cavities, subcutaneous tissues, etc.
Jaundice
Mucus gel-like stool
Prolapsed rectum
Salivation
Vomiting
CNS, PNS, Muscle, Skeletal
Convulsions
Head tilt
Muscular flaccidity, rigidity or weakness
Lameness
Paralysis
Paresis
Twitching
Heart/Respiration
Difficulty breathing (dyspnea)
Heart rate changes (increased/decreased)
Nasal discharge
Noisy breathing from congestion in lungs (rales)
Respiratory rate changes (increased/decreased)
Other
Dehydration
Skin tenting
Sunken eyes
C)
Which of the symptoms in B) above might be considered significant physiological/behavioural indicators that an animal
is at or near endpoint?
D)
What is the proposed monitoring frequency once the animals show signs of sickness, pain, distress or suffering in the
experiment? This must ensure the animals can be euthanized prior to death to avoid unnecessary pain and distress.
The baseline parameter is that a normal animal should be examined at least once per 24-hour period.
E)
Who will do the monitoring? Do these people require any specific training in order to recognize the indicators
discussed above? If CAF staff requires training by the research laboratory, state below.
F)
Name a primary and secondary contact in the event that the animals reach Endpoint as judged by CAF staff, and
provide respective cell phone numbers.
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Section 10 – Endpoints
G)
Who has the authority to euthanize in the Principal Investigator’s group?
H)
Animals that die unexpectedly or are euthanized at Endpoint may be submitted for post-mortem examination by CAF
Veterinary Staff. Are there any special instructions for sample collection from the animals at the time of euthanasia?
Summary (must be completed)
List the specific welfare endpoints that are to be agreed to in this project by both the Principal Investigator and AREB. These
will be applied by research staff and overseen by veterinary/animal care staff (as required by the CCAC guidelines on
choosing an appropriate endpoint in experiments using animals for research, teaching and testing).
Examples are: maximum percent loss of body weight based on proper control animals; loss of body condition based on the
Body Condition Scoring SOP; potential experiment specific complications; etc.
Attach a corresponding endpoint monitoring form that is to be completed by the investigator or staff/students and kept at the
animal room level to allow oversight by veterinary staff. A generic endpoint monitoring form is available at
http://www.fhs.mcmaster.ca/csd/ethics/areb/forms.htm.
Revised: September 2008
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