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Policy
8.0 Criteria for Evaluating Animal Care and Use Non-complieance and
Deviations
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8.1.0
PUBLIC HEALTH SERVICE MANDATE1
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As an assured institution, the University
of Hawaii and its vertebrate animal research and teaching/training
programs are required to comply with the following. The PHS Policy
on Humane Care and Use of Laboratory Animals (Policy) identifies
three areas that require prompt reporting to the Office
of Laboratory Animal Welfare — OLAW (Section IV.F., paragraph
3).
A. Any serious deviations or continuing noncompliance
with the PHS Policy
B. Any serious deviation from the provisions
of the Guide for the Care and Use of Laboratory Animal;
and
C. Any suspension of an activity by the
IACUC
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8.2.0 OFFICE OF LABORATORY
ANIMAL WELFARE (OLAW) GUIDANCE
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According to OLAW, determination that a problem
at an awardee institution falls within the meaning [letter or
spirit] of (A) or (B) requires that the institution’s IACUC
exercise a degree of professional judgment prior to reporting
the deviation to the agency.
The language used in the Policy permits judicious
application of professional judgment by animal care and use committees
in determining the incidents that should be reported to OLAW.
OLAW requires any serious noncompliance or
deviation of (A) or (B) with the PHS Policy or the Guide
must be reported, even if identified initially by other agencies,
site visitors or consultants.
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8.3.0 EXAMPLES OF OCCURRENCES
THAT MEET REPORTING CRITERIA
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A. Serious or continuing noncompliance
with the PHS Policy
- Failure to correct situations identified
in previous semiannual evaluations and approval deficiencies
- Conducting animal-related activities without
appropriate IACUC review and approval
- Failure of animal care and use personnel
to adhere to IACUC — reviewed and approved institutional
policies and procedures.
B. Serious deviation from the provisions of
the Guide
- Conditions that jeopardize the health or
well-being of animals, including accidents, natural disasters
and mechanical failures resulting in actual harm or death to
animals
- Shortcomings in programs of veterinary
care, occupational health or training, identified during semiannual
program review and not corrected within the institutionally
determined time frame.
C. Suspension of an activity by the IACUC
- An IACUC intervention that results in the
temporary or permanent interruption of an activity involving
animals.
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8.4.0 EFFECTIVE DATE
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July 2002
IACUC Approved
07/02 Reference:
1OPRR
Reports: Requirements for Prompt Reporting of Problems to OPRR,
1994
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