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Policy 8.0 Criteria for Evaluating Animal Care and Use Non-complieance and Deviations

8.1.0 PUBLIC HEALTH SERVICE MANDATE1

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

8.2.0 OFFICE OF LABORATORY ANIMAL WELFARE (OLAW) GUIDANCE

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.

8.3.0 EXAMPLES OF OCCURRENCES THAT MEET REPORTING CRITERIA

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.

8.4.0 EFFECTIVE DATE

July 2002

IACUC Approved 07/02 Reference:

1OPRR Reports: Requirements for Prompt Reporting of Problems to OPRR, 1994

For more information Contact the University of Hawaii Compliance Officer:

University of Hawaii
2538 McCarthy Mall
Snyder Hall 410
Honolulu, HI 96822
Phone: (808) 956-4552, (808) 956-4446
Fax: (808) 956-5785
Email:
Mr. Norman Magno at nmagno@hawaii.edu
Ms. Denise Yee at deniseye@hawaii.edu

Web Page Maintained by: sylviak@hawaii.edu
Last modified: [10-7-02]