Approved June 28, 2000.

Policy:

All concerns and significant deficiencies will be reported to the attending veterinarian, the IACUC chair or vice chair, and the IACUC coordinator for review and discussion. [An exception will be made when the concern involves one of the aforementioned.] After careful deliberation, these individuals will collectively agree upon and follow a course of action deemed to be in the best interest of the welfare of the animals. The Institutional Official will be included in such deliberations if available; otherwise he will be apprised of the situation as expeditiously as possible. A written report of such action will be submitted to the IACUC on the next working day. This report should indicate whether deficiencies are husbandry, programmatic, or facilities.

The Universitys attending veterinarian, or his designee, unilaterally may decide to euthanize an animal in extreme distress or pain that cannot be alleviated, if euthanasia is determined to be in the best interest of the animal. (See II.A.7, IACUC SOP on Adequate Veterinary Care.) All reasonable attempts to receive advice from the above individuals and the principal investigator should be exhausted before such decision is made. A written record of such action will be submitted to the IACUC on the next working day. This report should indicate whether deficiencies are husbandry, programmatic, or facilities.

Similarly, the Universitys attending veterinarian, or his designee, unilaterally may ask an investigator to cease procedures in process when the veterinarian determines the animal to be in extreme distress or pain, if cessation of work in progress is determined to be in the best interest of the animal. (See II.A.7, IACUC SOP on Adequate Veterinary Care.) All reasonable attempts to receive advice from the above individuals and the principal investigator should be exhausted before such decision is made. A written record of such action will be submitted to the IACUC on the next working day. This report should indicate whether deficiencies are husbandry, programmatic, or facilities.

Minor deficiencies encountered during the IACUC inspection of facilities should be addressed and, if feasible, corrected at that time with a notation made on the inspection report. IACP or LAR staff will follow-up on those not corrected at the time of the inspection.

Definitions:

1. For the purposes of this policy, Deficiencies include:
   1. Significant: one which is or may be a threat to the health or safety of the animals.

      The official definition is "with reference to Subchapter A of the Animal Welfare Act," or "one which, consistent with PHS Policy, and, in the judgment of the IACUC and the Institutional Official, is or may be a threat to the health or safety of the animals" (9CFR2.31(c)(3) and PHS IV.B.3).

   2. Minor: any deficiency not considered significant.

2. For the purposes of this policy, Concerns include
   1. Complaints received from members of the public regarding the care and use of animals at any of the UTHSCSA facilities, or
   2. Reports of noncompliance received from laboratory or research facility personnel or employees regarding the care and use of animals at any of the UTHSCSA facilities.

Required action:

Related to inspections and the semi-annual review of programs:

9CFR2.31(c)(3): "If [in the semi-annual review of programs] program or facility deficiencies are noted, the reports must contain a reasonable and specific plan and schedule with dates for correcting each deficiency. Any failure to adhere to the plan and schedule that results in a significant deficiency remaining uncorrected shall be reported in writing within 15 business days by the IACUC, through the Institutional Official, to APHIS and any Federal agency funding that activity;

PHS: IV.B.3: Report of the semi-annual review of programs "must identify specifically any departures from the provisions of the Guide and this Policy, and must state the reasons for each departure. The reports must distinguish significant deficiencies from minor deficiencies. If program or facility deficiencies are noted, the reports must contain a reasonable and specific plan and schedule for correcting each deficiency."

Suspension of work in progress:

9CFR2.31(d)(6) and PHS: IV.C.6: "The IACUC may suspend an activity only after review of the matter at a convened meeting of a quorum of the IACUC and with the suspension vote of a majority of the quorum present."

9CFR2.31(d)(7) and PHS: IV.C.7: "If the IACUC suspends an activity involving animals, the Institutional Official in consultation with the IACUC shall review the reasons for suspension, take appropriate corrective action, and report that action with a full explanation to OLAW [APHIS] and any Federal agency funding that activity".

Under the Texas Open Meetings Act, notice of such a meeting would have to be posted in Austin a minimum of 7 days prior to the meeting.

Review of concerns about the use of animals:

9CFR2.31(c)(4): "Review, and, if warranted, investigate concerns involving the care and use of animals at the research facility resulting from public complaints received and from reports of noncompliance received from laboratory or research facility personnel or employees;"

PHS IV.B.4: With respect to PHS-conducted or supported activities, the IACUC shall "review concerns involving the care and use of animals at the institution" and "be authorized to suspend an activity involving animals" as set forth in IV.C.6.

Reporting requirements in addition to the above:

PHS: IV.F.3: The IACUC, through the Institutional Official, shall promptly provide OPRR with a full explanation of the circumstances and actions taken with respect to:

1. any serious or continuing noncompliance with this Policy;
2. any serious deviation from the provisions of the Guide; or
3. any suspension of an activity by the IACUC.

Authority:

9CFR2.31(d)(6): "The IACUC may suspend an activity that it previously approved if it determines that the activity is not being conducted in accordance with the description of that activity provided by the principal investigator and approved by the Committee. "

PHS IV.C.6: "The IACUC may suspend an activity that it previously approved if it determines that the activity is not being conducted in accordance with applicable provisions of the Animal Welfare Act, the Guide, the institution's Assurance, or IV.C.1.a.-g. of this Policy."

9CFR2.31(c)(8): The IACUC shall "be authorized to suspend an activity involving animals in accordance with the specifications set forth in" 9CFR2.31(d)(6) above.

9CFR2.31(c)(3): With respect to activities involving animals, the IACUC shall conduct evaluations and prepare reports of such evaluations. "The reports must contain a description of the nature and extent of the research facility's adherence to this subchapter, must identify specifically any departures from the provisions of title 9, chapter I, subchapter A--Animal Welfare, and must state the reasons for each departure. The reports must distinguish significant deficiencies from minor deficiencies.

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