IACUC OVERSIGHT PROGRAM
(March 2003, rev May 2003)

The Animal Welfare Act (AWA), Public Health Service (PHS), and UCSF policies require that a comprehensive ongoing inspection and audit program be in place to review the compliance record of the users and the facility. This includes the review of procedures to ensure compliance with the terms of approved protocols, checking of supplies for expired materials and controlled substances, noting general facility conditions and performing other specific mandates required by the Institutional Animal Care and Use Committee (IACUC).

The IACUC oversight will fall under one of the three categories defined below:

1. Inspections

Inspections are conducted as a result of a specific issue or concern and could be prompted by receipt of a complaint, an Animal Care and Use Concern Reporting Form, request from a regulatory agency or the Institutional Animal Care and Use Committee. All these instances will be investigated in accordance with the protocol outlined under the existing UCSF-Animal Welfare IACUC Policy on Report and Follow-up of Animal Care and Use Concerns.

2. Audits

Audits are part of the routine quality control program during which IACUC staff conducts ongoing audits of approved protocols. Current Policy is to annually audit all protocols with USDA covered species and at least annually 20 % of others.

The extent and content of the audits will vary depending on the specific protocol being audited.

At the end of each audit the IACUC staff will:

1. Discuss their findings with the PI or the Alternate Responsible Person named in the protocol when appropriate. The discussion will include any corrective actions needed.
2. Send, within five working days, the PI or the Alternate Responsible Person a written report describing any findings, corrective actions required and the deadline for a written response.
3. Determine, upon receipt of the responses from the PI, if a Follow-up visit is necessary to conclude the audit. In the event of failure by the PI to respond to the report in a timely manner IACUC staff will contact the PI by phone or in person.
4. Determine the type and severity of the findings and corrective actions taken. The IACUC has classified the infractions into three broad categories:
   1. Active welfare concern for an animal still on project: IACUC, or LARC, veterinarian will examine the animal and take necessary immediate actions to assure animal welfare. IACUC Chair will be contacted with findings to discuss the need for subcommittee review.
   2. Protocol deviations with no immediate welfare concerns for animals present may fall within one of the following categories and corresponding actions:
      • Major deviations (e.g. failure of monitoring, departure from anesthesia or analgesia commitments) The PI will be given a deadline to respond to IACUC report with an explanation of the reason for failure and plans for correction and/or protocol modification as necessary. Based on the significance of the infraction, the IACUC Chair may be notified and the case will be reported to IACUC during meetings.
      • Moderate Deviations (e.g. personnel qualified but not added to protocol, unapproved procedures with no animal welfare concerns): The PI will be given a deadline to respond to IACUC report with an explanation of the reason for failure and plans for correction and/or protocol modification as necessary. Based on the significance of the infraction the IACUC Chair may be notified and the case will be reported to IACUC during meetings.
   Notes:
   • The investigators are reminded that they must follow their approved protocols exactly until they have obtained a written modification approval from the IACUC.
   • In addition to IACUC staff audits, Departmental Safety Advisors (Office of Environmental Health and Safety) audit animal use semi-annually during their routine laboratory safety audits, and report their findings to the IACUC compliance staff.
5. IACUC Actions. After reviewing the facts surrounding the violation, and after having given the investigators an opportunity to present his or her case to the IACUC, the Committee will take appropriate corrective action. This action may range from, but is not limited to, requiring more frequent laboratory inspections and/or monitoring, requiring additional training, placing the PI on probation for a period of time, removing certification of certain individuals, to suspension of the approval of the protocol.
6. Maintain a file of the original report, supporting documents, responses and follow-up visits in a separate filing system. Routine Audits are reported as described above and no Animal Care and Use Concern Reporting Forms will be generated.
1. Note: LARC VETERINARIANS ARE AUTHORIZED TO STOP ALL ACTIVITIES WHICH ARE
   • Unapproved
   • Clear violation of the approved protocol, or
   • Have unapproved adverse animal welfare impacts
2. Major violations of Animal Welfare Act will be reported to the IACUC Chair immediately. The IACUC Chair has the discretion to call together a subcommittee to discuss the violation before the next convened full committee meeting.
3. Suspension of a protocol requires IACUC approval by a convened quorum of the IACUC.



3. Reviews
1. Lab Review

Reviews are site visits conducted to observe certain procedures or activities and may be requested by the IACUC or the PI. In general the purpose of these reviews is to observe an activity (e.g., a PI is starting a procedure that they have not conducted before) and provide feedback to the IACUC or a PI. Depending on the nature of the request these reviews are often excellent forums for training and may or may not require a formal report to the IACUC.

2. Semi-Annual Facilities and Program Reviews

   IACUC is required to conduct semi-annual facilities and program reviews and submit written reports to the Institutional Official.

   These reviews include a review of both IACUC related activities and LARC operations.

Record Keeping

The AWA, PHS and UCSF policies mandates certain specific record keeping requirements; IACUC will be responsible for maintaining copies of the following records:

• Protocol applications and related correspondence
• Training records and materials
• Inspections, audits and review reports and related correspondence
• Semi-annual program review and responses
• Member handbook
• IACUC related documents and full-committee meeting minutes
• Animal Welfare Assurance
• USDA and OLAW Inspections, responses and related correspondence
• Forms and guidance current on the IACUC web site.