IACUC POLICY ON REPORT AND FOLLOW-UP OF ANIMAL CARE AND USE CONCERNS (Rev. 2/05, Rev. 11/03, Rev. 6/01/01)

Background

UCSF recognizes that it is a privilege to use animals in research and instruction, and is committed to protecting the welfare of these animals. The Institutional Animal Care and Use Committee, and the Laboratory Animal Resource Center rely upon all who work with research animals at the University to share this commitment. Thus, any time any UCSF employee has concerns with respect to the animal care or use at UCSF, they are encouraged to report the situation immediately. These concerns may include but are not limited to all aspects of the NIH Guide for the Care and Use of Laboratory Animals.

Policy

For any situation in which UCSF personnel become concerned about any aspect of animal care or use at the University, the Institutional Animal Care and Use Committee (IACUC), and the Laboratory Animal Resource Center (LARC) have established a formal process and set of procedures for reporting and following up on such concerns.

Individuals may report their concerns by phone, in writing, or by fax or e-mail if confidentiality is not an issue (see specific information below, under "Individual Reporting Concern"). The person making the report is not required to provide his or her name. A LARC veterinarian will evaluate the situation, attend to the health of the animals, and then complete a report form that is immediately forwarded to the IACUC. The IACUC will take appropriate action in a timely manner. The procedures for reporting and follow-up of animal care or use concerns are described below.

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Implementation

Individual Reporting Concern

All calls and reports may be made anonymously.

Any individual identifying any animal care and/or use concern(s) or possible protocol violation(s) should do either of the following:

1) Talk to or call one of the individuals listed below. Contact numbers are also listed on flyers posted throughout the LARC facilities.

LARC On-Call Veterinarian
Phone: 502-8687; Fax: 502-8252; Box 0564

Institutional Animal Care and Use Committee (IACUC) Office and Chair
Phone: 476-2197; Fax: 502-7991; Box 0547

Associate Vice Chancellor, Research
Phone: 476-5869; Fax: 502-0478; Box 0962

2) Obtain a copy of the "UCSF Animal Care and Use Reporting Form". The individual may also call the LARC office (476-2204) or the IACUC office (476-2197) for a copy of the form.

Then fill out Part A of the form. Once Part A is completed, forward a copy to the form to one of the fax or box numbers listed above. Alternatively, if anonymity is not at issue, you can instead hand the form directly to a LARC veterinarian or drop the form off at the LARC or IACUC office. Note: If a concerned individual calls instead of filling out the form, the person who takes the call will fill out Section A of the Report Form and forward it to a veterinarian.

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Veterinarian

1) The veterinarian will immediately attend to any health issues of the animal(s), up to an including immediate termination of the experiment on the animal(s), if needed.

2) The veterinarian will then complete Part B of the form. Part B documents the veterinary evaluation of the situation, any discussions with personnel on site and/or with the PI, any actions taken with respect to the health of the animals and an initial assessment of whether there were any possible protocol violations. Note: This Report Form does not replace Health Notes entered in the charts.

3) After completing Part B, the veterinarian will forward a copy of the form to the IACUC office and the PI. He will then make the following determination:

a) If neither major animal health concerns nor protocol violations were noted in Part B, then the information on this form will be provided to the IACUC at one of its regularly scheduled meetings.

b) If any health concerns or possible protocol violations were found, the veterinarian will immediately contact (by phone or pager) the IACUC Chair and fax a copy of the Report Form to him/her. Examples of protocol violations include the following: personnel who are not listed on the approved protocol and/or not properly trained performing procedures; procedures not listed in protocol being performed; procedures listed in protocol not being performed as appropriate. The veterinarian will also alert the PI to the situation.

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Institutional Animal Care and Use Committee

Depending on its assessment of the report, the IACUC will handle the matter as follows:

1) If the situation is determined to be severe, the Chair or Vice Chair will call an immediate meeting of a subcommittee composed of the Chair, a veterinarian, and one other IACUC member. This subcommittee will review the case immediately and take appropriate action. This action may include placing a temporary hold on all activity on the study until the full committee is able to meet and review the incident. The PI, or Alternate Responsible Individual if the PI is unavailable, will be notified of such action (by phone or pager) by the Chair and in writing by the IACUC office. The veterinarian will notify LARC. If a temporary hold is placed on the study, the investigator will not be able to order more animals until the matter is resolved.

2) At the next meeting of the full IACUC, which may be either a regularly scheduled meeting or a specially convened meeting if necessary, the full committee will review and evaluate the report and any additional information. The full committee will determine the appropriate course of action and/or sanctions to follow. This determination will be based on several factors including but not limited to the nature, cause and severity of the violation as well as other circumstances.

3) 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.

4) The IACUC will immediately notify the PI and LARC in writing of any enforcement actions taken and any corrective actions required.

5) Only the IACUC can authorize protocol reinstatements. All reinstatements will be made in writing to the PI and to LARC.

Notes about Protocol Suspensions:

• All suspensions have to be reported to the Office of Laboratory Animal Welfare (OLAW) at the NIH and the federal granting agencies. If regulated species are involved in the research, then the USDA must also be notified. The reports need to include the reasons for the suspension and the corrective action taken.
• All animals housed under a suspended protocol will be transferred to a LARC holding protocol; the PI (and his or her staff) will not be allowed to continue the research with these animals during the period of the suspension.
• The PI will be liable for continued housing per diems as well as any additional animal care costs incurred as a result of the transfer.

The Investigator

The veterinarian will contact the investigator before he completes Part B of the UCSF Animal Care and Use Concerns Reporting Form.

The investigator will be given an opportunity to present his or her case before the Committee. The case may be made in writing or in person.

Unless a sanction results in a suspension of the IACUC approval by a convened quorum of the IACUC, if a PI disagrees with the findings of, or the sanctions imposed by, the IACUC, he or she may appeal to the Institutional Official (currently Executive Vice Chancellor A. Eugene Washington, M.D., M.Sc.).