IACUC Guideline VII
Procedures for Correcting Significant Violations of Animal Care and Use Policies

The Pennsylvania State University operates its animal care and use program according to the policies of the Public Health Service (PHS) and the requirements of the Animal Welfare Act (AWA). This includes submitting an assurance to the PHS, indicating the program's compliance with all PHS regulations. The purpose of this document is to describe the process that will be followed when a significant violation of compliance occurs.

Individuals who utilize vertebrate animals under the auspices of Pennsylvania State University must comply with the Animal Care and Use Program Assurance. Failure to comply jeopardizes the privilege of using any animals in research or related activities at the Pennsylvania State University. The Institutional Animal Care and Use Committee (IACUC) has the responsibility of providing oversight of all animal related activities conducted at Penn State. Both Federal law and the University's assurance provide guidelines for suspending animal related activities in the event of violations to the Animal Welfare Act or the PHS submitted assurance.

If animals are determined to be at risk by the Attending Animal Resource Program Veterinarians, the Animal Resource Program staff in conjunction with Office for Research Protections staff may confiscate animals, remove them from the control of the principal investigator, treat the animals, and/or euthanize them pending an inquiry/investigation as described below. Certain situations may also necessitate the Senior Vice President for Research, or designee, to suspend animal activities until an inquiry/investigation is conducted as described below.

Definitions:

Inquiry is defined as information-gathering and preliminary fact-finding to determine whether the potential noncompliance warrants an investigation.

Investigation is defined as a formal examination and evaluation of relevant facts to determine whether noncompliance has taken place or, if noncompliance has already been confirmed, to assess its extent and consequences and determine appropriate action.

Procedures:

Inquiry process: Upon notification of an alleged noncompliance issue, the IACUC Chair (or his/her designee), the Compliance Coordinator, an IACUC veterinarian, and at least one other IACUC member will immediately conduct an inquiry. If after the inquiry it is determined that the alleged non-compliance requires no further investigation by the IACUC, the summary will be provided to the IACUC as which time each member of the committee will have the opportunity to ask that the incident be sent to full committee review for further investigation or clarification.

If it is determined from the inquiry that the alleged noncompliance warrants further investigation, the Compliance Coordinator will:

1. Notify the principal investigator (PI) of the allegation(s) of noncompliance and the procedures to be followed until the IACUC can fully investigate the issue. The principal investigator will be personally contacted by ORP and confirmation of the conversation is verified by email;
2. Notify the Institutional Official, principal investigator's department head and research dean of the allegations;
3. Schedule a meeting of the IACUC as quickly as possible to conduct an investigation of the alleged noncompliance;

Notification of governing bodies: Upon completion of the inquiry process OLAW, AAALAC and the USDA (if it is a USDA cover species) will be notified if:

1. The IACUC suspends protocol activities;
2. The IACUC determines there has been serious or continuing non-compliance or;
3. The IACUC determines that there has been serious deviation from the provisions of the Guide.

Investigation Process: The principal investigator involved in the alleged non-compliance will be requested to meet with the IACUC to explain the circumstances and/or discuss possible solutions to the problem. If necessary the IACUC may schedule additional meetings with other faculty, research technicians, animal care staff, and/or students to provide additional information. The IACUC may also review records or documents related to the protocol.

Once the IACUC has completed the investigation and made a determination, the principal investigator responsible for the actions will be directly contacted in writing, with a copy being provided to the institutional official, the investigator's department head, and research dean. The correspondence will summarize the findings of the committee and provide IACUC implemented sanctions. If necessary, the correspondence will provide the conditions to be met prior to the investigator resuming animal related activities. The Office for Research Protections will submit the IACUC's findings and determination as a written report to AAALAC, OLAW and the USDA (if a covered species is involved), as required.

Should non-compliance activities continue by a principal investigator, the investigator may permanently lose the privilege of utilizing animals as part of his/her research activities. If necessary, additional corrective actions may occur.

Last Revised by the IACUC on 12/11/2006
Last Approved by the IACUC on 12/08/2008