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Policy#: 529-205

Title: IACUC PROCEDURES: Investigation and Resolution of Non-Compliance Involving Vertebrate Animals

Effective: 2/21/2023


I: Related Policies and Guidance

Policy 529-201: Reporting the Mistreatment of Animals and Deficiencies in Their Care at UCR

Policy 529-271: Authority of the Attending Veterinarian

II: Background

UCR maintains standards to comply with the Federal Law of the United States Department of Agriculture (USDA), the Office of Laboratory Animal Welfare (OLAW), and voluntary accrediting bodies such as the AAALAC. All individuals using animals at UCR must follow standards set forth by IACUC and UCR internal policy, accreditation agencies guidelines, and regulatory agencies. When non-compliance is alleged or reported, the IACUC must determine if noncompliance has occurred and then possibly take corrective action.

At any time, the Attending Veterinarian (AV) can halt or prevent any unacceptable procedures. The situation is then referred to the IACUC for immediate review and possible action.

The following Policy describes the procedure when noncompliance has been identified.

III: Policy

A. Investigation:  

a) Any suspicion of non-compliance should be reported, according to the policy “Reporting the Mistreatment of Animals and Deficiencies in Their Care at the University of California, Riverside”.
b) When the possibility of noncompliance is referred to the IACUC, an investigational record will be opened and the possibility of non-compliance will be ascertained.
c) The IACUC Office Manager (IOM) will organize a meeting with the AV or designee and the Principal Investigator (PI). The IACUC Chair will be alerted of the noncompliance and determine whether they will attend the meeting or appoint another IACUC member.
d) During the meeting, the IOM and the AV will inform the PI of the allegation and gather information to present to the IACUC at a convened meeting.  
e) The members will receive a written summary of the meeting that occurred for evaluation prior to discussion and deliberation at the next scheduled IACUC meeting.
f) The following is discussed during the IACUC meeting
o    The nature of the noncompliance (e.g., procedural or administrative level of risk to the animals).
o    Cause of noncompliance (e.g., intentional or due to misunderstanding).
o    Investigator attitude (e.g., self-reporting, attempts at concealment).
o    Are federal funds involved?
o    Are USDA-covered species involved?
o    What external reports must be filed?
o    What actions should be taken in regard to the animals and the investigator?
g) Once the investigation is complete, the IOM will send the PI a formal written notification regarding the IACUC’s decisions and request a response.

B. Consequences

a) Minor violations: Noncompliance violations that are not the result of willful intent and do not pose an immediate threat to animal health or welfare or violate Federal regulations
may be resolved administratively. However, continuing minor noncompliance events
from an individual may be reclassified as serious noncompliance.

b) Serious noncompliance violations: The IACUC may mandate remedial corrective actions.
Such corrective actions may include, but are not limited to:
i. Requiring specific training or retraining of individuals involved in noncompliance
or animal welfare incidents.
ii. Additional monitoring by the IACUC of animal-related activities or
regulations that pertain to the violation.
iii. Regular updates on the status of the corrective action plan.
iv. Requiring submission and approval of an IACUC protocol or modification to an
already approved IACUC protocol prior to continuing the research for which the
noncompliance was reported.
v. Restricting or limiting the scope of activities the individual(s) may engage.
vi. Suspension of PI’s privileges to continue animal research or suspension of an approved protocol or a specific procedure defined in the protocol for a definite or indefinite period
Suspensions must be reviewed with the IO.
vii. A probationary period during which IACUC may arrange for unannounced visits
to PI’s laboratory

C. Reporting

a) Report to the Institutional Official (IO): The IACUC will report the situation to the IO. At UCR the IO is the Vice Chancellor for Research.
b) External Reports: If required, the IACUC will report the situation to external agencies. These agencies include the PHS Office of Laboratory Animal Welfare (OLAW), USDA, AAALAC, and related granting agencies.   A preliminary report must be submitted once the noncompliance is identified. The final report that describes the action plan must be submitted and signed by the IO. The IOM will access the UCR Sponsored Programs, identify the designated staff assigned to the department of the PI with noncompliance, and provide information to report to the funding agency.
c) Dissemination of Information: Generally, data obtained without IACUC approval should not be presented in any format, including articles, books, posters, and seminars. The IACUC will make this determination on a case-by-case basis.

VI: References

1. The Guide for the Care and Use of Laboratory Animals, 8th edition, 2011.

2. The IACUC Handbook, 2nd Edition, 2007.