Guidelines for addressing noncompliance1

Information gathering and committee assessment
Factual information related to the identified incident(s) will be gathered by the Training and Compliance Office, Institutional Animal Care and Use Committee (IACUC) designee or veterinary staff and presented to the IACUC at a convened meeting with a quorum. Reports should include nature of the incident (e.g. unapproved procedure(s), housing violations, lack of skill/training, neglect, abuse) and details of specific events (e.g. species, investigator, individuals involved procedures performed, adverse effects).

The following should be considered in determining whether to report to OLAW2 :

• Were the procedures approved?
• Would prior review and approval of the procedures by IACUC or veterinarians have identified potential adverse outcomes?
• What adverse effects did the animal(s) experience?
• Was the animals' health or well being jeopardized?
• Was medical intervention including euthanasia by veterinary staff necessary?
• Was IACUC intervention necessary to interrupt this activity? If yes, must be reported.
• Are the individuals aware of rules and regulations involving animal use and care?
• Is this a repeat violation by the investigator? Have there been other previous violations by the investigator?
• Was there an intent to circumvent [disregard] IACUC or institutional policies in order to perform the animal activity? [Is the evidence of willful disregard?]
  

Sequence of IACUC actions

a. Immediate written warning accompanied by a verbal contact to assure that the warning is clear and unambiguous. If the non-compliance is not addressed go to b.
b. Second written warning with a copy to departmental chair. If the non-compliance is not addressed go to c.
c. Suspension of protocol at a convened meeting of a quorum of voting members of the IACUC [with detailed itemization of what must be rectified for protocol to be reinstated] copied to Departmental Chair, Vice Dean of the appropriate school in which the PI is a faculty member and Vice Provost for Research (Institutional Official).
d. If the non-compliance is serious proceed directly to c.

PHS policy requirement
The IACUC acting through the Institutional Official, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to:

a. serious or continuing noncompliance with PHS policy
b. serious deviation from provisions of the Guide3 .
c. any suspension of an activity by the IACUC.

A preliminary report should be filled through a telephone call to OLAW. A written report must be filled after a telephone notification, unless OLAW determines it is not warranted. USDA must be notified if it is a covered species.

References:
1. Approved by the IACUC on: August 16, 2001
2. Office of Laboratory Animal Welfare, NIH
3. The Guide for the Care and Use of Laboratory Animals, National Academy Press, 1996.

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