Concerns about animal care and use may be reported anonymously to the Chair of the IACUC or to responsible personnel at each facility. Contact information is made available through the posting of notices in facilities and laboratories that provide contact names and phone numbers. The IACUC Chair, in most cases with assistance from the Director of LARC, will investigate every concern that is reported and gather pertinent facts concerning the allegations. They will then notify the individuals involved that a complaint has been received and that it is under investigation. If the results of the initial investigation suggest that a significant problem or deliberate non-compliance with the PHS Policy occurred, the issue will be discussed at a convened meeting of the IACUC. If a quorum of the IACUC recommends that the activity be suspended, the Dean shall be consulted. He will immediately institute appropriate corrective measures and notify OLAW, other appropriate governmental agencies (USDA), and university officials. As required by the Animal Welfare Act, individuals who truthfully report concerns about the care and use of animals are protected against reprisal.

To report issues of non-compliance or animal use concerns contact one of the following individuals.

Robert Bigsby, Ph.D., IACUC Chair
317-274-8970 
rbigsby@iupui.edu

Andrew Blickman, D.V.M.
317-274-1958
pager: 541-7316
ablickma@iupui.edu

Guidelines to Resolve Issues of Non-compliance

Introduction
The Indiana University School of Medicine Institutional Animal Care and Use Committee (IACUC) has developed a system for evaluating issues of non-compliance with IACUC policies and regulatory guidelines. The IACUC will discriminate between serious issues and all other issues of non-compliance for which a point system will now be instituted.

Serious Issues of Non-compliance
Deficiencies or infractions directly resulting in animal distress or suffering are considered serious issues of non-compliance. If an occurrence of non-compliance directly results in animal distress, the Committee will interrupt all animal work immediately pending a review and details of the non-compliance will be reported to the appropriate regulatory agencies in compliance with the Public Health Service Policy, Office of Laboratory Animal Welfare (OLAW). The institution is required to "promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: a. any serious or continuing noncompliance with this Policy; b. any serious deviation from the provision of the Guide; or c. any suspension of an activity by the IACUC."

Examples of serious issues of non-compliance are:

• Acquiring animals for research without an IACUC approval and knowledge of the LARC.
• Cause harm to an animal - Performing a procedure in such a manner that animals endure distress, pain, or suffering that is not addressed in the approved protocol.
  
  Other issues of non-compliance will be addressed as noted below.

Other Issues of Non-compliance
If an occurrence of non-compliance does not directly result in animal distress, the principal investigators will be assigned points for each occurrence. This system was designed so the seriousness of an occurrence and/or repeated occurrence would determine the level of action taken. The point system will be reset to 0 each year. Some examples are listed below. Once an investigator has accumulated four points, the IACUC will use the procedures outlined in the first level as a guide in resolving the issue. Likewise, the second level is followed when six points are accumulated and the third level when eight points are accumulated.

Appeal Process
Investigators may appeal the application of points or levels of disciplinary actions taken. To do so, written correspondence must be submitted within two weeks of the action. The correspondence must addressed to The IUSM IACUC Chair and mailed to the IACUC office. Further it must identify the action they wish to appeal and clearly explain why it should be removed from their record. Appeals will be held and discussed at the next scheduled IACUC meeting after the appeal submission.

Examples of deficiencies noted or infractions incurred that would result in a one-point penalty:

• Not following safety procedures when working at a level of BSL1 or lower (such as proper personal protective equipment use, waste disposal or chemical handling)
• Housing animals in the laboratory without approval
• Insufficient records of monitoring animals (disease condition, PI care, or survival surgery)
• Exceeding the number of animals approved on the study (breeding colonies)
• Expired drugs or materials used for anesthesia or survival surgery, or expired drugs used for euthanasia
• Cage cards not containing the required information
• Cage overcrowding
• Controlled substances not stored properly or dispensing logs not kept
• Unlabeled bottles
• Moving laboratory without notifying the IACUC office of the new location
• Failure to notify the IACUC office of employee transfers of personnel with prior or existing documented training on file.
• Uncovered water bottles or open containers in animal rooms (PI care rooms)
• Failure to maintain standard operating procedures for room cleanliness and upkeep
• Failing to document post-procedure care
• Minor protocol deviation
• Failure to respond to IACUC concerns by designated deadlines.

Examples of deficiencies noted or infractions incurred that would result in a four-point penalty:

• Not following aseptic technique when performing survival surgery
• Not maintaining up-to-date-occupational health records when working with animals where participation is mandatory.
• Allowing new personnel to work with animals before completing and submitting the required training
• Performing a procedure that is not included in the protocol (not resulting in distress/suffering).
• Not observing safety procedures when working with animals at a level of BSL2 or higher
• Failure to monitor animals, adequately following an invasive procedure
• Major protocol deviation

Levels of disciplinary action
First level
When there is an accumulation of four points.
All activities involving the use of animals will not be interrupted; however, those activities related to the infraction will only be allowed to continue with consultation by an individual designated by the Committee. The consultation may include training and written exams.

Second level
When there is an accumulation of six points.
Activities involving all use of animals will not be interrupted; however, future animal orders will not be allowed until the principal investigator provides a written response addressing the specific issues to the satisfaction of the IACUC.

Third level
When there is an accumulation of eight points.
Activities involving the use of animals will be suspended immediately until such time as the IACUC can discuss the infraction and develop a recommendation during a convened meeting. These repeated offenses will be handled on a case-by-case basis. The Public Health Service, USDA (if applicable), and funding agencies will be notified of the suspension and the resolution.

Possible resolutions to a third level penalty include but are not limited to:

• Requiring that LARC perform the service for a fee
• Continuation of activities at a time approved by the IACUC
• Permanent suspension of activities using animals