Complaints and Violations

 Date Adopted: July 11, 2006

Last Review Date: December 11, 2020

 
I.  Policy

Federal animal welfare regulations (under the Animal Welfare Act) state that all employees or concerned parties must have the means to report deficiencies in animal care and treatment. Federal animal welfare regulations state that no facility employee, committee member or laboratory personnel shall be discriminated against or be subjected to any reprisal for reporting violations of any regulation or standards under the Animal Welfare Act.

The Institutional Animal Care and Use Committee (IACUC) will investigate concerns involving the care and use of animals used in teaching or research at the University of Montana (UM). This includes claims by the public or anonymous complaints concerning any aspect of the animal care and use program or by employees or students who report alleged instances of animal abuse, violation of approved protocols or standard operating procedures, use of animals not covered by approved protocols, violation of any animal-related regulation or standard (such as the Animal Welfare Act, Public Health Service Policy, or UM IACUC policy), or complaints regarding the care received by animals housed in UM laboratory animal facilities.

II.  Procedure

        A.  Reporting a Complaint or a Violation

1.  The Department of Laboratory Animal Resources (LAR) shall conspicuously post
     phone numbers, email addresses and office locations for reporting of complaints
     and violations in all University of Montana animal facilities. Such information must
     also be included on the UM Institutional Animal Care and Use Committee
     (IACUC) web site for easy public access. Contact information will be provided for
     the following:

a.  IACUC Manager

b.  IACUC Chair

c.  Attending Veterinarian (AV)

d.  LAR general information and phone numbers

2.  Any person who believes a laboratory animal or animals is/are subject to
     mistreatment, or that there is a potential violation of IACUC policy (even if

     immediate harm to animals is not present), is encouraged to report allegations of
     mistreatment or policy violations to any of the following: the Institutional Official
     (IO), the IACUC Chair, the IACUC Manager, the AV, a member of the IACUC,
     or LAR staff member.  A complainant may remain anonymous

3.  A complaint may be reported either orally or in writing and should include a
     description of the violation, the time and date of violation, the location, the type
     of animal involved, and any other items which are relevant to the complaint.

4.  The AV or designee will reduce the complaint to writing as soon as possible.

a.  The AV or designee will conduct the initial investigation and the results will
      be forwarded to the IACUC Chair.

b.  Complaints directed at LAR staff members will be forwarded to the
      IACUC Chair at the initiation of the investigation. At that time, the Chair
      may choose to conduct or reassign the investigation.

c.  If the AV is the subject of the complaint, the IACUC Chair will contact the
     IO and the IO will appoint an appropriate person to investigate the
     allegations.

d.  If the complaint is against the Chair, the person receiving the complaint
     will contact the IO.

5.  Investigation of and communications about the complaint shall be documented
     in writing and maintained in the office of the IACUC Manager.

6.  No person reporting a violation of LAR and/or IACUC standards, procedures, rules
     and protocols shall be subjected to any retaliation.

7.  Likewise, no person who is the subject of, or related to a complaint shall
     undertake reprisals. Retaliations or reprisals in the context of IACUC procedures for
     handling complaints represent violations of IACUC standards that could result in
     loss of privileges and/or access to the facilities for animal care and use under the
     oversight of the UM IACUC.

8.  The confidential nature of the complaint and violation procedures must be
     respected by all parties involved.

        B.  Initial Investigation by the Attending Veterinarian (AV) or designee

1.  The AV or designee will evaluate the complaint to determine whether there is
     sufficient information to investigate further.

a.  If mistreatment of animals is found, the AV or designee will take all
     necessary action which may include temporary suspension of use of
     animals by any and all individuals involved in the reported complaint.

b.  During an investigation, the AV or designee shall have the authority to
     question the PI and the PI’s laboratory staff members or students, and to
     request laboratory notebooks, datasheets, and spreadsheets.

b.  The AV or designee will submit the initial findings and recommendations
     to the IACUC Chair.

c.  The IACUC Chair and the AV or designee will consider the initial findings
     and recommendations for further action.

2.  If the AV is the subject of the complaint, the IACUC chair will contact the IO, and
     the IO will appoint someone to investigate the allegation.

        C.  Action Following Initial Investigation

1.  No violation - no findings of mistreatment of animals or policy noncompliance.

a.  The IACUC chair will inform the complainant, the AV or designee and the
     person who is the subject of the complaint in writing of the findings and
     recommendations and that no further action will be proposed, subject to
     IACUC review at the next regularly scheduled meeting.

2.  Minor violation - policy noncompliance but no inhumane treatment of animals.

a.  Examples of minor violations (this list is not intended to be exhaustive)

1)  Significant expansion or use of animal numbers or experiments under
     an existing IACUC approved protocol without proper amendments

2) Violation of SPF protocol or standard operating procedures

b.  The IACUC chair will inform the complainant and the person who is the
     subject of the complaint (and his/her direct supervisor or PI) in writing of all
     findings, recommendations, and any remediation (except for confidential
     personnel actions) required to be completed within a specified time
     frame.  Such findings, recommendations, and remediation (except for
     confidential personnel actions) are subject to IACUC review at its next
     regularly scheduled meeting.

c.  The IACUC Manager will be responsible for verifying that the remedies
     are completed within the established time frame.

3.  Major violation - inhumane treatment or neglect of animals.

a.  Examples of major violations (this list is not intended to be exhaustive)

1)  Use of animals without an IACUC approved protocol

2)  Disregard for animal pain and suffering

3)  Improper euthanasia

4)  Improper surgical techniques or experimental treatments

5)  Exposing humans or animals to substantial and unnecessary risks

6)  Knowingly providing false or inaccurate information to LAR or IACUC

b.  The AV or IACUC Manager should self-report the incident to OLAW in a
      timely manner, and self-report to USDA if a protocol suspension occurs for
      an USDA-covered species.

c.  The IACUC Chair will determine if the IACUC should meet immediately or
     wait until the next scheduled monthly IACUC meeting to discuss the
     violation. A quorum of the IACUC must be present for the meeting.

1)  IACUC members or institutional employees with a conflict of interest
     shall immediately notify the committee and remove themselves from
     further participation in the matter.

d.  The IACUC will review the complaint and the initial findings and
      recommendations of the AV or designee and obtain additional
      information as needed.

1)  The complainant may be requested to meet with the IACUC. If the
     complainant is unwilling or unable to make a personal appearance,
     the complainant may submit a written statement to the IACUC Chair
     prior to the meeting.

2)  The person who is the subject of the complaint will be provided a
     written description of the substance of the complaint and will be
     given an opportunity to meet with the IACUC to respond to the
     complaint. If the person who is the subject of the complaint is not the
     PI, the complaint will be forwarded to the PI responsible for the 
     animal or protocol described in the complaint or the direct supervisor
     if a LAR employee is the subject of the complaint.

3) The complainant and the person who is the subject of the complaint
     may have an advisor at the meeting with the IACUC. Advisors are
     present in an advisory capacity only and are not permitted to speak
     or present information directly to the IACUC.

4)  If the complainant and/or the person who is the subject of the
     complaint elect not to meet with the IACUC, the complaint will be
     reviewed on the basis of information available, and a
     recommendation will be made by the IACUC. No inference may be
     drawn against the complainant and/or person who is/are the subject
     of the complaint for failure to appear before the IACUC.

5)  When the IACUC concludes that all pertinent information has been
     received, the IACUC (after excluding all nonmembers) shall discuss,
     deliberate and prepare its findings and recommendations. By majority
     vote of those present, the IACUC will determine whether or not
     mistreatment of animals or policy noncompliance has occurred and
     make recommendations. If the findings and recommendations are
     not unanimous, minority opinions may be written and attached by
     those who differ with the majority's findings and recommendations.

e.  The IACUC will then determine the final action to be recommended to
     the IO. The IACUC recommendation shall be immediately binding until
     such time as the IO has reviewed the recommendation.  IACUC action(s)
     may include, but is/are not limited to:

1)  A finding of no violation and/or the complaint was not substantiated.

2)  A reprimand to the person who is the subject of the complaint, which
     may include notice to the supervisor that if the same or similar
     circumstances which were the basis of the complaint are found to
     continue, this could result in suspension or complete revocation of the
     protocol approval under which animal(s) were obtained and/or may
     include suspension or complete revocation of the violator's privileges
     to access LAR and animals.

3)  A suspension of the protocol for a stated period of time, or immediate
     revocation of the protocol approval.

4)  Permanently revoke all LAR access of the person who is the subject of
     the complaint.

f.  The IACUC Chair will report in writing, as appropriate, to the following
    individuals:

1)  The complainant;

2)  The person who is the subject of the complaint;

3)  The Departmental Chair or direct supervisor of the person who is the
     subject of the complaint; and

4)  The IO.

g.  The IO, after review and approval, will report the findings and actions
     taken by the IACUC to external organizations and/or government
     agencies as required.

        D.  Record Keeping 

1.  The IACUC Manager will keep all records of complaints, violation,
      investigations, action plans and outcomes on file for a minimum of 3 years.