Investigation of Alleged Mistreatment or Noncompliance in University Research Involving Animals Standard

It is the policy of the University of North Carolina at Chapel Hill that all research involving animals conducted through use of University facilities and resources be carried out consistent with applicable law and policy and with the highest regard for the safety, comfort and ethical treatment of research animals. These Procedures and Guidelines are meant to guide the IACUC and its staff in conducting investigations as required under University Standard.

University Standard

Title

University of North Carolina at Chapel Hill Standard on Investigation of Alleged Mistreatment or Noncompliance in University Research Involving Animals

Introduction

Purpose

The standards and procedures described below provide guidance to all researchers and animal handlers for the use of visual or audio media (e.g., photograph, videos, audio recordings) at the University of North Carolina at Chapel Hill (“UNC-Chapel Hill” or “University”).

Scope

This Standard applies to anyone who has witnessed mistreatment or noncompliance involving animals in research conducted through use of University facilities. The UNC-Chapel Hill IACUC expects that anyone involved in animal work at the University will comply with this Standard. 

Standard

Guidelines

I. It is the policy of the University of North Carolina at Chapel Hill that all research involving animals conducted through use of University facilities and resources be carried out consistent with applicable law and policy and with the highest regard for the safety, comfort and ethical treatment of research animals. As required by federal law, the University Institutional Animal Care and Use Committee (IACUC) is authorized to review and approve or disapprove all proposed University research involving research animals. In addition, the IACUC, as required by the Office of Laboratory Welfare (OLAW) and by regulations of the U.S. Department of Agriculture, is authorized “to review and, if warranted, investigate concerns involving the care and use of animals . . . resulting from public complaints received and from reports of noncompliance received from laboratory or research facility personnel or employees.” 9 CFR Part 2, Subpart C, Section 231(c)(4). 

II. Anyone who has witnessed mistreatment or noncompliance in regard to research animals is encouraged to report their concerns immediately to the Chair of the IACUC, the Director of the IACUC, any member of the IACUC professional staff, the Institutional Official (IO), the Senior Associate Vice Chancellor for Research, the Office of University Counsel (OUC), or anonymously online through EthicsPoint. As used in this Standard and Procedures, “mistreatment” means wrongful or abusive physical and/or psychological treatment of an animal, whether intentional or not.

“Noncompliance” means substantial failure to comply with applicable policies or substantial deviation from an approved animal use protocol and includes the conduct of research involving animals in the absence of a current, approved protocol. If requested, the identity of the complainant will remain confidential, subject to the constraints of state and federal law. The individual receiving the complaint of mistreatment or noncompliance shall immediately forward to the Chair of the IACUC either the written report or a written summary of an oral report. 

III. Retaliation against any person reporting alleged mistreatment or noncompliance will subject the person or persons found to have retaliated to disciplinary action, up to and including dismissal. False charges brought maliciously by a complainant purposely to harm the University or any of its departments, divisions, or units, the IACUC, or any individual, will be handled according to pertinent employment or other policies of the University.

IV. The IACUC shall review and investigate reports of alleged mistreatment or noncompliance as provided in Supplements A and B. The IACUC review and investigation shall be conducted with all due regard for protecting the reputation of both the University and the Investigator while attempting to establish the facts. As a condition of employment or enrollment, University faculty, staff and students are required to cooperate fully with an IACUC review or investigation conducted under this Standard.

V. Where any University faculty, staff or student Investigator is determined by the IACUC to have mistreated research animals or to have failed to comply with University policies or procedures for ethical treatment of research animals, appropriate sanctions, including the following, may be applied by the IACUC, singly or in combination:

1. Letter of reprimand and warning.
2. Temporary suspension of approval of and of animal research activities under a specific protocol with a vote conducted in a convened IACUC meeting with a majority of the quorum voting for suspension.
3. Imposition of probation, under terms specified by the IACUC.
4. Mandatory education and training and oversight requirements.
5. Recommendation to the IO that, upon consultation with the Investigator’s Chair and Dean, that official temporarily or permanently disallow the Investigator from any access to animal facilities and/or involvement in University research involving animals.
6. Recommendation to the IO that the Investigator’s Dean be requested to impose disciplinary action against the Investigator, up to and including dismissal from employment or enrollment.  Any such action must follow established institutional policy and procedures.
7. Recommendation to the IO that the mistreatment or noncompliance be reported to the entity or entities funding the research and, as required, to the Public Health Service Office of Laboratory Animal Welfare (OLAW) and, as required, to the United States Department of Agriculture (USDA) and as required by AAALAC International to maintain accreditation. 

VI. Any decision to suspend or limit research privileges may be appealed by the investigator by written notice filed with the IACUC office not later than ten (10) business days after the investigator is notified of the decision being appealed. Such notice will include a statement outlining the reasons why the investigator believes that the decision appealed and/or the sanctions imposed are incorrect. The IACUC will transmit the appeal and all pertinent materials in its file to the Vice Chancellor for Research, to determine whether to confirm, vacate or amend the sanctions imposed. Nothing in these Procedures or in the Standard shall be interpreted to deny any Investigator grievance rights otherwise afforded under University policies.

Supplement A: Procedures and Guidelines for Conducting Investigations

The following Procedures and Guidelines are meant to guide the IACUC and its staff in conducting investigations as required under University Standard.

Recording a Complaint

1. Animal concerns or allegations may be received by the Chair of the IACUC, any member of the IACUC staff (i.e., Office of Animal Care and Use [OACU]), the Institutional Official, the University Compliance Coordinator or a Senior Office of Vice Chancellor for Research (OVCR) personnel, or the OUC.  All such reports should be forwarded to the IACUC Education and Oversight (E&O) Manager immediately. Reports may be accepted where presented orally or in writing, in person, by phone, by electronic mail or by the online anonymous reporting system. 
2. The person receiving a complaint should gather as much specific, relevant information from the complainant during the initial contact as possible, including if possible the name of the Principal Investigator or research staff members involved; location of research activities; dates and time periods of alleged animal welfare concerns; species of animal involved; specific allegations; and relationship of the complainant to individuals involved in the complaint.
3. The written complaint or a written summary of an oral complaint of mistreatment or noncompliance shall immediately be forwarded by the IACUC staff to the Chair of the IACUC with a copy to the Institutional Official, the Vice Chancellor for Research. A copy of the written report shall be provided to the Investigator as soon as possible, along with information regarding the procedures to be followed by the IACUC in reviewing and investigating the report. 

The Animal Concern Subcommittee (ACS)

4. The Chair of the IACUC will appoint a standing ACS for the purpose of conducting initial investigations into alleged noncompliance or mistreatment on behalf of the IACUC.  The ACS will be composed of the Chair of the IACUC, a veterinarian, and at least two current or former members of the IACUC committee, at least one of whom is a scientist. If possible, at least one or two members of the IACUC should agree to serve as alternates, occasionally substituting for active members and agreeing to serve on the ACS following the completion of an active member’s term. If possible, the members of ACS should agree to a term of no less than 3 years. ¹

Initial Review

5. The ACS shall determine whether the report alleges mistreatment, noncompliance, or both, is reportable to appropriate agencies, and whether funds should be reimbursed for non-compliant activities. 
6. Where the ACS determines that a report alleges what, if true, would constitute mistreatment or serious or continuing noncompliance, the ACS, assisted as appropriate by the OACU staff, shall notify the Investigator, the Investigator’s Chair and Dean, the Institutional Official, the Vice Chancellor for Research, the OUC, and the IACUC. With the assistance of the OACU staff, the ACS shall determine whether immediate action is necessary for protection of the research animals or preservation of evidence:
   1. If deemed necessary to protect health or safety of the research animals, the ACS may request that the Chair convene an emergency meeting of the IACUC to consider suspending all activity under a protocol where severe mistreatment is indicated, pending resolution of the matter.  In such cases, the IACUC shall notify the Investigator, the Investigator’s Chair and Dean, the Institutional Official, the Vice Chancellor for Research, and the OUC of their action.²   The Institutional Official shall report on such determination to OLAW and as required the USDA.  
   2. Action to preserve evidence could include removal of research animals to a secure location, securing photographs or video recordings of research animals, and obtaining relevant research documentation of the Investigator or other members of the Investigator’s research group.  Every effort shall be made to avoid unnecessary disruption of the Investigator’s research activities.
7. Regardless of the nature of the allegations, where the ACS’s initial review of a report indicates that there is no evidence of mistreatment or noncompliance, the ACS may determine that no further action is required, subject to ratification of this decision by the IACUC at its next scheduled meeting. The IACUC by majority vote of the quorum may decide that notwithstanding the ACS’s preliminary determination, further investigation is warranted, in which case further investigation shall be conducted as provided by these Procedures. The Investigator shall be informed of the ultimate determination, with copy to the IO, the Vice Chancellor for Research, the Investigator’s chair and dean, and the OUC.  

Investigation

8. Where the ACS determines that further review and investigation is warranted, or the Committee so determines, the ACS shall investigate the matter with assistance from the OACU staff. 
   1. The Investigator, the Investigator’s Chair and Dean, the Institutional Official, the Vice Chancellor for Research, and the OUC shall be notified of the ACS’s determination to conduct further review and investigation. 
   2. The ACS will gather and review all available tangible evidence. The ACS may seek advice and assistance from the DCM, the OACU staff and the OUC in gathering and analyzing the evidence, which may include overall observation of the general environment, pertinent documentation (animal records, research records, logs), and interviews with the complainant, the Investigator, current members of the research staff, and/or other witnesses deemed appropriate.   
   3. If interviews of research personnel are necessary, they should be held in a private location, ideally with one ACS member conducting the interviews and another taking contemporaneous notes and corroborating interviewee statements.  It may be advisable to record interviews with the interviewee's knowledge. Interviewees should be made to feel as comfortable as possible.  Second interviews may be conducted to clarify discrepancies.
   4. A veterinary examination of the involved animals should be performed if their condition is relevant to the allegation. If conflicts of interest preclude use of DCM staff, the services of a practitioner external to the University or a board-certified laboratory animal veterinary consultant should be used. (A reference check should be conducted to determine that the consultant is in good standing with the North Carolina State Veterinary Board and other state boards if applicable and does not have any active liability suits or professional misconduct allegations filed against her/him.) It is preferable that both the veterinary consultant and the institutional veterinarian perform the examination of the animals and that an ACS member record their findings.
   5. OACU staff will prepare all the pertinent acquired documents for the ACS members to review. The ACS will discuss the allegation, make findings of fact, determine whether the incident is reportable and to which agency, determine if funds should be reimbursed, draw conclusions, and make recommendations for action and possible sanctions.
9. As soon as possible, the OACU shall submit a draft preliminary report of its findings, conclusions and recommendations to the IACUC, with a copy to the ACS and Investigator. ³
   1. The report shall include:
      1. Clear, precise statement of the complaint(s) and when and in what form it was received.
      2. Steps taken during investigation.
      3. Summary of the ACS's findings.
      4. Detail for each allegation:
         • Allegation
         • Standards (statement of the federally mandated standards, institutional standards, or the fact that no standards exist)
         • Findings of Fact
      5. Conclusions and recommendations:
         • Precise recommendations for Action (including “No action required” if that is appropriate)
      6. Summary and final recommendations.
   2. The ACS may consult with University Counsel in drafting its preliminary report.
10. The Investigator shall be given a specified deadline, usually two business days following receipt of the ACS’s draft preliminary report, to provide the IACUC with a written response to the draft report if he or she wishes to do so. 
11. The final report shall be filed with the IACUC, with a copy to the Investigator, following (a) receipt of the Investigator’s response to the preliminary report or (b) of the date by which the response was to have been filed in cases where the Investigator declines to respond to the preliminary report. The final report shall include findings of fact, consideration of the Investigator’s response, and conclusions regarding each allegation under consideration. Where the ACS concludes that mistreatment or noncompliance has occurred, the final report shall include recommended sanctions.  (See attached Exhibit B, Guidelines for Determination of Appropriate Sanctions in Cases of Noncompliance or Mistreatment.)

IACUC Review and Decision

The ACS’s report shall be reviewed at the next scheduled meeting of the IACUC. At the discretion of the Chair, the Investigator may be invited to meet with the full IACUC to present and answer questions regarding the allegations; however, where allowed by law the IACUC may go into closed session to discuss the report. 

12. Following its receipt of the ACS report, the IACUC shall issue a written decision to the IO, with copies to the Vice Chancellor for Research, and the Investigator.  In its written decision the IACUC may accept or reject the ACS’s findings and conclusions, and may accept, reject or modify the sanctions recommended by the ACS. The written decision must include an explanation of any rejection of the ACS’s findings, conclusions or recommendations for sanctions. The IACUC shall inform the complainant, if that person’s identity is known, that the matter has been resolved, without providing details of the resolution.

Institutional Response

13. The IACUC’s findings and conclusions, and any sanctions imposed by the IACUC under Section V. (A) and (B) of the Standard shall be final.  The IO shall consider any additional sanctions proposed by the IACUC, in coordination with the investigator’s department chair and dean, and in their discretion may impose more severe penalties than those recommended by the IACUC. The Investigator shall be informed in writing of any sanctions imposed by the IO, with copy to the Chair of the IACUC, the Investigator’s chair and dean. In cases of suspensions, removal of animal use privileges, or sanctions imposed on a student, the OUC may be consulted first and then copied on the correspondence. 
14. As required by federal policy, any finding of serious or continuing non-compliance must be reported promptly by the Institutional Official to the OLAW and, as appropriate, to the USDA and AAALAC International. The IO shall file any reports required by federal agencies or other research sponsors.

Supplement B: Guidelines for Determination of Appropriate Sanctions in Cases of Noncompliance or Mistreatment

The IACUC bears responsibility for determining what types of activities are and are not in compliance with the Animal Welfare Act Regulations (AWAR), the Guide for the Care and Use of Laboratory Animals (Guide), and Public Health Service (PHS) regulations. As mandated by OLAW, it is also the responsibility of the IACUC to deal with incidents of non-compliance in a timely and consistent manner and to invoke sanctions that are appropriate for each incident of non-compliance. While implementation of any program of corrective actions must include a provision for sanctions, a successful program must also provide a mechanism by which investigators can be educated regarding their responsibility to understanding and implementing the mandates of the AWAR, the Guide, and the PHS.

Although it is essential for the IACUC to adopt a standard approach to dealing with sanctions, given the diverse nature of violations and the extenuating circumstances that surround each violation, the IACUC must recognize that each violation, whether it be major or minor, must be evaluated on a case-by-case basis.

Considerations when evaluating non-compliance.

The following should be considered when making recommendations regarding sanctions for a particular incident of non-compliance or mistreatment: 

• Was the individual an investigator for or included on an active protocol at the time of the alleged noncompliance?
• What were the adverse outcomes on the animals (and the number of animals involved) and was medical intervention by the veterinary staff required?
• Were the individuals involved repeat offenders, has there been a record of similar infractions by the individual (and/or laboratory members) and how much time has elapsed since the last incident of non-compliance?
• Has the individual been sufficiently trained in the current regulatory policies?
• What was the intent of the violation (e.g., accidental, or to circumvent approval process) and was there evidence that the personnel involved willfully disregarded IACUC policies?
• Did the violation occur in a lab with a large number of active protocols, and with a large number of graduate students, lab technicians and postdoctoral fellows?
• Was the violation the use of a particular procedure that was a variant of an approved procedure (e.g., approved to do intraperitoneal injections, but gave subcutaneous injections) or did it deviate markedly from the approved procedures (e.g., approved to breed mice but implanted a tumor)?

The IACUC should consider the type of incident (unapproved procedures), the specific details of the incident of non-compliance (e.g., procedures used, adverse effects on the animals, personnel involved), the frequency of non-compliance from this investigator and/or laboratory personnel (e.g., first time offense, second time offense etc), as well as all relevant extenuating circumstances. The ACS must first decide if the incident represented a form of animal mistreatment or abuse (e.g., hitting animals, not providing food or water for punitive reasons) or protocol non-compliance. In the case of the overt mistreatment or abuse of animals, there are relatively few extenuating circumstances that need to be considered and it is essential that the IACUC take immediate actions to terminate the mistreatment.

Often, however, an incident of non-compliance cannot be categorized without taking into consideration the extenuating circumstances. For example, the use of a major surgical procedure under an animal protocol where no surgeries are described could be considered a major violation if this laboratory has a long history of violations, no expertise in performing surgical procedures, or the surgical procedure is not relevant to the goals of the protocol. On the other hand, although there is no question the inappropriate use of surgery represents an incident of non-compliance, under conditions in which the laboratory has a long history of using this particular surgical procedure, the protocol is a renewal of one in which this type of surgery was clearly outlined, the surgery was essential for the research outlined in the protocol, and the investigator can demonstrate that the failure to include the surgical procedure in their protocol was an oversight, then the incident of non-compliance could be considered minor.

The appropriate sanction(s) should be based on the type of incident of non-compliance, and should be consistent with the severity of incident, the repetitive nature of the incident, and the magnitude of the deviation from the approved animal research protocol. In each case, however, judgment of the appropriate sanctions should be rendered on a case-by-case basis, and whenever possible, assistance to rectify the situation should be provided to investigators and/or laboratory personnel without the need for the imposition of sanctions. Similarly, it is important that all investigators and laboratory personnel involved in the incident of non-compliance are informed of all relevant rules and regulatory policies involving the use of animals.

Further guidance and assistance on evaluation of incidents of noncompliance or mistreatment can be obtained from OACU and the OUC.  

End Notes

¹ If the violation involves a member of the IACUC (or his or her laboratory personnel), the facts of the case should be reviewed by a ACS designated by the appropriate university officials. This ACS should include a veterinarian and at least one active or past member of the IACUC. This latter member is essential for providing continuity with previous decisions concerning sanctions but should not have a direct say in whether sanctions are imposed or the type of sanctions imposed (i.e., a non-voting member).  Finally, if a collaborator (or member of a collaborator’s laboratory) of a member of the IACUC is involved in the incident of non-compliance, that member must abstain when voting on the decision to impose sanctions or the type of sanctions.

² Nothing herein shall be interpreted to affect the authority of the Division of Comparative Medicine to suspend activity under a protocol and to take such other actions as it deems necessary to protect the health or safety of the research animals or to alleviate pain and suffering, including euthanasia.

³ Any deadline set forth in these Procedures may be extended by the Chair for good cause.  A notation of such extension should be placed in the investigation file.

Related Requirements

External Regulations 

• The Guide for the Care and Use of Laboratory Animals, 8th ed. 2011.

University Policies, Standards, and Procedures

• For more detailed guidance, please refer to the University Policy on the Care and Use of Vertebrate Animals for Research, Training and Teaching Purposes.

Contact Information

Policy Contact

Name: Michael Chi
Email: mchi@unc.edu
 

Name: Office of Animal Care and Use
Telephone: 919-966-5569
Email: iacuc@med.unc.edu