I. IACUC Operations

As part of its mandate to ensure that all vertebrate animals are humanely cared for and used in accordance with the highest ethical standards, the College of Charleston Institutional Animal Care and Use Committee (IACUC) reviews, approves, and monitors animal activity carried out under its auspices for conformance with all applicable laws, regulations, policies, and procedures. The IACUC is also responsible for reviewing and, if warranted, fully investigating any allegations of animal mistreatment and/or injurious or non-injurious noncompliance raised by the public, employees, or students.

Definitions

Allegation – Any written or oral statement or other indication of possible animal mistreatment and/or injurious or non-injurious noncompliance made to a College official.

Mistreatment – Abusive or wrongful physical or psychological treatment of an animal. Examples include, but are not limited to, striking animals or otherwise inflicting physical pain or harm; taunting animals; not providing food for punitive reasons; and purposefully placing animals in an environment in which aggressive behavior against other animals or humans is encouraged.

Noncompliance – Failure of the investigator involved in animal activity to follow applicable laws, regulations, policies, procedures, approved protocols, and/or directives of the IACUC, the Attending Veterinarian, or the Institutional Animal Care and Use Program (IACUP) Director. Acts of noncompliance may be classified as injurious, non-injurious, or administrative. The three classes of noncompliance are not mutually exclusive. In terms of actions that the IACUC may take to ensure the well-being of animals used in research and instruction, one type of noncompliance is not necessarily more serious than another, and all may result in corrective and/or punitive actions.

Injurious Noncompliance – When an investigator conducts a painful, distressful, or invasive procedure on an animal without IACUC approval, or when the investigator does not follow procedures approved by the IACUC, that results in increased risk of animal pain, distress, morbidity, or mortality. Examples of injurious noncompliance include, but are not limited to:

• Performing unauthorized surgery;
• Performing surgery or other painful procedures without proper anesthesia;
• Performing unapproved repeated survival surgery;
• Excessive use of restraints;
• Use of drugs not previously approved for the protocol;
• Use of unapproved methods of euthanasia;
• Permitting untrained and/or unauthorized personnel to perform invasive or potentially painful or distressful procedures;
• Failing to inform the Attending Veterinarian in a timely manner of unexpected adverse events that result in increased animal pain, distress, morbidity, or mortality; Where husbandry is the responsibility of the investigator, failing to provide habitable living conditions and/or adequate food and water to the animals.

Non-Injurious Noncompliance – When an investigator, without IACUC approval, utilizes animals in research or teaching, but in such a way that the animals do not suffer pain or distress or experience morbidity or mortality; or when the investigator fails to follow IACUC approved procedures and an impact on the animals or the total animal population results, but without concomitant increase in risk of animal pain, distress, morbidity, or mortality. Examples of non-injurious noncompliance include, but are not limited to, the following types of activities, provided they do not increase the risk of animal pain, distress, morbidity, or mortality:

• Change in purpose or specific aim of study;
• Change in principal investigator;
• Change in species;
• Significant increase in the number of animals to be used;
• Change in sex of animal to be used;
• Minor modification to surgical procedures;
• Change in type or dosage of drugs used;
• Additional behavioral or noninvasive sampling;
• Failure to submit a protocol modification request prior to implementing the modification.

Administrative Noncompliance – Acts that do not directly impact the physical or psychological welfare of animals, including, but not limited to, such acts as failing to complete and submit reports and other paperwork in accordance with IACUC procedures and timelines, failing to follow administrative instructions given by the IACUC, the IACUP Director, the Attending Veterinarian, and/or the Office of Research & Grants Administration (ORGA); and failing to adhere to other related guidelines and practices. Administrative infractions are most commonly identified by ORGA and are dealt with directly by the IACUC as part of its regular business, as opposed to being addressed through a preliminary review and investigation process. Examples of administrative noncompliance include, but are not limited to:

• Failure to comply with all terms and conditions of protocol approval;
• Failure to consult with the IACUP Director before procurement of animals;
• Failure to submit a continuation request in adequate time for review prior to protocol expiration;
• Failure to file final reports when protocols have been completed;
• Failure to follow administrative directives from the IACUC, the IACUP Director, the Attending Veterinarian, and/or the ORGA;
• Failure to follow standard laboratory practices;
• Failure to adhere to applicable environmental, health, and safety regulations and guidelines.

Sanction – Any penalty or coercive action taken by the IACUC to help ensure compliance with applicable regulations, policies, and procedures for the care and use of animals in research and instruction.

Respondent – The person against whom an allegation of animal mistreatment and/or injurious or non-injurious noncompliance is directed or the person whose actions are the subject of a preliminary review and/or investigation. There can be more than one respondent in any preliminary review or investigation.

Responsibilities

Any faculty member, student, or staff member who suspects animal mistreatment or noncompliance with regulations and policies governing the care and use of animals used in research or for instruction at the College of Charleston has a legal and ethical obligation to report the suspected activity. Report may be made to the Research Compliance Coordinator in the Office of Research and Grants Administration, or any faculty member, staff member, dean or other College official. Allegations may be submitted anonymously. The person receiving the allegation shall report it to the Research Compliance Coordinator in the Office of Research and Grants Administration.

The Attending Veterinarian, the IACUC Chair, and the IACUP Director individually have the authority to immediately and indefinitely suspend an animal activity, in full or in part, upon receipt of an allegation of mistreatment and/or noncompliance in order to provide adequate veterinary care and/or husbandry until such time as the welfare of the animals can be assured. The IACUC Chair individually has the authority to suspend immediately and indefinitely an animal activity, in full or in part, for administrative noncompliance.

The Institutional Animal Care and Use Committee has primary responsibility for implementation of the procedures set forth in this SOP. This includes conducting preliminary reviews and investigations, specifying remedial measures to be undertaken by investigators when appropriate, and imposing sanctions when investigators have been found to have mistreated animals or to have been noncompliant.

If the alleged animal mistreatment and/or noncompliance involves externally sponsored research or other activities, the IACUC Chair will first inform the Senior Vice President for Academic Affairs, and then, if required by the sponsoring agency, will report the impending investigation to the agency according to its rules and regulations. (The sponsoring agency may reserve the right to initiate an investigation of its own.) The IACUC may also consult with General Counsel of the College to develop and initiate any other procedures appropriate to the circumstances.

Procedures

Procedures for addressing allegations of animal mistreatment and/or injurious or non-injurious noncompliance have been designed with recognition that determination of why, or even if, mistreatment and/or noncompliance has occurred may be difficult and that the process of review and/or investigation must be sufficiently flexible to be terminated when it becomes clear that charges are unjustified or that the issue can be resolved appropriately by other means. It is understood that persons conducting the preliminary review and/or investigation must possess the special knowledge necessary to judge the situation but must also have no immediate personal interest in the case.

When an allegation of mistreatment noncompliance is received, the IACUC Chair and the Attending Veterinarian, and the IACUP Director providing they have no conflict of interest, shall conduct a preliminary review. Should a conflict of interest arise, any full voting member of the IACUC may serve in his/her stead.

If the preliminary review indicates sufficient evidence and justification for additional study of the matter, an investigation will be conducted. The purpose of the investigation is to determine if animal mistreatment and/or injurious or non-injurious noncompliance, as defined herein, has occurred and, if so, to recommend appropriate sanctions. The investigation will begin immediately and will be completed as soon as practicable but will not exceed more than thirty (30) business days. At the request of any involved party, with appropriate documentation of extenuating circumstances, and with approval of the IACUC, the period of time for the investigation may be extended.

The IACUC Chair will promptly notify in writing the respondent, his/her cognizant administrators (generally the department chair and/or program director, and the dean), and as appropriate, the respondent’s immediate supervisor of the initiation of the investigation. At that time, all additional necessary administrative actions will be taken by the IACUC, on behalf of the College, to ensure the welfare of the animals, the integrity of the research or instruction, the observance of legal requirements and responsibilities, and the continued protection of the rights and confidentiality of the informant and the respondent.

Throughout the investigation, the respondent will be advised of the progress of the investigation and will be afforded the opportunity to respond and to provide additional information. At all times, diligent effort will be made to maintain confidentiality of deliberations.

Actions

The IACUC’s actions in response to review and/or investigation of allegations of animal mistreatment, and/or administrative noncompliance cannot be grieved, as the IACUC has statutory and institutional authority in these matters.

Actions may take the form of recommendations for changes in research protocols, additional training of investigators or other personnel, changes in IACUP procedures, sanctions, or referral to the Institutional Official for consideration under the policy on Misconduct in Research and Scholarship.

Sanctions will be determined on a case-by-case basis. Factors that will be considered include the seriousness of the offense, the past record of the investigator, and the level of cooperation that the investigator exhibits during the preliminary review and investigation. The IACUC may impose sanctions that include, but are not limited to, the following:

• Written warning (may or may not be entered into official personnel file)
• Written reprimand (may or may not be entered into official personnel file)
• Technical abilities subject to monitoring and approval of Attending Veterinarian
• Training requirements before animal use can continue requirement to add research staff
• Suspension of any or all of the investigator’s protocols reassignment of animals to the IACUP for disposition Denied access to the animal facility
• Permanent suspension of animal use privileges
• Charge to the respondent’s department for extra work done by veterinary or animal care staff
• Filing of complaint under institutional scientific misconduct policy Filing of complaint with the Student Honor Board.
• Should the IACUC determine that the mistreatment or noncompliant behavior warrants further action, the matter will be recommended to the Institutional Official for review under the policy on Misconduct in Research and Scholarship.

Approved: November 22, 2002

Institutional Official: March 18, 2003

Revised:  February 26, 2003, January 21, 2005, February 20, 2009

Reviewed and revised:  August 24, 2012, September 27, 2019