Animals (IACUC)

University policy‌ and federal law require a review of research and teaching projects involving live vertebrate animals for humane treatment and judicious use of vertebrate animals. At Loyola University of Chicago, adherence to this policy and federal law is assured by the Institutional Animal Care and Use Committee (IACUC) through review of this application. Loyola University of Chicago is committed only to complying with regulations, and to requiring the highest possible standard of professional and ethical conduct of all its faculty, students and staff. This application form serves that general goal in several important ways. It permits the IACUC and the Office of Research Services to maintain accurate records to meet statutory requirements. It also offers Loyola faculty the chance to explain - to their peers and potentially to a wider public - the ways in which animals are vital to their work and how that work serves the public at large.

For additional information, please contact the Office of Research Services at 773-508-2471.

Principal investigators and course directors must obtain approval from the IACUC before initiating any research, testing or instructional project involving the use of live vertebrate animals. FAILURE TO DO SO IS A VIOLATION OF FEDERAL LAW.

The primary investigator (PI) of a research project or course who is applying for approval must be a Loyola faculty member holding one of the following academic ranks: instructor or research associate; assistant, associate or full professor; assistant, associate or full research professor. Faculty with adjunct, emeritus, or visiting appointments may also apply.

• Research Projects: Responsibility for obtaining approval from the IACUC lies with the PI. The PI should submit materials for IACUC review well in advance of the proposed start date for the project. When applying for external funding, the grant application may be submitted to the agency with IACUC approval listed as "Pending"; this option does not, however, absolve the PI of his or her responsibility for obtaining IACUC approval before the research commences.

• Instructional Projects: Responsibility for soliciting approval from the IACUC lies with each course instructor who must first apply for clearance through the Department Chairperson of the department in which the course will be offered. Course instructors should submit applications well in advance of the deadline for scheduling courses for the semester in which animals will be used. This will ensure that adequate space can be provided for the animals at the appropriate time. It must be stressed that the IACUC approves the use of animals in a specific course and by a specific instructor. If a second individual is designated to teach the same course, an amendment must be submitted so that IACUC members can review that individual's credentials as well as the procedures to be used.

• Application Forms: Applications for IACUC approval must be made using the ORS Compliance Approval Portal (CAP) system. CAP can be accessed at https://cap.luc.edu/Secure/Login.aspx. The deadline for submitting applications is the last Friday of every month. When submitting a completed application, investigators must also include their current CV and documentation of completion of the on-line training modules for all research personnel (PI, students, doctoral fellows, other staff and faculty, etc.). For additional information on training modules, see http://www.luc.edu/ors/citicourse/. In addition, a "Verification of Tetanus Inoculation" form must be submitted for all non-student personnel (see section "Forms" below.

• General Instructions: Please fill out the Application completely; do not answer questions by simply referring to your response on another question. The Application was designed to simplify reporting requirements and ensure full compliance with the law. Please remember to sign the Application and, if applicable, obtain signatures of the Biosafety or Radiation Safety Committee Chairperson before submitting it to Research Services. The IACUC chairperson and the attending veterinarian will add their signatures once the protocol has been reviewed and approved by the IACUC.

• Funded Projects: It is important that investigators interested in applying for external funding consult with the IACUC chair and the chairperson of their respective departments when developing a research protocol. The experimental program and procedures must be discussed to ensure that Loyola is equipped to house and care for the animals and to ensure the safety of investigators and the university community at large. Only then, should investigators proceed to submit a grant proposal to a funding agency.

  After the funding agency has granted final approval of the project, investigators must submit both the Application (12 copies) and the approved grant proposal (3 copies) to the IACUC for review. Research activities may not begin until the IACUC confirms that the proposed experiments in the grant correspond with those described in the application.

Review Mechanisms The IACUC can review new protocols and proposed changes to previously approved protocols via two mechanisms: full committee review and designated member review.  In either case, the investigator must submit a complete Application to Use Vertebrate Animals to the committee.  Full committee review means that the protocol is reviewed at a convened IACUC meeting.  All protocols will be reviewed via full committee review unless a designated member review is specifically requested, in writing, by the primary investigator, a member of the IACUC or the Director for Research Compliance.

Requests for designated member review are appropriate for:

• Protocols falling under category C of the "Humane Use Categories" described in Section E of the application:  Category C- Animals upon which teaching, research, experiments, or tests will be conducted involving no pain, distress, or use of pain relieving agents;
• Amendments to any current protocol that would decrease the pain and distress of the animals involved; or
• The addition of students or staff to the protocol.

When a request for designated member review is received, the protocol is distributed to all IACUC members who are given three business days to review the protocol and decide if they concur with the use of a designated member review mechanism for the protocol. If any member requests full review, the protocol is sent to the next meeting for full review.  If a designated member review is to occur, the IACUC Chair or designee will select another committee member to review the protocol. On behalf of the committee and in consultation with the veterinarian when necessary, they will approve, conditionally approve, or refer the protocol for full review at the next meeting.  The IACUC chair will notify the investigator in writing of the decision within seven business days of submission.

Requirements for Approval and Outcomes of Review In order to approve an initial Application or an amendment to an already approved protocol, the IACUC must determine that the protocol conforms to the requirements set forth in the Public Health Service Policy (PHS) and the United States Department of Agriculture Regulations (USDA). After assessing the protocol in accordance with these requirements, the IACUC will vote to approve, conditionally approve, table, or disapprove.

• PHS Policy
• USDA Regulations

Approve If all requirements are satisfied, the IACUC will approve the project as outlined in the application and the IACUC chair will notify the investigator of the approval in writing.

Conditionally Approve If the IACUC determines that minor changes or clarifications are required that do not pose a significant threat to the care and safety of the animals, it will grant conditional approval of the project. If the project is granted conditional approval, the IACUC chair will inform the investigator in writing, indicating the conditions that must be met to secure final approval. The investigator must reply in writing, explaining how the project will satisfy these conditions. The IACUC chair and/or other designated member(s) will review the revised proposal and determine if the conditions have been met. If all the conditions have been met, the IACUC chair will notify the investigator in writing that the project has been approved and the research may proceed as outlined. Please note that the research may not proceed until the IACUC chair notifies the investigator of final IACUC approval.

Table If the IACUC lacks sufficient information about whether the project satisfies these requirements or major concerns exist about a threat to the care and use of animals, the IACUC will table the protocol and the IACUC Chair will notify the investigator of this in writing, explaining the reasons for the committee's decision and indicating the conditions that must be met in order to secure approval. The investigator must respond by submitting an original and 10 copies of the revised application; this will be reviewed by the IACUC at a subsequent meeting and the IACUC chair will notify the investigator in writing of the outcome of this review.

Disapprove If the IACUC believes there are serious concerns related to one or more of the requirements, it will disapprove the project and the IACUC chair will notify the investigator of this decision in writing, explaining the reasons for disapproval.

[NOTE: The requirements in this section represent directives of the LUC lakeside Institutional Animal Care and Use Committee (IACUC) and are applicable to all lakeside campuses locations.  The standard operating procedures of the Animal Care Facility (ACF), which are accessible through the CAP system, may be more restrictive.]

Quarantine Requirements

Aquatic animals: Animals received together from the same source should be maintained in a container (or containers depending on the number of animals shipped) separate from the rest of the ACF animals for 7 days following delivery.

All other animals:
Approved Vendor: Animals received from an approved vendor with a successful serological exam do not require quarantine. The IACUC reserved the right to require quarantine procedures on a case-by-case basis. This applies only to animals obtained directly from these approved sources:

• Harlan
• Charles River
• Taconic
• Jackson

Wild caught: Animals received together from the same source should be housed in a room isolated from the other animals housed in the ACF and their health monitored daily for 10 days following delivery.
    
All other animals: Animals received together from the same source should be housed in a room isolated from the other animals housed in the ACF and their health monitored daily for 7 days following delivery.
    
At the end of the designated period if all the animals from that shipment are healthy and alert they can be released from quarantine. If any animal is delivered ill or becomes ill during quarantine it will be reported to the Veterinarian for diagnosis and if necessary, treatment.  The disposition of the rest of the animals from that shipment will be determined by the Veterinarian.  

Ordering and Delivery Procedures

Aquatic animals:   

• Investigators must have an active protocol, approved by the IACUC, to place an order.
• If ACF housing is required, contact the ACF Supervisor to confirm housing arrangements.
• Once housing has been arranged, order animals from the vendor listed in the IACUC protocol, arrange for the PI to be notified to receive the delivery, and obtain a delivery schedule.
• Let the ACF supervisor know the delivery schedule.
• Upon delivery the animals should be received and inspected by the PI, a Quarantine Intake Form should be completed and posted in the room where the animals will be housed in a separate container for the designated time period (see quarantine requirements above).      

All other vertebrates:

• Investigators must have an active protocol, approved by the IACUC, to place an order.
• If ACF housing is required, contact the ACF Supervisor to confirm housing arrangements and the availability of the quarantine room.
• Once housing has been arranged, order animals from the vendor listed in the IACUC protocol, obtain a delivery schedule, and request that an animal health report be sent with the animals.  The animals should be shipped directly to the ACF, LSB (1050 West Sheridan Road), Room 015, 773-508-2776.  
• Let the ACF Supervisor know the delivery schedule and finalize the reservation for the quarantine room.  If the ACF Supervisor is unavailable, the Assistant Director for Research Compliance must be informed instead.
• The ACF supervisor will notify the PI when the animal shipment has arrived.
• Upon delivery, the animals should be received and inspected by the PI. A Quarantine Intake Form should be completed and posted in the quarantine room, along with the corresponding health report supplied by the shipper.
•  The animals should be housed in the quarantine room and monitored daily for the designated time period (see quarantine requirements above).

Census Reports

• are listed on the IACUC approved application;
• are properly trained in the care and use of the animals (supervised research personnel must complete on-line training modules; instructions are available at http://www.luc.edu/ors/citicourse/);
• have all necessary up-to-date immunizations;
• are informed of, and adhere to, the protocols outlined in the IACUC-approved proposal; and
• are informed of and adhere to the policies and procedures outlined in Loyola's policies for Live Vertebrate Animals in Research and Instruction and in the two National Research Council publications: Guide for the Care and Use of Laboratory Animals and Occupational Health and Safety in the Care and Use of Research Animals.

Provisions for Reporting Animal Care Concerns