UNC Charlotte - Research and Federal Relations

The University of North Carolina at Charlotte is committed to a program of animal care which ensures that all animals involved in research and teaching are used in ways judged to be scientifically, technically, and humanely appropriate. The University is further committed to assisting faculty and students in fulfilling their obligation to plan and conduct animal experiments in accord with the highest scientific, humane, and ethical principles, and in accord with the Public Health Service Policy on Humane Care and Use of Laboratory Animals, and the Animal Welfare Act.

In support of this commitment, the University has established the Institutional Animal Care and Use Committee (IACUC) that, together with the University Attending Veterinarian and the Director of Laboratory Animal Resources (DLAR), administers policies and procedures related to the University’s program of animal care. Final responsibility for the program rests with the Vice Chancellor for Research and Federal Relations, Dr. Stephen R. Mosier. As the Institutional Official responsible for the animal care and use program, he files assurances of compliance with USDA and the NIH Office of Protection from Research Risks (OPRR), appoints the chairperson and members of the IACUC, and is responsible for all University wide issues pertaining to animal care and use. He is also responsible for the management and oversight of the University Vivarium.

The Director of Laboratory Animal Resources, Mr. Norman Lefebvre, reports to the Vice Chancellor for Research and Federal Relations and is charged with the day-to-day operation of the University Vivarium and the implementation of the recommendations in the Guide for the Care and Use of Laboratory Animals. Questions and concerns regarding animal health should be referred to Mr. Lefebvre or the University Veterinarian.

The University’s Attending Veterinarian, Dr. Hal Farris, is charged with the oversight of all University animal care and use activities, including vivarium operation. Dr. Farris reports to the Vice Chancellor for Research and Federal Relations and is on call 24 hours per day, seven days per week, for consultation by faculty, staff, and students. He is charged with the implementation (along with the Vice Chancellor for Research and Federal Relations) of the institutional policy for the protection of animal subjects in research and teaching, the monitoring of the implementation of the recommendations in the Guide for the Care and Use of Laboratory Animals, the provision of veterinary care for all animals held by the Institution, and consultation with faculty and staff in the design of experimental protocols. The Attending Veterinarian has round-the-clock access to all animal facilities and has authority to suspend any activity involving animals or to order changes in animal care or facility operation.

The University requires that an animal research protocol be submitted for review and approval by the IACUC before any investigator purchases or obtains animals, or begins research or teaching involving animals. Dixie Airey, Office of Research Services- Compliance Manager, coordinates administrative support for the IACUC. She assists investigators in completing the appropriate animal research proposal forms, sends out notices of annual review for animal research protocols, assures participation in the occupational health and safety program, schedules meetings and compiles the minutes of the IACUC, and schedules the semi-annual inspection of animal facilities and the semi-annual review of the animal care and use program.

The Institutional Animal Care and Use Committee (IACUC) oversees the University’s program of animal care and use by:

Reviewing at least once every six months the institution's program for humane care and use of animals, using the Guide as a basis for evaluation;
Inspecting at least once every six months the institution's animal facilities using the Guide as a basis for evaluation;
Preparing reports of the IACUC evaluations and submitting the reports to the Vice Chancellor for Research and Federal Relations;
Reviewing concerns involving the care and use of animals at the institution; and
Making written recommendations to the Vice Chancellor for Research and Federal Relations regarding any aspect of the institution's animal program, facilities, or personnel training.

Procedures for 1-5 above
Every six months, the IACUC Chair appoints two members of the Committee to accompany the Attending Veterinarian and the DLAR in a walk-through inspection of the facility and to review the Institution’s overall program of animal care and use. Other members of the Committee who wish to participate in the inspection and review may do so.

Immediately following the walk-through, the team meets to complete the IACUC Semi-Annual Review and Inspection form. The form covers both the review of the institution’s program and the inspection of facilities. The completed report is then distributed to the full IACUC for discussion at its next meeting. Any concerns of the Committee, as well as minority views, are recorded in the minutes.

At the conclusion of the full IACUC review and approval, each member of the Committee signs the review and inspection form, and the report is submitted by the IACUC Chair to the Vice Chancellor for Research and Federal Relations. In that report, the Chair conveys the Committee’s concerns or recommendations involving the care and use of animals at the institution, including minority views within the Committee.

The IACUC may also make written recommendations to the Associate Provost, through the IACUC Chair, at any time regarding any aspect of the institution’s animal program, facilities, or personnel training. The Vice Chancellor for Research & Federal Relations communicates regularly with the IACUC Chair to discuss animal care issues order to facilitate open communication on matters of concern.

Reviewing and approving, requiring modifications in (to secure approval), or withholding approval of those activities related to the care and use of animals;
Reviewing and approving, requiring modifications in (to secure approval), or withholding approval of proposed significant changes regarding the use of animals in ongoing activities;
Notifying investigators and the institution in writing of its decision to approve or withhold approval of those activities related to the care and use of animals, or of modifications required to secure IACUC approval; and
Conducting continuing review of each previously approved, ongoing activity at appropriate intervals as determined by the IACUC, including a complete review at least once every three years.

Procedures for 6-9 above
NOTE: All protocols are reviewed by the full Committee.

A protocol for animal use is submitted to the Office of Research Services, using a form available on this web site. The protocol is distributed by email to the IACUC Committee. Any member of the IACUC has the opportunity to request full committee review of the protocol.

If full committee review is not requested, the UNC Charlotte IACUC implements the ‘Designated Member Review’ process. In this process, at least one member of the IACUC, designated by the chairperson and qualified to conduct the review, reviews the protocol and has the authority to approve, require modifications in (to secure approval), or request full committee review of any of the activities.

When full committee review is requested or if the protocol activities fit in Pain & Distress Categories D or E, then the protocol is distributed to each member of the IACUC at least one week prior to the Committee’s monthly meeting. Upon receipt, the ORS Compliance Office assigns a scientist member of the Committee to review the protocol and lead the discussion of the protocol at the next meeting.

A quorum, consisting of 50 percent of the voting members plus one member, must be present in order to take action on the protocol. Following discussion, the Committee may decline to approve the protocol, withhold approval until the protocol is revised as requested, or approve the protocol as submitted. Approval of research projects may only be granted with the approval vote of a majority of the quorum present.

If the IACUC has concerns about the use of hazardous substances which remain unaddressed after reviewing any hazardous material cerifications submitted with the protocol or following any discussion of such substances, the Committee may refer the protocol back to the Biosafety Committee, Chemical Safety Committee, or Radiation Safety Committee for resolution of such issues prior to giving its approval.

Meeting minutes are recorded by a staff member from the Office of Research Services. Following the meeting, the ORS Compliance Specialist conveys any concerns or requests for revision to the investigator and oversees the revision process.

When conditions for approval have been met, the Office of Research Services notifies the investigator in writing, and authorizes the DLAR to permit the work to begin.

If the protocol is not approved, the Office of Research Services similarly notifies the investigator.

Being authorized to suspend an activity involving animals. The IACUC may suspend an ongoing activity by a majority vote of the quorum in a regularly scheduled meeting or in a called meeting. A suspension discussion may be initiated by any member, by the Vice Chancellor for Research & Federal Relations, or in response to any complaint filed by any individual.

Starting a Project

The following steps should be followed in starting a new project.

1. IACUC Approval. An investigator should allow 4 to 6 weeks for the approval process. The Animal Use Protocol Approval Application must be completed and submitted to the Office of Research Services (ORS). The IACUC meets monthly, and the application must be received in ORS at least one week prior to the IACUC meeting in order to be reviewed at that meeting. If the application is received less than one week prior to the meeting, it may be held over for review in the following month.

Specific steps to be followed are:

i. Complete Animal Use Protocol Approval Application form. You can download it as a Microsoft Word document.

ii. Submit a draft copy of your protocol to the University Attending Veterinarian and the DLAR. Their review and input should be obtained before the protocol is submitted to the Committee. Their comments and/or suggestions will be emailed to you. If veterinary consultation is needed, schedule that prior to submitting your protocol to IACUC.

iii. Make arrangements for funds to purchase and maintain animals. Biology faculty who do not yet have external funding should consult their department chair. You may contact ORS for assistance in locating possible external funding sources. The DLAR can provide vendor names, price lists, and current per diem rates.

iv. It is the Primary Investigator's responsibility throughout the course of the study to ensure that anyone involved in the protocol has completed the proper training, including:

- the required on-line IACUC on-line tutorial,
- Vivarium animal-handling training,
- viewing appropriate video training tapes, and
- attending ORS workshops.

It is also the PI's responsibility to ensure:

- the safety of all procedures involved with the study,
- that the use of hazardous materials in the study has been reviewed and approved by the appropriate committee, and
- all elements and phases of the study are in compliance with those approved by the IACUC.

v. Submit the completed Animal Use Protocol form to ORS.

vi. Following IACUC review, ORS will notify the investigator of IACUC action on the protocol (e.g., approved, disapproved, or to be approved following revision).

2. Vivarium Space and Access. When first contemplating animal use, the investigator should talk to the DLAR about housing space needs for the project.

3. Ordering Animals. Following IACUC approval, the investigator may place an order for animals with the DLAR, who will notify the investigator when the animals have arrived. A source of funds which can be billed by the Vivarium must be identified before animals can be ordered. At this time, the DLAR and investigator will also discuss the care of the animals and any special needs that the investigator has.

4. Health and Safety. It is the Primary Investigator's responsibility to ensure that good standards of health and safety are followed. Prior to the beginning of each semester, all investigators with active protocols will receive a reminder from ORS about the need to inform students in writing about potential hazards.

5. Annual Review. On each anniversary date following the approval of a protocol, the investigator must submit a renewal request for IACUC review as required by law, using the Annual Protocol Renewal Request / Protocol Status Report form (download a Microsoft Word document). As a courtesy, the Compliance Office sends out reminders to the Primary Investigators of the need to do this. Investigators failing to submit the required renewal paperwork by their anniversary date will have their projects terminated.

Changes or Modifications in an Approved Project

Any change in an approved protocol requires an amendment to be submitted to the IACUC. The amendment should be submitted on the approved template form for Minor or Significant Changes.

Guidelines
Guidelines for determining whether the change is minor or significant can be found at http://www.uncc.edu/research/Files/amendguide.doc. For example, the addition of an anesthetic or analgesic or the replacement of one strain of the same species with another are examples of changes that can be made by amendment. Amendments are reviewed by the IACUC using the same procedures as for new protocols, and investigators are notified of the review outcome in the same manner as for new protocols.

Increase in Animal Numbers
Any change in animal numbers for the protocol require one of the following actions by the primary investigator:

- less than 10% increase in animal numbers requires a Minor Change Amendment form
- 10%-25% increase in animal numbers requires a Significant Change Amendment form
- 26% or more increase in animal numbers requires a new protocol to be submitted.

Addition of Personnel
The addition of personnel, including students, to a project must be reported to the Office of Research Services. Personnel changes require the submission of a Minor or Significant Change Amendment as follows:

- personnel changes involving animal-handling roles require a Minor Change Amendment form
- personnel changes in non-surgical related roles require a Minor Change Amendment form
- addition or deletion of personnel administering anesthesia, performing surgery, giving injections, etc. require a Significant Change Amendment form.

NOTE: It is the responsibility of the Primary Investigator (responsible faculty) to ensure that students who are named or added to a protocol obtain relevant training before they begin work on the project.

Changes that Require Submission of a New Protocol
The following changes require a new protocol submission:

- Changes that require an increase greater than 25% in animal numbers
- Any change that requires a new search for alternative procedures or
- Any change that requires a new search to verify that the research is not unnecessarily duplicative.

Training Requirements

A critical component of any animal use protocol is the relevant training and experience of all professional and technical personnel, including students. Thus, the addition of personnel, including students, to a project requires that experience and training for the new personnel be addressed. In addition, when students are added to the protocol, the faculty investigator should ensure that the students have acquired the appropriate training before IACUC approval is given to start the project.

For more information on the training program, go to UNC Charlotte's Animal Care Program Training Plan.

All personnel involved in the protocol must be familiar with the NIH Guide for the Care and Use of Laboratory Animals, as well as the requirements of the amended Animal Welfare Act.

Annual Renewal Procedures

On each anniversary date following the approval of a protocol, the investigator must submit a Renewal Request and Status Update form to the Office of Research Services for IACUC review. As a courtesy, the Compliance Office sends out reminders to the Primary Investigators of the need to do this. Investigators failing to submit the required renewal paperwork by their anniversary date will have their projects terminated.

At least once every three (3) years, previously approved, ongoing projects must receive a complete and new review by the IACUC. Investigators are notified to submit a new protocol utilizing all of the criteria mandated for initial review to the IACUC prior to the third anniversary of the original approval date of their current protocol.

Terminating a Project

At the completion of a project, the faculty investigator should consult the DLAR regarding the disposition of animals, relinquishing of space, and possible future facility needs.