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 Institutional Official, Dr. Stephen R. Mosier, Vice Chancellor for Research and Federal Relations. As the Institutional Official responsible for the animal care and use program, he files assurances of compliance with the USDA, the NIH Office of Laboratory Animal Welfare (OLAW), and the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), 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 (the Guide) and the Animal Welfare Act and Regulations (AWA). 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 and the AWA, the provision of veterinary care for all animals held by the Institution, and consultation with faculty and staff in the design of experimental Applications. 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 an Animal Care Application (ACAP) 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, Compliance Manager and Elizabeth Thames, IACUC Coordinator, both in the Office of Research Services (ORS),coordinate administrative support for the IACUC. The Compliance Office assists investigators in completing the appropriate Animal Care Application form, sends out notices of annual review for Animal Care Applications, 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 and AWA as a basis for evaluation;
Inspecting at least once every six months the institution's animal facilities using the Guide and AWA as a basis for evaluation;
Preparing reports of the IACUC evaluations and submitting the reports to the Institutional Official;
Reviewing concerns involving the care and use of animals at the institution; and
Making written recommendations to the Institutional Official 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 (2) voting members of the Committee to conduct a comprehensive inspection and evaluation of the animal facility. 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 Semi-Annual Program Review is completed at a convened IACUC meeting. The completed Semi-Annual 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 Institutional Official. 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 Institutional Official, through the IACUC Chair, at any time regarding any aspect of the institution’s animal program, facilities, or personnel training. The Institutional Official communicates regularly with the IACUC Chair to discuss animal care issues in 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 applications are reviewed by the full Committee.

As of January 15, 2008, all Applications for animal use is submitted via the ACAP System to the Office of Research Services. The Application is distributed to the IACUC Members by the Compliance Office. Any member of the IACUC has the opportunity to request full committee review of the Application.

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 Application and has the authority to approve, require modifications to secure approval, or request full committee review of any of the activities.

When full committee review is requested or if the Application includes USDA Pain & Distress Category E procedures, then the Application 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 Application and lead the discussion of the Application 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 Application. Following discussion, the Committee may approve the Application, require modifications to secure approval, or withhold approval of the Application. 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 certifications submitted with the Application or following any discussion of such substances, the Committee may refer the Application 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 Application 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 as Institutional Official, 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 online Animal Care 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 prior to the submission deadline.

Specific steps to be followed are:

i. Complete the online Animal Care Application form. Access the online application system at https://uncc.myresearchonline.org/acap/.

ii. Submit a draft copy of your protocol to the University Attending Veterinarian and the DLAR. Their review and input are required before the Application is submitted to the Committee. Their comments and/or suggestions will be emailed to you. Veterinary consultation is required by AWAR (§2.31,d,1,iv,B) for procedures involving more than momentary or slight pain and distress. Scheduling this consultation should be done prior to submitting your Application to the 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 or 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 study 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 Care Application (ACAP) form to ORS.

vi. Following IACUC review, ORS will notify the investigator of IACUC action on the application (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 Applications will receive a reminder from ORS about the need to inform students in writing about potential hazards.

5. Annual Review. Prior to each approval anniversary date of an Application, the investigator must submit a renewal request for IACUC review as required by law. Annual Renewals can be submitted via the ACAP system. 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. Any protocol approved before January 15, 2008 must submit the Annual Renewal using the Word form located at http://www.research.uncc.edu/comp/animal.cfm under Forms for PIs.

Changes or Modifications in Projects Approved prior to January 15, 2008

Any change in an approved protocol always requires an amendment to be submitted to the IACUC for approval prior to implementing the change. The amendment should be submitted on the approved template form for Minor or Significant Changes. Amendments to protocols approved before January 15, 2008 should be submitted based on the Guidelines below for determining Minor or Significant Changes.

Determining "Minor or Significant" Amendment Status for Projects Approved prior to January 15, 2008
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 replacement of one strain (of the same species) with another can be made by completing and submitting a Minor Change amendment form. Significant Change Amendments include things such as: change in species; surgery or intra-operative procedures; or requests for 10%-25% increases in animal numbers. 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
Requests for increases for 10% or less in number of animals originally approved by the IACUC may be submitted on a Minor Change Amendment form. Additions are limited to a one-time increase of 10% or less in the number originally approved for species originally approved.

Requests for 10%-25% increases require submission of a Significant Change Amendment form. Increase requests of 26% or more require submission of a new protocol.

Addition of Personnel
The addition of personnel, including students, to a project must be reported. 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 (and/or responsible faculty) to ensure that students who are named or added to a protocol obtain relevant training before they begin work on the project.

Amendment Guidelines for Projects Approved after January 15, 2008
Any change in an approved protocol always requires an amendment to be submitted to the IACUC for approval prior to implementing the change. For projects approved after January 15, 2008, the amendment must be completed as part of the original Application and submitted online through the ACAP system at https://uncc.myresearchonline.org/acap/.

Changes that Always Require Submission of a New Application
The following changes require a new Application submission regardless of the original approval date:

- 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.

NOTE: submitted online through the ACAP system at https://uncc.myresearchonline.org/acap/.

Training Requirements

A critical component of any Animal Care Application 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 Application, 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.

Three Year Renewal Procedures

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 Application 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 Application. NOTE: submitted online through the ACAP system at https://uncc.myresearchonline.org/acap/.

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. The PI should submit a Renewal Form requesting the Approved Application be terminated.