THE UNIVERSITY OF TEXAS AT AUSTIN
INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE
Written Description for Proposed Animal Use in Human Subject Study Environments
This document is to be used to outline the information required by the IACUC in order to approve the use of animals in human subject study areas. NOTE: The actual procedural details and the names of the personnel performing the procedures will need to be separately added in a protocol submission. This template covers the specific health, safety and security precautions taken to protect the both animals and people when animal studies are done in human subject areas.
1. Name of Principal Investigator(s)
Office address (building and room number)
Mailing Address
Phone, fax, email, pager
2. IACUC Protocol Number and Title (state “pending” if this is a first submission)
3. Brief description of research to be performed. Include information on why the animal facility or a laboratory area cannot be utilized for the proposed procedures.
4. Identify the species and number of animals to be used.
5. Identify the equipment and location (building and room numbers) of the patient care area(s) to be used.
6. Explain how frequently these procedures will be performed.
7. List the date and time of day that the procedure will be performed. If a series of recurring procedures are planned, provide the typical day(s) of the week for the procedure, and the time window being considered.
8. List the name(s) of the persons who will perform the transport.
9. Discuss the method of transporting the animals to and from the procedural area. Include a description of the transport containers, any vehicles used, and precautions to be taken to shield the animal from view and to avoid contact with students, visitors, and other non-research personnel. If animals are sedated, explain how they will be monitored during transit. The time required for this transfer should be provided, based on an actual dry run walk-through of the proposed methods.
[insert response here]10. Discuss the route used for both the external transport between the vivarium and the building where the procedure will be done and the internal transport within the building. Discuss entry and exit doors used, elevators selected, etc.
11. Provide a complete description of how and where the animals will be kept while in the human subject area as well as the measures to be taken to prevent disturbances (e.g., noise, odors) in order to minimize contact with human subjects and non-affiliated persons that may be in the area.
12. Describe the precautions taken to protect exposed surfaces, structures, unused equipment and furniture in the human subject use area from contamination by animal feces, urine, saliva, blood, or other body fluids. Examples include removing certain items from room, closing all doors, drawers and cabinets; draping areas with sheets; covering instrument surfaces with plastic, absorbent chucks/diapers, etc).
13. Describe the personal protective equipment used by personnel working with the animals (gowns, gloves, masks, etc.) during transport or when performing the procedures. What will be available as far as first aid supplies, a bite kit (for macaque studies), etc?
[insert response here]14. Provide details of the procedures to be followed in cleaning and disinfecting equipment and room surfaces prior to and following animal use. List the disinfectant used, concentration or dilution factor, and the contact time that will be provided during decontamination. Explain how soiled cleaning materials will be disposed. For terminal procedures, describe how and where the animal carcasses will be stored and disposed.
15. Confirm that:
a) A copy of the current, approved IACUC protocol (including this description) will accompany the animals during transport and while the procedures are being performed
b) The Director of ARC will be notified each time that animals are scheduled to be transported to the human subject area for a procedure. Information provided will include: date of visit, time departing animal housing area and time returning to housing area, approximate time and duration in the human subject area. NOTE: In some instances (e.g., certain rodent procedures) this requirement may be waived by the ARC Director.
c) Any untoward events (animal-related injury, animal escape, and animal death) are to be promptly reported to the IACUC and the Director of ARC.
16. Required signatures.
a) Principal Investigator(s) submitting this request.
Name(s) of Principal Investigator(s) / Signature(s) / Dateb) Approving officials.
Attending Veterinarian / Signature / DateFacility Director or Manager responsible for the human subject area / Signature / Date
Vice President for Research
(or designee) / Signature / Date