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Animal Research at UTHealth

Protocol Guidelines

Animal Research Protocol Guidelines

  • Protocols may be submitted at any time.  The AWC Office will complete the pre-review and provide comments within 5 business days.  Revised protocols addressing the pre-review comments must be received by the second Friday of the month to be reviewed in the same month.  Protocols received after the second Friday will be reviewed the following month
  • Protocols are reviewed at a convened meeting on the Fourth Friday of every month
  • Grants and other documents associated with a protocol must be submitted. Please include the face page, research strategy, and the vertebrate animal’s section at a minimum
  • Annual Renewal 
    • All protocols utilizing USDA animals (monkeys, dogs, cats, ferrets, rabbits, guinea pigs, hamsters) must be renewed annually as specified by the expiration date on the AWC approval letter. The iRIS system will send electronic reminders 30-days before the annual review form is due.  All non-USDA species (mice, rats, birds, fish, frogs, salamanders) protocols will have a three year approval with no requirement for annual review
  • Three Year Resubmission
    • According to federal regulations, all approved animal protocols must be resubmitted to the Animal Welfare Committee for a complete review and approval every three years. 
    • You will need to fill out a new protocol application and submit any grants associated with the protocol.  If your protocol is already entered into iRIS you can use the copy feature to begin your resubmission.
  • Change Requests
    • All modifications to approved research protocols must be submitted to the AWC for review and approval prior to implementation. A change request form must be completed and submitted through iRIS.

Adverse Events / Unanticipated Problems / Protocol Deviations

  • Adverse Events / Unanticipated Problems
    • PIs are responsible for completing and submitting an Adverse Event / Unanticipated Problem / Protocol Deviation Form within 7 days of an occurrence that has a negative impact on animal welfare which was not expected nor described in an approved protocol or its subsequent approved modifications.   PIs MUST involve the veterinary staff if animals are suffering from unplanned pain or distress.  The reporting of such events will allow the AWC to review the circumstances and subsequent actions to determine if further procedural changes are required in order to facilitate research effectiveness and to improve animal welfare.
  • Protocol Deviations
    • PIs are responsible for completing and submitting an Adverse Event / Unanticipated Problem / Protocol Deviation Form within 7 days of any departure from the approved protocol whether intentional or unintentional.  The institution and the PI must ensure that all animal manipulations, their location, and personnel involved are in accordance with the approved protocol.  By self-reporting protocol deviations, PIs are demonstrating their commitment to this responsibility and seeking resolutions for minimizing this occurrence in the future.