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IACUC Protocol Amendment Review

Requirements and Submission

Any and all changes to a protocol must be reviewed and approved by the IACUC before they are implemented. Failure to do so may result in non-compliance or protocol closure.

 

To submit a protocol amendment, use the form below:


Types of Amendments

Significant changes include, but are not limited to:

  • A change from non-survival to survival surgery
  • Procedures that result in greater pain, distress, or degree of invasiveness
  • Changes in housing and/or use of animals in a location that is not part of the animal program overseen by the IACUC
  • Change in species
  • Modification of study objectives
  • Change in Principal Investigator (PI)
  • Increased impact on the safety of personnel

 

Minor changes include, but are not limited to:

  • Increasing the number of an already approved species (greater than 10% but less than or equal to 25% of the approved number)
  • Adding a new strain of the same species
  • Deleting a species
  • Change in age of animals already approved for the study
  • A change in administration of an already approved experiment/treatment as it relates to the timing, dose, route of administration, and/or specific chemical composition
  • Changing animal use location or field site

 

Administrative changes include, but are not limited to:

  • Changing the protocol title or funding source
  • Changing addresses, phone numbers, or email addresses
  • Increasing the number of an already approved species (if increase is less than 10% and not from Pain Category E)

Approval Process

All amendments will be subject to review in order to determine whether a change is significant or minor. Significant changes can only be approved by FCR or DMR. Minor or administrative changes may be handled by the IACUC office, depending on the nature of the change.

Once the amendment request is classified as significant or minor, the following will occur:

 

Significant or minor amendments

  • A DMR Subcommittee consisting of one or more IACUC members will make a decision regarding the change.
  • The DMR subcommittee may also refer the amendment to the full committee for review.

 

Administrative amendments

  • The IACUC office will review and approve the amendments and, if necessary, forward them to the full committee or DMR for review.
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