Explanation

Modifications to an approved IACUC protocol:

• All proposed changes to approved animal care and use protocols must be approved by the IACUC before they are instituted.
• The NIH and USDA require different review mechanisms for MINOR versus SIGNIFICANT / MAJOR modifications. In general:
• Minor modifications can be approved by the IACUC Chair
• Significant / Major Modifications must be approved in a convened full committee meeting

The following categorization of activities is not exhaustive but is intended as a guide to the type of changes that the IACUC might regard as minor or significant changes to a protocol.

MINOR MODIFICATION: A minor modification is a change to the approved activity (protocol) that is unlikely to be a physiological cost to the animal, or the change may decrease the potential for pain/distress (i.e. a refmement).

• Change in age of animals ordered (2-3 days for rodents if younger)
• Adjusting experimental end point for earlier termination of the study resulting in reduced pain and/or distress
• Decreased dose levels or reduced dosing frequency of animals with experimental item
• Reduced blood samplings
• Change in personnel (not PI)

SIGNIFICANT I MAJOR MODIFICATION: A significant modification is defined as any change to the approved activity (protocol) that is likely exact a physiological cost to the animal (i.e. there is a potential to increase pain/distress).

• Change in study objective/goals
• Increase in the number of animals approved by the IACUC
• Any procedure that has the potential to increase in potential pain/distress
• New or additional procedures~ especially those that involve more than
• Momentary restraint, or other surgical or invasive procedures not listed in the approved activity
• Significant food/water restrictions (not routine fasting)
• Increase in bleeding volumes or time points
• Change in frequency of observations for morbidity (decrease)
• Change in dose volume of experimental materials (increase)
• Change in dose route (i.e., changing from I.P. to LV. infusion)
• Change in dose frequency (increase)
• Change in experimental vehicle or adjuvants
• Change in animal housing or husbandry
• Change in experimental end point (longer duration of study)
• Change/addition in species (some listed rodent to non-rodent)
• Addition of a hazardous agent
• Change in method of euthanasia
• Change of species
• Extension of the study
• Change in PI
• Change in method of anesthesia, sedation or analgesia.

** All proposed changes to IACUC approved activities should be submitted to the IACUC and approved before they are instituted.

** If in doubt, contact the URCO, the attending veterinarian or the Chair of the IACUC for guidance.