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.