Guideline #16
Protocol Modifications
1. References:
1.1. NIH NOT-OD-14-126 Guidance on Significant Changes to Animal Activities
2. Purpose: To provide guidance with regards to minor versus major protocol modifications.
3. Policy: PI’s must request approval for any proposed change, or modification, to an approved, or ongoing, activity. This request is submitted to the URCO, and summarized in a designated section of the application form, with all appropriate changes made throughout the protocol document.
3.1. Minor Modifications: 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 refinement).
3.1.1. Minor modifications may be reviewed and approved by the IACUC Chair.
3.1.2. Minor modifications include, but are not limited to, the following:
3.1.2.1. Adjusting experimental end point for earlier termination of the study, resulting in reduced pain and/or distress;
3.1.2.2. Decreasing dose levels, or reducing dosing frequency, of experimental item;
3.1.2.3. Reduced blood sampling frequency.
3.1.3. Minor modifications such as corrections of typographical errors, correction of grammar, contact information updates, and change in personnel, other than the PI, may be reviewed and approved administratively, by URCO, after an administrative review has been conducted to ensure new personnel have completed all required training and completed their occupational health enrollment.
3.2. Major Modifications: A major modification is defined as any change to the approved activity (protocol) that has the potential to substantially impact the health and well-being of the animal (i.e. there is a potential to increase pain/distress).
3.2.1. Changes deemed to be significant, or major modifications, by the URCO and/or the IACUC Chair are reviewed at the next available full committee meeting.
3.2.2. Major modifications include, but are not limited to, the following:
3.2.2.1. Increase in the number of animals approved by the IACUC;
3.2.2.2. Addition of surgery, change from non-survival to survival surgery, from minor to major surgery, or from single to multiple survival surgery;
3.2.2.3. Addition of a hazardous agent;
3.2.2.4. Changes in anesthesia, analgesia, sedation or experimental substances;
3.2.2.5. Change in method of euthanasia;
3.2.2.6. Changes in duration, frequency, type, or number of procedures performed on an animal;
3.2.2.7. Change in procedures that could result in greater pain or distress;
3.2.2.8. Change in degree of invasiveness from less to more invasive;
3.2.2.9. Change in housing of animals or use of animals in a location that is not part of the animal program overseen by the IACUC;
3.2.2.10. Change/addition in species;
3.2.2.11. Change in study objectives;
3.2.2.12. Change in Principal Investigator (PI);
3.2.2.13. Change that has the potential to impact personnel safety.
LAST REVIEWED AND ADOPTED BY THE IACUC: March 3, 2022