Protocol modifications

PURPOSE:  The IACUC must review and approve all research study proposals (protocols) involving vertebrate animals in compliance with PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy II) and the Animal Welfare Act Regulations (AWAR §1.1 and §2.31). Principal investigators wanting to make any changes to an IACUC approved protocol must obtain IACUC approval in compliance with PHS Policy (IV, B, 7) and the AWAR (§2.31, c, 7) prior to implementation.

POLICY:  Protocol modifications are classified as either significant, minor or administrative and are handled in the following manner;

Significant Changes:  In brief, significant changes are those that have, or have the potential to have a negative impact on animal welfare.   Significant changes must be approved by the IACUC either through the Designated Member Review (DMR) or Full Committee Review (FCR) process, and include changes: 

1. resulting in greater pain, distress, or degree of invasiveness;
2. from nonsurvival to survival surgery;
3. that impact personnel safety;
4. in Principal Investigator (PI);
5. in species;
6. in animal numbers more than 25% of the originally approved allocation in pain categories C or D or any increase in category E;
7. in housing and or use of animals in a location that is not part of the animal program overseen by the IACUC;
8. in study objectives (which may require a new protocol submission);
9. in anesthesia, analgesia, sedation, or experimental substances;
10. in euthanasia; and
11. in duration, frequency, type, or number of procedures performed on an animal.

Minor Changes:  Minor changes are those not having direct animal welfare/well-being impact and can be approved by the Attending Veterinarian or IACUC Chair outside of a convened meeting.  Changes with a veterinary component (ex. procedural change) requires veterinary approval.  All other changes may be approved by the Chair.  Minor changes may include:

1. addition of another strain of same animal species;
2. change in sex of animal to be used;
3. Increase in animal numbers of not more than 25% of the originally approved allocation in pain categories C or D
4. additional non-invasive sampling; and
5. a procedural change deemed minor by the IACUC Chair and Veterinarian.

 Administrative Changes:  Administrative changes include typographical errors, correction of grammar, contact information updates and change in qualified personnel, other than the PI.  Administrative changes are approved by the IACUC Administrator (AI).

Note:  All approvals will be reported to the IACUC at the next scheduled meeting. Any approved activity may be called for re-consideration by the IACUC if any member determines that a review of an approved amendment is necessary.

PROCEDURE: 

Protocol Modifications – The PI submits the Protocol Modification Request Form along with an updated copy of the approved protocol to the IA who determines the correct classification after consultation from the IACUC Chair and Veterinarian.

• If it is an administrative change, the IA will review it. 
• If it is minor change with no veterinary component, it will be forwarded to the IACUC Chair for review.  If there is a veterinary component, it will be forwarded to the AV.
• If it is a significant change, it will be sent to the IACUC and either reviewed through DMR or at a full committee meeting.

Adoption Date: 6/15/17
Amended: 2/8/18
Reference minutes: 6/15/17, 2/7/18