In this scenario, Green, the IACUC administrator, is basically correct. According to Guidance on Significant Changes to Animal Activities1, any of the following changes must be approved by one of the valid IACUC approval methods described in the PHS Policy (IV.C.2; ref. 2), that is, by either Full Committee Review, or Designated Member Review:

“a. from non-survival to survival surgery;

b. resulting in greater pain, distress, or degree of invasiveness;

c. in housing and or use of animals in a location that is not part of the animal program overseen by the IACUC;

d. in species;

e. in study objectives;

f. in Principal Investigator (PI); and

g. procedures that impact personnel safety.”

Adding either of the procedures described by Green would fit under either situation a, b or e above. As minor as a procedure may be, if it is a new procedure being added to a protocol, according to the Guide, it has to be approved by the IACUC.

The Veterinary Verification and Consultation process (VVC) which Dr. Thorne refers to can be used to make significant changes to animal activities that are already part of a protocol which was previously reviewed and approved.

No matter what classification the amendment is given, the animal's welfare should prevail.

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