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Modifications to a Protocol

The IACUC must review any significant change to a protocol before the change is implemented. A significant change is any change that has animal welfare implications. Examples of animal care and use changes generally considered significant and that require IACUC approval include changes in:

• the objectives of a study;
• blood collection site, frequency, volume;
• non-survival to survival surgery;
• minor to major surgery;
• increase from one to multiple survival surgeries;
• the degree of invasiveness of procedures or the level of discomfort, pain or distress to animals;
• tumor being transplanted;
• Principal Investigator (PI);
• the species or approximate number of animals used in the protocol or in procedures within the protocol;
• anesthetic or analgesic drugs or adding them if they were to be withheld, or withholding them if they were to have been administered;
• methods of euthanasia; and/or
• duration, frequency, or number of procedures performed on individual animals.

The principal investigator (PI) submits a description of the change to the IACUC; generally this is referred to as an amendment. The IACUC Chair or his/her designee determines whether the change is “significant.” If the change is considered significant, it is reviewed in the same manner as a new protocol.

A notice from NIH clarifies the specific issue of whether personnel changes are “significant,” and includes links to information on other significant changes.