Making Modifications/Changes to Approved Protocols

Amendments to an existing protocol must be reviewed and approved by the Institutional Animal Care & Use Committee before the changes are implemented. Changes made to a protocol may be categorized as one of two types, significant or minor. Significant amendment applications are reviewed either by the full committee at a convened meeting or through the designated reviewer process.

The Office of Laboratory Animal Welfare has designated the following as significant changes:

1. change in objectives of a study;
2. proposals to switch from non-survival to survival surgery;
3. change in degree of invasiveness of a procedure or discomfort to an animal;
4. change in species or in the approximate number of animals used;
5. change in anesthetic agent(s) or in the withholding of analgesics; change in methods of euthanasia;
6. change in duration, frequency or number of procedures performed on an animal; and
7. change in Principal Investigator (PI).

Minor amendments include changes in personnel other than the PI or co-PI, change in protocol title, and change in funding source. Such minor amendments may be administratively reviewed and approved by the Office of Research Compliance. A minor amendment form is available to accommodate such requests.

Revisions to an existing protocol do not extend the current approval period.