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.

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