Hit

Home

Policies/Guidelines

Alerts

Occupational
Health Information
and Forms

Pulse
on Animal Rights

Ask the Veterinarians

Related Links

Training

Emergency Numbers

How to report issues
of non-compliance
or concerns

 
When is a Study Amendment Form Required?

All changes to approved studies require approval from the IACUC. Changes in study protocols may NOT be initiated until the principal investigator receives written approval of the amendment. The amendment must describe all of the proposed changes in complete detail.

An Amendment Form is intended as a streamlined mechanism for fine-tuning and making minor changes to an existing approved Animal Care and Use study. The Amendment Form is intended for situations where the proposed changes will not be likely to increase the risks to animals or qualitatively alter the scope or aims of the original study in major ways. The decision of what constitutes an acceptable change appropriate for request as an Amendment rests with the IACUC.

Common examples of protocol changes that might be handled with an Amendment Form include:

• Increasing the number of animals

• Adding a new strain or species

• Adding or modifying blood drawing and animal husbandry regimens in ways that do not expand the risks to the animals or alter the scope and focus of the study in major ways, in the judgment of the IACUC.

The Amendment may NOT be used as a mechanism for extending the term of the original approved protocol beyond its maximum life (6 years). In these cases, a new Animal Care and Use Application form is required.