Modification Request for Approved Research Projects

Any change to an existing approved protocol study must be reviewed and approved by the IRB prior to implementing the change except when the change is necessary to eliminate apparent immediate hazards to subjects.

Click here to visit the Forms page and download the Modification Request Form.

Modifications include, but are not limited to, procedural changes to a protocol, adding or removing investigators, changing the title of the project, requesting additional subjects beyond the original approved number, new funding sources, new or revised advertisements, changes to Informed Consent Documents, surveys, questionnaires, correspondence with potential or current subjects, or additional new items.

Modifications to an approved project should be submitted on a Modification Request Form and submitted for review by the IRB. Minor modifications, such as title changes, changes in investigators, and changes in funding source, may be approved by the IRB Chair alone using the expedited review procedure. More extensive modifications may require full board review.

Notification of IRB determination of a Modification Request will be sent to the PI by email from OPRS.