Changes and Amendments

Changes/Amendments to Existing Study

Investigators must report any changes whatsoever, regardless of the level of the original review and regardless of their assessment of the importance of the change.

The IRB requires that any proposed changes in approved research be reviewed and approved prior to implementing these changes to determine whether the modified research continues to fulfill the criteria for approval.

Investigators may request approval of proposed changes by the completion and submission of the Study Amendment form located on the Forms page.

Investigators are reminded that changes may not be implemented until final written approval is received from the Committee.

• Guidelines for Determining the Type of Amendment