IBC Modifications

Modifications and amendments to an approved IBC protocol must be reviewed and approved by the IBC before those modifications and amendments can occur. These modifications and amendments may be submitted to the IBC through the iRIS electronic compliance platform with a Modification Form.

Acceptable modifications may include the following:

• Changes to the PI or other personnel.

• Changes to the protocol title.

• Changes to study design, protocol procedures, study location, or other approved protocol activities.

Protocol modifications that do not result in increased risk qualify for administrative review. All other modifications will require Full Committee review.

Submission Checklist

A complete submission increases the chance of approval. The following information should be included in an IBC protocol modification request:

• If a modification pertains to a change of PI or study personnel, a CV/biosketch, along with CITI training certifications, must be provided.

• If the modification pertains to changes to the study title, a rationale for this change must be provided, including any changes to specific aims of the project.

• If the change pertains to a change in procedures, a detailed description of the changes must be provided. If changing locations (room number), a new room number must be provided.

• Any additions of recombinant DNA technology, infectious agents or biological agents must be accompanied by their respective Safety Data Sheets, vector or gene map.