How do I make changes to the content of my Board-approved consent form?

Changes to the content of a consent form, outside of site specific contact information, that are not submitted by the sponsor are considered “unique changes.” Unique changes may include the addition of a Witness Statement, language added/modified to fulfill state law requirements, or other changes to the wording of the consent form.

All unique consent form changes must be tracked into an electronic copy of the current Board-approved version of the consent form and submitted electronically. For central studies, requests for unique consent form changes must be accompanied by rationale and documentation of sponsor approval for the change. Failure to submit unique changes in the appropriate format or with the necessary sponsor authorization will result in delays in review.

Revised consent forms will be reviewed according to regular submission deadlines (see the Quorum Review Board Meeting Schedule). Some revised consent forms may qualify for Expedited Review. Please contact Quorum’s Client Support Team at 1-877-IRB-9883 or for more information.