With the Maestro Care implementation of Care Everywhere, the DUHS Sample Consent Form (select Form Type: Consent Form Templates) has been updated to reflect the Health Information Exchange capabilities of Care Everywhere. Please see the minor changes on page 5 of the DUHS Sample Consent: a tracked version has been posted on the IRB web site to allow study teams to see the exact changes. The changes reflect the fact that participants’ research information is often embedded in the medical record.
Any study that uses the Investigational Drug Service (IDS) and has the subject ID number on the study drug order must submit an amendment to the IRB to revise the consent form language in the section “WILL MY INFORMATION BE KEPT CONFIDENTIAL?” Please see the DUHS Sample Consent, page 5, to see the required changes. This amendment can be submitted at the next renewal of IRB approval for the study. Other study teams using Maestro Care are encouraged to include the updated language in their consent forms as well.
For assistance please contact the IRB Specialist for your CRU.