OHRE implemented date stamping of consent forms in May 2024. Since that time, we have noted some instances where the stamp fails to be placed or is obscured by other text. Please follow the steps below to ensure that all consent forms are stamped appropriately. Note that only stamped consent forms should be used when obtaining consent.
- Always use the consent builder to draft your consent form. This ensures the text specific to your study is included. Detailed information can be found here.
- Do not alter the footer. Any alteration could disrupt the placement of the stamped approval date.
- If you need to update a consent form, always download the current Word version from the ‘Submitted Documents’ tab in the submission draft.
- Do not convert the Word documents to pdf. The formatting will not allow proper placement of the approval stamp, and the IRB cannot easily identify your changes from one version to the next.
- All consent forms should be submitted as clean/unmarked documents. This means that all changes should be accepted, all comments should be deleted, and track changes should be disabled.
A few reminders:
- New consent forms will be stamped at the time of approval regardless of submission type.
- Â Previously approved consent forms will be stamped at the following time points:
- At Renewal, if the consent form has not been previously stamped.
- During a modification where the consent form is updated.
- The approval stamp is not updated at each Renewal. Once the form is approved and stamped, that approval remains in force until the form is modified or no longer in use.
- Consent forms will not be stamped during annual Administrative Review. If you require an update to the stamp on a consent form, please submit a modification and include that request in your modification summary.
See past Did You Know posts.
To submit a topic or question for a future DYK, email Celeste Cantrell.