Do I re-attach the consent form as part of an amendment submission?

Answer

It depends. 

Assuming a study includes one consent document (Consent Form A), when the study receives its original approval, Consent Form A is approved and is listed in #23.1 of the application and available under the "Stamped Documents" section on the Documents tab in the IRBOnline project.  (Please note the information below states "Consent Forms", but the concept applies to any IRB approved documents, e.g. surveys, recruitment materials, etc.)

If a change is needed for the study that requires an amendment, the research team will need to determine which one of the following situations applies: 

1. Changes are required to Consent Form A, or
2. Changes require an additional consent form for a new cohort (Consent Form B), or
3. Changes have no impact on Consent Form A

Situation 1 - Making changes to an approved consent form
Leave Consent Form A (the approved consent document) attached to the application.  Do not re-upload it nor delete it.  OPRS staff will remove it when they finalize your amendment.  To make changes to Consent Form A, you will need to attach a track change version of Consent Form A version showing the changes from the approved version to your new version with the changes incorporated and a clean version of your updated Consent Form A.  Once the IRB has completed the review and everything is ready to be approved, the OPRS staff member will delete the track change version and the original version so that they are only approving and stamping the clean copy of the updated consent. 

Situation 2 - Adding a completely new consent form
Although rare, it is possible a situation may arise when you will be adding a second consent form.  Leave Consent Form A (the approved consent document) attached to the application.  Do not re-upload it nor delete it (unless it will no longer be used).  Attach Consent Form B as a new, separate document.  Follow the standard track change/clean version process if revisions are required during the review process. 

Situation 3 - Changes do not impact the consent form
If you are making changes to the IRB application via the amendment and the changes do not require changes be made to the consent document, do not do anything to the consent document.  Do not upload a new or unstamped version.  Do not touch the consent form unless changes are being made to it.  

Study with Multiple Consent Forms
Some studies are originally approved with multiple consent forms.  If the change is only going to impact one of the consent forms, only provide new versions of the consent form that is changing.  Do not touch the consent form that has no changes being made to it.  Do not upload a new or unstamped version.  

Background on Documents and Stamping
During an amendment submission, the IRB is only reviewing consent forms that have been changed.  They are not supposed to be re-reviewing consent forms that were previously approved if no changes were made, unless there is a risk to participants.  IRBOnline is designed to automatically stamp new documents but not remove old stamps.  Since the IRB did not re-review the old documents, they remain approved.  The stamping is based on what documents have been attached since the last approval.  So, if you remove a document and then re-attach it, it will stamp over the old stamp and it will look like the IRB re-reviewed it when it did not.  

When the IRB stamps an approval date on a consent form, they stamp the date that that specific documents was approved - not the approval date of the most recent amendment.  The stamp date refers to the date that a full review of all consent criteria was completed and documented for that specific form. For example, if you had a study that was originally approved on 9/1/24 with Consent Form A, the stamp date on Consent Form A would be 9/1/24.  If you submitted an amendment to add a second consent form for some reason, but were making no changes to Consent Form A, your amendment wouldn't touch Consent Form A and would just add Consent Form B.  Then, your amendment approval letter on 11/15/24 would only show Consent Form B as an "Approved Document" because the Amendment approval letter only lists documents that were approved as part of that amendment review, not all approved documents for the study.  When you logged into the system to look at your consent forms, Consent Form A would show an approval date of 9/1/24 and Consent Form B would show an approval date of 11/15/24.  If your study had an expiration date, the expiration date remains the same across all amendments and only gets changed during continuing review.  So, you would have Consent Form A showing Approval Date 9/1/24, Expiration Date 8/31/25 and Consent Form B showing Approval Date 11/15/24, Expiration Date 8/31/25.