Modification to the IRB Stamp - FAQ

Common questions study teams have about modifications made to the IRB approval stamp that went into effect February 2017.

What is being changed?
Starting in February, IRB approval stamps on your study documents – which include consent forms, assent forms, and information sheets – will no longer include an expiration date. This means that these documents will no longer automatically expire at the date of a study’s continuing review. We are also removing the IRB FWA number that was included in the approval stamp.

Why was this change made?
Members of the Human Subjects Protection Program (HRPP) on campus continually review our regulatory policies and procedures for adherence with federal law and guidelines. As part of this review, HRPP members determined that having study documents expire annually is not a required element of compliant human subjects research. In addition, annual expiration for these documents does not add any benefit or protections to study participants.

How do we transition existing stamped study documents used by ongoing studies?
Study teams will not be required to take any action due to this change. After February, study documents will be re-stamped at your next continuing review without an expiration date. Thereafter, the continuing review process will not include an update to the approval stamp.

Once all existing studies have been given the new stamp, if my study documents don’t expire, when will they be stamped or re-stamped?
After February, the documents noted above will be stamped with an approval date at the following times during the course of the study:
     • Initial approval of the study (stamped)
     • With changes of protocol only when a revision has been made to the consent document(s) (re-stamped)**
     • With changes of protocol if a new consent document is being added (stamped)
     • When your study gets renewed after 5 years (stamped)

How will I know which version of the consent form to use?
You will continue using the consent form(s) mostly recently approved by your IRB, just as you have done in the past. You can find the most recently approved consent document(s) in the Study Documents tab of the main study workspace in ARROW.

Who do I contact if I have questions?
Please direct any questions or concerns regarding this change to Peter Johnson in the Office of Research Policy: 890-1241 or peter.johnson3@wisc.edu.

**Note: if you submit a change in protocol after the rollout of the new stamp and your next continuing review that requires a new consent form or revision to an existing consent form, all consent forms will be re-stamped. Once your change has been approved, you will need to use the re-stamped consent form when enrolling new subjects.




Keywords:stamp, consent form   Doc ID:68070
Owner:Peter J.Group:VCRGE and Graduate School
Created:2016-10-26 14:45 CDTUpdated:2017-07-19 14:46 CDT
Sites:VCRGE and Graduate School
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