Whenever a consent document is revised,
the IRB must approve the changes prior to implementing. The IRB will stamp the
new version of the consent document and return it to the researcher.
Revised consents require a new
IRB stamp of approval.
Revised consent forms will
have the same expiration date.
An identifying letter (i.e.,
A, B, C, …) will be placed directly below the IRB stamp and is associated
with the approved informed consent revision. For example:
A: 1st revision to the
consent during the review period
B: 2nd revision to the
consent during the review period
An internal procedure should
be in place to notify all consenting researchers that there is a newly revised
and IRB approved consent form. The extra blank copies of old versions must
be removed from their access!
If you use the wrong
version of the consent document, you have NOT obtained legally effective
informed consent. The correct procedures, risks, time commitment,
etc. may not have been disclosed to the subject.
Example of
an IRB-approval stamp on an amended consent form: