Whenever a consent
document is revised, the IRB must approve the changes prior to
implementing. The IRB will stamp the revised version of the consent
document with a new approval date and return it to the researcher.
Revised consent forms require
a new IRB stamp of approval.
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 previous versions must
be destroyed.
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.