Protocol and informed consent
approval will be renewed by the IRB at least every 12 months at the time of
continuing review.
No participant should ever be
given a consent document without the stamp of IRB approval, nor a consent
document in which the expiration date has passed.
After continuing review approval
the designated Primary Contact for the study will receive a clean consent
with an IRB stamp that has a new expiration date.
REMEMBER: Submit
a clean copy of the consent document at time of continuing review since the
document will need a new IRB approval stamp.