Research Protocol

1
Research Protocol
Transition to HIPAA
After 4/14/03
Prior to 4/14/03
Date of Approval
HIPAA language must be incorporated into
submitted consent or PI request waiver of
authorization
Written informed consent required?
If data is still being collected (i.e., chart
review) submit a Request for Waiver
of Authorization form to IRB
No
Yes
Subjects enrolled after 4/14/03
Subjects enrolled prior to 4/14/03
Subjects can sign stand-along authorization in
addition to signing the informed consent
Nothing additional needs to be done for HIPAA
At renewal incorporate HIPAA language
into informed consent
Revised 10/24/03