YES, if any of the 18 protected health identifiers
are created, used, or disclosed in the course of providing
a health care service.
•
THEN,
if study was approved before April
14, 2003:
•
Continue CHR-approved study until time of next renewal or until requesting consent modification.
•
Use currently approved consent (if any).
•
Any
new subjects enrolled April 14, 2003 or after will have to
sign a Subject Authorization in addition to consent form
(PI keeps until study is ended).
•
Consent/Authorization plan will be revisited by CHR at renewal
time.
•
Note: The CHR does not need to review the Subject Authorization
as long as the standard UCSF(Spanish
Version:UCSF
Subject Authorization for Release of PHI for Research)or VAMC Authorization
is used. All other versions require review by the CHR and their
use will result in a delay of approval.
•
THEN,
if study was approved April 14, 2003 or after:
