Note: Commercial companies sponsoring research often request their own language be used or
that minor changes be made to the HIPAA authorization. Such requests cannot be honored. The
wording and formatting used in the authorization was formulated on University of California
policy and with the intent of adhering to the requirements of federal and state regulations.
As of September 23, 2013, the compliance date of the HIPAA Final Rule, participants must
"opt-in" to allow the use of their PHI for optional sub-studies as well for future secondary use
of PHI. The HIPAA authorization has been updated to include a checkbox to indicate that the
participant has agree to allow information to be disclosed for the additional optional research
activities explained in the informed consent process.
Research involving an IND exemption
— required for research requesting an IND exemption for the use of a drug,
bioavailability or bioequivalence studies, studies involving radioactive or cold isotopes, or
foods including dietary supplements and conventional/medical foods