Note: Commercial companies sponsoring research often request their own language be used for
subject injury or harm clause wording or that minor changes be made to this wording. Such
requests cannot be honored. The wording was formulated with the intent of adhering to the
requirements of federal regulations and University of California policy and conveying the
basic, necessary information to the subject.
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
(released 1/28/2014)
Informed Consent/Assent resources for UCSD-RCHSD projects:
Note: Commercial companies sponsoring research often request their own language be used for
subject injury or harm clause wording or that minor changes be made to this wording. Such
requests cannot be honored. The wording was formulated with the intent of adhering to the
requirements of federal regulations and University of California and RCHSD policy and
conveying the basic, necessary information to the subject.
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
and RCHSD policy and with the intent of adhering to the requirements of federal and state
regulations.
Note: In addition to IRB review and approval, all research or related activities conducted on the Rady Children's campus or
involving Rady Children's patients, data, or resources requires Rady Children's Research Administration review and approval (Ready-to-Accrue Letter)
before the project can start. To initiate the process, a Project Initiation Form must be submitted to
research@rchsd.org. You may access the form at
http://intranet.rchsd.org/categories/departmentsesearch/forms-resources-research
(click on Project Initiation Form to open the form). If the form cannot be accessed through this link, please contact
research@rchsd.org to request the form.