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- Transitioning to New
Website: The IRB/HRPP website
is transitioning to a new website. To begin using the new website,
click here. For the present
time, the "old" website will be still be available and a link to the
old website can be found at the top of each page of the new website.
(Released 8/2/16)
- HRPP Office has
Moved: The HRPP Office has
moved to the Altman Clinical and Translational Research Institute
(ACTRI). The new HRPP Office phone number is 858-246-HRPP
(858-246-4777). For more updated HRPP contact information, please see
the Contacts page. (Released
5/31/16) (Updated 6/16/16)
- Additional Sample
Informed Consent: An additional sample
informed consent has been created for adult subjects for research where
Rady Children's Hospital - San Diego is a site of performance. The
sample consent can be found on the Biomedical
Research forms page. (Released 4/4/16)
- Additional Sample
Informed Consent Forms and Wording About Changes to Harm Clause/HIPAA
Authorization: Three additional
sample informed consent forms for studies associated with exempt
studies or studies associated with paper or online surveys have been
created. In addition, wording regarding changes to the subject harm
clause and HIPAA authorization indicating requests for changes cannot
be honored has been provided. The sample consents for paper or online
surveys can be found on the Biomedical
Research forms page and SBS Research
forms page. The exempt consent can be found on the Exempt Status forms page. The wording
regarding changes to the harm clause and HIPAA authorization can be
found on the Biomedical Research
forms page. (Released 3/14/16)
- Change in Fee
Schedule for Commercially Sponsored Clinical Trials: Effective
immediately, there will be a change in the fee schedule for UCSD IRB
review of commercially sponsored clinical trials to reflect a flat rate
of $3510 for an initial review and $3510 for each 10-year resubmission
(treated as a "new" project review by the IRB) and $1300 for each
annual continuing review. More information can be found on the HRPP
Fact Sheet, "Institutional Review Board (IRB) Fees for Commercially
Sponsored Projects" located here.
(Released 2/19/16)
- One-on-One Advising
Sessions: The HRPP is
introducing 15-minute, One-on-One advising sessions. These sessions
will be done once a month and are designed for investigators, study
staff, and students conducting research involving human subjects to
obtain guidance from HRPP staff. For more information, please see the Training
page.
(Released 3/18/13)
- Secondary Use of
Existing Data/Specimens Requires IRB Approval or Certificate of
Exemption Reminder: Investigators and
study staff are reminded that the secondary use of existing
data/specmens including review of existing medical records, student
records, accessing computer databases that have been produced from
previous studies, etc., requires IRB approval or Certification of
Exemption from IRB review. For more information about this, please see
the HRPP Fact Sheet, Research Involving
the Use of Existing Data/Specimens. (Released 11/28/12)
- Submitting Documents
to the IRB/HRPP Reminder: The IRB/HRPP does not
accept study-related documents by e-mail. All documents must be
uploaded to the appropriate project number through "My Protocols at a
Glance" using e-IRB services on the HRPP website or may be provided
hard
copy only if the document requires the signature of the PI, Department
Chair and/or Submitter. Or
if a copy of the stamped,
approved consent/assent that is currently in use is being provided for
Continuing Review. If the PI has appropriate means to convert each
document into a PDF, such as a document scanner, then each document can
be submitted via the web. (Released 8/24/2012)
- HIPAA
(Health Insurance Portability and Accountability Act of 1996)
information
for researchers. Details
here...
- More...
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