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- Additional
FDA-required consent wording: Additional wording
regarding a statement informing participants about the
ClinicalTrial.gov trial registry for applicable clinical trials must be
included in the consent of applicable trials initiated on or after
March 7, 2012. For more information, please see the FAQ, Frequently
Asked Questions--FDA Final Rule: Clinical Trials.gov Consent Wording.
- Updated and new
SOPPs: SOPP, section 3.15,
Radition Exposure and Radioisotopes, has been updated to include that
HERC approval may be obtained before, during, or after application to
the IRB; the IRB has final approval of the wording regarding human
subject radiation exposure in the consent/assent document(s); and
wording regarding review documentation provided to the IRB by HERC. In
addition, a new SOPP has been created, section 3.18, Review of Subject
Complaints/Concerns/Questions. This section provided procedures for
both the PI and the IRB/HRPP when a Subject has a complaint, concern,
or question. These SOPPs can be found on the SOPP
page.
- Change In Fee
Schedule For Commercially Sponsored Clinical Trials: For
projects submitted after January 1, 2012, there will be a change in the
fee schedule for IRB review
of commercially sponsored clinical trials to reflect a flat rate of
$2150 for an initual review and $2150 for each 7-year resubmission
review (treated as a "new" projecct by the IRB) and $500 for each
annual continuing review. For more information about this, please see
the HRPP fact sheet "Institutional Review Board (IRB) Fees for
Commercially Sponsored Projects" located here. (Released 11/28/11)
- THE HRPP HAS MOVED:
The HRPP Office has
moved to the first floor of the "new" East Campus Office Building
(ECOB). For our updated contact information, please see the Contact Us page. (Released 11/2/11; Updated
12/15/11)
- FAQ-Common Qs:
Ever wanted to know
what "Expedited Review" means? Do you know what the specific
requirements for font and font size for consent/assent and recruitment
documents are? What do all those red boxes on the application
Facesheets mean? Answers to these and other questions can be found on
an HRPP FAQ available here. (Released
8/19/11).
- Amendment/Compliance
Reminder: The Department of
Health and Human Services has notified UCSD that at least one UCSD
IRB-approved research protocol was out of compliance with IRB-approved
procedures. We remind all faculty and research staff that federal rules
require IRB review and approval of all proposed changes in reseach
activity prior to initiation
of such change, except when necessary to eliminate apparent immediate
hazard to subjects. Conducting research procedures without IRB approval
can negatively impact the rights, welfare, and safety of human subjects
who participate in research at this Institution. Any modification to an
approved protocol must be reviewed and approved by the IRB prior to
implementing the change, regardless of the nature of the modification.
It is strongly recommended that faculty responsible for ongoing human
subject research at UCSD discuss this requirement with your research
staff and conduct periodic audits of your approved protocols to ensure
compliance. Instances of non-adherence to IRB-approved protocols must
be rectified and reported to the IRB immediately. Please remember,
research compliance is a shared responsibility. (Released 03/08/11)
- HIPAA
(Health Insurance Portability and Accountability Act of 1996)
information
for researchers. Details
here...
- More...
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About
HRPP
