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- Updated Forms:
The Biomedical
Standard Facesheets, the Continuing Review Facepages, the Continuing
Review Narrative Summary of Progress; and the Study Closure/Withdrawal
Facepages and Narrative Summary of Progress at Study Closure for both
Biomedical and Social and Behavioral studies have been updated to
collect additional information requested by OHRP; FDA; the University
of California, Office of the President; and HRPP-collaborating offices.
The additional information requested on the Facesheets includes whether
a study is associated with an FDA-regulated product(s), who holds the
IND, and more specific information regarding study funding support. The
additional information requested on the Facepages and Narratives is
regarding Adverse Events of any type. The updated forms can be found here. (Released 11/2/09)
- UPDATED--New UCSD
HRPP Human
Subject Protection Training Required: Because of the noted
increased burden to investigators and key personnel associated with
obtaining certificate completion, the IRB Chairs have extended the CITI
certificate completion requirement date. All investigators and key
personnel are now required to complete appropriate CITI training by
November 13, 2009. For more
information, please see the fact sheet, "Introduction of New Training
for Human Research Protections Collaborative Institutional Training
Initiative (CITI) Programs" available here.
(Updated 10/2/09; Released 7/17/09)
- NEW Social and
Behavioral Sciences Project "Standard" Application Available: The
"New" SBS standard application is now available. The application is now
available as a Word template and the application face sheet is a "pdf"
form that can be filled out and uploaded online. For more information
about submitting the complete application electronically, please see
the instructions provided here and on the
application face sheet that can be obtained here.
(Released 10/12/09)
- Furlough Plan May
Cause
Delays: Because of the UC
Systemwide furlough plan that is currently in effect, there may be
delays in review/response of documents submitted to the HRPP. The HRPP
has initiated a plan to prioritize submissions to ensure participant
safety and well being and best serve our investigators. We apologize
for any delays the furlough plan may cause and appreciate your
understanding and support during these challenging times. (Released
10/8/09)
- IMPORTANT--October,
November, December 2009 and January 2010 Due Date and Meeting Date
Changes: As is customary, the
schedule for the IRB (due dates and meeting dates) changes duiring the
months of October, November and December because of University holidays
and the need to ensure meeting quorum. As a result of the consdensed
schedule, please note that no late submissions can be accomodated
during this period. The updated schedule is available here. (Released 10/5/09)
- New Procedures and
Forms for Study Closure/Withdrawal: By federal
regulation, changes in research activity require reporting to the IRB.
Study closure/withdrawal is such an activity. New procedures for
closing/withdrawing a study can be found here. In addition, because
of the new procedures, the Continuing Review Facepages and the
Narrative Summay of Progress has been
updated. For Biomedical studies, the updated forms can be found here and here. For Social and
Behavioral studies, the updated forms can be found here and here. (Released 7/31/09)
- New Regulations
Regarding IRB Registration: The FDA and OHRP have
recently added new regulations regarding registration of IRBs. More
information about these new regulations can be obtained here. (Released 7/10/09;
updated 7/15/09)
- Updated Consent
Examples:
The updated
Biomedical consent example can be
obtained here, and the SBS
consent example can be obtained here.
(Released 7/6/09)
- New "Medical Device"
Fact Sheet: A new fact sheet
regarding projects associated with medical devices including policy for
review and information required for review can be found here. (Released 3/5/09; Updated
4/2/09)
- Exemption from IRB
Review Application: More information
about projects
that may be exempt from IRB review at UCSD can be found here. (Released
2/6/09)
- HIPAA
(Health Insurance Portability and Accountability Act of 1996)
information
for researchers. Details
here...
- More...
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