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- 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. The "Common Rule" (45
CFR 46 subpart A) defines a set of research activities that may be
exempt from its purview. Research that is exempt from IRB review has
very little, if any, associated risk. More information about projects
that may be exempt from IRB review at UCSD can be found here. (Released 2/6/09)
- Updated Form and
Fact Sheet. The form, Continuing
Review Narrative Summary of Progress to Date, has been updated to
include an additional section to report adverse events (non-URPs) at
this site to the IRB. This updated form can be found here. In addition, the fact sheet,
Submitting an Amendment/Modification to a Research Plan (Protocol), has
been updated including a more specfic description of information
required in association with an amendment request. The updated fact
sheet can be found here. (Released
1/26/09)
- Pre-screening of all
"new" applications. As of September 24,
2008, the HRPP will be pre-screening all new applications submitted for
review. This pre-screening is designed to comply with federal rules by
ensuring the documentation necessary for an accurate and thorough
review of the application is obtained prior to the IRB review. As noted
in a prior announcement, incomplete applications will not be placed on
an IRB meeting agenda. HRPP staff will notify PIs of incomplete
submissions and provide information regarding missing documentation.
When an application is found to be complete, it will be assigned to the
next appropriate IRB meeting. It is important to note that incomplete
applications cannot attain final approval by the IRB. A copy of the IRB
pre-screening form can be found here.
(Released
9/19/08)
- SDSU/UCSD Agreement
for Joint Doctoral Program Research Review. The students enrolled
in a SDSU/UCSD Joint Doctoral Program (JDP) who plan to involve human
subjects in research are required to obtain approval from both the SDSU
and UCSD Institutional Review Boards in advance of initiating research.
We are pleased to announce that an agreement between SDSU and UCSD is
now in place allowing for a cooperative review of research protocols
involving SDSU/UCSD JDP students. Under this agreement, one campus will
serve as the "reviewing" IRB and the other as the "relying" IRB. More
information about this agreement and application submitting procedures
can be found here.
(Released 9/19/08)
- As a reminder,
please ensure that
complete continuing review materials are submitted approximately 45
days prior
to expiration (check the most recent approval letter) to avoid any
lapse in approval or the need to submit a NEW application should the
study's
approval expire. Also,
if there is no lapse
in approval, a study may receive up to 4 IRB
reviews. A study may undergo an Initial and 3 Continuing Reviews.
Please check the status of the study carefully before submitting
Continuing Review materials.
- HRPP announces new
guidelines for reporting adverse events to the IRB. Guidance for
Prinicipal Investigators and research staff
when reporting unanticipated problems or adverse events to the IRB is
provided in this fact sheet.
- HIPAA
(Health Insurance Portability and Accountability Act of 1996)
information
for researchers. Details
here...
- More...
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