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- Updated Forms, "New"
Consent Sample, and "New" Fact Sheet: The Biomedical and
Social and Behavioral Application Facesheets have been updated. The
updates include minor changes to Section 5, Funding, Funding Mechanisms
regarding through whom study contacts are done. The "new" consent
sample is for pregnant partner studies. And the "new" Fact Sheet
provides information regarding timeframes for postapproval reporting of
events, deviations, violations, incidents, updated study information,
etc. The updated forms and new sample can be found on the Biomedical Forms page and Social and Bahavioral Forms page. The new
Fact Sheet can be found on the Fact Sheets
page and Guidelines page. (Released
5/10/13)
- Updated Biomedical
Research Samples: The Biomedical
Research adult consent,
the parent
consent, and the adolescent assent samples have been updated. The
samples have been updated to include wording that should be used when
a project involves randomization and/or standard of care procedures.
The updated wording is in the "What will happen..." and "What risks are
associated..." sections of the consents/assent. The updated samples can
be found on the Biomedial
Research forms page.
(Released 4/30/13)
- New SOPP: A new
SOPP has been created, section 3.21, IRB Oversight by Non-UCSD
"Centralized" IRBs. This SOPP provides information regarding the
procedures for requesting oversight of specific UCSD research studies
by non-UCSD IRBs, such as Western IRB and the National Cancer Institute
Central IRB. The new SOPP can be found on the SOPPs
page. (Released
4/16/13)
- One-on-One Advising
Sessions: The HRPP is
introducing 15-minute, One-on-One advising sessions. These sesssions
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)
- Updated Fact Sheets:
The Fact Sheets
regarding
advertisements/recruitment materials and amendments/modifications have
been updated. The advertisements/recruitment materials Fact Sheet has
been updated to reflect the updated SOPP, section 3.17. The
amendment/modification Fact Sheet has been updated to more clearly
indicate what documents/procedures are associated with submitting an
amendment/modification including that the cover letter provided with
the submission must be sent over the PI's signature. The updated Fact
Sheets can be found on the Fact Sheets page. (Released 3/1/2013)
- New and Updated
SOPPs: A new SOPP has been
added, section 3.20, Confidentiality of Collected Specimens or Data. In
addition, section 3.17, Advertisements, Recruitment Materials, and
Procedures; and section 4.2, Categories of Action, have been updated.
Section 3.20 includes guidelines and standards for maintaining
confidentiality of specimens and data collected in a research study.
Section 3.17 has been updated to include limits to information provided
in advertisement/recruitment material and that lotteries, raffles,
and/or drawing may not be used as these procedures provide inequitable
compensation for subjects. Section 4.2 has been updated to provide
additional procedures associated with deferred projects. The new and
updated SOPPs can be found on the SOPP page. (Released 3/1/2013)
- Updated Forms:
The Biomedical
Research and Social and Behvioral Sciences Continuing Review Facepages
and Biomedical Research application Facesheets have been updated. The
Facepages have been updated to include a request for additional
information in Section 3, Study Participant Status, regarding the
number of participants currently approved for enrollment by a UCSD IRB.
This information is being requested in response to guidelines published
by ORHP and FDA regarding continuing review evaluation of research
progress including whether "enrollment is consistent with the planned
number of subjects described in the IRB-approved protocol " and that a
"marked difference between actual and expected rates of enrollment may
indicate a problem with the research project that requires further
evaluation including whether the research project is likely to provide
sufficient data to answer the scientific question(s) being posed." The
Facesheets have been updated to include "Yes/No" boxes to indicate
whether a study involves event(s)procedure(s) billiable to
sponsor/insurance/subject (for more information contact the Office of Coverage Analysis Administration),
and whether a study invovles a partial waiver of individual HIPAA
authorization. The updated forms can be found on the Forms page. (Released 3/1/2013)
- 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, VA Service Chief 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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