UCSD
and San Diego
Children's Hospital and Health Center (CHHC) have created a process by
which UCSD salaried faculty, staff, and students may submit a single
set of application materials and protocol-related documents, and
receive IRB review from both institutions. These services apply
to the initial submissoin of a new project, and to the ongoing review
and monitoring by both institutions that is mandated by federal
regulations and institutional policy. This page contains answers
to Frequently Asked Questions regarding the
single-submission/dual-review process.
Q.
Who Qualifies for Single Submission/Dual Tracking?
A.
NEW STUDIES involving:
- UCSD
salaried PI
- UCSD
salaried co-investigator
- UCSD
students, fellows, residents as PI or co-investigator
Q. When
Can New Studies be Submitted for Dual Tracking?
A. The
single-submission/dual tracking process begins JUNE 1, 2004
Q. How
Do Qualifying Researchers/Coordinators Submit?
A.
Use the e-IRB submission process via the UCSD HRPP Web-site (http://irb.ucsd.edu). Forms
specifically developed for CHHC-UCSD combined submission are available here.
- UCSD
IRB committees, acting on behalf of both institutions, will also review
subsequent study amendments, renewals, adverse events, IND safety
reports, etc, so those would also be submitted through the
e-IRB feature at the UCSD IRB Web-site.
Q.
How Will I Know When My Study Is Approved?
A.
Approval
letters will be joint letters with both institutional logos, signed by
the Director
of HRPP at UCSD and the IRB Coordinator at CHHC.
- Consent
Forms and Assent Forms will represent both
institutions, inclusive of
the CHHC format. The forms will be issued with a joint electronic stamp.
- UCSD
will release the IRB approval letter. In
addition to IRB
approval, a CHHC RTA (Ready to Accrue) letter must be
received prior to the initiation of study procedures or recruitment at
CHHC.
Q. Are
There Any New Procedures to Be Aware of?
A. Yes
:-)
- CHHC will
adopt the UCSD format (application facesheets,
research plan,
consents and assents.)
- Two
application versions will exist:
- UCSD-CHHC dual tracking, available from the UCSD HRPP website
- CHHC ONLY, for investigators whose research does not
require dual IRB
approval, available from the CHHC website.
- Studies
will have a lifespan of 4 years (initial and up to 3 annual continuing
reviews)
- CHHC will
have an additional Web-site for the new process that includes access
for
committee members, e-IRB services and online tutorial, beginning
mid-June 2004
- Investigators
may still receive correspondence from either IRB. In such case,
responses would be returned to the IRB that issued
the communication.
- The
subject injury statement (harm clause) in the research consent will
follow the funding.
- If
UCSD receives the funding for a study,
one of UCSD’s standard harm clauses should be included in the research
plan and
the consent form(s).
- If
CHHC receives
the funding, CHHC’s standard subject injury statement must be
included.
Note that if the sponsor is responsible for
covering costs of treatment of study related injuries that should be
stated
clearly.
Q.
How Can I Keep My Current Projects Flowing Smoothly?
A. Plan to renew current studies early at UCSD as a NEW study
submission (30-60 days
ahead of the expiration of IRB approval at either UCSD or CHHC,
whichever comes earlier.)
- Currently
active projects that have both UCSD and CHHC approval will continue to
require independent submission to both IRBs on the currently approved
schedule ie., currently active projects are not 'grandfathered' and
automatically included in the dual tracking model because of timeline
and documentation differences between insitutions that existed prior to
the start of the dual tracking process.
- If
the study has been recently approved, plan to “resubmit
as NEW” with
the next amendment or prior to your renewal due date (30-60 days
ahead).
Q. How Do I Proceed If
My
Study Is currently Reviewed by CHHC ONLY, but a UCSD investigator
(current or
new faculty, resident, fellow, student…) is associated with the study?
A. The
study would then require review by both institutions and would need to
be
submitted to
the dual tracking system as a NEW study via the process outlined above.
Q.
Who can I contact with questions about the single submission/dual
tracking process?
A. Contact
either the UCSD HRPP office or the CHHC Office for Human
Subjects Protection.
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