General
Information
The IRB office has transitioned to
a web-based application system called
IRBManager. For all new projects
seeking IRB review, please submit
an application using IRBManager (link available
below). Amendment applications
(i.e., any request to make changes to an already approved
project),
annual progress reports, and annual continuing review
requests should also be submitted in IRBManager. A
user guide with instructions for accessing and
navigating IRBManager is located below. Contact the
IRB office via email at
IRB@ph.lacounty.gov
with any questions.
The following figures illustrate the IRB review and
application processes:
Unanticipated/Adverse Events: If you
would like to report an unanticipated/adverse event
(i.e., any deviation from the approved protocol), please
submit an Unanticipated/adverse event form in IRBManager.
Refer to Section 12 of the user manual (below) for
assistance completing this form.
Not Human Subjects Research Determinations:
Please consult with the IRB office before submitting a
Not Human Subjects Research application.
Please review the information
below before you submit an IRB application. Project
activities CANNOT begin
until an official approval letter from the IRB has been
obtained.
When you
are ready to submit your application, click the
following link to access the IRBManager login page:
IRBManager
If you encounter any technical
difficulties while using IRBManager, please contact the
IRB via email and we will respond to your
inquiry within 3 business days.
Refer to the following User Guide for
instructions on how to access and use IRBManager:
New Applications
Review the checklist below to make sure you have all
the items necessary to submit a complete IRB application.
When an application is first submitted, IRB staff will
screen it for completeness. This stage, known as Office
Screening, is an administrative check that is done
before the IRB review can begin. If IRB staff identify
any items that need revision, the application will be
returned to the applicant. The application and/or
project materials should be revised accordingly, and the
application should be re-submitted. IRB staff will
screen the application again to verify that revisions
are adequate and the application is complete before the
IRB review can officially begin. Please refer to Figures
1 and 2, above, for more details about the IRB
application process.
From the time a complete application
is received by the IRB, review of exempt projects
takes on average 2-3 weeks and review
of expedited projects take on
average 2-4 weeks.
Projects requiring Full Board review typically require
at least 2 months to receive IRB approval. Applications
for Full Board projects should be submitted at least 4
weeks before the date of the following IRB meeting to ensure inclusion in
the meeting agenda.
Please make sure you have obtained ROB approval (for DHS
projects) or RATE review (see survey policy below) prior to submitting your
application. Please allow up to two weeks to obtain
ROB/RATE approval. Refer to the application checklist
above for instructions on how to comply with ROB/RATE
approval requirements.
DPH RATE Survey Policy:
Per DPH Policy 117, any projects that intend to collect data from
or about any DPH staff members, facilities, patients, and/or
clients
using surveys or questionnaires must have the
surveys/questionnaires reviewed by the Office of Health
Assessment and Epidemiology (OHAE)
Rapid Assessment, Training and Evaluation (RATE) team.
-
The IRB facilitates compliance with this
department-wide policy.
To comply, please submit your study protocol
(must follow the protocol
template)
and any survey(s)
to
irb@ph.lacounty.gov.
The IRB office will forward your email
to the RATE team to request the review. If
you are unsure whether your project
requires RATE review, please contact the
IRB.
-
Once the review is complete, the RATE
team will provide their feedback via
email. Study documents should be revised
to address the RATE team's feedback, as
necessary, and they should be uploaded
to your electronic application in IRBManager
(do not send revised documents to the
IRB via email).
-
Note: The RATE review
process should be completed prior to
the submission of your IRB application.
The RATE team reviews projects in the
order that they are received so please
keep that in mind as you are developing
your project timeline and allow
approximately 2 weeks (sometimes longer) for RATE review.
NEW!
Translation Services Available
The DPH Center for Health Equity’s Language Justice Unit
is now offering written translation services available
to DPH staff involved with DPH-related projects. If you
would like more information about the languages that are
offered and the process for
submitting written translation requests, please visit
the following page: http://intranet.ph.lacounty.gov/ph/hitsystem.htm
After Approval
IMPORTANT: An annual progress report
is due for both exempt and expedited projects even if
they do
not have an expiration date. Any project that
does not submit an annual progress report
at least 1 day before the due date (listed on the most recent
approval letter) will be closed and a new application
will need to be submitted in order to continue.
Please contact the IRB
office if you anticipate any challenges in meeting any
due dates.
Continuing Review: A request for
continuing review must be approved for all full board
projects and any projects that are given an expiration
date by the IRB (expiration date is noted on the
approval letter). If directed in the approval letter to
apply for continuing review, please submit a continuing
review application in IRBManager.
Amendments: Please submit an
amendment request in IRBManager PRIOR to implementing
any modifications to any previously approved materials
including the protocol, data collection instruments, or personnel.
Review the checklist below to make sure you have all
the items necessary to submit a complete amendment application.
Checklist for Amendment Applications
- If you are not able to locate
your study in the IRBManager system, please contact
the IRB office at
irb@ph.lacounty.gov.
-
Note: amendments
may not be submitted with annual
continuing review requests.