We encourage you to attend
our training workshops on submitting an application to the IRB.
We are also available to provide assistance via phone, Teams
or email.
Contact
Office of the Institutional Review Board
LA County Department of Public Health
313 N. Figueroa St., Room 127
Los Angeles, CA 90012
Email us at:
irb@ph.lacounty.gov
IRB Application Information
All new projects seeking IRB
review must submit an application using our web-based
application system called IRBManager (link
located in the New IRB application section below).
For projects that have already received IRB approval, if
you need to make any changes to your project, including
adding/removing personnel, please submit an amendment
application using IRBManager (refer to the Amendments
section below).
Annual progress reports are required
for all projects and must
also be submitted in IRBManager (refer to the Annual
Progress Reports section below). Some projects
may be required to submit Continuing Review requests
instead of progress reports (as noted on the original
approval letter). Continuing Review requests must be
submitted in IRBManager (refer to the Continuing
Review section below).
A user guide with instructions for using IRBManager is
located in the New IRB application section 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:
The IRB reviews any DPH-related, DHS related, or partner
CBOs-related project that involves the collection or
analysis of data from or about human subjects including but
not limited to the following:
Focus groups
Semi-structured interviews
Data abstraction from medical records
Surveys
Note: IRB procedures allow exemption for some data
collection projects that are classified as routine public health
activity rather than research or related activities. Please
consult with the Office of the IRB for a determination.
Not Human Subjects Research Determinations
Please consult with the Office of the IRB before
submitting a Not Human Subjects Research application.
The Not Human Subjects Research application is not the
appropriate application for projects that the IRB deems
"Exempt as Non research".
Please review the
information below before submitting an IRB application
for review.
Project activities
CANNOT begin until a formal
approval letter from the Office of the IRB has been
obtained.
Review the checklist below to make sure you have all items necessary to submit a complete IRB application.
An application cannot undergo IRB review until it is
screened and deemed complete.
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:
Please make sure you have obtained Research Oversight Board (ROB) review (for DHS projects) or OHAE RATE review (see section below) prior to submitting your application. These external processes must be completed prior to IRB application submission. Please allow at least two weeks to obtain ROB/RATE review (timeframe may vary, dependent on volume of submissions). Refer to the application checklist above or the sections below for instructions on how to comply with ROB/RATE review requirements.
When an application is first submitted:
Step 1 - IRB Screening Process
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 additional information needed, the application will be returned to the applicant. Of note, additional information needed during the screening process are different from stipulations identified during the review process (see Step 2 below for more information). If additional information is needed, 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 additional information provided/revisions are adequate and the application is complete before the IRB review can officially begin.
Step 2 – IRB Review
Once a complete application has been received, the IRB review can begin. If the IRB staff identify stipulations, the application and/or project materials should be revised accordingly, and the application should be re-submitted. The application will be returned to applicant if stipulations are not adequately addressed. All stipulations must be satisfactorily addressed in order for the project to be approved.
Please refer to Figures 1 and 2, in the “IRB application screening and review process” section for more details.
From the time a complete application is received by the IRB,
Review of exempt
projects takes on average 2-3 weeks
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 note:
timeframes depend on how long the project team
takes to respond to stipulations. *Stipulations
are different from the additional information
needed during the screening in that they are
reflection of the IRB review not the initial
screening process.
DPH RATE
Per DPH Policy 117, any projects that intend to collect data from or about any DPH staff members, facilities, patients, and/or clients (e.g., community members) 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 Office of 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 Office of the IRB will forward your email to the RATE team to request the review. Please DO NOT send materials directly to the RATE team. If you are unsure whether your project requires RATE review, please contact the Office of 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 IRBManager application (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. Please include your timeline in your email to the IRB, particularly if you are on a tight timeline, and the RATE team will do their best to review as quickly as possible.
DHS ROB
You will need to include with your IRB application documentation that the project has been reviewed and assigned a category by DHS’ Research Oversight Board (ROB). To comply with the ROB requirement, please submit all project materials including a project protocol, budget and any data collection instruments to irb@ph.lacounty.gov and IRB staff will forward it to the ROB for review. The requestor will be contacted via email with the results of the ROB review. Save this email confirmation as a PDF document and upload it to your IRB application.
PHIS Information Security Office Approval
PHIS Information Security Office approval is only required for DPH projects using non-County approved or installed software OR projects that satisfy BOTH of the following requirements:
1) projects collecting/accessing Personally Identifiable Information (PII)/ Protected Health Information (PHI);
2) projects involving outside contractors.
DPH employees using County approved devices/software do not need PHIS Information Security approval whether or not they are collecting/accessing PII/PHI.
DHS Information Security Approval
For DHS projects, verify that DHS projects have gone through Vahe Hartounian for DHS Information Security approval – you can email Vahe directly at vharatounian@dhs.lacounty.gov.
Any adverse/reportable events or deviations from
approved protocols must be reported to the Office of the IRB no
later than 7 days after the research team has been made aware of
the event in question. If you are project staff and need to report an
adverse/reportable event/protocol deviation, please submit
an adverse/reportable events form inIRBManager. Refer to Section 12 of the IRBManager
user guide for
assistance with completing this form.
An annual progress report is due for both exempt and expedited projects even
if they do not have an expiration date. Progress reports must be submitted
through IRBManager. Any project that does not submit an
annual progress report at least 2 weeks before the due date
(stated on the most recent approval letter) will be automatically closed by
the system and a new application will need to be submitted in order to
continue. Please contact the Office of the IRB if you anticipate any
challenges in meeting any due dates. Refer to Section 6 of
the IRBManager
user guide for instructions
on how to submit a progress report application.
Please submit an
amendment request in IRBManager PRIOR
to implementing any modifications to any previously
approved activities and/or materials including the protocol, data
collection instruments, or
personnel. PI/project lead changes must be submitted as amendments
and the current PI/project lead must provide their
signature on the application before it can be approved.
Review the checklist below to make sure you have all
the items necessary to submit a complete amendment
application.
When you are ready to submit your amendment
application, refer to Section 6 of the IRBManager
user guide for instructions
on how to submit an amendment application.
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;
please submit these applications separately.
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 continuing review is required, as stated
in the approval letter, please submit a continuing review
application in IRBManager.
Refer to Section 6 of
the IRBManager
user guide for instructions
on how to submit a Continuing Review application.
