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
Please review the
information below before submitting an IRB application
for review.
All projects seeking IRB
review must submit an application using a web-based
application called IRBManager. Visit the
IRBManager page when you are ready to submit an
application. If you are not sure whether your project
needs IRB review, please contact the Office of the IRB via
email at
IRB@ph.lacounty.gov
for clarification.
Project activities
CANNOT begin until a formal
approval letter from the Office of the IRB has been
obtained.
If you would like to submit a new application for IRB
review, review the New IRB Application
section below and familiarize yourself with the new
application checklist as well as requirements for RATE
review of surveys (for DPH projects) and DHS ROB
approval (for DHS projects).
If you need to make any changes to a project that has
already received IRB approval, including adding/removing
personnel, please submit an amendment application (refer to the Amendments
section below).
Any changes to IRB-approved projects should not be
implemented until the IRB approves an amendment
application for the proposed changes.
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 in the original
approval letter (refer to the Continuing
Review section below).
Click on the image to view an overview of the
steps involved in the IRB application process:
Overview of the IRB Application Process
The DPH IRB reviews projects involving clients/patients,
staff, facilities, and/or funding from the Department of
Public Health (DPH), the Department of Health Services (DHS) (excluding
the hospitals), and certain community-based organizations. A
project is defined as the collection or
analysis of data from or about human subjects, including but
not limited to the following activities:
Focus groups
Semi-structured interviews
Data abstraction from medical records
Surveys
If your project involves only one or more of the activities
listed below, you do NOT
need to submit an application for IRB
review:
the collection of data in
the course of providing clinical care
conducting local, state or federal statutorily
mandated surveillance*
environmental or criminal investigations
activities in support of national security
measures
anonymous meeting evaluations
customer satisfaction surveys that do not
collect/access data from or about persons
belonging to vulnerable populations (such as
minors)
customer satisfaction surveys that do not
collect/access data about sensitive topics such
as substance use/disorder
customer satisfaction surveys that do not
collect/access personally identifiable
information (PII) or protected health
information (PHI)
staff assessments or other internal queries that
pertain to core job duties and skills
program evaluations for internal use with no
intention to publish and that do not
collect/access data about sensitive topics such
as substance use/disorder and that do not
collect/access data from or about persons
belonging to vulnerable populations
evaluations for internal use for trainings that
are linked to receiving CE units or certificates
of completion or that do not involve vulnerable
populations and/or where the IRB determines that
informed consent is not required for
participation in the trainings
projects involving only secondary analysis of
de-identified data (biomarkers such as retinal
scans, etc., are not considered de-identified)
*IRB procedures allow exemption for some 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.
The best policy is to contact the Office
of the IRB
if you are not sure whether IRB review is required, and never assumethat a past determination by the IRB will automatically apply to
a new project!
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".
Once the IRB receives an application, it undergoes a
two-phase process: 1) Screening, and
2) Review.
Phase 1 - IRB Screening
This phase involves IRB
staff performing an administrative check to make sure the application is
complete, including required approvals and documents, as
described in the New IRB application checklist below. If
any issues are identified, IRB staff will return the
application to the applicant with an
itemized request for changes and/or additional
information. The application should be re-submitted with
the requested changes. IRB staff will screen the
application again; this will repeat until an application
is deemed complete. An application cannot proceed to the
Review phase until it is deemed complete.
Phase 2 – IRB Review
Once an application is
complete, it is assigned to a reviewer who reviews the
application and supporting materials to ensure the
proposed activities meet the ethical and quality
standards outlined in the code of federal regulations
(45 CFR 46, known as "the Common Rule") as well as DPH
IRB Standards of Practice/policies. A reviewer may
identify issues (referred to as "stipulations") that need to be addressed, in which case
the application will be returned to the applicant so that changes can be
made. The application will need to be re-submitted with
the stipulations addressed.
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.
Please make sure you have obtained Research Oversight Board (ROB) review (for DHS projects) or OHAE RATE review (for
DPH projects) prior to submitting your application. These external processes must be completed prior to
submitting an application for IRB review. Please allow at least two weeks to obtain ROB/RATE review (timeframe may vary, dependent on volume of submissions).
Some projects may need to undergo both ROB and RATE
review; in these cases, the two processes can happen
concurrently. Instructions on how to comply with ROB/RATE review requirements
are located in the application checklist (above) and
also in the sections below.
From the time a complete application is received by the IRB:
Review of exempt
projects takes on average 1-3 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:
estimated turnaround times depend on how long the
applicant
takes to respond to IRB requests for changes
and/or additional information.
DPH RATE Review
Per DPH Policy 117, if any projects intend to collect data from or about any DPH staff members, facilities, patients, and/or clients (e.g., community members) using survey(s),
the survey(s) must be reviewed by the Office of Health Assessment and Epidemiology (OHAE) Rapid Assessment, Training and Evaluation (RATE) team.
Eligibility screening surveys may require RATE review at the discretion of IRB staff.Interview guides and
focus group guides do
not need to undergo RATE
review.
If your project plans to use a
survey to collect data AND your project
requires IRB review, the Office of IRB facilitates compliance with
DPH Policy 117. To comply, please submit your protocol (must follow the protocol template
available
here) 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 IRB
staff for clarification.
If your project plans to use a
survey but IRB review is NOT required
for your project, please contact the
RATE team directly at
rate@ph.lacounty.gov and include
your protocol (must follow the protocol
template available
here) and survey(s) as attachments.
If you are unsure whether IRB review is
required for your project, please
contact IRB staff for clarification.
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).
A copy of the email confirming that RATE
review is complete should be saved as a
PDF and included with the IRB
application.
If you are seeking to make changes to a
survey that has already been approved by
the IRB, consult with IRB staff who will
confirm whether the proposed changes
warrant RATE review. This should be
completed prior to submitting an
amendment application to the IRB.
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 Review
If your project involves DHS
(excluding the hospitals), you will need to include with your IRB application documentation that the project has been reviewed and assigned a priority category by DHS’ Research Oversight Board (ROB). To comply with the ROB requirement, please submit all project materials including a 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 (ISO) approval is only required for DPH projects using software/devices that are not County-approved 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
If PHIS ISO approval is needed for your project, you will be
asked to answer a set of information security questions on your IRB application.
The questions in the application are conditioned in such a way that they will
only appear if you satisfy one of the scenarios described above. Once your
application is submitted, a support ticket will automatically be opened with PHIS.
PHIS staff will review your responses to the information security
questions and they will contact you directly with any questions.
PHIS ISO approval will be sent via email; a copy of the email confirming
approval should be saved as a PDF and included with the IRB application.
DHS Information Security Approval
For DHS projects, applicants should contact DHS'
Information Security Officer, Vahe Haratounian, at
vharatounian@dhs.lacounty.gov to obtain security approval. A copy of the
email from Vahe confirming approval should be saved as a PDF and included
with the IRB application.
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 changes to 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.
IMPORTANT:If the PI or co-PI plan to
end/change their institutional affiliation, an amendment
application should be submitted BEFORE
the date of the change in affiliation to ensure access
to the institutional email address on file
(notifications for
providing signatures will be sent to this email
address).
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.
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.
