Let’s Start From the Very Beginning….
Research
The systematic investigation, including research
development, testing and evaluation, designed to develop
or contribute to generalizable knowledge.
Human Subject
A living individual about whom an investigator conducting
research obtains data through the intervention, or
interaction with the individual or identifiable private
information.
IRB
An administrative body established to protect the rights
and welfare of research subjects recruited to participate in
research activities conducted at the institution with which
it is affiliated.
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The Institutional Review Board (IRB):
WHERE
HOW
WHO
WHAT
The IRB must have at
least five members of
varying backgrounds
in order to provide
complete and
adequate review of
human research and
its institutional, legal,
scientific, and social
implications. The
Board will also include
at least one member
who is not affiliated
with the institution
and one member who
is not a scientist.
Responsible for
reviewing all research
involving human
participants prior to
its initiation. The IRB
is concerned with
protecting the
welfare, rights, and
privacy of human
subjects and to ensure
research activities are
being conducted per
institutional policies
and federal
guidelines.
The UNT Institutional
Review Board (IRB)
reviews all proposed
research projects
involving human
subjects to be
conducted at UNT or
to be conducted at
any location by UNT
faculty, staff, and
students in
connection with their
institutional
responsibilities.
Operating under a
Federal-wide
Assurance (FWA)
issued by the Office
for Human Research
Protections (part of
the U.S. Department
of Health and
Human Services)
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Frequently Asked Questions
1. What type of training do I need to complete?
2. Who can serve as the Principal Investigator?
3. How can I prepare my study for IRB submission?
4. How do we submit a study for review?
5. What does the IRB review process entail?
6. After approval, what else do we need to worry about?
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What type of training do I need to
complete?
All research team members must complete required training before receiving
IRB approval
Complete the Collaborative Institutional Research Initiative (CITI Program)
course:
https://about.citiprogram.org/en/homepage/
“Social & Behavioral Research – Basic/Refresher”
“Biomedical Research – Basic/Refresher”
Training must be renewed every 3 years
.
Thir. Photo by Unknown Au
Additional Trainings
Responsible Conduct of Research (RCR)
Required for studies funded by the NSF, NIH, USDA
In Person training workshops monthly
Good Clinical Practice
Personnel working on clinical studies
Custom upon request
.
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Can I serve as a Principal Investigator?
Do
Principal Investigator must be:
• Full-time UNT faculty member
• Full-time staff employee whose job
responsibilities include conducting human
subject research
Cannot be:
Student
Lecturer*
Adjunct instructor*
Hof
“Scientist by sayos is licensed under
O
*Can serve as a Pl if they have a letter from their Department
Chair that supports their role as a Pl.
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How can I prepare my study for IRB
submission?
Plan ahead to allow a sufficient amount of time for submission, review and approval of your
study.
The current review timeline is posted in a message in the Cayuse system
Timeline will depend on the volume of submissions received by the IRB office.
Timeline will vary throughout the year.
Please reach out to the office at [email protected] if you have questions regarding the
posted review timeline.
Protocols that are incomplete or lack details will be returned to the team
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How can I prepare my study for IRB
submission?
.
a
Plan ahead to allow a sufficient amount of time for submission, review and approval of your
study.
• The current review timeline is posted in a message in the Cayuse system
• Timeline will depend on the volume of submissions received by the IRB office.
• Timeline will vary throughout the year.
• Please reach out to the office at [email protected] if you have questions regarding the
posted review timeline.
Protocols that are incomplete or lack details will be returned to the team
o
Role: Admin
Ili
cayuse
Human Ethics
More
Studies
Submissions
Tasks
Meetings
Reporting
Dashboard
CURRENT REVIEW TIMELINE:
Currently, our turnaround time is approximately 30 business day or less to complete an initial review of all submissions. During the initial revieve, if we will ask for revisions or need further clarification all comments will be made in the Cayuse
system for you to address within the System. You will be contacted via email from Cayuse regarding any requested revisions or clarification. Watch your email for notifications from the Cayuse system to ensure you are following the review
process. Once the requested revisions are made, it takes the office approximately 10 business days to finaliza review of submission.
If you have any questions regarding the content of the protocol submission, please contact the UNT IRB at nurturdu.
007
46
If you have any technical access questions or technical issues outside of the Cayuse maintenance window. please contacter
13
Pre-Review
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How can I prepare my study for IRB
submission?
O
Gather your attachments
Attachments include, but are not limited to:
Informed consent forms/notices
Training completion certificates
Recruitment materials (flyers, e-mail scripts,
classroom announcements, advertisements, etc.)
A copy of all data collection instruments, interview
scripts, and intervention protocols.
• A copy of all questionnaires and surveys.
TERRA
.
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17 Photo by uningas mucharikkondunder
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How do I submit my study for review?
I
Hannah Snowberger
Cayuse
Human Ethics
To get access to Cayuse Human Ethics submission portal, submit the
access request form
Submission Steps:
1. Log in to Cayuse Human Ethics portal
2. Use EUID and password to log in.
3. Upper right hand corner → blue button “+ New Study”
4. Enter title of study and click save.
5. blue button>” + New Submission” → Select Edit.
6. Add personnel (Remember rules about being a Principal
Investigator)
7. Complete submission and mark “complete”
8. Principal Investigator mark”certify”
9. Once the principal investigator certifies, the submission will be
received by the UNT IRB.
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What does the IRB review process entai
Hannah Snowberger
IRB submissions are reviewed in the order that they are received
Check the status of your protocol in the Cayuse Human Ethics from
your Dashboard
Research Compliance Analyst will conduct an initial review of your
study
If revisions are needed, we will return the study to you in the
Cayuse Human Ethics System for edits.
You will receive an email from the Cayuse System, which will let
you know your protocol has been returned.
Please complete the revisions in their entirety and resubmit the
revised documents within the Cayuse System.
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I now have approval. What else do I
need to worry about?
a
Modifications:
Any changes to your final approved study must be approved by
the IRB
Submit a modification form before you implement any changes
(i.e. adding key personnel, increasing recruitment, changes in
study procedures, etc.)
Continuing Reviews:
“Renewals”
Only required for Full Board Studies.
Reportable Events:
Any adverse effects, unanticipated problems, and protocol
deviations or errors must be reported to our office.
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What does the IRB review process entail?
DIV
A
IRB submissions are reviewed in the order that they are received
Check the status of your protocol in the Cayuse Human Ethics from
your Dashboard
O
Research Compliance Analyst will conduct an initial review of your
study
If revisions are needed, we will return the study to you in the
Cayuse Human Ethics System for edits.
You will receive an email from the Cayuse System, which will let
you know your protocol has been returned.
Please complete the revisions in their entirety and resubmit the
revised documents within the Cayuse System.
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What does the IRB review process entail? YUNI
DIVISION OF RESEAR
& INNOVATION
Research Integrity
& Compliance
BE
Hannah Snow
Based on the risk of your study, you will be assigned a review
category by the Research Compliance Analyst or Board Member:
Exempt
Expedited
Full Board
Approval Documentation- Once you have satisfied all necessary
requirements, and approval is issued, we will:
Email the approval letter
Attach your stamped informed consent document to your
Cayuse IRB study
.
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Need help?
DIVIS
Res
&
One-on-one meetings
By appointment via Zoom or Microsoft Teams
Call
На.
940-565-4643
HELP!
Email
[email protected]
or by unknown Authorina und AS
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IRB Protocol Submission
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HOME 7 RESEARCH AND INNOVATION SERVICES RESEARCH INTEGRITY AND COMPLIANCE 1 HUMAN SUBJECTS (IRB) / IRB PROTOCOL SUBMISSION
About RIC
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IRB Protocol Submission
ocol Submission
Human Subjects (IRB)
Animal Subjects (IACUC)
Conflict of Interest (COI)
Export Control
Federal Research Regulations
Intemational Affiliations in Research
IRB Forms and Templates
ance
ad to allow a sufficient amount of time for submission, review, and approval of your study. The current review timeline is posted in a
Training and Education
Cayuse system and will depend on the volume of submissions received by the IRB office. The turnaround time for IRB protocol approvals
Multi-Institutional or I by many variables and will vary throughout the year. Protocols are reviewed on a rolling basis, in the order that they are received. Protocol
Collaborative Research
lexity or risk will take more time to review. Please reach out to the office if you have questions regarding the posted review timeline. If the
meline will place undue burden on your research, please contact our team at untirb @unt.edu immediately to discuss the situation.
IRB Deadlines, Review, and
Roster
e incomplete or lack details will be returned to the Principal Investigator (PI), further delaying the review and approval processes. Please
Human Subjects Research IRB Resources for Researchers to assess the readiness of your study documents for review.
Determinations
IRB Policies and
Cayuse Human Ethics (formerly Cayuse IRB)
Procedures
mission requires access to Cayuse Human Ethics (formerly Cayuse IRB), UNT’s electronic IRB submission portal. If you are new, please
External Resources
Request Cayuse Access. Current researchers who have previously logged into Cayuse successfully, please skip to Step 4 to Log into
Ethics
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Responsible Conduct of Research (RCR)
International Visiting Scholars
Student Research
Guidance
equest Cayuse Access
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Step 2: Install/update and configure Mozilla Firefox browser for Cayuse
kyltschunt.edu/research-services/iesesich-interdy-and-compliance/human subject ab/orb protocol-submission
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