IRB Insights
UTHSC IRB
irb@uthsc.edu
448-4824
Categories
• Review Process
– Exempt
– Expedited
– Full Board
• Forms
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Initial Application
Form 2 – Change Request & Amendment
Form 3 – Continuation & Renewal
Form 4 – Unanticipated & Adverse Events and Protocol Deviations
Form 6 – Recruitment Materials
Form 7 – Study/Project Closure
• PI Response Form & Routing Process
– Sign-off
– Attachments
• Pot Luck
Review Process
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Question 1
Question 2
Question 3
Question 4
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Question 5
Question 6
Question 7
Question 8
Forms
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Question 1
Question 2
Question 3
Question 4
Question 5
Question 6
Question 7
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Question 8
Question 9
Question 10
Question 11
Question 12
Question 13
PI Response Form & Routing Process
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Question 1
Question 2
Question 3
Question 4
Question 5
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Question 6
Question 7
Question 8
Question 9
Pot Luck
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Question 1
Question 2
Question 3
Question 4
Question 5
Question 6
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Question 7
Question 8
Question 9
Question 10
Question 11
Question 12
Review Process
Question #1:
Under what type of review would the following
study fall: I am conducting a chart review on
patients with lung transplants from 1/1/2008
to 1/1/2018
Review Process
Question #2:
Under what type of review would the following
study fall: I am conducting a survey about UT
dining using UT students and their identities
will be known
Review Process
Question #3:
Under what type of review would the following
study fall: I will draw 50 cc of blood from
adult subjects 3 times a week for research
purposes only
Review Process
Question #4:
Under what type of review would the following
study fall: I will take one x-ray of the elbow
for research purposes only and conduct a
retrospective chart review
Review Process
Question #5:
Under what type of review would the following
study fall: I will compare 2 types of teeth
whitening strips
Review Process
Question #6:
Under what type of review would the following
study fall: I will conduct a program evaluation
of a resident training program where the
intent is to better the UT training process
Review Process
Question #7:
Under what type of review would the following
study fall: I am conducting an expedited study
where one of the subjects has now become
detained in a court-ordered substance abuse
treatment facility
Review Process
Question #8:
Under what type of review would the following
study fall: I am conducting a study using
moderate exercise and an EEG
(electroencephalography) for research
purposes only
Forms
Question #1:
Which form do I use to report a serious,
unanticipated adverse event that is not
related to the study drug/procedures?
Forms
Question #2:
Which form do I use to submit an updated
Investigator’s Brochure or drug/device
package inserts?
Forms
Question #3:
A sponsor grants a waiver for a certain
inclusion/exclusion criterion for a specific
subject. Which form do I use to submit this?
Forms
Question #4:
The IRB has approved for 10 subjects to be
enrolled in our study; however, I just realized
we have enrolled 12. What do I do?
Forms
Question #5:
Regarding my continuation form, do the
participants who did not qualify after
completing the screening procedures count
toward my total enrollment number?
Forms
Question #6:
Who do I need to add to section 3.6 if my study
includes machine-produced ionizing radiation,
such as x-rays, solely for research purposes?
Forms
Question #7:
I want to send some information out via campus
listserv about my IRB-approved study. Do I
need to ask the IRB first?
Forms
Question #8:
If my study was originally approved on paper
(prior to Jan. 2009), do I still have to revise my
project descriptors when I submit a Form 2?
Forms
Question #9:
If the IRB approves 10 subjects to be enrolled in
our study and one drops out of the study, can I
replace him/her?
Forms
Question #10:
I am conducting research at a Methodist/Le
Bonheur facility and I have a reportable local
adverse event. Which form do I use to submit
it?
Forms
Question #11:
Do I need to notify the IRB when my
study/project is completed?
Forms
Question #12:
I want to do a study with anonymized human
cell lines (not purchased or acquired from
ATCC). What do I need to do for the IRB?
Forms
Question #13:
Do I have to attach a formal protocol to my
submission if the study will be investigator
initiated?
PI Response Form &
Routing Process
Question #1:
I am submitting a drug study; what attachments
do I need?
PI Response Form &
Routing Process
Question #2:
Does my faculty advisor have to sign off on my
submission?
PI Response Form &
Routing Process
Question #3:
Who needs to sign off on my initial Form 1
submission?
PI Response Form &
Routing Process
Question #4:
The IRB says I did not attach my revised consent
form to my PI Response form. I thought I did.
What was my mistake?
PI Response Form &
Routing Process
Question #5:
How do I route my submission to have other
people sign off on it?
PI Response Form &
Routing Process
Question #6:
What do I do if I disagree with a proviso?
PI Response Form &
Routing Process
Question #7:
I am in the routing form for my Form 1 initial
submission and I do not see my department
chair’s name for routing. Why not?
PI Response Form &
Routing Process
Question #8:
Who needs to sign off on my PI Response Form
submission?
PI Response Form &
Routing Process
Question #9:
I have submitted my application but the IRB says
they haven’t received it yet. Why?
Pot Luck
Question #1:
Can a student, resident, or fellow be a principal
investigator?
Pot Luck
Question #2:
I am conducting a pediatric study. What do I do
when a currently enrolled subject turns 18?
Pot Luck
Question #3:
How long do I need to keep my research records
after a study has closed?
Pot Luck
Question #4:
I want to conduct research using anonymized
human cell lines purchased from ATCC. What
do I do?
Pot Luck
Question #5:
I am working outside of business hours and
need help with iMedRIS. What do I do?
Pot Luck
Question #6:
I want to conduct a study but I have purchased
some stock in the sponsor’s company. What
do I do?
Pot Luck
Question #7:
I just received approval from the IRB to conduct
my study but the status in iMedRIS says
“Approved- Awaiting Payment.” What does
that mean?
Pot Luck
Question #8:
I completed Group 2 CITI training at another
institution, but the IRB is still saying my CITI
training is not up-to-date. Why?
Pot Luck
Question #9:
I am conducting a research study that includes
the genetic analysis of specimens that will be
collected. Do I need a separate consent form
for the genetic analysis portion of the study?
Pot Luck
Question #10:
There are several versions of my consent form
listed in iMedRIS. Does it matter which
version I use with the subjects?
Pot Luck
Question #11:
Do I need to re-consent the subjects if we have
had a change in PI for the study?
Pot Luck
Question #12:
My research study includes children as research
subjects. Do I have to use the assent form?
IRB Insights
UTHSC IRB
irb@uthsc.edu
448-4824