Post on 22-Feb-2016
description
IRB InsightsUTHSC IRB
irb@uthsc.edu448-4824
Categories• Review Process
– Exempt– Expedited– Full Board
• Forms– 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
• Question 1• Question 2• Question 3• Question 4
• Question 5• Question 6• Question 7• Question 8
Forms
• Question 1• Question 2• Question 3• Question 4• Question 5• Question 6• Question 7
• Question 8• Question 9• Question 10• Question 11• Question 12• Question 13• Question 14
PI Response Form & Routing Process
• Question 1• Question 2• Question 3• Question 4• Question 5
• Question 6• Question 7• Question 8• Question 9
Pot Luck
• Question 1• Question 2• Question 3• Question 4• Question 5• Question 6
• 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 1/1/2014
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 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?
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. Do I need to submit a Form 4e (Meth/Le Bon adverse event) and a Form 4a
(local, reportable adverse event)?
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 a human cell line purchased or acquired from commercial vendors, IRB approved repositories, or
government tissue banks. How should I handle my Form 1- initial application?
Forms
Question #13:
The IRB says I have not completed the exempt, expedited, or informed consent subforms.
How do I know if I have or not?
Forms
Question #14:
I have listed all the possible risks and discomforts associated with my study in the
consent form. Do I have to list them anywhere else?
PI Response Form & Routing Process
Question #1:
I am submitting a drug study; what attachments do I need?
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.
Where is it?
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 after 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 InsightsUTHSC IRB
irb@uthsc.edu448-4824