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Page 1: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

IRB Insights

UTHSC [email protected]

448-4824

Page 2: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

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

Page 3: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

Review Process

• Question 1• Question 2• Question 3• Question 4

• Question 5• Question 6• Question 7• Question 8

Page 4: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

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

Page 5: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

PI Response Form & Routing Process

• Question 1• Question 2• Question 3• Question 4• Question 5

• Question 6• Question 7• Question 8• Question 9

Page 6: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

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

Page 7: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

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

Page 8: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

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

Page 9: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

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

Page 10: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

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

Page 11: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

Review Process

Question #5:

Under what type of review would the following study fall: I will compare 2 types of teeth

whitening strips

Page 12: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

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

Page 13: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

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

Page 14: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

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

Page 15: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

Forms

Question #1:

Which form do I use to report a serious, unanticipated adverse event that is not related to the study drug/procedures?

Page 16: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

Forms

Question #2:

Which form do I use to submit an updated Investigator’s Brochure or drug/device

package inserts?

Page 17: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

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?

Page 18: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

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?

Page 19: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

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?

Page 20: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

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?

Page 21: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

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?

Page 22: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

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?

Page 23: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

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?

Page 24: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

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?

Page 25: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

Forms

Question #11:

Do I need to notify the IRB when my study/project is completed?

Page 26: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

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?

Page 27: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

Forms

Question #13:

Do I have to attach a formal protocol to my submission if the study will be investigator

initiated?

Page 28: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

PI Response Form & Routing Process

Question #1:

I am submitting a drug study; what attachments do I need?

Page 29: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

PI Response Form & Routing Process

Question #2:

Does my faculty advisor have to sign off on my submission?

Page 30: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

PI Response Form & Routing Process

Question #3:

Who needs to sign off on my initial Form 1 submission?

Page 31: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

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?

Page 32: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

PI Response Form & Routing Process

Question #5:

How do I route my submission to have other people sign off on it?

Page 33: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

PI Response Form & Routing Process

Question #6:

What do I do if I disagree with a proviso?

Page 34: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

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?

Page 35: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

PI Response Form & Routing Process

Question #8:

Who needs to sign off on my PI Response Form submission?

Page 36: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

PI Response Form & Routing Process

Question #9:

I have submitted my application but the IRB says they haven’t received it yet. Why?

Page 37: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

Pot Luck

Question #1:

Can a student, resident, or fellow be a principal investigator?

Page 38: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

Pot Luck

Question #2:

I am conducting a pediatric study. What do I do when a currently enrolled subject turns 18?

Page 39: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

Pot Luck

Question #3:

How long do I need to keep my research records after a study has closed?

Page 40: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

Pot Luck

Question #4:

I want to conduct research using anonymized human cell lines purchased from ATCC. What

do I do?

Page 41: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

Pot Luck

Question #5:

I am working outside of business hours and need help with iMedRIS. What do I do?

Page 42: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

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?

Page 43: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

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?

Page 44: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

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?

Page 45: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

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?

Page 46: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

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?

Page 47: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

Pot Luck

Question #11:

Do I need to re-consent the subjects if we have had a change in PI for the study?

Page 48: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

Pot Luck

Question #12:

My research study includes children as research subjects. Do I have to use the assent form?

Page 49: IRB Insights UTHSC IRB irb@uthsc.edu 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change

IRB Insights

UTHSC [email protected]

448-4824


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