irb insights

IRB InsightsUTHSC IRB

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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


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


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?


Question #1:

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


Question #2:

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


Question #3:

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


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?


Question #5:

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


Question #6:

What do I do if I disagree with a proviso?


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?


Question #8:

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


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

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irb insights

Documents

pot luckquestion

research study

drug study

following study fall

separate consent form

type of review

assent form

research subjects