Presentation on theme: "IRB Insights UTHSC IRB 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change."— Presentation transcript:
IRB Insights UTHSC IRB
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: 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?