1 / 51

IRB Insights

IRB Insights. UTHSC IRB irb@uthsc.edu 448-4824. 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

deion
Télécharger la présentation

IRB Insights

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. IRB Insights UTHSC IRB irb@uthsc.edu 448-4824

  2. 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

  3. Review Process • Question 1 • Question 2 • Question 3 • Question 4 • Question 5 • Question 6 • Question 7 • Question 8

  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

  5. PI Response Form & Routing Process • Question 1 • Question 2 • Question 3 • Question 4 • Question 5 • Question 6 • Question 7 • Question 8 • Question 9

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. Review Process Question #5: Under what type of review would the following study fall: I will compare 2 types of teeth whitening strips

  12. 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

  13. 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

  14. 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

  15. Forms Question #1: Which form do I use to report a serious, unanticipated adverse event that is not related to the study drug/procedures?

  16. Forms Question #2: Which form do I use to submit an updated Investigator’s Brochure or drug/device package inserts?

  17. 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?

  18. 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?

  19. 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?

  20. 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?

  21. 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?

  22. 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?

  23. 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?

  24. 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)?

  25. Forms Question #11: Do I need to notify the IRB when my study/project is completed?

  26. 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?

  27. 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?

  28. 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?

  29. PI Response Form & Routing Process Question #1: I am submitting a drug study; what attachments do I need?

  30. PI Response Form & Routing Process Question #1: I am submitting a drug study; what attachments do I need?

  31. PI Response Form & Routing Process Question #2: Does my faculty advisor have to sign off on my submission?

  32. PI Response Form & Routing Process Question #3: Who needs to sign off on my initial Form 1 submission?

  33. 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?

  34. PI Response Form & Routing Process Question #5: How do I route my submission to have other people sign off on it?

  35. PI Response Form & Routing Process Question #6: What do I do if I disagree with a proviso?

  36. 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?

  37. PI Response Form & Routing Process Question #8: Who needs to sign off on my PI Response Form submission?

  38. PI Response Form & Routing Process Question #9: I have submitted my application but the IRB says they haven’t received it yet. Why?

  39. Pot Luck Question #1: Can a student, resident, or fellow be a principal investigator?

  40. Pot Luck Question #2: I am conducting a pediatric study. What do I do when a currently enrolled subject turns 18?

  41. Pot Luck Question #3: How long do I need to keep my research records after a study has closed?

  42. Pot Luck Question #4: I want to conduct research using anonymized human cell lines purchased from ATCC. What do I do?

  43. Pot Luck Question #5: I am working after business hours and need help with iMedRIS. What do I do?

  44. 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?

  45. 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?

  46. 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?

  47. 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?

  48. 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?

  49. Pot Luck Question #11: Do I need to re-consent the subjects if we have had a change in PI for the study?

  50. Pot Luck Question #12: My research study includes children as research subjects. Do I have to use the assent form?

More Related