1. The Ten Most Common Mistakes in IRB Submissions (How to avoid “3-tylenol-days”)

2. #10 CITI Training  Forgetting to add CITI training for one or more staff  Biomedical: Biomedical (group 1) Research for Investigators and Key Personnel course.  Social Behavioral: Social and Behavioral (group 2) Research for Investigators and Key Personnel  Good for 3 years

3. #10 CITI Training  Adding a CITI training that is expired or is about to expire. Remember that a certificate needs to still be current by the time the study is reviewed and approved.

4. #9 Leaving “BLANKS” in documents  Like Old Mother Hubbard’s Cupboard, empty is empty, and “empty” just doesn’t work.

5. #8 Failing to Submit All Necessary Supplements (App.2)  At the end of the application, there is a check-off to indicate which supplements are required.  Be certain that all required supplements are completed and that no piece is missing from your submission.

6. #7 Missing Emergency Evacuation Card  Make sure you include the card, if applicable.

7. #7 Missing Emergency Evacuation Card  Make certain you have filled in all of the information on the card.  No blanks left empty

8. #6 No DSMB (or other similar reports)  If the protocol states that these reviews will be done periodically, reports should be received by the site or PI and submitted to IRB.

9. #5 Consent Problems: CR  If completing a continuing review and participants have been enrolled in the last period, add copies of two most recently signed consents, with signatures blocked out.

10. #4 Consent Problems: Revision  If a consent form change is required, a marked consent form and a “clean” consent form must be submitted.

11. #3 Consent Problems: Construction  Be certain that the consent you are submitting includes all of the “required” template language.

12. #2 Consent Problems: Construction  Make certain that page numbers are correct

13. #1 Consent Problems: Construction  Run spell checker on document before you submit it.

14. What else can I do?  Check and re-check the checklist before submitting a package  Rely on the information on IRBNet and the HRPO website, including the IRBNet User’s Guide, to help with submissions

15. What else can I do?  Make sure that your answers are consistent with past submissions (example):  2011 submission stated there were 6 people on study  2012 submission states that there are 12 people on the study with 4 recruited in this period.

16. Study Closure  Requires submission of a study closure package via IRBNet  Include a complete report of research results.

17. Continuing Reviews  Courtesy notices: 90-day, 60-day, 30-day  Submit minimum of 30 days before the expiration day  If your study has lapsed, you must submit a report to the IRB indicating that no research is/was conducted during that period of expiration. Cease all research activities immediately. If this presents any risk to patients, contact the IRB immediately.

18. IT’s (clinical trials-industry-sponsored)  Original IT’s (completed and signed) for Initial Submissions or Continuing Reviews must be hand delivered to HRPO. This is a University requirement.  Failing to provide in a timely manner will delay processing your submission.

19. Training & Credentials Mgmt  Investigators and staff can upload training and credentials (CV) in an integrated manner.  Upload documents once within User Profile; they can now be linked to project packages in streamlined fashion  Training and credentials reflected across all of user’s projects & interactions

20. Deadlines for Submissions  For all deadline dates, the deadline time is 3:00 PM that day.  Submissions must be deemed complete by the HRPO before 3:00 PM on the deadline date.  Volume constraints, committee member availability and unforeseen circumstances can force a project to be moved to a later meeting.

21. Meeting Dates/Deadlines  These apply to submissions to be reviewed by the convened IRB board.  Exempt & Expedited submissions are reviewed on an ongoing basis  The IRB Review Timeline provides an estimated timeline for each type of submission (http://tulane.edu/asvpr/irb)http://tulane.edu/asvpr/irb

22. AAHRPP Re-accreditation  In preparation for re-accreditation, the IRB is currently revising forms and policies  Everyone will be updated on the HRPO website and Listserv

23.  If you are not currently receiving messages through the IRB Listserv, please email: irbmain@tulane.edu

24. Feedback, Comments, Questions and Concerns  Please contact the HRPO at irbmain@tulane.edu with any/all of the above irbmain@tulane.edu  Please also let the HRPO know if there are other areas, including regulations and/or policies, on which you would like more information or education