The Ten Most Common Mistakes in IRB Submissions (How to avoid “ 3 -tylenol-days”)
#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
#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.
#9 Leaving “BLANKS” in documents Like Old Mother Hubbard’s Cupboard, empty is empty, and “empty” just doesn’t work.
#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.
#7 Missing Emergency Evacuation Card Make sure you include the card, if applicable.
#7 Missing Emergency Evacuation Card Make certain you have filled in all of the information on the card. No blanks left empty
#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.
#5 Consent Problems: CR 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. If
#4 Consent Problems: Revision If a consent form change is required, a marked consent form and a “clean” consent form must be submitted.
#3 Consent Problems: Construction Be certain that the consent you are submitting includes all of the “required” template language.
#2 Consent Problems: Construction Make certain that page numbers are correct
#1 Consent Problems: Construction Run spell checker on document before you submit it.
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
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 v 2012 submission states that there are 12 people on the study with 4 recruited in this period. v
Study Closure Requires submission of a study closure package via IRBNet Include a complete report of research results.
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.
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.
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
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.
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)
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
Listserv If you are not currently receiving messages through the IRB Listserv, please email: tulane. edu
Feedback, Comments, Questions and Concerns Please contact the HRPO at irbmain@tulane. edu with any/all of the above 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
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