the ten most common mistakes in irb submissions (how to avoid “3-tylenol-days”)
TRANSCRIPT
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 MotherHubbard’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 indicatewhich 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 havefilled in all of theinformation 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 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.
#4 Consent Problems: Revision If a consent form change isrequired, a marked consentform and a “clean” consentform 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 beforesubmitting 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 2012 submission states that there are 12 people on the study with 4 recruited in this period.
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: [email protected]
Feedback, Comments, Questions and Concerns Please contact the HRPO at
[email protected] 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
