the ten most common mistakes in irb submissions (how to avoid “3-tylenol-days”)

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: irbmain@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