Converting Paper Studies to myIRB

NOTICE TO INVESTIGATORS: Since February 2016, the IRB has allowed investigators to avoid converting certain types of active studies to myIRB.  However, the recently revised Common Rule that goes into effect January 19, 2018 will result in many changes that UF will need to implement.

As a result, all studies currently in the IRB’s legacy system (i.e. in paper) must either be converted to myIRB or be closed by December 31, 2017.  If we have not heard from you or your study staff regarding your intentions for your active study by December 1, 2017, the IRB will proceed to close any remaining “paper” studies.  The IRB will contact the PI before closing a study when there is a possibility of currently active study subjects.

 

PI PROCESS FOR CONVERTING EXISTING PAPER STUDIES TO myIRB

1. Investigators will create a new study in myIRB based on the current study activities that remain.

2. After creating the new myIRB study, on the myIRB Legacy Conversion smartform page – Investigators MUST:

  • Indicate the previous IRB #
  • Attach their completed Continuing Review Report for the paper study to include:
    • The appropriate Continuing Review Report Continuing Review or Continuing Review for TISSUE/DATA banks
      • Please keep in mind that for many regulatory reasons, if the paper study also contains a local tissue or data bank, these must be “uncoupled,” meaning that both the primary study and the tissue and/or data bank must be submitted in myIRB as two separate studies.
    • Copy of the last signed ICF (with participants name blacked out)
    • Cumulative Adverse Event Table
    • Cumulative Deviation Tracking Table
    • Publications
    • Current ancillary reviews for RAC, HURRC, or COI, as applicable
  • Submit the new study for review
  • Notifications will be sent to the PI (and Coordinator) via email if changes are needed.
  • Once approval documents are generated, the approval letter will indicate approval for the myIRB study AND indicate that the paper study has been converted. All future submissions MUST be submitted within myIRB

*NOTE: REVISIONS TO THE PAPER STUDY WILL NOT BE ACCEPTED DURING THE CONVERSION PROCESS *

FAQ’S

  • REVISIONS CANNOT BE MADE TO THE PAPER STUDY DURING THE CONVERSION PROCESS
  • The study will be reviewed as a new study; IRB reviewers will have access to supporting documentation from previous paper IRB submissions
  • Plan ahead to make sure all study staff are registered in myIRB and completed the mandatory IRB training and HIPAA for researchers training is up to date.
  • The myIRB approval letter will indicate the new status for the paper study as “Converted”
  • VA studies: You should receive an email from the HRPP Office requesting that you begin the conversion process well before the 90 day expiration notice. This is to begin the VA Paperwork that will be required to be uploaded prior to submitting your new conversion study.
  • If your study included the option for subjects to indicate if they wanted to be contacted for future research (i.e. noted by the IRB to be a “piggy bank”), this will need to be a separate banking study for research (Registry or Data Bank).  Please call the IRB office for assistance.
  • If the paper study that is now converting to data analysis or longitudinal review was reviewed by the full board last year, the new myIRB Retrospective Data/Chart review will need to go to full board initially, then will be approved to move to expedited review.
  • Deadlines will still apply for full Board studies

If you have any further questions, call the applicable IRB Office for assistance:

IRB-01 Office (352) 273-9600
IRB-02 Office (352) 392-0433
IRB-03 Office (904) 244-9427