Notice to Investigators: Mandatory Conversion of Paper Studies to myIRB

Since February of 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 on 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.

For more information regarding the conversion process, please see the website:

http://irb.ufl.edu/irb01/forms/converting-paper-studies-to-myirb.html

If you have any further questions, call the IRB-01 Office (352) 273-9600.

PI PROCESS FOR CONVERTING EXISTING PAPER STUDIES TO myIRB

• Investigators will create a new study in myIRB.
  • The myIRB link is: https://my.irb.ufl.edu. Users must be 1). Registered 2). Training must be up-to-date 3). VPN may be required in order to access the site. For information on myIRB requirements, please visit: http://irb.ufl.edu/myirb.html
  • The Researcher Manual includes helpful information to become familiar with myIRB.
• After creating the new 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 the LAR and participant’s 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.

FAQs

• 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 have 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: Plan 3 months ahead 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.
• Deadlines will still apply for full Board studies.

If you have any further questions, call the IRB-01 Office (352) 273-9600