Converting Paper Studies to myIRB

NOTICE TO INVESTIGATORS: The IRB is requiring that all applicable paper studies be converted to myIRB.  Beginning February 1, 2016, with each 90-day study expiration notice, the office staff will be sending a notification of the need to convert via email correspondence to the Principal Investigator and all active study staff on record for that study.

BEGINNING MAY 1, 2016, IF YOUR STUDY WAS ELIGIBLE TO BE CONVERTED TO myIRB, THE IRB OFFICE WILL NOT ACCEPT THE PAPER CONTINUING REVIEW.

WHO DOES THIS APPLY TO?

You are required to submit existing paper studies into myIRB as a new study , unless any of the following conditions apply:

  • Study is a Retrospective Chart Review
  • Study is in Longitudinal status
  • Study is closed to enrollment, no interventions continue
  • Study is in data analysis only
  • Study is anticipated to close in the upcoming year

If your study meets one of the above conditions, your study will remain in paper for now.

 

PI PROCESS FOR CONVERTING EXISTING PAPER STUDIES TO myIRB

1. Investigators will be contacted by the IRB Office to begin the conversion process within the 90-day Study Expiration notice

  • Converting the study to myIRB is mandatory for actively accruing projects: if accrual is slow or you don’t think you can complete the research study, then submit a study closure and do not convert the study to myIRB.

2. Investigators will create a new study in myIRB.

3. 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

  • Submissions must be submitted in myIRB no sooner than 90 days prior to study expiration, any received prior to this date may be returned to the PI or administratively withdrawn by the IRB Office.
  • 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.
  • Deadlines will still apply for full Board studies

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