[Itech] Fw: Electronic IRB Announcement

[Moore, David]

New changes coming in January for IRB.

thanks

-Dave


David Richard Moore Ph.D.
Secretary to the Board of Trustees and
Professor, Instructional Technology
Ohio University
110 Cutler Office: 740.593.2958  (Mornings)
S205 Lindley Office: 740.597-1322  (Afternoons)





________________________________
From: Research Compliance
Sent: Friday, December 11, 2015 4:16 PM
To: Research Compliance
Subject: Electronic IRB Announcement


Dear Colleagues,



After over a year of planning, programming, testing, and reviewing, we are pleased to announce that we are now ready to launch the new electronic Institutional Review Board (IRB) program.  The Office of Research Compliance has been testing the electronic IRB program since approximately June 2015.  This process has included evaluating all aspects of the software for functionality and accuracy, and to "work out the bugs."  We have reviewed the investigator preparation and submission process, the activities of the Office of Research Compliance, as well as the activities of the respective IRBs.  These processes all appear to be functioning very well.



  *   Effective January 1, 2016, all IRB documents must be submitted to the Ohio University Office of Research Compliance using the electronic LEO IRB system.  The documents will be deemed signed off when the research team members agree to the stipulations listed on the submission page.



  *   During the transition to the electronic IRB system, investigators that received approval for a new IRB protocol or a periodic review (renewal) from August 24 through December 31, 2015 (or had a new protocol or periodic review pending IRB approval as of December 31, 2015), that need to make a modification (amendment) or submit a deviation / event report for the specific protocol (that was approved or is pending from August 24 through December 31, 2015), have the option of filing using the electronic system (provide all of the required study information in the electronic system) or submitting a hard copy modification or deviation / event report.  This transition period is in effect through April 30, 2016.



  *   Effective May 1, 2016, all submissions (of any type) must be made using the electronic system.  The investigator will need to update and upload all approved information and any approved documents (for example, consent forms, assent forms, et cetera) into the electronic LEO IRB system.



  *   Please note that effective January 1, 2016, any investigator(s) / research team(s) that did not obtain approval for a specific IRB protocol or periodic review, from August 24 through December 31, 2015 (or had a new protocol or periodic review pending IRB approval as of December 31, 2015), and they want to modify the protocol, submit a periodic review, event report or deviation, must submit the request using the electronic LEO IRB system.  For example, each new protocol, periodic review, an amendment to a protocol approved prior to August 24, 2015, et cetera.



We know that you will be pleased with the new system.  Additional information will be posted on the Research Compliance website.  Please feel free to share this email to spread the word.



Regards,

Office of Research Compliance Staff


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