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JUNE 8, 2016 –

As previously noted with the release of the new IRB Continuing Review Form (ORA V.2016), HSERA is scheduled to update the Continuing Review (CR) submission design to align the system with the use of the new form. Any Continuing Reviews (CRs) that are in Draft at the time the system is updated will be drastically altered and any information provided in the HSERA form fields will be permanently lost. The IRB has determined that approximately 440 minimal risk studies and at least 50 greater than minimal risk studies are likely to have continuing review submissions in draft based on their impending expiration between now and July 30, 2016.

To ease the transition and prevent as much confusion as possible, the IRB is providing a 3 week window for all study teams to; adjust their process for creating new Continuing Reviews, assess any current draft Continuing Reviews and revise if needed in preparation for the change. THE FORMAT OF THE HSERA CONTINUING REVIEW SUBMISSION WILL BE CHANGED ON JULY 5, 2016. To view images of the new HSERA Continuing Review submission and for information on how to submit Continuing Reviews please see the related “How to Submit” page for Continuing Review.

Please Note that these changes are also planned for the HSERA Submissions for Deviations, Exceptions, Reportable Events and Modifications in the near future. Please note that these changes WILL NOT EFFECT THE PROCESS FOR SUBMITTING NEW RESEARCH AT THIS TIME. The IRB is requiring that after June 1, 2016 ALL TYPES OF SUBMISSIONS for fully approved research be created such that all relevant information is included in the attached form and other attached documents instead of utilizing the HSERA form fields. Additional information about this process can be found on the relevant “How to Submit” page for the particular submission you have questions about.

 

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