E-IRB News and Updates 2017
December 13, 2017
Reminder - An update to E-IRB applications will be put into production effective December 15, 2017. In this update, the primary change will be to collect additional information in the Exempt IRB Application to accommodate the proposed New Federal IRB Regulations Exempt Categories (for more info about the “common rule” changes, attend the overview, or read a summary in the November IRB Review Newsletter).
E-IRB applications submitted to ORI/IRB before December 15th will not contain the updates. All E-IRB applications in draft and not submitted to ORI/IRB by December 15th will automatically be converted to the updated E-IRB application. No previously saved data will be lost; however, the research investigator will need to verify the information in certain sections of the draft application, and if applicable, provide supplemental information before submission.
These changes in E-IRB should facilitate a smoother transition for UK-wide mandatory submission of all initial and continuation reviews in E-IRB starting January 22, 2018 (regardless of whether there is a delay in implementation of the New Federal IRB Regulations).
December 1, 2017
In anticipation of the New Federal IRB Regulations, an update to E-IRB will be put into production effective December 15, 2017. In this update, E-IRB will collect additional information in the Exempt IRB Application to accommodate the proposed Exempt Categories.
E-IRB applications submitted to ORI/IRB before December 15th will not contain the updates. All E-IRB applications in development but not submitted to ORI/IRB by December 15th will automatically be transferred to the updated E-IRB. No previously saved data will be lost; however, the research investigator will need to verify the information in certain sections of the draft application, and if applicable, provide supplemental information before submission.
November 1, 2017
The E-IRB Pilot has been expanded for the Department of Neurology, Department of Surgery, and the College of Communication and Information to include import of full review and expedited review applications previously approved external to the E-IRB system. Other researchers interested in participating in the import pilot on a volunteer basis are welcome to do so. A new video tutorial "How to Import a Full or Expedited Application" is now available to assist with this new functionality.
October 23, 2017
The transition to E-IRB will affect how your initial and continuation review IRB materials will be accepted by the Office of Research Integrity (ORI) starting mid-January 2018. To keep apprised of news and updates about this transition, as well as training options, please review this E-IRB Info web page for FAQ's, known issues, and more. To learn how to navigate in the new system prior to institution-wide implementation, review the various E-IRB Video Tutorials and online resources today.
October 23, 2017
The E-IRB Pilot Phase has been expanded to include mandatory participation for Initial Full and Initial Expedited reviews for the College of Dentistry and the Markey Cancer Center. Participation in the Pilot phase for importing existing applications begins Nov. 1 for the units who started piloting in June 2017 (Departments of Surgery, Neurology and College of Communication & Information). Of course, anyone interested in participating in the pilot on a volunteer basis is welcome! Users willing to train in and test the system are instrumental in the program’s progress.
June 22, 2017
All new Exemption applications are required to be submitted in E-IRB while the E-IRB Pilot Phase continues for Initial Full and Initial Expedited reviews with mandatory participation as agreed by the Departments of Surgery, Neurology, and the College of Communication and Information.
Link to the live E-IRB system will become available to the UK research community for mandatory submission of Exemption Applications effective June 21, 2017. Initial Full and Initial Expedited review applications will continue in the Pilot Phase until further notice. Trainings are being offered for those participating in the pilot phase and for those who will be submitting exemption applications; see online training schedule.
- E-IRB Pilot Phase details in a nutshell:
- Purpose: Allows the system to be used in a live environment by select users from submission to approval.
- Method: This is live data and there is no longer a separate paper/email backup for the users.
- Timeline: In progress. Completion will be based on the success level of users participating in the Pilot Phase, and when Research Information Services (RIS) implements the remaining components needed to round out the system.
E-IRB is currently in the pilot phase. This means the system is live for a handful of trained researchers, and initial review applications are being accepted while RIS continues to work on other components of the E-IRB system.