January 22, 2018 Transition to E-IRB

The proposed effective date for the revised common rule regulations is January 19, 2018.  However, as of January 8th, the Office of Research Integrity (ORI) and the Institutional Review Boards (IRB) are still waiting to learn whether the requested delay for implementation of the final rule is granted and therefore which regulations will apply as of January 19, 2018.  Regardless of the federal agency’s decision on implementation of the revised common rule, effective January 22, 2018, new Expedited and Full Review Applications must be submitted via the new web-based application system, "E-IRB".  In addition, all full and expedited IRB studies previously approved external to E-IRB will need to be imported and completed in E-IRB at Continuation Review time. For details, see the pertinent FAQ on the E-IRB Info web page. Submission of new Exemption applications in E-IRB has been mandatory since June 21, 2017.  Access E-IRB Log-on, E‐IRB news, updates, video tutorials, online training schedules and more on the E‐IRB Info web page.

Note that the E-IRB application available on January 19th may reflect the changes required by the common rule.  All E-IRB applications in draft and not submitted to ORI/IRB by January 19th 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. E-IRB applications submitted to ORI/IRB before January 19th will not contain the updates;subsequent modification request or continuation review will trigger the application update.

We appreciate your patience during this time and as always ORI will do their best to answer any questions.