ORI Efforts to Minimize Impact of Freeze

The transition to the Revised Federal Policy for the Protection of Human Subjects (Common Rule) has forced the Office of Research Integrity (ORI) and Institutional Review Boards (IRB) to issue a Temporary Freeze on New Initial IRB Applications.  Any protocol approved prior to January 20, 2019, must comply with the Current Rule and any protocol approved on or after January 21, 2019, must comply with the Revised Rule.

ORI and Research Information Services (RIS) have worked to lessen the impact of the temporary freeze for researchers wishing to create and begin work on new IRB applications during that time. 

• New Initial Applications can be created during the freeze. However, if submitted, they will be returned to the researcher; but they will NOT be cancelled.  The draft application can be found in the researcher’s Inbox.  The researcher may continue to work on the draft application.  On January 22, 2019, when the freeze is lifted, new questions based on the Revised Rule will appear in the E-IRB application. The researcher will need to answer the new questions prior to submitting.  

• ORI and the IRB will strive to complete reviews on protocols submitted prior to the freeze.  Those that are approved prior to January 21, 2019, will be grandfathered in under the Current Common Rule.

• During the freeze, ORI will work individually with researchers on a case-by-case basis to manage submissions with special circumstances (e.g., funding award deadlines).

E-IRB System Shutdown Dates

E-IRB will be offline from noon Friday, January 18, 2019, through 8:00 am Tuesday, January 22, 2019. The shutdown is required for RIS to implement programming changes based on the Revised Rule.