Office of Research Integrity (ORI)

IMPORTANT DATES REGARDING NEW INITIAL IRB APPLICATIONS TO PREPARE FOR IMPLEMENTATION of the Revised Policy for the Protection of Human Subjects (aka Revised Common Rule).

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.

Temporary Freeze on New Initial IRB Applications

To manage the transition given the volume of initial submissions, the ORI, IRB, and Research Information Service are implementing a freeze on new Full IRB applications effective December 5, 2018 and a freeze on new Expedited/Exempt applications effective December 14, 2018.  The freeze will remain in effect through the January 21, 2019, implementation date of the Revised Common Rule.

ORI Efforts to Minimize Impact of Freeze

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.  If an application is returned, it can be found in the researcher's Inbox in its completed state. The researcher may work on the returned application if needed.  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 to the E-IRB system based on the Revised Rule.

Reason for Temporary Freeze - NO FEDERAL GRACE PERIOD

January 21, 2019 is both the effective date and the compliance date for the Revised Common Rule.  This means that the institution cannot implement the revised rule before the effective date.  It also means the regulation provides no grace period for which to transition to become compliant with the revised rule. 

• All initial applications submitted under the current rule, must obtain approval prior to January 21, 2019.
• All initial applications submitted after the effective date must comply with the new elements and regulatory requirements of the revised rule.

Due to the federal delay, the effective and general compliance date of the Revised Common Rule is January 21, 2019.

• Research approved prior to January 21, 2019 may continue through completion based on the Current Common Rule regulations. 
• Research approved on and after January 21, 2019, will need to comply with the Revised Common Rule. The Revised Common Rule regulatory changes will be incorporated into the version of E-IRB that will be released January 22, 2019.  
• FDA-Regulations have not yet harmonized with all of the Revised Common Rule provisions.  However, we will implement those changes that do not conflict with current FDA regulations.