Office of Research Integrity
Transforming tomorrow by Promoting Ethical Research

News & Announcements

This page offers news-worthy topics, helpful regulatory tips, and updates to IRB/ORI policy, procedures, and guidelines for IRB Members and others involved in human research. Note: Due to the nature of web page evolution, some links may be broken.

December 12, 2018

Important Message for Investigators Who Are Conducting Research Initially Approved Prior to E-IRB Implementation:

All studies approved external to E-IRB, and subsequently converted into an E-IRB application, must have the old protocol number in the upper right-hand corner of the blue E-IRB application banner.  The old protocol number is the trigger for the system to recognize that the protocol was IRB-approved prior to implementation of the revised common rule regulations. 

E-IRB Banner

 

If you have an active study initially approved outside of E-IRB and it is missing the old protocol number, e-mail Judi Kuhl, E-IRB System Administrator, at judi.kuhl@uky.edu and provide your old protocol number and your new E-IRB number; Judi will ensure your old number is inserted into the blue banner of your E-IRB application so the system and the IRB appropriately applies the old common rule or the revised common rule to future reviews of your study. 

Existing Studies Not Yet Established in E-IRB

If you have not imported an approved protocol not yet established in the E-IRB system, you may import anytime, but must complete the import at Continuation Review.

See video tutorial on how to “Import a Full or Expedited Application”).

E-IRB Import Application

 

November 29, 2018

ORI Guidance on the Revised Federal Policy for the Protection of Human Subjects

The UK Office of Research Integrity (ORI) has developed a guidance document outlining plans for transitioning to the revised human subject regulations (a.k.a., “the Common Rule”). The document also provides an overview of the key changes that will be effective after January 21, 2019. ORI will update the document with additional information as the federal Office for Human Research Protection (OHRP) releases guidance on interpretation and practical application of the new rule.  Read more… [PDF]

November 12, 2018

General IRB Announcement: Follow up regarding Temporary Freeze on Initial IRB Applications 

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.

November 2, 2018

IMPORTANT DATES REGARDING IRB PROTOCOL SUBMISSION TO PREPARE FOR IMPLEMENTATION OF the Revised Policy for the Protection of Human Subjects (aka Revised Common Rule).

For simplicity, we will refer to the current regulations as the “Current Common Rule” and the January 21, 2019 regulations as the “Revised Common 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 until the January 21, 2019 implementation date of the Revised Common Rule.

If your submitted protocol cannot be approved by January 21, the submission will be canceled and ORI will provide you with a PDF version for use in resubmitting after January 21 when the Revised Common Rule is implemented in E-IRB.

Ongoing Approved Research:
During this period, investigators will need to continue preparing and submitting modifications, violations, reports, and continuations to maintain compliance for existing studies approved under the Current Common Rule.

CAUTIONARY NOTICE

BEGINNING November 14, 2018 Investigators are strongly encouraged to delay the creation of New Initial Review submissions until on or after January 21, 2019.  If your submitted protocol cannot be approved by January 21, the submission will be canceled and ORI will provide you with a PDF version for use in resubmitting after January 21 when the Revised Common Rule is implemented in E-IRB.

  • Initial Full Review Submissions:
    MINOR REVISIONS: If revisions are minor, investigators are expected to provide prompt responses in order for the IRB to review revisions and issue approval before January 21.

    MAJOR REVISIONS: Substantive revisions must be reviewed at a convened meeting. Initial applications requiring substantive changes are unlikely to be approved prior to January 21, 2019.
  • Initial Expedited or Exempt Submissions:
    Investigators are expected to provide prompt responses in order for the IRB to review revisions and issue approval before January 21.

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 21, 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.