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.

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.

 

September 26, 2018

General Announcement: IRB Review Newsletter

Click here to read the IRB Review Newsletter:

In this issue:

  • Importing Protocols into E-IRB at Continuation Review Time: what to include and how to incorporate changes
  • Updated UK IRB Informed Consent Templates
  • Replaced human subject training options for Non-UK study personnel
  • October 4th Annual Human Subject Protection Conference; Advance registration ends Thursday, September 27, 2018.

September 17, 2018

General Announcement: Updated Informed Consent Templates

Based on feedback from researchers, IRB members, and participants from the Informed Consent Workshops, we have made revisions to both the Medical and Nonmedical Informed Consent Template. The changes involve:

  • Clarifications in instructions and simplification of the section describing storage and sharing for future secondary use. 
  • Addition of collapsed sections the user can click to open and include if applicable.  If not related to the research, the user simply deletes the section. 
  • Reducing appendix examples in the nonmedical template to one, as most nonmedical consents are sufficiently concise and not enhanced by appendices that merely duplicate information.  

Available now for new submissions:

The updated medical and nonmedical informed consent templates are available for use immediately.  Archive any saved versions of past templates, and use the current templates available in the “All Templates” menu option of your  E-IRB application, or the UK Template website for new submissions. The template updates have not prompted ORI to ask investigators to edit consents that already have IRB approval or are submitted for IRB review. 

Guides not carved in stone:

Templates are provided as guides to be customized to best meet the needs of the potential population and the context of the research.  We encourage researchers to use conversational style, lay terminology resources and “plain language” techniques to create a consent document that facilitates understanding.  After drafting, use the Consent Checklists to assess for regulatory compliance.

For more information on using consent templates, see the updated UK consent Form Template FAQ.

Background:

The UK ORI and IRB implemented a revised informed consent template December 2017, along with newsletter announcements, FAQs, and Informed Consent Workshop offerings. This transition occurred a year in advance of the January 2019 effective date of the new “Common Rule” regulations for protecting human subjects.  The revision has provided an opportunity for researchers and IRB members to become familiar with select requirements from the new rule.  In addition, the revised template included design and organization options for presenting information in a format intended to aid in understanding and help prospective subjects decide whether to participate in the research.  

August 15, 2018

E-IRB Featured Highlights: “Add Related Grant” option and “Approval Letter Details” option 

Based on feedback acquired from investigators and the Office of Research Integrity (ORI) staff during the design phase of the E-IRB system, features were built in to enable researchers to customize their E-IRB application. The following highlights two examples. For future reference, details about these features are available on the E-IRB page under the “E-IRB Features/Known Issues" menu in the sidebar.

  • The “Add Related Grants” feature, located in the Funding/Support section of the E-IRB application, enables the researcher to associate a specific research grant with the proposed (or approved) research activities. Please click here for more details.
  • The “Approval Letter Details” feature, located in the Additional Information/Materials section of the E-IRB application, allows the researcher to write specific verbiage that they would like added to the IRB approval letter.  When the approval letter is issued, the system will automatically add the verbiage to the letter. Please click here for more details.

July 11, 2018

General Announcement: IRB Review Newsletter [PDF]

In this issue:

  • Updated Office of Research Integrity (ORI) Website
  • CITI “Revised Common Rule” Course meets 3-year Human Subject Refresher Training requirement
  • New Guidance for Researchers and IRB Members on Research Banks, Registries, & Digital Data
  • Consent Contact for Greater than Minimal Risk Research
  • Registration now open for the Annual Regional Conference, Human Subject Protection: Roll With It
    October 4, 2018 Northern Kentucky Convention Center Early-Registration Discount