What's New in 2017?

December 22, 2017

General Announcement: FAQs on New UK Informed Consent Template [PDF]

The New Common Rule Regulations for the Protection of Human Subjects is scheduled to go into effect January 19, 2018. The UK IRB and Office of Research Integrity (ORI) are implementing tools to facilitate compliance and take advantage of streamlined provisions provided under the new rule. New Informed Consent templates were posted to the ORI website December 20, 2017 (see 12/15/17 announcement).
Please see the Frequently Asked Questions (FAQs) document [PDF] regarding the new templates and changes to the consent regulations based on the new rule. We will update the FAQ as new information and federal guidance becomes available.

December 15, 2017

General Announcement: New Informed Consent Template - Details [PDF]

The Federal Policy for the Protection of Human Subjects (the Common Rule), has updated regulations including revised requirements for the informed consent process. The intent of these consent changes is to facilitate a prospective subject’s comprehension by presenting information in a format that helps him/her decide whether or not to participate in the research.

The new template is available on applicable IRB application web pages, and in E-IRB under the All Templates menu selection on the left hand side of an E-IRB application.

December 13, 2017

General Announcement: E-IRB Update Reminder [PDF]

December 1, 2017

General Announcement: E-IRB Update [PDF]

An update to E-IRB will be put into production effective December 15, 2017.  In this update, E-IRB will collect additional information in the Exempt IRB Application to accommodate the proposed Exempt Categories.

E-IRB applications submitted to ORI/IRB before December 15th will not contain the updates.

E-IRB applications in draft and not submitted to ORI/IRB by December 15th 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 the draft application, and if applicable, provide supplemental information before submission.

November 21, 2017

IRB Review Newsletter [PDF]

  • E-IRB System Progress: Roll-Out Schedule, Mandatory Implementation, Learning Resources
  • New "Common Rule" IRB Regulations
  • Randomization Video for Potential Participant Education

October 31, 2017

General Announcement: New "Common Rule" IRB Regulations, Effective January 2018 

The scheduled date for the majority of the revisions to the New Federal IRB Regulations is quickly approaching. The 125-page policy governing research involving human subjects involves significant changes to improve protections and streamline the IRB review process. While there is a chance of a one-year delay in implementing some of the provisions, IRBs would likely be able to proceed with implementing several “burden-reducing” changes. The Office of Research Integrity (ORI) is preparing for the upcoming regulatory shift by revising applications, procedure/guidance documents, checklists, and even the new E-IRB submission system to take advantage of regulatory flexibility. The hope is that the E-IRB system, currently in pilot phase, can be launched campus-wide based on the new rule.  This would allow researchers to transition to a version of E-IRB that will closely mirror the future of research oversight.

Changes researchers can prepare for include:

  • New exempt review categories for low-risk research
  • Streamlined continuing review requirement for certain types or stages of research
  • Revised consent template to include new elements and reorganize both the document and the process to facilitate a prospective subject’s decision about whether to participate

ORI and the Center for Clinical and Translational Science (CCTS) are continuing to provide education sessions to introduce changes based on the new regulations.  Similar to sessions offered earlier this year, a presentation being offered Nov. 21, noon, will provide an overview of the changes that most directly affect research investigators.  Additional sessions, including topic-specific workshops, will be offered.

October 23, 2017

General Announcement: E-IRB News & Updates [PDF]

The E-IRB Pilot Phase has been expanded to include mandatory participation for Initial Full and Initial Expedited reviews for the College of Dentistry and the Markey Cancer Center. Participation in the Pilot phase for importing existing applications begins November 1 for the units who started piloting in June 2017 (Departments of Surgery, Neurology and College of Communications). Of course, anyone interested in participating in the pilot on a volunteer basis is welcome!  Users willing to train in and test the system are instrumental in the program’s progress.

August 11, 2017

IRB Review Newsletter [PDF]

  • New FDA Guidance on Waiving Informed Consent Requirements
  • Sample IRB Application & Protocol Development Resources
  • Data Management: Balancing Confidentiality & Reproducibility
  • E-IRB Progress
  • Education Events Announcements 

July 13, 2017

General Announcement: Recruiting Community IRB Members - Past Research Participants may be a Perfect Fit

In order to convene a meeting, the Institutional Review Board (IRB) must have a non-scientist and an unaffiliated member present.  Referred to as a “Community Member”, individuals who meet both of these qualifications represent the lay public and reflect the perspective of the community.   Past study participants are excellent candidates to serve in this role.  Their insight and experience from the participant point-of-view contribute to the IRB review process.

Research personnel can help us spread the word regarding this volunteer opportunity by displaying or sharing an informational brochure with research participants or others interested in learning more. To obtain copies of the brochure, contact Belinda Smith at Belinda.smith@uky.edu.

May 23, 2017

IRB Review Newsletter [PDF]

  • E-IRB Submission Pilot Progress: EXEMPTION SUBMISSIONS GOING LIVE June 21, 2017!
  • FDA & NIH Release Final Electronic Template for Clinical Trial Protocols
  • Registration open for OHRP 2-day Research Community Forum (9/6 - 9/7/17, Northern KY Convention Center)

April 17, 2017

IRB Review Newsletter [PDF]

  • Updates to Human Subject Research Courses on CITI
  • E-IRB Pilot Phase
  • Future Education Events

March 16, 2017

IRB Review Newsletter [PDF]

  • HHS issues a New Common Rule, but is it here to stay? 

January 11, 2017

IRB Review Newsletter [PDF]

  • New National Research Participant Website
  • Pre-screening Potential Subjects Using REDCap
  • Human Subject Protection Update: What the Future Holds
  • Increase in One-Time Fee to Industry-Sponsors of Clinical Trials