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Click the year 2018 for current highlights:

For archived highlights, click on the year of your choice below:

[Note some links in these archived pages could be outdated. To ensure you have access to the most recent resource, visit ORI's current web pages.]

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What's New? (2017)

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 in the year 2017. Note that due to the nature of web page evolution, some links may be broken. For the most current document links, search for the name of the document using the following search tool:

In order to receive electronic issues of the IRB Review Newsletter, or to receive a hard copy of past issues, contact the Office of Research Integrity at 859-323-2446 or e-mail Belinda.Smith@uky.edu and provide your name, e-mail address, department, campus address and phone number.

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February
June
September

 

December

12/22/17: General Announcement: FAQs on New UK Informed Consent Template

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.

12/15/17: 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.

12/13/17: General Announcement: E-IRB Update Reminder [PDF]

12/1/17: 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

11/21/17: 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

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October

10/23/17: 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.

 

10/31/17: 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, [Details], will provide an overview of the changes that most directly affect research investigators.  Additional sessions, including topic-specific workshops, will be offered.

September

 

August

8/11/17: 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

7/13/17: 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.

 

June

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May

5/23/17: 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)

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April

4/17/17: IRB Review Newsletter [PDF]

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

March

3/16/17: IRB Review Newsletter [PDF]

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

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February

 

 

January

1/11/17: 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

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