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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[Note some links in these archived pages could be outdated.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
August 
September
October 
November
December

 

December

 

November

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October

 

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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