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[Note some links in these archived pages could be outdated.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? (2018)

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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April

4/17/18: General Announcement: Streamlining E-IRB Application Process [Details: PDF]

Anticipated by mid-May, 2018:

Study personnel who have been delegated edit authorization of the E-IRB application will be permitted to:
  • send the E-IRB application to other assurance statement signees like the Department Authorization (e.g., Dept. Chair or equivalent), Faculty Advisor, “Review by Other”, and,
  • send the E-IRB IR, MR, or CR application to ORI for processing.

An addition to the PI’s Assurance Statement indicating the PI attests to his/her awareness of and full responsibility for the accuracy of all materials submitted to the IRB for review. The PI will still be required to log-in to E-IRB and verify his/her identity with Link Blue ID and password in order to complete the PI Assurance Statement task.

 

4/3/18: IRB Review Newsletter [PDF]

  • NIH Certificate of Confidentiality (CoC) Policy Change
  • E-IRB: Tips for Choosing the Correct Study Personnel

March

3/5/18: IRB Review Newsletter [PDF]

  • Delayed Effective Date for Revised "Common Rule" Regulation
    • Informed Consent Changes based on New Common Rule
  • Human Research Update at the 2/27/18 Clinical Research Update Series
  • E-IRB Update & Details on Mandatory Use
  • Informed Consent Workshop Announcement

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February

 

 

January

1/5/18: General Announcement: E-IRB Transition [Details: PDF]

We are just two weeks away from the proposed effective date of January 19, 2018, for the revised common rule regulations!

Effective January 22, 2018, new Expedited and Full Review Applications must be submitted via the new web‐based application system, "E‐IRB". In addition, all full and expedited IRB studies previously approved external to E‐IRB will need to be imported and completed in E‐IRB at Continuation Review time. For details, see the pertinent FAQ on the E‐IRB Info web page.

Note that the E-IRB application available on January 19th may reflect the changes required by the common rule. All E-IRB applications in draft and not submitted to ORI/IRB by January 19th 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 certain sections of the draft application, and if applicable, provide supplemental information before submission. E-IRB applications submitted to ORI/IRB before January 19th will not contain the updates; subsequent modification request or continuation review will trigger the application update.

1/2/18: General Announcement: Frequently Asked Questions on New UK Informed Consent Form Template [PDF]

 

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