April 2023 IRB Review Newsletter

April 2023

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The IRB Review

A compilation of information, announcements, & updates for UK Institutional Review Board (IRB) members, research investigators, & others involved with human subject research.

New Consent

KEY INFORMATION

Samples

Key Information on a consent form should be written in plain language to help individuals recognize the reasons they may choose to or choose not to participate in a research study.

Key Information that is easy to read and visually appealing is even more critical when the detailed consent that follows is exorbitantly long. Check out ORI's new and innovative Key Information Samples using lay language and graphics.

Check Out New Key Information Samples

IRB Protocol Options If Leaving UK

If a Principal Investigator relocates to another institution, can they continue to serve as

PI on a UK IRB protocol?

While remaining as a PI after leaving is not an option, a PI may close the protocol(s) to resume research at the new institution, or submit a modification request to transfer the protocol(s) to another PI who will then take responsibility for the research.

If the original PI wishes to continue to collaborate as study personnel, they should contact UK IRB Reliance (IRBReliance@uky.edu) to determine what agreements may need to be put in place, prior to submitting an IRB modification request.

Read UK Policy on Transferring Data

WEBINAR

Applying the FDA Framework in

Conducting IRB Review

Monday, May 15th 1:00 pm - 2:15 pm

Ada Sue Selwitz, MA

Executive Integrity/Compliance Advisor Office of the Vice President for Research & Associate Director, Regulatory Support & Research Ethics,

Center for Clinical and Translational Sciences

Belinda M. Smith, MS, RD, CCRC

Office of Research Integrity, Research Education Specialist

Objectives:

Examine when an activity falls under FDA regulations
Outline a step-by-step framework for applying FDA regulations in clinical investigations

Zoom Link

Test Your IRB Knowledge:

Is inclusion of an IRB approval stamp a regulatory requirement for informed consent?

Text Link

***Keep Reading for the Answer***

Upcoming ORI Office Hours

Thursday, May 11th 1-:00pm - 2:00pm

https://uky.zoom.us/j/87360486187

Click Here for All Office Hours Dates/Times

The Office of Research Integrity offers consultations by phone, Zoom, or in-person. Consultations are offered for studies in development (with or without an E-IRB submission) as well as approved research projects.

Click Here to Request a Consult

Answer to the Trivia Question:

No. Federal IRB regulations do not require a consent form to include an approval stamp. For documentation purposes, the UK IRB stamps the approval date on consent documents. However, many electronic systems do not accommodate approval stamps. The UK IRB standard operating procedure instructs investigators to enroll subjects using informed consent/assent forms which have a valid “IRB approval” stamp unless circumstances do not permit use of a version containing an IRB stamp (e.g., use of an electronic system).