April 2021

‌	Visit Our Website

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

Phase 4 of the University of Kentucky Resumption of Research Phased Plan Message from the Vice President for Research April 2, 2021 Dear Researchers, We are pleased to announce that we are moving forward to Phase 4 of the University of Kentucky Resumption of Research Phased Plan. Phase 4 places us at research activity up to 100% of pre-pandemic levels while continuing to follow CDC and institutional guidelines of 6-ft physical distancing, mask wearing requirements in research workspaces, washing hands and disinfecting workspaces.

Click to read more and view updated COVID-19 FAQs

Please note: Individuals conducting human subjects research must review and comply with the requirements of the VPR’s Resumption of Research Phased Plan before initiating or resuming any research. See the VPR's Phase 2-4 Guidance for developing individualized plans.

Available at no cost on UK CITI Learning Platform With the transition to remote work due to the COVID-19 pandemic, research teams, Institutional Review Boards (IRBs), and others supporting human research have worked to develop alternate workflows for processes that would normally be done face-to-face. This webinar explores the conduct of remote informed consent including components, process options, documentation requirements, and agency-specific regulatory requirements and flexibilities. See instructions for accessing the webinar from the Optional Course menu on CITI.

Click for Webinar Access Instructions

Future Use Tool

The time to consider future use of research data is when you are initially planning the primary research study.

Future Use Tool

This ORI tool allows you to consider plans for keeping, using, and sharing data or material for future use and ensure the consent language is consistent with your plan.

Tools to identify applicable local regulations, laws, and/or ethics requirements for International Research.

The Office for Human Research Protections (OHRP) International website provides resources to ensure that human subjects outside of the United States receive an equal level of protection as research participants inside the United States. Review country-level European General Data Protection Regulation (GDPR) guidance from across Europe as well as a Compilation of laws and regulations from over 100 countries. The National Institutes of Health (NIH) ClinRegs interactive map provides access to an online database of country-specific clinical research regulatory information designed to assist in planning and implementing international clinical research.

Five Reasons Why You Should Close a Protocol Instead of Letting it Expire  Formally closing the protocol is an investigator responsibility. The process signals the date IRB oversight is no longer required. Allowing a protocol to expire is not an acceptable alternative to submitting a closure request. When submitting a closure request, E-IRB asks a series of questions to determine whether the study meets regulatory criteria for closure. FDA, pre-2019 Common Rule, and 2019 Common Rule regulations differ in this regard.  The answers to the closure questions also tell you whether a Final Review is needed. Many studies will be able to close without completing a Final Review.  Closing the protocol allows the audit and records retention timelines to begin. UK IRB policy requires investigators to maintain their research records (signed documents and IRB records) for six years after completion of the study.  IRB closure records have been relied upon by investigators as a source of information for funding organizations, regulatory agencies, and reporting in clinicaltrials.gov.   To submit a closure request for your study, select “Continuation (CR) or Study Closure” on the PI/Researcher Dashboard under CREATE NEW.   See ORI's E-IRB Video Tutorial "How to Create and Manage Study Closures"

Upcoming UK Electronic Research Notebook Webinars

LabArchives® Electronic Research Notebook (ERN): Overview and Demonstration Webinars May 12, 2021 Science, Technology, Engineering and Mathematics (STEM) Disciplines Click here to Register for this event May 13, 2021 Social/Behavioral Disciplines Click here to Register for this event

To schedule an event for your team/department/college/center/ institute, please submit a request and a UK LabArchives team member will contact you promptly. Visit the new website today! Information is added regularly! Subscribe to the LabArchives newsletter for updates.

UK LabArchives ERN Website

Upcoming ORI Office Hours

April 29, 2021 11:00 am - 12:00 pm

May 12, 2021 1:00 pm - 2:00 pm

https://uky.zoom.us/j/242100365

Click Here for All Office Hours Dates/Times

Click Here to Request a Consult