May 2021

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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.

EPIC Coming Soon!

On June 5th, 2021 a new medical record system (EPIC) will go into production. From that point forward all HIPAA forms for research will need to include EPIC instead of Sunrise Clinical Manager (SCM), Ambulatory Electronic Health Records (AEHR) or other legacy systems implemented prior to EPIC as a source of Public Health Information (PHI). Existing HIPAA forms for research do NOT need to be modified to include EPIC.

Updated UK Guidance on NIH Certificates of Confidentiality

ORI has updated the guidance document on the National Institutes of Health (NIH) Certificates of Confidentiality (CoC) in response to the new NIH CoC website. Not only has the guidance been updated, so has the title. You can find the "University of Kentucky Certificate of Confidentiality Frequently Asked Questions (FAQs)" in the IRB Survival Handbook under Confidentiality.

Click here to view the PDF

Save the Date for the 22nd Annual* Human Subject Protection Conference Bioethics, Citizen Science, & Human Subject Protection: Waiting on the World to Change September 8-10, 10:30am–1:30pm ET each day via Zoom *Merged for the first time with the biennial Bioethics Symposium This year’s event will address issues of significant importance to human subjects protections and bioethics, including:  Ethics of engaging patients in research Considerations of a research participant and caregiver Citizen science and how it fits with traditional research Regulatory updates including practical guidance on the Common Rule Conducting reviews on emergent health issues/outbreaks Conference brochure and registration coming soon!

Full Save the Date Flyer [PDF]

Calling all Research Faculty Advisors

Please take just a few minutes to check out the ORI video training "Faculty Advisor Responsibilities" including ORI tools to help your students succeed with human subject research.

Faculty Advisor Video

Publicly Available HSP Training Courses for NON-UK Collaborators serving as IRB Study Personnel

UK ORI Non-UK HSP Training This five-module course serves as HSP training for study personnel who are not employed by or enrolled at UK. It does not qualify as HSP training for UK employees or students. The course material presents basic concepts, principles, and issues related to the protection of research participants. Office for Human Research Protections (OHRP) "Human Research Protection Training" The four module training is based on the requirements of the revised Common Rule regulation. This comprehensive training for the research community on human research protections based on the requirements of the revised Common Rule. Both courses offer a printable certificate upon completion. After the investigator adds the Non-UK personnel to the E-IRB system [see video tutorial ], send copies of the completion certificates to HSPTrainingSupport@uky.edu. The individual's training record will be updated accordingly.

Non-English Speaking Participants Facility vs. IRB Policies: Does the IRB require a certified translator or interpreter? The IRB Non-English application instructions and Informed Consent SOP do NOT specify that either document translation or an interpreter involved in the consent process be certified. However, IRB policy does require a cultural consultant review to assess the accuracy of the document translation and the appropriateness of the consent process. If an investigator has offered a certified translation, the IRB may have chosen to accept it in lieu of the required cultural consult. However, this would have been on a protocol-specific basis, since the cultural consultant generally reviews both the translated document and the proposed consent process.   The facility or institution in which you will obtain consent or conduct the research may have additional policies regarding translations or interpreters. Investigators are responsible for being aware of and compliant with all applicable facility-based requirements. The IRB reviews extremely diverse research including international, off-site, and non-medical studies. They determine on a protocol-specific basis what is most appropriate, and certification is not always what addresses and aids the situation. Therefore, the IRB cannot adopt facility-specific policies that apply to a limited portion of the protocols it reviews. For protocol-specific inquires, email IRBSubmission@uky.edu with your IRB protocol number.

Upcoming UK Electronic Research Notebook Webinars

LabArchives® Electronic Research Notebook (ERN): Overview and Demonstration Webinars June 8, 2021 Science, Technology, Engineering and Mathematics (STEM) Disciplines Click here to Register for this event June 9, 2021 Social/Behavioral Disciplines Click here to Register for this event June 16, 2021 LabArchives Widgets and Templates 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

June 17, 2021 11:00 am - 12:00 pm

July 13, 2021 12:30 pm - 1:30 pm

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

Click Here for All Office Hours Dates/Times

Click Here to Request a Consult