Office of Research Integrity (ORI)

May 29, 2020 (Update 10 - 5:00 pm)

The Vice President for Research (VPR) has released UK’s Resumption of Research Phased Plan. Please read the VPR’s plan, which outlines specific institutional resumption requirements and instructions (click here for a PDF version).

ORI has developed Human Subjects Research FAQs for applying the plan and safeguards in human subject research including a Human Subjects Research Phases Table with examples of the type of study appropriate to resume with each phase.

April 27, 2020 

As previously announced, all human research activities remain paused except for the following:

• Research with direct participant benefit

• Research where stopping intervention would cause harm

• COVID-19 research

• Studies with no in-person contact

The current pause will remain in place until further notice. Please see the COVID-19 Research FAQs for important frequently asked research questions related to human research.

April 16, 2020 (Update 9 - 8:10 am)

***Effective April 16, 2020: If your research involves investigating any aspect of COVID-19, please enter “COVID-19” at the start of your Project Title in your IRB protocol application.***

Please add COVID-19 to “Title of Project” and “Short Title Description” of your current IRB protocol.

For protocols being reviewed by an external IRB, please enter “RELIANCE COVID-19” before the PROJECT and SHORT titles.

April 7, 2020 (Update 8 - 1:30 pm)

Remote informed consent may be proposed for new COVID-19 research or implemented for an existing protocol in response to the pandemic. See ORI guidance for best practice in obtaining remote informed consent.

April 7, 2020 (Update 7 - 11:45 am)

IRB meetings

Due to current COVID-19 concerns, IRB meetings are being conducted electronically through Zoom. Investigators will receive an invite containing a Zoom link prior to the meeting. Investigators should inform ORI staff if they have other study personnel to whom they need a meeting invitation sent.

Investigators should not forward the meeting link to their study personnel. It’s important for ORI staff to know everyone who will be attending so they are aware of who is and is not supposed to be admitted into the virtual meeting during each scheduled appointment time.

In addition, the number of attendees for each protocol needs to be limited in order to keep attendance tracking manageable for documentation purposes, so we ask that investigators have no more than two (2) individuals from the list of study personnel join them for the meeting.

April 7, 2020 (Update 6 - 10:30 am)

Notice regarding ORI Quality Assurance Wellness Checks

The ORI Quality Improvement/Quality Assurance (QA/QI) Program is not scheduling or conducting any visits at this time due to COVID-19 concerns. We will resume our visits once the university returns to regular business function and the conduct of in-person events.

Investigators who had Wellness Check visits scheduled for late March and all of April 2020 have been contacted and informed their visit will be delayed until after the current COVID-19 restrictions have been lifted and staff/students return to campus. We will work with investigators to reschedule their visit as soon as possible.

Please contact Pam Stafford (pastaf3@uky.edu) or Kasandra Lambert (kasandra.lambert@uky.edu) if you have questions or concerns.

March 26, 2020 (Update 5 – 2:00 pm)

The Clinical Research COVID-19 FAQ webpage is now COVID-19 Research FAQs and includes FAQs regarding all human research studies.

Please refer to the COVID-19 Research FAQs for added or updated questions/answers. The new FAQs have the date that they were added and an alert icon next to them.

The ORI homepage and ORI COVID-19 Alerts page will post new announcements related to the conduct of human studies as they are made available.  

Revised Common Rule Cooperative Research Provision Compliance Date is January 20, 2020

As of January 20, 2020, According to the Revised Common Rule’s Cooperative Research Provision (45 CFR 46.114), all institutions located in the United States that are engaged in cooperative research conducted or supported by a Common Rule department or agency must rely upon approval by a Single IRB for the portion of the research conducted in the United States. For further information, click here.

Need help with a research or IRB related topic? Find answers and A-Z guidance in the IRB Survival Handbook.

ORI supports the institution in promoting ethical conduct of human research and educating University of Kentucky (UK) faculty, staff, and students regarding human research compliance and research ethics.  

ORI provides research support services including IRB review, policy development, web-based IRB submission (E-IRB), HIPAA/FERPA research reviews, protocol review management, ethical and regulatory education, quality improvement review, reliance agreement management, and research misconduct prevention and allegation management. ORI provides support for six federally mandated review committees: four Medical and one Nonmedical Institutional Review Boards (IRB), and the Radioactive Drug Research Committee (RDRC).  

The UK Human Research Program is fully accredited by the Association for the Accreditation of Human Research Protection Program (AAHRPP). 

UK Human Research Protection Program (HRPP) Comprehensive Plan (PDF, 22 pgs)

In December 2018, the University of Kentucky Office of Research Integrity (ORI) won an Award of Excellence for Best Practice in Human Research Protection for the “Informed Consent Workshop: From Perception to Process.” The four-hour, hands-on workshop assists researchers in adopting new informed consent rules. Read more…