August 2019
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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.
Single IRB Review in 2020 -
Ceded Protocols Reviewed by External IRBs
After January 20, 2020, any federally-funded research involving two or more sites may use single IRB review. Ceded protocols are those in which an external IRB is providing regulatory and ethical review and oversight of research involving human subjects. 

As the number of ceded protocols increases, tracking will be crucial to ensure UK investigators address local human research protection program (HRPP) requirements in addition to and separate from IRB Review.
The ORI Reliance Team has completed more than 100 new reliance agreements since January 2019.
Tracking Ceded Protocols

Reliance Registration/Request Form:
Currently UK investigators submit the Reliance Registration/Request Form to irbreliance@uky.edu for any protocol ceded to an external IRB.

E-IRB Abbreviated Applications (AA) for Ceded Review (Coming Soon):
Investigators will receive notification to submit an “Abbreviated Application (AA)” for their ceded research project in E-IRB. The application will provide prompts and links to requirements or processes handled locally, not by the external IRB. There are many local ancillary processes independent from IRB review (e.g., conflict of interest, HIPAA, Investigational Drug Service, Institutional Biosafety Review). The AA will help investigators identify and keep up with these local requirements. 
Single IRB/Reliance Reminders

If your research involves collaboration with any sites and/or personnel outside the University of Kentucky, it is considered multi-site research and IRB reliance issues will need to be addressed.

Single IRB may apply to national multi-center trials as well as local studies involving sites/personnel external to UK.

If you would like to request that the UK IRB cede review to another IRB, please complete the IRB Reliance Request/Registration Form and submit to irbreliance@uky.edu .
Reliance Contacts
Jessica Roe Williams 
859-218-1501

Joe Brown 
859-257-9084

Unable to attend Office Hours or want
one-on-one assistance from ORI staff?  
Request a Consult
This new service allows investigators, research staff, and/or students easily set up a meeting with appropriate ORI staff. We are available to meet in our office, on campus, or by phone.

Consultations are offered for studies in development as well as approved research projects.
(859-257-2910) with questions.
Additional Office Hours Have Been Added

Investigators, research staff, and/or students are encouraged to drop in with questions about ongoing research, developing research projects, the E-IRB system, and general IRB operations. A variety of staff from the ORI will be available to answer questions and provide in-person support. Both medical and non-medical researchers are welcome to attend.  

Next ORI Office Hours

August 21, 2019
12 pm - 1 pm
Don and Cathy Jacobs Science
Building (JSB), Room 347

September 9, 2019
11 am - 12 pm
CM Gatton College of Business
and Economics, Room 330