UK Office of Research Integrity


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Frequently Asked Questions (FAQs)
in Human Research

To jump to questions grouped by topic, click on your choice in the menu below:

"Do I need IRB review?" FAQs Mandatory Training FAQ [new page]
Continuation Review FAQs E-mail Submission FAQ [new page]
Consent FAQs (**including for New UK Consent Form Template!!) New Faculty FAQ [new page]
General FAQs Community-Engaged and Community-Based Participatory Research FAQ [new page]
  Common Acronyms (List) [new page]

"Do I need IRB review?" FAQs
Q.  When do activities involving human subjects need Institutional Review Board (IRB) review? Answer
Q.  How does the University of Kentucky define research? Answer
Q.  How does the University of Kentucky define human subjects? Answer
Q.  Does my master's thesis/doctoral dissertation require IRB review? Answer
Q.  I plan to conduct my research at another institution. Does UK's IRB need to review my research proposal? Answer
Q.  My research involves tissue/specimens. Do I need IRB review? Answer
Q.  Do class projects require IRB review? Answer
Q. Is use of drug, device or biologic with a single patient in an emergency situation within IRB purview? Answer
General FAQs                                                                                           Back to Top
Q.  What is an Institutional Review Board (IRB)? Answer
Q.  UK has a Medical & Nonmedical IRB.  Which IRB will review my research? Answer
Q.  What type of reviews does the IRB conduct? Answer
Q.  What do I include with my IRB submission? Answer
Q.  How do I get on an IRB agenda? Answer
Q.  How long does it take to get a study approved by the IRB? Answer
Q.  I have some questions about my IRB submission. Who can I talk to?  Answer
Q.  Do I need to take/complete a training program/class to conduct research at UK? Answer
Q.  What are my responsibilities as a human subject researcher? Answer
Q.  Do I need to notify the IRB every time I make a change to the study?  Answer
Q.  How do I know if my study is regulated by UK HIPAA requirements? Answer
Q. Does the IRB charge for review of industry sponsored clinical trials? Answer
Q.  How does UK define an enrolled subject?  Answer
Q.  I don't understand UK's Prompt Reporting Policy. Where can I find additional information? Answer
Q.  How long does data collected from a human research project need to be maintained by the PI? Answer
Q. I'm leaving the University; how do I close my study or transfer the study to another investigator? Answer
Q. What is the definition of clinical research vs. a clinical trial? Answer
Q. What if I have a high school student volunteer who is going to serve as study personnel on my project? Answer
Continuation Review FAQs
Q. When should I submit my continuation request? Answer
Q. What if my continuation was not submitted on time and approval has lapsed? Answer
Consent FAQs
Q.  What is a consent form? Answer
Q.  How do I know which version of the IRB approved consent/assent form to use? Answer
Q.  How can I waive consent procedures for my research proposal? Answer
**NEW UK Consent Form Template FAQ's** 1/2/18 PDF
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