What Needs IRB Review?
Any activity that meets either (a) the Department of Health and Human Services (DHHS) definition of both “research” and “human subjects” or (b) the Food and Drug Administration (FDA) definitions of both “clinical investigation” and “human subjects” requires review and approval by the University of Kentucky (UK) IRB.
For more information see ORI's Frequently Asked Questions (FAQs) for "Do I need IRB review", and/or download one or more of the following:
- "When do activities involving human subjects need Institutional Review Board (IRB) review and approval?" guidance document [PDF];
- IRB/ORI "Determination of Activities That Need IRB Review" SOP [PDF];
- UK Step-by-Step diagram (guidance on whether IRB review is needed OR whether a protocol can be exempt or expedited review) [PDF]
- Guide For Determining When Protocols Involving Coded Private Information or Biological Specimens Meet the Federal Definition of “Human Research” [PDF]
- Not Human Research (NHR) Determination Form [PDF]
For additional guidance, visit OHRP's Human Subject Regulations Decision Charts web page.
Research (DHHS): “A systematic investigation designed to develop or contribute to generalizable knowledge” [45 CFR 46.102(d)]
Human Subject (DHHS): “A living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information” [45 CFR 46.102(f)]
Clinical Investigation (FDA): “Involves use of a test article (i.e., drug, device, food substance or biologic), one or more human subjects, meets requirements for prior submission to FDA, or results are intended to be part of an application for research or marketing permit” [21 CFR 56.102]
Human Subject (FDA): “An individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient.” [21 CFR 56.102(e)] (Drug, Food, Biologic)
Human Subject (FDA for medical devices): “A human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A subject may be in normal health or may have a medical condition or disease.” [21 CFR 812.3(p)] (Medical Devices) NOTE: This definition includes use of tissue specimens even if they are unidentified.
For Department of Defense-supported research, institutional oversight of the activity follows the definitions of “research” and “experimental subject” as defined by Department of Defense regulations [DoD Directive 3216.02].
Faculty, staff or students from UK Medical Center's Clinical Science Departments, College of Allied Health, College of Public Health, Basic Sciences Departments, Communicative Disorders, Nursing, and Pharmacy, should present any research involving use of human subjects to the Medical Institutional Review Board (IRB) for review and approval prior to initiation of the project.
Faculty, staff, or students from the Colleges of Agriculture, Arts & Sciences, Business & Economics, Communications & Information Studies, Design, Education, Engineering, Fine Arts, Law, Social Work or other Lexington Campus department should present any research involving the use of human subjects to the Nonmedical Institutional Review Board (IRB) for review and approval prior to initiation of the project. Please note the Nonmedical IRB does not review studies that involve administration of drugs or studies that involves invasive medical procedures.