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Institutional Review Board
147 Sycamore Street
Pikeville, Kentucky 41501
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 Pikeville IRB.
Research: “A systematic investigation designed to develop or contribute to generalizable knowledge.” [45 CFR 46.102(d)]
Human Subjects (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: “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 Subjects (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 Subjects (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.
In cases in which any other federal agency apply, institutional oversight of the activity follows the definitions for “research” and “human subjects” as defined by the relevant agency as appropriate. 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]
Activities that do not require IRB Approval: Examples of activities that do not require UPIKE IRB review are listed on the following chart. If you are in doubt whether or not the planned activity requires IRB approval, please contact the IRB administrator: Rita Thacker (email@example.com).
Examples of What Does Not Require IRB Review and Approval Prior to Initiation of Research.
Adapted from the University of Michigan Vice President for Research Operations manual (http://www.hrpp.umich.edu/om/Part4.html).