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.
Guidance
- "When do activities involving human subjects need Institutional Review Board (IRB) review and approval?" [PDF]
- University of Kentucky (UK) Research vs. Quality Assurance/Improvement (QA/QI) Guidance [PDF]
- UK Step-by-Step diagram (guidance on whether IRB review is needed OR whether a protocol can be exempt or expedited review [PDF]
- "What needs IRB review?" [Fast-Pass Video Training on YouTube]
- UK ORI Interactive FDA Flow Chart: Medical Device Trials [HTML]
- UK ORI Interactive FDA Flow Chart: Drugs/Biologics Trials [HTML]
- Guide for Determining When Protocols Involving Coded Private Information or Biological Specimens Meet the Federal Definition of "Human Research" [PDF]
- OHRP Human Subject Regulations Decision Charts
- NIH Decision Chart for Research Involving Private Information or Biological Specimens [PDF]
Definitions
- 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 (DHHS): “A living individual about whom an investigator (whether professional or student) conducting research: Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or Obtains uses studies, analyzes, or generates identifiable private information or identifiable biospecimens.” [45 CFR 46.102(e)]
- 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.
- Research (DHHS): “A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities”. [45 CFR 46.102(l)]
- 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].