Does the activity involve human subjects or their bodily materials?
The IRB Office will review the involvement of human subjects in the research activity to ensure that they are “living individuals about whom the investigator obtains (1) data through intervention or interaction with the individual or (2) identifiable private information.” Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the ide
Related Questions
- Activities must meet the definition of research and involve human subjects as defined in DHHS regulations, or be research and involve human subjects as defined in FDA regulations to be subject to the IRBs jurisdiction. How do I know if my project meets the definition of human research?
- Does the required education apply to research that does not involve human subjects?
- Does the activity involve human subjects or their bodily materials?
