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Does my project involve human subjects?

Question: 
Does my project involve human subjects?
Answer: 

Federal regulations define a human subject as a "living individual about whom an investigator (whether professional or student) conducting research: (i) obtains information or biospecimens through intervention or interaction with an individual, and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens." ~ 45 CFR 46.102

  • Data includes information or specimens collected from living subjects
  • About whom indicates that the data must be personal information about an individual
  • Intervention includes physical procedures, manipulations of the subject, or manipulations of a subject's environment for research purposes (e.g., taking saliva or blood samples, havin a subject view a video)
  • Interaction refers to communication (e.g., face-to-face, internet, mail, phone, etc.) between the investigator and the subject 
  • Identifiable means that the subject's identity is or may be readily ascertained by the investigator or others, or is associated with the information or biospecimen.
  • Private information includes information about behavior that occurs in a context in which the subject can reasonably expect that no observation or recording is taking place; or, information provided for specific purposes by the subject in which the subject can reasonably expect will not be made public (e.g., medical records, academic records, personal journals). 

NOT human subjects research:

  • Research using data from the 1880 Census because the data isn't from living individuals
  • Survey that collects data about an organization's activities because the data isn't about individuals
  • Research using de-identified data sets because the data are not individually identifiable