This 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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
45 CFR 46.102 (f) 45 CFR 46.102 (f)
Reference: humansubjects.nih.gov/from-applicantsSource: NFU - D4LS versie 0.8 van 26-10-2016 0.1 5/23/17
Alternatieven en discussie hieronder: