When biobanks receive de-identified data and samples that were collected for purposes other than the biobank’s research, the biobank may not be conducting human subjects research under the Common Rule.13–15 Whether the Common Rule applies affects the responsibilities of the biobank, including responsibilities for managing IFs and IRRs (see Part II., section D. below). The Common Rule specifies that research on human subjects is research using information that is “individually identifiable (i.e., the identity of the subject is or may be readily ascertained by the investigator or associated with the information).”11(§46.102 (f)) Excluded is research on data and samples when “subjects cannot be identified, directly or through identifiers linked to the subjects.”11(§46.101 (b)(4))
