investigator A has biological specimens that are coded and linked to identifiers of the source individuals. Investigator A provides the specimens to Investigator B but does not provide the individual identifiers. Investigator B agrees not to re-identify the source individuals. Is Investigator B’s research using the biospecimens human subjects research according to the definition of human subjects research in the federal regulations?
Answer: No, because investigator B cannot readily be sure about the identity of the source individual and investigator B has agreed not to try re-identification.
