Is Investigator B's research using the biospecimens considered human subjects research if the identifiers are retained by Investigator A?

The situation described revolves around the definitions and criteria for determining whether research involves human subjects, particularly in the context of biospecimens. For research to qualify as human subjects research under federal regulations, it generally involves a living individual from whom data is obtained through intervention or interaction, or identifiable private information is directly obtained.

In this scenario, even though Investigator A retains the identifiers linked to the biospecimens, Investigator B does not have access to this identifying information and has agreed not to attempt any means of re-identifying the individuals from whom the specimens were taken. This lack of access to identifiers means that, while the specimens are originally derived from human subjects, the research being conducted by Investigator B does not involve identifiable individuals at that stage.

As a result, Investigator B is not engaging in human subjects research because they cannot "readily ascertain the identity of the source individual." Therefore, the research is not subject to the same regulatory constraints as studies involving identifiable human subjects, aligned with the understanding that protections for human subjects center around the ability to identify and interact with individuals directly.

This reasoning clarifies why the correct response highlights the inability of Investigator B to identify the sources of the specimens, which is crucial for the designation of research as involving human subjects.