Question

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?
A. No, because Investigator B’s research does not involve interaction with humans. Yes, because Investigator A retains the identifiers and therefore the specimens are identifiable.
B. No, because Investigator B cannot readily ascertain the identity of the specimen sources. Yes, because the specimens are from human subjects.
C. No, because Investigator B cannot readily ascertain the identity of the source individual and Investigator B has agreed not to attempt re-identification.

Answer 1

Answer:

The correct answer is option C.

Explanation:

Human subject research is an investigation or research that include human as the subject. In other words, An Investigator conducts clinical research on humans getting data through interaction and intervention of individuals.

investigator A has investigated biological specimens. These specimens are coded and linked to the identifiers. Investigator B's research using biospecimens human subject is not according to the human subject research in the federal regulations as investigator B did not get the individual identifiers.

Thus, the correct answer is option C.