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

Investigator B’s research is not considered human subjects research because the biospecimens are de-identified and the identifiers are not shared, ensuring participant privacy in accordance with federal regulations and IRB guidelines.

Step-by-step explanation:

According to the definition of human subjects research in the federal regulations, Investigator B’s research using the biospecimens would not be classified as human subjects research. This determination is because Investigator B cannot readily ascertain the identity of the source individuals and has agreed not to attempt re-identification of the source individuals. Since the specimens are coded and the identifiers are not shared, the biospecimens are effectively de-identified, which aligns with the ethical and legal standards for protecting research participants' privacy.

Institutional Review Boards (IRBs) play a crucial role in ensuring the ethical conduct of research involving human subjects. These oversight committees review research proposals with these ethical considerations in mind, including the handling of biological specimens and associated data. Compliance with IRB regulations and federal regulations is vital to ensuring that ethical considerations, especially concerning participant privacy, are upheld in research activities.

Answer 2

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.