If Investigator B does not have identifiers but uses coded biospecimens provided by Investigator A, is this human subjects research?

In the context of human subjects research, the distinction between identifiable and non-identifiable data plays a crucial role. When Investigator B uses coded biospecimens without identifiers, it indicates that the samples have been de-identified to some degree—meaning that they cannot be directly linked back to the individuals from whom they were derived without additional information.

The agreement by Investigator B not to attempt re-identification is an important factor because it demonstrates an understanding of the ethical considerations involved in handling human specimens. This agreement suggests that Investigator B is committed to protecting participant privacy and confidentiality, thereby aligning with the ethical principles that govern research involving human subjects.

Although the specimens are originally sourced from human subjects, the absence of identifiers and the commitment against re-identification effectively mitigate the risks related to participant privacy. Therefore, this situation does not constitute human subjects research as per regulatory definitions, which typically emphasize the direct involvement and identification of individuals.

In contrast, other options fail to capture the nuanced understanding of human subjects research and the implications of using coded versus identifiable data. The focus on codes and efforts to maintain anonymity is what distinguishes this scenario from traditional definitions of human subjects research.