In a study involving tissue samples from cadavers, if personal information about the deceased is used, is it considered human subjects research?

In the context of research involving tissue samples from cadavers, it is generally considered that such research does not involve human subjects if the individuals involved are deceased and no personal information can be tied back to living individuals. This is because the definition of human subjects research typically focuses on living individuals whose data can inform about their health, personal circumstances, or behaviors.

When personal information about the deceased is utilized but cannot be linked back to living individuals, the research may not meet the federal definition of human subjects research. In such cases, since the research does not involve living persons, it is not subject to the same ethical considerations that apply to studies involving human subjects, such as the need for consent or institutional review board (IRB) approval related to the protection of human participants.

However, it is imperative that researchers ensure thorough understanding of any applicable regulations or institutional policies concerning the use of deceased individuals' data and tissue samples, as well as privacy laws that may still apply.