F02 - Approaches to Ethical Oversight of Research Involving Recently Deceased

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You might think, “Dead people aren’t human subjects,” and you’d be correct—HHS regulations define a human subject as a “living individual,” and FDA regulations similarly focus on “healthy humans or patients,” excluding decedents. Consequently, research involving deceased individuals is not governed by the same regulations as human subjects research. However, advances in technology, especially around brain death and life support, blur the lines between biological, legal, and social definitions of death, creating complex ethical and regulatory challenges. The absence of uniform oversight does not grant researchers unrestricted freedom, nor does it diminish the relevance of ethical principles like respect for persons, beneficence, and justice. This session will explore research involving recently deceased individuals—such as xenotransplantation—and share best practices from institutions committed to maintaining high ethical standards in this uniquely challenging area.