The IRB review requirements for research involving decedents varies depending on whether the study involves ONLY decedents or decedents and living individuals.

The Common Rule (45 CFR 46.102(e)(1)) defines a human subject as “a living individual about whom an investigator (whether profession or student) conducting research (1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) obtains, uses, analyzes, or generates identifiable private information or identifiable biospecimens.”

The FDA does not explicitly state that regulations apply only to “living individuals.” The regulations, however, imply that the subject is alive. FDA regulations (21 CFR 56.102(e)) define a “human subject” as “an individual who is or becomes a participant in research, either as a recipient of a test article or as a control.” That section goes on to state that a subject may be “either a healthy individual or a patient.” And, at 21 CFR 812.3(p), “subject” means “a human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A subject may be in normal health or may have a medical condition or disease.”

Based on the above, the IRB Office has determined that Common Rule and FDA Regulations do NOT apply to studies ONLY using information or biospecimens from deceased individuals. In these cases, researchers do not need to submit an IRB application for review of decedent ONLY research.

Researchers who are conducting a study that includes both deceased AND living individuals, however, may need IRB review and oversight and should consult the IRB Office for guidance. In addition, although research on decedent only research is outside of the IRB’s purview, other regulations (e.g., HIPAA Privacy Rule) and institutional requirements (e.g., MTAs), may still apply. Researchers should ensure they are in compliance with other applicable regulations and institutional policies when conducting decedent research.