Using Specimens/Information from Decedents: The Common Rule and FDA Regulations
The Common Rule (45 CFR 46.102(f)) defines a human subject as "a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information".
Version Date: November 19, 2012
The FDA does not explicitly state that regulations apply only to âliving individualsâ. The regulations, however, imply that the subject is alive. FDA regulations (21 CFR 56.102(e)) define a "human subject" as âan individual who is or becomes a participant in research, either as a recipient of a test article or as a control.â That section goes on to state that a subject may be âeither a healthy individual or a patientâ. And, at 21 CFR 812.3(p), âsubjectâ means âa 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.â
Additionally, the Public Responsibility in Medicine and Research (PRIM&R) Working Group on Human Tissue/Specimen Banking stated in its March 2007 report that:
âSpecimens or associated data that are obtained from deceased individuals (e.g., autopsy materials) are not covered by the Common Rule or FDA regulations, but other federal regulations and state and local laws may apply.â
The HS IRBs Office, with the assistance of UW Administrative Legal Services, has therefore determined that Common Rule and FDA Regulations do NOT apply to studies which ONLY use specimens from deceased individuals.