Do You Know Me?: The Subtle Distinction Between "Anonymous" And "De-Identified" Data In Clinical Research

By R. Bert Wilkins, JD, MHA, CIP, IRB Chair, WCG IR

There is a subtle, but important distinction between research using anonymous datasets/biological samples and de-identified datasets/biological samples, in that it can change whether the research is considered research involving human subjects (and therefore subject to regulations governing human subject research). For sponsors and clinical researchers, it is important to understand these terms and which status applies to data being collected or data that will be used in research, to ensure that the research is in compliance with the necessary regulations.