In keeping with the Common Rule, the Office for Human Research Protections (OHRP) has advised that when researchers use data or samples that were not collected for that research and the source individuals cannot readily be identified by the researchers, this does not meet the regulatory definition of research involving “human subjects” (a term defined by the Common Rule at 45 C.F.R. § 46.102(f) to be a “living individual about whom an investigator…obtains data through intervention or interaction with the individual or identifiable private information”).13 Similarly, OHRP has stated that institutions are not engaged in human subjects research when they receive coded data or samples from another institution engaged in research that retains the code, and the receiving institution cannot readily re-identify the subjects.14 OHRP’s predecessor, the Office for Protection from Research Risks (OPRR), specifically addressed research using stored data or tissue, stating that “human subjects” are not involved when the material “was collected for purposes other than submission to the Repository,” and the “material is submitted to the Repository without any identifiable private data or information.”15 Thus, some biobank
