MCW Defined Public Data Sets
Per 45 CFR 46.101, research using certain publicly available data sets does not involve “human subjects�. The data contained within these specific data sets are neither identifiable nor private and thus do not meet the federal definition of “human subject� as defined in 45 CFR 46.102. Therefore these research projects do not need to be reviewed and approved by the Institutional Review Board, (IRB). MCW HRPP office has worked with a number of investigators to identify and classify numerous data sets as "publicly available data sets" or "restricted use data sets".