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/FH HRPP has worked a number of investigators to identify and classify numerous data sets as "publicly available data sets" or "restricted use data sets". The following list has been determined as "publically available" and if the investigator follows IRB SOP: Public Data Sets, the use of the data set does not require an IRB review and approval.
If a data set is not listed, and an investigator believes it to qualify as "publically available", they should submit the Public Data Set Nomination Checklist. This will allow the HRPP office to make a determination after reviewing the data set, their policies and procedures, and data use agreement templates.