Many private organizations and public agencies make individual level data available to the public. Such files fall outside the federal regulations for the protection of human participants, once they have been classified as public use data files. Not all publicly available data, however, has been classified as public use.
To classify files as public use, producers and suppliers of such files are responsible for having the data reviewed by the appropriate IRB before making them available to the public. Information to this effect should be indicated on the documentation supplied with the file.
PIs do not need to obtain IRB approval to use public use data files nor do they need to seek IRB review of the exemption status of the data. Where applicable, such information has already been reviewed for the protection of human participants and the files produced have been certified not to violate confidentiality.
If University PI plans to obtain individually identifiable data (from the sponsor of the public use data file or any other source) and merge with the public use data file, the University investigator must seek IRB approval.
If the public use status cannot be ascertained from the documentation supplied with the file, the University PI must contact the supplier to ascertain the public use status of the data. If this status cannot be ascertained and provided to the PI in writing or if the data are not classifiable as “public use,” then the University PI must submit an application for IRB review. For example, this situation may occur when an investigator receives permission from a PI at another University to use data produced from a research project that is ongoing.
In addition to data files, any published hard copy or electronic documents (including web pages) available to the public that contain individual data (whether identifiable or not identifiable) fall outside federal regulations for the protection of human participants. PIs do not need to obtain IRB approval to use such information nor do they need to seek IRB review of the exemption status of the data.