The Social Services Administration/Chapin Hall Institutional Review Board (IRB) of the University of Chicago recently reviewed its policies and procedures for reviewing research involving public use data sets and data archives. Although some research involving public use data sets or archives may be either outside the purview of the IRB (i.e., not involving human subjects) or exempt from the HHS regulations at 45 CFR 46, the IRB often requires submission of the research in order to make such a determination. In an effort to reduce the burden on investigators whose research relies solely on public use data, the IRB has determined that research involving the following public use data sets and archives meet the exemption requirements at 45 CFR 46.101(b)(4) (research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects) and so does not require review and approval by the IRB:
Investigators whose research involves solely the use of one of these data sets/archives do not need to submit a formal proposal to the IRB, since the IRB has already determined that these data sets/archives meet the requirements for exemption at 45 CFR 46.101(b)(4). Research projects that merge more than one data set/archive are not covered by this policy, and require review and approval by the Social Service Administration/Chapin Hall IRB.
However, researchers do need to register their research by submitting the following information to the IRB: (1) researcher's name, title, and department; (2) title of the research study; and (3) name of data set/archive that will be used. This information should be sent to the IRB via email at abg@uchicago.edu.
Note that additional data sets and archives may qualify for inclusion on this list. Researchers who wish to have a specific data set or data archive considered for inclusion on this list must submit the following information to the Social Service Administration/Chapin Hall IRB: