Research Involving Existing Data Sets

The SBS IRB recognizes that some research involving existing data sets and archives may not meet the definition of "human subjects" research requiring IRB review; some secondary data analysis may be exempt from the HHS regulations at 45 CFR 46; and some secondary data analysis may require IRB review. An IRB review may not be required for a research study that relies exclusively on secondary use of anonymous information, provided that the process of data linkage or recording or dissemination of results does not generate identifiable information. For more information and guidance on IRB review policies and procedures for research that involves only the analysis of existing data sets and archives, see the IRB's guidance document at /page/sbs-irb-policy-manual-and-guidance-documents.