pre-2018 Federal Exemption 4 applies only to existing data and/or specimens. “Existing” means existing before the research is proposed … to the IRB to determine whether the research is exempt. An application for Exemption 4 must include an explicit “end date” for data/specimens collection before the date of submission of the application.
Analysis of existing, publicly available, identifiable data (like a phone book) is eligible for Exemption 4. “Publicly available” is defined as information shared without conditions on use. Datasets requiring a Data Use Agreement (DUA or DSA) are not “publicly available.” A “publicly available” dataset may still require payment of a fee to gain access.
pre-2018 Exemption 4 applies to non-public data sources such as medical records only if both of the following are true:
- all data already exists at time of IRB application, and
- study team may view but will not record any direct or indirect identifiers.
Data recorded from non-public sources must be de-identified during data collection by the study team, such that no one could “re-identify” based on the research dataset: not the researchers, nor the data provider, nor anyone else. A code permitting re-identification is not permitted. Research utilizing multiple datasets is not eligible for Exemption 4, since at least some identifiers must be maintained temporarily to collate the data.
NOTE: a dataset de-identified under HIPAA definition, but retaining a code permitting re-identification, is not eligible for pre-2018 Federal Exemption 4. If criteria per OHRP Guidance on … Coded Private Information are met, such research may be eligible for “Not Regulated” determination. If criteria for a Flexibililty Initiative are met, such research may be eligible for "HIPAA Exemption."
U-M Flexibility Initiative Exemption extends the applicability of Exemption 4 to analysis of
- data and/or specimens that may also be generated prospectively, and
- identifiable data regulated under HIPAA ("HIPAA Exemption").
See also U-MIC presentation "Exemption Changes under the Revised Common Rule."