Existing Data, Documents, or Records

Basic Exempt Criteria 45 CFR 46.101(b)(4)

Research is most commonly conducted on data derived from patients' medical records, but other research or clinical records may also be accessed under this exemption. Although investigators can review those records (if they have a legitimate right to access those records), they cannot record any private identifiable information from these records. An Honest Broker can be used, however.

  • All data are currently in existence
  • All information is publically available, OR 
  • All information is recorded anonymously, OR
  • Data are recorded in such a way that researchers cannot identify subjects. Two acceptable strategies for this de-identification exist:
    • Identifiable data are de-identified by an appropriate software program
      OR
    • The de-identification of data is carried out by a person who is independent of the research (i.e., an independent "honest broker") and who has been identified by name in the protocol, and has completed the "honest broker" certification form. Information linking the assigned code numbers to the subjects’ identity (if applicable) is maintained solely by the independent “honest broker”

Additional Requirements or Considerations

  • A copy of the data extraction form or a list of variables to-be-studied must be submitted with the IRB application                 
  • Investigator’s right to access records (including medical records) must be documented in protocol  

Exempt Form: Existing Data, Documents, or Records