What are the requirements for Exemption 4 (E4)?
HHS regulations state: “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.” 46.101(b)(2) If you receive or have access to existing individually identifiable private information or identifiable specimens from living individuals (e.g., pathology or medical records), you are conducting human subjects research. If you as the investigator or your collaborator record the information in such a manner that you cannot subsequently access or obtain direct or indirect identifiers that are linked to the subjects, research activities that involve data recorded in this manner meets the requirements of Exemption 4. If you will retain or can access any identifiers, the research project is not exempt under Exemption 4.
