When does the study of medical records that contain patient identifiers qualify for exempt status?
The federal regulations set two conditions for assigning exempt status for this sort of study. First, all the records must be in existence prior to initiation of the study. The application for exempt status should specify the inclusive dates of the records to be reviewed under the description of the subject population. Second, the investigator must record the data from the medical record in a manner that subjects cannot be directly or indirectly identified. In satisfying this condition, it is permissible retain linkage between individual medical records and entries on a data collection sheet, provided that this linkage is destroyed once the data abstraction is complete. The intention to follow this procedure should be clearly stated in the section of the exempt application on study procedures.
