Research involving the collection or study of existing data, documents, or records.
Harm from research on data from records occurs as a result of a breach of confidentiality. Additional protections and regulations governing access to certain types of records, e.g. medical, court and school information, are considered below.
When is a Data Use Agreement required? <link>
Accessing court records <link>
Researchers often request assistance in determining whether their interaction-based research is eligible for exemption or if it will be reviewed under expedited procedures or by the full board. Protocols may be eligible under multiple categories; the most protective standard will be applied.
More on Levels of Review
De-identified data (exempt cat. 4)
More about Research on Data
NOTE: Research involving prisoners may not be exempt. Research to which FDA regulations or policies apply are not eligible for exemption categories 1-5.
Research involving materials (data, documents, records) that have been collected, or will be collected solely for NONRESEARCH purposes (such as medical treatment or diagnosis) (expedited cat. 5)
Collection of data from voice, video, digital, or image recordings made for research purposes (expedited cat. 6)
Research on records/data that do not fit into an exempt or expedited category must be reviewed and approved during a convened full board meeting.