What does not require IRB review?
•Preparatory to Research
–defined as any action taken, where access to PHI is required, for assessing the research question/hypothesis such as accessing medical records or querying of databases to prepare a research protocol.
•The use or disclosure of the PHI is sought solely for the purpose of preparing a research protocol. 
•The PHI will not be removed from the covered entity. 
•This PHI is necessary for the purpose of a research study.