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.