Because it may be necessary for a researcher to obtain access to and review PHI in order to prepare a research study, HIPAA rules allow such a review upon compliance with specified criteria. An application for review of PHI preparatory to research must be submitted to the IRB for review and approval.
For researchers at UP and all other campuses and colleges, the “Data Collection for Reviews Preparatory to Research” form located on the IRB website should be submitted as a supporting document in the CATS IRB submission. In most cases, investigators conducting chart reviews to prepare a study should use the protocol template HRP-596 – Protocol for Human Subject Research - Chart Review and/or Analysis of Existing Restricted Data Set Study for their submission. The template can be found in the CATS IRB “Library.”
For additional information see Penn State policy RP07 HIPAA and Research at Penn State University.