Investigators may access PHI in activities that are "preparatory to research." This type of access is limited to a review of data to assist in formulating a hypothesis, determining the feasibility of conducting the study, or other similar uses that precede the development of an actual protocol.
While an investigator may review PHI during the course of a review preparatory to research, he or she may not remove, copy, or include any PHI in notes. Investigators may not use PHI to identify potential research subjects by name or by any other HIPAA identifier. However, investigators may write down and remove summary data (e.g., number of individuals with a certain disease).
Before accessing PHI for a review preparatory to research, a researcher must provide written assurances to the holder of the PHI that the review of the PHI is necessary to prepare a research protocol and that the PHI will not be removed by the researcher from the entity. No further review or approval is required.
Researchers wishing to conduct activities preparatory to research using Bridgeport Hospital medical records, imaging studies, pathology information, lab information, etc., must do so through helix.ynhh.org