Before HIPAA, researchers were often given access to patient records to review
when they were designing research studies. This is necessary to determine
what information is available, what form it is in, and how the study must be
designed to retrieve the information. HIPAA continues this exception to the
right of patients to control access to their medical information for non-
treatment purposes, but with certain limitations. The access is limited to
preparatory research, it cannot be a ruse to do research on the PHI without
satisfying IRB requirements. The information must be necessary for the
preparation. Most importantly, the information cannot be taken from the
covered entity. This includes copies of the information or excepts in the
researcher's notes. The researcher can only review the records but cannot
extract data from them. This exception applies to the HIPAA requirements on
access to records, unless the preparatory research meets one of the
exemptions from the Common Rule, it is still subject to IRB review.