Designing Research Studies
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.