The CLARA new submission form asks investigators about the source of any protected health information (PHI) they may be using for the research. One query asks whether any PHI will be collected directly from subjects, and another asks whether you will access PHI from medical records. Please note that if you are doing a chart review study that involves no subject interaction, you will NOT be collecting PHI directly from subjects. For some reason, we’ve noticed PIs responding “yes” to the query asking whether PHI will be obtained directly from subjects, even though their submission makes it clear all information will come only from medical records.
Before submitting a new submission form, please double-check to make sure that these HIPAA-related questions are answered correctly. You may avoid a prereview contingency that way.