The IRB’s new submission form asks about the protected health information, or PHI, that is going to be accessed or collected as part of the research. PHI is information that identifies the individual and that relates to past, present, or future physical or mental health; provision of health care services; or payment for the provision of health care services. The IRB has noticed that in response to the new submission form query, “Describe the PHI that will be obtained/recorded for the research,” study teams occasionally write responses such as “Name, address, phone number, etc.” These items are identifiers, and there is a separate query in the HIPAA section that asks for identifiers. Health information — typically collected either from the medical record or directly from the study participant — is the better answer for the question about PHI.
So, on the new submission form, please provide details about the health information your project involves.
And then indicate what identifiers you’ll be collecting.