As a reminder, when a study collects information on communicable disease status (sensitive information in general), the IRB requests justification for the collection of this information. Regardless of whether the study team is conducting the communicable disease testing, if the study is collecting disease status, this needs to be described in the protocol and possibly in the informed consent document. Certain types of communicable diseases have additional requirements that apply (e.g., HIV). Please refer to the following posted guidance for more information.
Reminder for Collection of Communicable Disease Information
September 15, 2026