Final answer:
An informed consent form is the IRB document which allows the use or disclosure of protected health information with authorization in research settings, in accordance with ethical standards and federal regulations like HIPAA.
Step-by-step explanation:
The document from the Institutional Review Board (IRB) that permits a covered entity to use or disclose protected health information with an authorization in the context of research is known as an informed consent. This form must be fully understood and signed by participants before they partake in any research activity. The informed consent form outlines the nature of the study, potential risks, benefits, confidentiality measures, and the voluntary nature of participation. In cases involving minors, parents or legal guardians are required to sign on their behalf. The process of obtaining informed consent ensures compliance with ethical standards and federal regulations, such as the Health Insurance Portability and Accountability Act (HIPAA), aimed at safeguarding the privacy and rights of research subjects.