TAMUK HIPAA Authorization template: HIPAA Authorization Template

 

What is a HIPAA authorization form?

A HIPAA authorization form is required when researchers are collecting or using a person's protected health information (PHI) for a study and the study involves a clinical trial or research protocol reviewed by the TAMUK Institutional Review Board (IRB). The purpose of the HIPAA authorization form is to ensure that participants give explicit consent for the use or disclosure of their PHI, as governed by the Health Insurance Portability and Accountability Act (HIPAA).

When is the HIPAA authorization form needed with the IRB?

1. Use or Disclosure of PHI in Research: When researchers need access to medical records or other PHI for the purpose of conducting a study, they must obtain explicit authorization from the individual whose information is being used. This is typically done through a HIPAA authorization form.
2. IRB Approval: The IRB is responsible for reviewing the ethical aspects of the research, including the protection of participant privacy. If the research involves PHI, the IRB will review whether appropriate consent procedures are in place, including obtaining a HIPAA authorization. The IRB will confirm that the form meets HIPAA requirements for privacy protection and that the participant is fully informed.
3. Non-Exempt Research: If the research involves the use of PHI and is not exempt from HIPAA requirements (e.g., de-identified data or data collected before HIPAA regulations), a HIPAA authorization must be obtained. If the research is conducted at an institution subject to HIPAA, the IRB will often require the authorization form to be part of the research consent process.
4. Data Sharing and Secondary Use: If the PHI is being used for secondary purposes (e.g., for future studies or shared with other researchers), the HIPAA authorization form should clearly outline these purposes, and the participant’s consent should be obtained.

 

HIPAA authorization is a requirement when PHI is involved in the research process. The IRB reviews the study protocols and confirms that appropriate HIPAA consent procedures are

followed. The HIPAA authorization form ensures that the participant is aware of and agrees to the use of their PHI for research purposes.

In summary, a HIPAA authorization form is essential in clinical or health-related research to ensure participants’ health data is used in compliance with privacy laws and that informed consent is provided, which must be reviewed and approved by the TAMUK IRB.