IRB Review & Approval of the HIPAA Authorization, Partial & Full Waivers

Review of a clinical study by the institutional review board (IRB) is the approval process for a study. The IRB is also empowered to review the HIPAA authorization and approve that for use in the study. The HIPAA Authorization may be part of the consent form or it may be a separate document, at the discretion of the study sponsor.

During review of the study, the IRB is the reviewing board, but when reviewing the HIPAA Authorization the board sits as the Privacy Board. This module reviews the difference between these two board functions, ensuring the regulations for these different functions are met correctly.

In addition, this module reviews the Partial and Full Waiver of consent. The IRB must make specific findings, and these findings must be documented in the IRB minutes. Compliance with these requirements is necessary and becomes the review process of the board.

This module is designed to assist the IRB in these important regulatory functions.