Is documentation of Institutional Review Boards (IRB) and Privacy Board approval required by the HIPAA Privacy Rule before a covered entity would be permitted to disclose protected health information for research purposes without an individual's authorization?

Answer:

No. The HIPAA Privacy Rule requires documentation of waiver approval by either an IRB or a Privacy Board, not both.

See our research section and frequently asked questions about the research provisions for more information about Institutional Review and Privacy Boards.