Does HIPAA override the Common Rule and IRB Regulations?

No. HIPAA does not override IRB requirements. After April 14, 2003 you will need to comply with both the Common Rule and the Privacy Rule. Here is a summary of their requirements.

  • The Common Rule requires either an informed consent or a waiver of informed consent for any human subjects research. Records review research is usually approved via an expedited review and a waiver of informed consent. The common rule allows a waiver only if specific criteria are met.
  • The Privacy Rule requires a written authorization or waiver of authorization for access to existing protected health information. It is assumed that most records review will be allowed with a waiver of the authorization. The Privacy Rule allows a waiver of authorization if specific criteria are met.

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