Corporate Compliance

Tip: Steps for conducting an IRB audit

Compliance Monitor, April 13, 2005

It's a good idea to conduct an audit of your organization's institutional review board (IRB) to determine whether the IRB effectively protects the rights and welfare of human research subjects, as well as meets its federal government obligations. Review the IRB meeting minutes to be sure you can answer "yes" to the following questions:

  • Did enough IRB members attend the meeting to have a quorum: the majority of members are present?
  • Did the IRB sufficiently review each protocol to ensure that appropriate criteria were met?
  • Did the IRB spend ample time on each study?
  • Did consent forms given to the IRB contain all necessary disclosures?
  • Were members with a potential conflict of interest absent for deliberation and voting?

The above tip is an excerpt from the book "Hospital Auditing and Monitoring: Sample Programs for Key Risk Areas." Copyright 2004 by HCPro, Inc. This book is a step-by-step, practical manual that offers sample audit programs for the most troublesome areas that a hospital must audit. The binder and CD-ROM are filled with actual audit programs used by auditors and compliance officers in the field.

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