Corporate Compliance

Tip: Conducting an IRB audit

Healthcare Auditing Weekly, January 23, 2007

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?

    To determine whether the IRB meets the proper standards, make sure it includes:

  • A minimum of five members
  • Diversity in race, gender, and culture
  • One member not affiliated with the institution
  • A member knowledgeable and experienced with research involving vulnerable subjects
  • The appropriate number of members with the required expertise

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