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What may the FDA do until the IRB or parent institution takes appropriate corrective action?

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The FDA can...

  • Withhold approval of new studies that are conducted at the institution or reviewed by the IRB
  • Direct that no new subjects be added to ongoing studies
  • Terminate ongoing studies when doing so would not endanger the subjects
  • Notify relevant State and Federal regulatory agencies and other parties with direct interest in the FDA's action of the deficiencies in the operation of the IRB in instances when the apparent noncompliance creates a significant threat to the rights and welfare of human subjects

The FDA Commissioner can also begin proceedings to disqualify an IRB or the institution if the IRB has refused or repeatedly failed to comply with FDA’s IRB regulations (21 CFR Part 56) and the noncompliance adversely affects the rights or welfare of the human subjects in a clinical investigation.

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