109. FDA Requirements and Administrative Actions for FDA Inspections (§56.115, 120-124)

FDA Inspections

  • The Biomedical IRB shall provide authorized representatives of the FDA with access to IRB records for inspection and copying, at reasonable times and in a reasonable manner.
  • If the IRB refuses to allow FDA inspections, the FDA may refuse to consider clinical investigations in support of an application for research or marketing permit.

FDA Observations of Apparent Noncompliance

FDA presumes the University is responsible for the operation of the IRB and will ordinarily direct any administrative action related to apparent noncompliance towards the University. FDA may restrict its administrative actions to the IRB or to a component of the University according to evidence of responsibility for deficiencies determined during the investigation.

  • If an FDA inspector observes IRB operations that constitute apparent noncompliance, the inspector will present an oral or written summary of observations to an appropriate representative of the IRB.
  • The FDA may subsequently send a letter describing the noncompliance to the IRB and the University.
  • The IRB or the University will respond to this letter within the time specified by the FDA. The response will describe the corrective actions that will be taken by the IRB, the institution, or both.
  • The FDA may schedule a follow-up inspection to assess the adequacy of corrective actions and for studies subject to FDA regulations,

o   may withhold approval of new FDA-regulated studies conducted at the institution or reviewed by the IRB;

o   direct that no new subjects be added to ongoing studies; or

o   terminate ongoing studies when doing so would not endanger the subjects.

  • When the noncompliance creates a significant threat to the rights and welfare of human subjects, FDA may notify relevant State and Federal regulatory agencies and other parties with a direct interest in the FDA's action related to operational deficiencies of the IRB.

FDA Disqualification and Reinstatement of an IRB or an institution.

If the IRB or the University fails to take adequate steps to correct apparent noncompliance, the FDA Commissioner may determine the noncompliance justifies disqualification of the IRB or the University, and may institute proceedings in accordance with the requirements for a regulatory hearing towards that effect.

The FDA will not approve applications for research permits for clinical investigations that are to be reviewed by a disqualified IRB or conducted at a disqualified institution, and may refuse to consider data from a clinical investigation that was reviewed by a disqualified IRB.

The IRB or the University may ask to be reinstated by providing the FDA Commissioner with a written explanation of the corrective action planned or taken, and by providing assurance that it will operate in compliance with FDA regulations and standards set forth in this part.

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