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FDA Guidance - IRB Inspections
Letters may also be issued in accordance with 21 CFR 56.120. In such cases, the Agency will require that the IRB or parent institution respond to the letter within a time period specified by FDA and describe the corrective actions that will be taken by the IRB or parent institution, or both, to achieve compliance. Based on the response from the IRB or institution to these letters, FDA may schedule a re-inspection to confirm the adequacy of corrective actions. In addition to issuing these letters, FDA can take other administrative actions against IRBs, or their institutions, for noncompliance with applicable statures and regulations (21 CFR Part 56, subpart E). Until the IRB or parent institution takes appropriate action, FDA may (studies subject to FDA’s IRB regulation):
* 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 subject
* Notify relevant State and Federal regulatory agencies and other parties with direct interest in the Agency’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.
WHO CAN PROVIDE MORE INFORMATION?
If, during an inspection, and IRB official has any questions the FDA personnel conducting the inspection has not answered, either the District Office Director or the contact person at the Center that assigned the inspection can be contacted. The GDA personnel conducting the inspection should be able to provide the name and telephone number of the District Office Director and the Center contact person.
In addition, the FDA Compliance Program Guidance Manual for Institutional Review Board Inspections (Program 7348.809), used by FDA to conduct these inspections, is available on the Internet at http://www.fda.gov/ora/cpgm/default.htm#bimo.
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