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Suspension or Termination of IRB Approval

Under 21 CFR 56.113, an IRB shall have the authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB`s action and shall be reported promptly to the investigator, appropriate institutional officials, and the Food and Drug Administration.

21 CFR 56.108(b) requires that the IRB follow written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the Food and Drug Administration of:

1. Any unanticipated problems involving risks to human subjects or others;
2. any instance of serious or continuing noncompliance with these regulations or the requirements or determinations of the IRB; or
3. any suspension or termination of IRB approval.

The following provides information about where to submit these required reports to FDA.

For Drug Products:

Please report suspension or termination of IRB approval; unanticipated problems involving risks to human subjects; or serious or continuing noncompliance with the regulations or the requirements or determinations of the IRB to:

Division of Scientific Investigations (HFD-45)
Office of Medical Policy
Center for Drug Evaluation and Research
7520 Standish Place
Rockville, MD 20855
Phone: 301-594-0020
Fax: 301-594-1204

For Biologic Products:

Please report suspension or termination of IRB approval; unanticipated problems involving risks to human subjects; or serious or continuing noncompliance with the regulations or the requirements or determination of the IRB to:

Bioresearch Monitoring Branch (HFM-664)
Division of Inspections and Surveillance
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research/FDA
1401 Rockville Pike, Room 400S
Rockville, MD 20852-1448
Phone: 301-827-6347
Fax: 301-827-6748

For Medical Devices:

Please report suspension or termination of IRB approval; unanticipated problems involving risks to human subjects; or serious or continuing noncompliance with the regulations or the requirements or determination of the IRB to:

Divison of Bioresearch Monitoring (HFZ-310)
Office of Compliance
Center for Device and Radiological Health (CDRH)
2094 Gaither Road
Rockville, MD 20850
Phone: 301-594-4718
Fax: 301-827-6748

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