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.

When reporting suspensions or terminations of IRB approval, please include the IND or IDE number, the full name of the research protocol, the name(s) of the clinical investigators, and the reason(s) for the suspension or termination. These reports may be submitted via e-mail or in hard copy by FAX or mail. Submit information to the following locations/contacts:

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:

Ms. Dana Walters
Dana.Walters@fda.hhs.gov
Division of Scientific Investigations (HFD-45)
Office of Compliance
Center for Drug Evaluation and Research
White Oak Campus
10903 New Hampshire Ave.
BLDG 51, Rm. 5341
Silver Spring, MD 20993
Phone: (301) 796-3150
Fax: (301) 847-8748

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:

Ms. Patricia Holobaugh
Patricia.Holobaugh@fda.hhs.gov
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:

Ms. Sheila Brown
Sheila.Brown@fda.hhs.gov
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire
WO66 RM 1651
Silver Spring, MD 20993
Phone (301) 796-6563
Fax: (301) 847-8120