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  6. Mandatory IRB Reporting: FDA Contacts
  1. Report Problems to FDA

Mandatory IRB Reporting: FDA Contacts

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:

Office of Scientific Investigations

Email: CDER-OSI-GCPReferrals@fda.hhs.gov
Phone: (301) 796-3150

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:

Email: CBERBIMONotification@fda.hhs.gov
Bioresearch Monitoring Branch
Division of Inspections and Surveillance
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research/FDA
10903 New Hampshire Ave.
Building 71, Room 5126
Silver Spring, MD 20993
eFax: (301) 480-9748

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:

Phone (301) 796-5490
Fax: (301) 847-8136
Email: bimo@cdrh.fda.gov

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