Suspension or Termination of Research
- Unanticipated problems involving risk to subjects or others must be reported immediately to the IRB and may lead to suspension or termination of research.
- Serious or continuing noncompliance with federal regulations or the requirements or determinations of the IRB may lead to suspension or termination of research.
- An IRB shall have 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 department or agency head supporting the research, and any other necessary parties.