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. (Approved by the Office of Management and Budget under Control Number 0990-0260) [56 FR 28012, 28022, June 18, 1991, as amended at 70 FR 36328, June 23, 2005]