[Code of Federal Regulations] [Title 34, Volume 1] [Revised as of July 1, 2005] From the U.S. Government Printing Office via GPO Access [CITE: 34CFR97.113] [Page 306] TITLE 34--EDUCATION PART 97_PROTECTION OF HUMAN SUBJECTS--Table of Contents Subpart A_Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) Sec. 97.113 Suspension or termination of IRB approval 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. (Approved by the Office of Management and Budget under Control Number 0990-0260.) (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; and 42 U.S.C. 300v- 1(b)) [56 FR 28012, 28021, June 18, 1991, as amended at 70 FR 36328, June 23, 2005]