-CITE-

    45 CFR Sec. 46.113

-EXPCITE-

    Title 45
    SUBTITLE A
    PART 46
    Subpart A

-HEAD-

    Sec. 46.113 Suspension or termination of IRB approval of research.

-TEXT-

      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 Secretary. (SUPERSCRIPT 1)
       (SUPERSCRIPT 1) Reports should be filed with the Office for
    Protection from Research Risks, National Institutes of Health,
    Department of Health and Human Services, Bethesda, Maryland 20205.
    (46 FR 8386, Jan. 26, 1981; 46 FR 19195, Mar. 27, 1981)