-CITE-

    45 CFR Sec. 46.109

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    Title 45
    SUBTITLE A
    PART 46
    Subpart A

-HEAD-

    Sec. 46.109 IRB review of research.

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      (a) An IRB shall review and have authority to approve, require
    modifications in (to secure approval), or disapprove all research
    activities covered by these regulations.
      (b) An IRB shall require that information given to subjects as
    part of informed consent is in accordance with Sec. 46.116. The IRB
    may require that information, in addition to that specifically
    mentioned in Sec. 46.116, be given to the subjects when in the
    IRB's judgment the information would meaningfully add to the
    protection of the rights and welfare of subjects.
      (c) An IRB shall require documentation of informed consent or may
    waive documentation in accordance with Sec. 46.117.
      (d) An IRB shall notify investigators and the institution in
    writing of its decision to approve or disapprove the proposed
    research activity, or of modifications required to secure IRB
    approval of the research activity.  If the IRB decides to
    disapprove a research activity, it shall include in its written
    notification a statement of the reasons for its decision and give
    the investigator an opportunity to respond in person or in writing.
      (e) An IRB shall conduct continuing review of research covered by
    these regulations at intervals appropriate to the degree of risk,
    but not less than once per year, and shall have authority to
    observe or have a third party observe the consent process and the
    research.