-CITE-

    45 CFR Sec. 46.108

-EXPCITE-

    Title 45
    SUBTITLE A
    PART 46
    Subpart A

-HEAD-

    Sec. 46.108 IRB functions and operations.

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      In order to fulfill the requirements of these regulations each
    IRB shall:
      (a) Follow written procedures as provided in Sec. 46.103(b)(4).
      (b) Except when an expedited review procedure is used (see Sec.
    46.110), review proposed research at convened meetings at which a
    majority of the members of the IRB are present, including at least
    one member whose primary concerns are in nonscientific areas.  In
    order for the research to be approved, it shall receive the
    approval of a majority of those members present at the meeting.
      (c) Be responsible for reporting to the appropriate institutional
    officials and the Secretary (SUPERSCRIPT 1) any serious or
    continuing noncompliance by investigators with the requirements and
    determinations of the IRB.
       (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)