-CITE-

    45 CFR Sec. 46.205

-EXPCITE-

    Title 45
    SUBTITLE A
    PART 46
    Subpart B

-HEAD-

    Sec. 46.205 Additional duties of the Institutional Review Boards in
        connection with activities involving fetuses, pregnant women,
        or human in vitro fertilization.

-TEXT-

      (a) In addition to the responsibilities prescribed for
    Institutional Review Boards under Subpart A of this part, the
    applicant's or offeror's Board shall, with respect to activities
    covered by this subpart, carry out the following additional duties:
      (1) Determine that all aspects of the activity meet the
    requirements of this subpart;
      (2) Determine that adequate consideration has been given to the
    manner in which potential subjects will be selected, and adequate
    provision has been made by the applicant or offeror for monitoring
    the actual informed consent process (e.g., through such mechanisms,
    when appropriate, as participation by the Institutional Review
    Board or subject advocates in: (i) Overseeing the actual process by
    which individual consents required by this subpart are secured
    either by approving induction of each individual into the activity
    or verifying, perhaps through sampling, that approved procedures
    for induction of individuals into the activity are being followed,
    and (ii) monitoring the progress of the activity and intervening as
    necessary through such steps as visits to the activity site and
    continuing evaluation to determine if any unanticipated risks have
    arisen);
      (3) Carry out such other responsibilities as may be assigned by
    the Secretary.
      (b) No award may be issued until the applicant or offeror has
    certified to the Secretary that the Institutional Review Board has
    made the determinations required under paragraph (a) of this
    section and the Secretary has approved these determinations, as
    provided in Sec. 46.120 of Subpart A of this part.
      (c) Applicants or offerors seeking support for activities covered
    by this subpart must provide for the designation of an
    Institutional Review Board, subject to approval by the Secretary,
    where no such Board has been established under Subpart A of this
    part.
    (40 FR 33528, Aug. 8, 1975, as amended at 46 FR 8386, Jan. 26,
    1981)