-CITE-

    45 CFR Sec. 46.401

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    Title 45
    SUBTITLE A
    PART 46
    Subpart D

-HEAD-

    Sec. 46.401 To what do these regulations apply?

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      (a) This subpart applies to all research involving children as
    subjects, conducted or supported by the Department of Health and
    Human Services.
      (1) This includes research conducted by Department employees,
    except that each head of an Operating Division of the Department
    may adopt such nonsubstantive, procedural modifications as may be
    appropriate from an administrative standpoint.
      (2) It also includes research conducted or supported by the
    Department of Health and Human Services outside the United States,
    but in appropriate circumstances, the Secretary may, under
    paragraph (e) of Sec. 46.101 of Subpart A, waive the applicability
    of some or all of the requirements of these regulations for
    research of this type.
      (b) Exemptions (1), (2), (5) and (6) as listed in Subpart A at
    Sec. 46.101(b) are applicable to this subpart.  Exemption (4),
    research involving the observation of public behavior, listed at
    Sec. 46.101(b), is applicable to this subpart where the
    investigator(s) does not participate in the activities being
    observed.  Exemption (3), research involving survey or interview
    procedures, listed at Sec. 46.101(b) does not apply to research
    covered by this subpart.
      (c) The exceptions, additions, and provisions for waiver as they
    appear in paragraphs (c) through (i) of Sec. 46.101 of Subpart A
    are applicable to this subpart.