[Code of Federal Regulations]

[Title 45, Volume 1]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 45CFR46.401]



[Page 131]

 

                        TITLE 45--PUBLIC WELFARE

 

           SUBTITLE A--DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

PART 46_PROTECTION OF HUMAN SUBJECTS--Table of Contents

 

 Subpart D_Additional Protections for Children Involved as Subjects in 

                                Research

 

Sec. 46.401  To what do these regulations apply?



    Source: 48 FR 9818, Mar. 8, 1983, unless otherwise noted.





    (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 at Sec. 46.101(b)(1) and (b)(3) through (b)(6) are 

applicable to this subpart. The exemption at Sec. 46.101(b)(2) 

regarding educational tests is also applicable to this subpart. However, 

the exemption at Sec. 46.101(b)(2) for research involving survey or 

interview procedures or observations of public behavior does not apply 

to research covered by this subpart, except for research involving 

observation of public behavior when the investigator(s) do not 

participate in the activities being observed.

    (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.



[48 FR 9818, Mar. 8, 1983; 56 FR 28032, June 18, 1991; 56 FR 29757, June 

28, 1991]