[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: 45CFR46.201]



[Page 126]

 

                        TITLE 45--PUBLIC WELFARE

 

           SUBTITLE A--DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

PART 46_PROTECTION OF HUMAN SUBJECTS--Table of Contents

 

 Subpart B_Additional Protections for Pregnant Women, Human Fetuses and 

                      Neonates Involved in Research

 

Sec. 46.201  To what do these regulations apply?



    Source: 66 FR 56778, Nov. 13, 2001, unless otherwise noted.





    (a) Except as provided in paragraph (b) of this section, this 

subpart applies to all research involving pregnant women, human fetuses, 

neonates of uncertain viability, or nonviable neonates conducted or 

supported by the Department of Health and Human Services (DHHS). This 

includes all research conducted in DHHS facilities by any person and all 

research conducted in any facility by DHHS employees.

    (b) The exemptions at Sec. 46.101(b)(1) through (6) are applicable 

to this subpart.

    (c) The provisions of Sec. 46.101(c) through (i) are applicable to 

this subpart. Reference to State or local laws in this subpart and in 

Sec. 46.101(f) is intended to include the laws of federally recognized 

American Indian and Alaska Native Tribal Governments.

    (d) The requirements of this subpart are in addition to those 

imposed under the other subparts of this part.