[Code of Federal Regulations]
[Title 10, Volume 1]
[Revised as of January 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 10CFR35.6]

[Page 555]
 
                            TITLE 10--ENERGY
 
                CHAPTER I--NUCLEAR REGULATORY COMMISSION
 
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL--Table of Contents
 
                     Subpart A--General Information
 
Sec. 35.6  Provisions for research involving human subjects.

    A licensee may conduct research involving human subjects using 
byproduct material provided that the research is conducted, funded, 
supported, or regulated by another Federal Agency which has implemented 
the Federal Policy for the Protection of Human Subjects. Otherwise, a 
licensee shall apply for and receive approval of a specific amendment to 
its NRC license before conducting such research. Both types of licensees 
shall, at a minimum, obtain informed consent from the human subjects and 
obtain prior review and approval of the research activities by an 
``Institutional Review Board'' in accordance with the meaning of these 
terms as defined and described in the Federal Policy for the Protection 
of Human Subjects.

[59 FR 61781, Dec. 2, 1994]