[Code of Federal Regulations]
[Title 10, Volume 1]
[Revised as of January 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 10CFR35.6]

[Page 569]
 
                            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 the protection of human research subjects.

    (a) A licensee may conduct research involving human research 
subjects only if it uses the byproduct materials specified on its 
license for the uses authorized on its license.
    (b) If the research is conducted, funded, supported, or regulated by 
another Federal agency that has implemented the Federal Policy for the 
Protection of Human Subjects (Federal Policy), the licensee shall, 
before conducting research--
    (1) Obtain review and approval of the research from an 
``Institutional Review Board,'' as defined and described in the Federal 
Policy; and
    (2) Obtain ``informed consent,'' as defined and described in the 
Federal Policy, from the human research subject.
    (c) If the research will not be conducted, funded, supported, or 
regulated by another Federal agency that has implemented the Federal 
Policy, the licensee shall, before conducting research, apply for and 
receive a specific amendment to its NRC medical use license. The 
amendment request must include a written commitment that the licensee 
will, before conducting research--
    (1) Obtain review and approval of the research from an 
``Institutional Review Board,'' as defined and described in the Federal 
Policy; and
    (2) Obtain ``informed consent'', as defined and described in the 
Federal Policy, from the human research subject.
    (d) Nothing in this section relieves licensees from complying with 
the other requirements in this part.

[67 FR 20370, Apr. 24, 2002; 67 FR 62872, Oct. 9, 2002]