Title 10

SECTION 35.6

35.6 Provisions for the protection of human research subjects.

§ 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]

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