Section 0400-20-07-.07 - PROVISIONS FOR THE PROTECTION OF HUMAN RESEARCH SUBJECTS(1) A licensee may conduct research involving human subjects using radioactive material provided that: (a) The research is conducted, funded, supported, or regulated by a 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 license before conducting such research. In both instances, the licensees shall, at a minimum, obtain prior 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;(b) The research involving human subjects authorized in subparagraph (a) of this paragraph shall be conducted using radioactive material authorized for medical use in the license; and(c) Nothing in this rule relieves licensees from complying with the other requirements in this rule.Tenn. Comp. R. & Regs. 0400-20-07-.07
Original rule filed February 22, 2012; effective May 22, 2012.Authority: T.C.A. §§ 68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq.