Provisions for Research Involving Human Subjects

A licensee may conduct research involving human subjects using radioactive material provided: (A) That 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 Agency license before conducting such research. Both types of 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 105 CMR 120.504(A) shall be conducted using radioactive material authorized for medical use in the license; and (C) Nothing in 105 CMR 120.504 relieves licensees from complying with the other requirements in 105 CMR 120.500. (D) FDA, Other Federal, and State Requirements. Nothing in 105 CMR 120.500 relieves the licensee from complying with applicable U.S. Food and Drug Administration, other Federal, and State requirements governing radioactive drugs or devices.