1. A. A licensee may conduct basic research involving human research subjects and research involving patients receiving investigational new drugs or devices if the licensee only uses the radioactive material specified on the license for the uses authorized on the license.

2. B. If research is conducted, funded, supported, or regulated by a federal agency that has implemented the federal Policy for Protection of Human Research Subjects (45 CFR 46, June 23, 2005, which is incorporated by reference, published by the Office of Federal Register, National Archives and Records Administration, Washington, DC 20408, on file with the Department, and contains no future editions or amendments), the licensee shall:

   1. 1. Obtain review and approval of the research from an Institutional Review Board (IRB); and
   2. 2. Obtain informed consent from the human research subject.

3. C. If research will not be conducted, funded, supported, or regulated by a federal agency that has implemented the federal policy in subsection (B), a medical licensee shall, before conducting research, apply for and receive a specific amendment to its use license. The amendment request shall include a written commitment that the licensee will, before conducting research:

   1. 1. Obtain review and approval of the research from an IRB, as defined and described in the federal policy; and
   2. 2. Obtain informed consent from the human research subject.

4. D. Before conducting the research described in subsection (A) the licensee shall apply to the Department for and receive a specific amendment to its medical use license. The amendment request shall include a written commitment that the licensee will, before conducting research:

   1. 1. Obtain any review and approval required by this Section, and
   2. 2. Obtain informed consent from the human research subject if applicable.
5. E. Nothing in this Section relieves a licensee from complying with the other requirements in this Article.

Historical Note

New Section R9-7-704 recodified from R12-1-704 at 24 A.A.R. 813, effective March 22, 2018 (Supp. 18-1).