Section R12-1-704. Provisions for the Protection of Human Research Subjects

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.

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 Agency, and contains no future editions or amendments), the licensee shall:

1.        Obtain review and approval of the research from an Insti- tutional Review Board (IRB); and

2.        Obtain informed consent from the human research sub- ject.

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

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

2.        Obtain informed consent from the human research sub- ject.

D.      Before conducting the research described in subsection (A) the licensee shall apply to the Agency 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.        Obtain any review and approval required by this Section, and

2.        Obtain informed consent from the human research sub- ject if applicable.

E.       Nothing in this Section relieves a licensee from complying with the other requirements in this Article.

Historical Note

Repealed effective June 30, 1977 (Supp. 77-3). Former Section R12-1-703 renumbered and amended as Section R12-1-704 effective December 20, 1985 (Supp. 85-6).

Section repealed and new Section adopted by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). Amended by final rulemaking at 9 A.A.R. 1126, effective May 9, 2003 (Supp. 03-1). Amended by

final rulemaking at 10 A.A.R. 2122, effective July 3, 2004 (Supp. 04-2). Section repealed; new Section made by final rulemaking at 13 A.A.R. 1217, effective May 5, 2007 (Supp. 07-1).