Ariz. Admin. Code § R9-7-704 - 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 Department, and contains no future
editions or amendments), the licensee shall:
1. Obtain review and approval of the research
from an Institutional Review Board (IRB); and
2. Obtain informed consent from the human
research subject.
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. 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 subject.
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.
Obtain any review and approval required by this Section, and
2. Obtain informed consent from the human
research subject if applicable.
E. Nothing in this Section relieves a
licensee from complying with the other requirements in this Article.
Notes
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