La. Admin. Code tit. 33 § XV-703

Current through Register Vol. 50, No. 11, November 20, 2024

Section XV-703 - License Amendments and Provisions for Research Involving Human Subjects

A. A licensee shall apply for and receive a license amendment:

1. before using radioactive material for a method or type of medical use not permitted by the license issued under this Chapter;

2. before permitting anyone to work as an authorized user, authorized medical physicist, or authorized nuclear pharmacist under the license, except an individual who is:

a. an authorized user certified by the organizations specified in LAC 33:XV.763.C.1, D.1, E.1, F.1, H.1, or I.1;

b. an authorized nuclear pharmacist certified by the organization specified in LAC 33:XV.763.K.1;

c. identified as an authorized user, an authorized medical physicist, or an authorized nuclear pharmacist on a department, Nuclear Regulatory Commission, licensing state, or agreement state license that authorizes the use of radioactive material in medical use or in the practice of nuclear pharmacy, respectively; or

d. identified as an authorized user, an authorized medical physicist, or an authorized nuclear pharmacist on a permit issued by a department, Nuclear Regulatory Commission, licensing state, or agreement state specific licensee of broad scope that is authorized to permit the use of radioactive material in medical use or in the practice of nuclear pharmacy, respectively;

3. before changing a radiation safety officer, authorized medical physicist, or teletherapy physicist;

4. before receiving radioactive material in excess of the amount authorized on the license;

5. before adding to or changing the areas of use or address or addresses of use identified in the application or on the license; and

6. before changing statements, representations, and procedures incorporated into the license.

B. A licensee may conduct research involving human subjects using radioactive material, provided that the research is conducted, funded, supported, or regulated by a federal agency that has implemented the Federal Policy for the Protection of Human Subjects. The licensee shall, before conducting such research:

1. obtain review and approval of the research from an Institutional Review Board, as defined and described in the Federal Policy; and

2. obtain informed consent, as defined and described in the Federal Policy, from the human research subject.

C. If the research will not be conducted, funded, supported, or regulated by a federal agency that has implemented the Federal Policy for the Protection of Human Subjects, the licensee shall, before conducting research, apply for and receive a specific amendment to its U.S. Nuclear Regulatory Commission medical use license. The amendment request must include a written commitment that the licensee will, before conducting research:

1. obtain review and approval of the research from an Institutional Review Board, as defined and described in the Federal Policy; and

2. obtain informed consent, as defined and described in the Federal Policy, from the human research subject.

D. Nothing in this Section relieves licensees from complying with the other requirements in this Chapter.

La. Admin. Code tit. 33, § XV-703

Promulgated by the Department of Environmental Quality, Nuclear Energy Division, LR 13:569 (October 1987), amended by the Office of Air Quality and Radiation Protection, Radiation Protection Division, LR 18:34 (January 1992), LR 24:2101 (November 1998), amended by the Office of Environmental Assessment, Environmental Planning Division, LR 26:2587 (November 2000), LR 30:1173 (June 2004), amended by the Office of Environmental Assessment, LR 31:1061 (May 2005), amended by the Office of the Secretary, Legal Affairs Division, LR 32:812 (May 2006).

AUTHORITY NOTE: Promulgated in accordance with R.S. 30:2001 et seq.