Current through Register Vol. 50, No. 9, September 20, 2024
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.
AUTHORITY NOTE:
Promulgated in accordance with
R.S.
30:2001 et
seq.
