Nebraska Administrative Code
Topic - HEALTH AND HUMAN SERVICES SYSTEM
Title 180 - CONTROL OF RADIATION
Chapter 7 - MEDICAL USE OF RADIOACTIVE MATERIAL
Section 180-7-004 - PROVISIONS FOR RESEARCH INVOLVING HUMAN SUBJECTS
Current through March 20, 2024
Requirements for research involving human subjects are as follows:
(A) Research must be conducted, funded, supported, or regulated by a Federal agency that has implemented the Federal Policy for the Protection of Human Subjects. Otherwise, a licensee may apply for and receive approval of a specific amendment to its Department license before conducting such research. Both types of licensees must, at a minimum, obtain prior informed consent from the human subjects and obtain prior review and approval of the research activities by an "Institutional Review Board" according to the meaning of these terms as defined and described in the Federal Policy for the Protection of Human Subjects;
(B) Research involving human subjects authorized in 180 NAC 7-004 will be conducted using radioactive material authorized for medical use in the license; and
(C) Nothing in 180 NAC 7-004 relieves the licensee from complying with the requirements in 180 NAC 7.
