Section 216-RICR-40-20-5.1 - Authority and Incorporation by Reference5.1.1AuthorityA. This Part is promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-1.3-5.B. This Part establishes requirements, for which a registrant is responsible, for use of therapeutic radiation machines. The provisions of this Part are in addition to, and not in substitution for, other applicable provisions of this Subchapter.C. The use of therapeutic radiation machines must be by, or under the supervision of, an Authorized Physician who meets the criteria established by §5.3.3 of this Part.D. Provisions for Research Involving Human Subjects. A registrant may conduct research involving human subjects using therapeutic radiation machines provided that: 1. If the research will be conducted, funded, supported, or regulated by a Federal Agency which has implemented the Federal Policy for the Protection of Human Subjects ( 45 C.F.R. Part 46), the registrant must, before conducting research: a. Obtain review and approval of the research from an "Institutional Review Board," as defined and described in the Federal Policy; andb. Obtain "informed consent," as defined and described in the Federal Policy, from the human research subject; or2. If the research will not be conducted, funded, supported, or regulated by a Federal agency that has implemented the Federal Policy, the registrant must, before conducting research: a. Apply for and receive approval of a specific amendment to its Agency registration; andb. Obtain review and approval of the research from an "Institutional Review Board," as defined and described in the Federal Policy; andc. Obtain "informed consent," as defined and described in the Federal Policy, from the human research subject.E. FDA, Other Federal and State Requirements. Nothing in this Part relieves the registrant from complying with applicable Agency, FDA, other Federal, and State requirements governing therapeutic radiation machines or auxiliary devices.F. Electronic brachytherapy devices are subject to the requirements of § 5.8 of this Part and are exempt from the requirements of § 5.6 of this Part.G. Any notifications, reports or correspondence required by this Part must be directed to the Agency using contact information specified in § 1.4 of this Subchapter.5.1.2Incorporation by ReferenceA. These Regulations hereby adopt and incorporate the National Council on Radiation Protection and Measurements' (NCRP) Report 49 "Structural Shielding Design and Evaluation for Medical Use of X Rays and Gamma Rays of Energies Up to 10 MeV" (1976) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.B. These Regulations hereby adopt and incorporate the National Council on Radiation Protection and Measurements' (NCRP) Report 79, "Neutron Contamination from Medical Electron Accelerators" (1984) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.C. These Regulations hereby adopt and incorporate the National Council on Radiation Protection and Measurements' (NCRP) Report 144, "Radiation Protection for Particle Accelerator Facilities" (2003) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.D. These Regulations hereby adopt and incorporate the National Council on Radiation Protection and Measurements' (NCRP) Report 151, "Structural Shielding Design and Evaluation for Megavoltage X- and Gamma-Ray Radiotherapy Facilities" (2006) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.216 R.I. Code R. 216-RICR-40-20-5.1
Adopted effective 1/1/2019
Amended effective 5/25/2022
Amended effective 11/27/2023