216 R.I. Code R. 216-RICR-40-20-9.4

Current through December 26, 2024

Section 216-RICR-40-20-9.4 - General Requirements

9.4.1Provisions for Research Involving Human Subjects

A. A licensee may conduct research involving human subjects using radioactive material provided:

1. That the research is conducted, funded, supported, or regulated by a Federal agency which has implemented the Federal Policy for the Protection of Human Subjects. Otherwise, a licensee shall apply for and receive approval of a specific amendment to its Agency license before conducting such research. Both types of licensees shall, 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" in accordance with the meaning of these terms as defined and described in the Federal Policy for the Protection of Human Subjects;

2. The research involving human subjects authorized in §9.4.1(A)(1) shall be conducted using radioactive material authorized for medical use in the license; and

3. Nothing in this section relieves licensees from having to comply with the other requirements in this Part.

9.4.2FDA, Other Federal and State Requirements

Nothing in this Part relieves the licensee from having to comply with applicable FDA, other Federal, and State requirements governing radioactive drugs or devices.

9.4.3License Required

A. A person shall manufacture, produce, acquire, receive, possess, use or transfer radioactive material for medical use only in accordance with a specific license issued by the Agency, the U.S. Nuclear Regulatory Commission or another Agreement State, or as allowed by §§9.5.3(A) and (B) of this Part. A specific license is not needed for an individual who:

1. Receives, possesses, uses, or transfers radioactive material in accordance with this Subchapter under the supervision of an Authorized User as provided in §9.5.3 of this Part, unless prohibited by license condition; or

2. Prepares unsealed radioactive material for medical use in accordance with this Part under the supervision of an Authorized Nuclear Pharmacist or Authorized User as provided in §9.5.3 of this Part, unless prohibited by license condition.

B. Human Use of Radioactive Material. In addition to the requirements set forth in §7.6.2(A) of this Subchapter and other sections of this Part, a specific license for human use of radioactive material will be issued under the following conditions:

1. If the application is for human use sited in a medical institution, only the institution's management may apply. If the application is for human use not sited in a medical institution, the applicant or a person duly authorized to act for and on their behalf may apply.

2. The application includes the facility diagram, equipment, and training and experience qualifications of the Radiation Safety Officer, Associate Radiation Safety Officer(s), Authorized User(s), Authorized Medical Physicist(s), Ophthalmic Physicist(s), and Authorized Nuclear Pharmacist(s).

3. The application includes procedures required by §§9.11.2, 9.11.4, 9.11. 10, 9.11.11, and 9.11.12 of this Part, as applicable.

4. An application for human use of radioactive material as described in § 9.12 of this Part must also include information regarding any radiation safety aspects of the human use of the material that is not addressed in this Part. The applicant shall also provide specific information on:

a. Radiation safety precautions and instructions;

b. Methodology for measurement of dosages or doses to be administered to patients or human research subjects; and

c. Calibration, maintenance, and repair of instruments and equipment necessary for radiation safety.

9.4.4Maintenance of Records

Each record required by this Part shall be legible throughout the specified retention period specified by each Agency Regulation. The record may be the original, a reproduced copy, or a microform if the copy or microform is authenticated by authorized personnel and the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, and specifications, shall include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.

9.4.5License Amendments

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

1. Before it receives or uses radioactive material for a type of use that is permitted under this Part, but that is not authorized on the licensee's current license issued pursuant to this Part;

2. Before permitting anyone, except a Visiting Authorized User, Visiting Authorized Medical Physicist, Visiting Authorized Nuclear Pharmacist or Visiting Ophthalmic Physicist as described §9.5.6 of this Part, to work as an Authorized User, Authorized Medical Physicist, Authorized Nuclear Pharmacist or Visiting Ophthalmic Physicist under the license;

3. Before changing a Radiation Safety Officer, except as provided in §9.5.1(C) of this Part, or Authorized Medical Physicist;

4. Before ordering radioactive material in excess of the amount, or radionuclide or form different than 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;

6. Before changing statements, representations, and procedures which are incorporated into the license, except as provided for in §9.5.15 of this Part;

7. Before it releases licensed facilities for unrestricted use.

8. In addition to the requirements specified above, a therapeutic medical unit licensee shall apply for and receive a license amendment before:

a. Making any change in the treatment room shielding;

b. Making any change in the location of the therapeutic medical unit within the treatment room;

c. Using the therapeutic medical unit in a manner that could result in increased radiation levels in areas outside the treatment room;

d. Relocating the therapeutic medical unit; or

e. Allowing an individual not listed on the licensee's license to perform the duties of the Authorized Medical Physicist, except as provided in §9.5.6(B) of this Part.

9. Before a licensee receives a sealed source from a different manufacturer or of a different model number than authorized by its license unless the sealed source is used for manual brachytherapy, is listed in the Sealed Source and Device Registry, and is in a quantity and for an isotope authorized by the license.

10. Before a licensee permits anyone to work as an Associate Radiation Safety Officer, or before the Radiation Safety Officer assigns duties and tasks to an Associate Radiation Safety Officer that differ from those for which this individual is authorized on the license.

9.4.6Notifications

A. A licensee shall notify the Agency by letter no later than thirty (30) days after:

1. An Authorized User, an Authorized Nuclear Pharmacist, Radiation Safety Officer, Associate Radiation Safety Officer, Ophthalmic Physicist, or Authorized Medical Physicist permanently discontinues performance of duties under the license or has a name change; or

2. The licensee's mailing address changes; or

3. The licensee's name changes, but the name change does not constitute a transfer of control of the license as described in §7.6.3 of this Subchapter; or

4. The licensee has added to or changed the areas of use identified in the application or on the license where radioactive material is used in accordance with either §§9.7.1 or 9.7.3 of this Part if the change does not include addition or relocation of either an area where PET radionuclides are produced or a PET radioactive drug delivery line from the PET radionuclide/PET radioactive drug production area.

5. The licensee obtains a sealed source for use in manual brachytherapy from a different manufacturer or with a different model number than authorized by its license for which it did not require a license amendment as provided in §9.4.5 of this Part. The notification must include the manufacturer and model number of the sealed source, the isotope, and the quantity per sealed source.

6. The licensee permits an individual qualified to be a Radiation Safety Officer under §§9.5.10 and 9.5.14 of this Part to function as a temporary Radiation Safety Officer and to perform the functions of a Radiation Safety Officer in accordance with §9.5.1(C) of this Part;

9.4.7Exemptions Regarding Type A Specific Licenses of Broad Scope

For the purpose of this Part, exemptions regarding Type A specific licenses of broad scope are defined by 10 C.F.R. § 35.15.

216 R.I. Code R. 216-RICR-40-20-9.4

Adopted effective 1/1/2019
Amended effective 5/25/2022