Human Subject Research. Administration of Radiation and Radioactive Materials. Human Use of Radiation and Radioactive Materials is subject to specific Federal and Agreement State Regulation. 10 CFR 35 – Medical Use Of Byproduct Material
Human Subject Research
Radiation and Radioactive Materials
10 CFR 35 – Medical Use Of Byproduct Material
10 CFR 361.1 – Radioactive drugs for certain research uses
RCNY 175.103 – Medical use of radioactive material
NYS Public Health Law –
Part 35 – Practice of X-Ray Technology
Part 16.19 – Limitations on application of radiation to
Part 405.15 - Radiologic and nuclear medicine services
By formal Agreement, U.S. Nuclear Regulatory
Commission authority and responsibility for the
regulation, licensing and inspection of the possession
and use of radioactive material has been assumed by:
The City of New York Department of Health and
LICENSING OF RADIOACTIVE MATERIALS USE
ESTABLISHMENT OF A RADIATION SAFETY
COMMITTEE AND APPOINTMENT OF A RADIATION
LIMITATION OF HUMAN USE TO QUALIFIED
“(2) License required. (1) No person shall … possess … radioactive material for medical use except in accordance with a specific license …
(3) … If the application is for medical use sited at a medical institution, only the institution’s management may apply.” (RCNY 175.103(a)
Research activities at CUMC, NYPH and NYSPI are
typically performed under:
NYC Radioactive Materials License No. 75-2878-01
NYC Radioactive Materials License No. 74-2878-03
-Non-Human in-vitro and animal use
“(3) Radiation safety committee. Each medical institution licensee shall establish a radiation safety committee...
(ii)...the committee shall:
(B) review, on the basis of safety and with regard to the training and experience standards of this Code, and approve or disapprove any individual who is to listed as an authorized user, ...
(C) Review on the basis of safety and approve or disapprove each proposed use of radioactive material;“
The present Joint Radiation Safety Committee was created in the Agreement of February 12, 1991 between the New York State Psychiatric Institute, the College of Physicians and Surgeons and Presbyterian Hospital in the City of New York.
“(18) Authorized user” means an individual who is identified as an authorized user on a Department, Agreement State, or U.S. Nuclear Regulatory Commission license that authorizes the use of radioactive material or is named as an authorized user on a certified registration issued by the Department.” RCNY 175.02(18)
In NYC the authorized user is to be a physician:
b)Or have completed 200 hours of instruction in radioisotopes, 500 hours of supervised work experience and 500 hours of supervised clinical experience.
In the Federal Register dated Wednesday, March 30,
2005, Nuclear Regulatory Commission 10 CFR Part 35,
Medical Use of Byproduct Material – Recognition of
Specialty Boards; Final Rule the U.S.N.R.C. indicated that
no later than five (5) years from that date all jurisdictions
will need to comply with new requirements regarding
board certification and training.
a)Examination of patients and medical records.
b)Prescription of the radiation dose and how it is to be administered.
c) c) Actual use of, and direction of other paramedical personnel in the use of, radioactive material.
d)Interpretation of diagnostic procedures and evaluation of therapy procedures.
(City of New York DOH, License Guide 10.8, Rev. 2, pp 10-11)
“(218) "Supervision" means...(ii) for radioactive materials licenses which do authorize human use, the training of a physician in the use of radioactive materials in the clinical treatment or diagnosis of disease. Such training shall provide that specified in §175.102), as applicable.”
a) Instruct the supervised individual in principles and practices as appropriate.
b) For physicians provide instruction by the supervising authorized user as stipulated in RCNY 175.103(j), as appropriate. Maintain records of training for three years.
c) Require the supervising authorized user to review the supervised individual’s use of radioactive material, review records of this use and provide re-instruction.
d) Require only individuals specifically trained and designated by the authorized user to administer radionuclides or radiation. (RCNY 175.103(b)(5))
IN ALL CASES:
“(v) A licensee that supervises an individual is responsible for the acts and omissions of the supervised individual.”
Authorized User Physicians (JRSC Human-Use “R.I.”)
Supervised Individual Physicians (under the supervision of an Authorized User)
Registered Professional Nurses (under the supervision of an Authorized User)
Registered Nuclear Medicine Technologists (as approved
by the JRSC as delegated by the hospital medical board
and under the supervision of an Authorized User)
Registered and Licensed Radiologic Technologist
Radiologic Technology Student (under the direct supervision of a Licensed Physician or Licensed Technologist)
NOTE: A Licensed Physicians Assistant or a Licensed Nurse Practitioner may order (but not perform) an X-Ray study
New York State Title 10, Section 16.19
A board certified or board admissible radiologist
Practioners within their field of specialization
NUCLEAR MEDICINE STUDIES
An Authorized User Physician named on the facility’s
Radioactive Materials License
A Physician under their tutelage (supervision)
New York State Title 10, Part 405.15 (a & c)
THE JRSC HAS THE REGULATORY
RESPONSIBILITY AND AUTHORITY TO
APPROVE ALL AUTHORIZED USER
PHYSICIANS AND EACH USE OF RADIOACTIVE
MATERIAL AT CUMC, NYPH AND NYSPI
In addition, the JRSC has been delegated by both the CUMC
and the NYSPI IRB to review and approve all IND
applications and consents with regard to the use or
administration of radiation or radioactive materials. The JRSC
serves as a sub-committee of the IRB.
The approval of basic research in metabolism and
physiology using certain radioactive drugs, recognized as
safe and effective may be delegated by the U.S.F.D.A. to
a local Radioactive Drug Research Committee.
The Columbia Presbyterian Medical Center Radioactive
Drug Research Committee was approved by the
U.S.F.D.A. as RDRC No. 1, the first RDRC in the United
States on July 25, 1975. The RDRC serves as a sub-
committee of the IRB.
LIMITATIONS ON RDRC APPROVED RESEARCH
Radioactive material is used for basic research into
metabolism and physiology and not for a diagnostic study
or clinical trial.
Pharmacological dose cannot cause clinically detectable
Annual and total radiation dose commitment have
The JRSC and the RDRC review the applications and
consents of research studies involving the administration of
radiation and/or radioactive material and send their
Findings and comments to the IRB
The application must accurately estimate the radiation dose
received by the subject as a result of participating in the
The consent must accurately inform the subject of the risk
resulting from receiving the radiation dose associated with
The Licensee is required to appoint a Radiation
Safety Officer to implement the radiation safety
The R.S.O. assists the radiation safety committee in
the performance of its duties and reports to
management regarding the radiation safety
Program (RCNY 175.103(b)(2))
The R.S.O. has the regulatory responsibility and authority to:
Establish, implement and maintain policies and procedures
Authorize the purchase of radioactive material and train
personnel in it’s safe use
Investigate misadministrations, accidents, unauthorized use
and implement corrective actions as necessary
1.)Radiation from a source other than the one ordered by the prescribing physician.
2.)Radiation to the wrong person.
3.)Radiation to a part of the body other than that ordered by the prescribing physician.
4.)Activity of a diagnostic radiopharmaceutical differing by more than 50% of that prescribed.
5.)Activity of a therapeutic radiopharmaceutical differing by more than 10% of that prescribed.
6.)A therapeutic radiation dose from an external beam source resulting in a calculated total treatment dose differing by more than 10% of that prescribed.
7.)A therapeutic radiation dose from a brachytherapy source resulting in a calculated total treatment dose differing by more than 10% of that prescribed.
8.) Any individual fraction in a fractionated treatment that differs from the fraction prescribed by more than 50%.
ALL categories of therapeutic medical misadministrations must be recorded and records maintained for 6 years. Records of diagnostic misadministrations must be maintained for 3 years.
Medical misadministrations of types: 1, 2, 3 and 8; wrong source, wrong patient, wrong part of the body and error in an individual fraction of over 50% must be reported. Misadministrations of types: 5, 6 and 7; in which the error in total dose administered to the patient is greater than 20% must be reported.
In addition, ALL misadministrations which result in a whole body dose to the patient greater than 5 rem (50 mSv) or a dose to an individual organ greater than 50 rem (500 mSv) must be reported in writing to the New York City Department of Health, Office of Radiological Health within 15 days. (RCNY 175.07(e)