Transcript Human Subject Research

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
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
Humans
Part 405.15 - Radiologic and nuclear medicine services
FEDERAL /AGREEMENT STATE
JURISDICTION
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
Mental Hygiene
Rules of the City Of New York
Article 175, Radiation control
Section 175.103 Medical use of
radioactive material
MAJOR REGULATORY
REQUIREMENTS:
LICENSING OF RADIOACTIVE MATERIALS USE
ESTABLISHMENT OF A RADIATION SAFETY
COMMITTEE AND APPOINTMENT OF A RADIATION
SAFETY OFFICER
LIMITATION OF HUMAN USE TO QUALIFIED
AUTHORIZED USERS
SUPERVISION
LICENSING OF RADIOACTIVE MATERIAL
“(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)
CUMC / NYPH / NYSPI
NYC DOH&MH LICENSES
Research activities at CUMC, NYPH and NYSPI are
typically performed under:
NYC Radioactive Materials License No. 75-2878-01
- Broad Scope Human use
NYC Radioactive Materials License No. 74-2878-03
-Non-Human in-vitro and animal use
RADIATION SAFETY COMMITTEE
“(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;“
(RCNY 175.103(3)(ii)(B))
CUMC, NYPH & NYSPI JOINT
RADIATION SAFETY COMMITTEE
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.
AUTHORIZED USER: DEFINITION
“(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)
AUTHORIZED USER: QUALIFICATIONS
In NYC the authorized user is to be a physician:
a)
b)
c)
Certified by the American Board of Nuclear Medicine,
American Board of Radiology, or
American Osteopatic Board of Radiology.
b)
Or have completed 200 hours of instruction in radioisotopes,
500 hours of supervised work experience and 500 hours of
supervised clinical experience.
c)
Or have completed a six (6) month training program in nuclear
approved by the Accreditation Council for Graduate Medical
Education.
(RCNY 175.103(j)(3&4))
d)
NEW U.S.N.R.C. REQUIREMENTS
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.
NYC AUTHORIZED USER RESPONSIBILITIES
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)
SUPERVISION: DEFINITION
“(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.”
(RCNY 175.02(218)(ii))
SPECIFIC LICENSEE RESPONSIBILITIES:
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))
ADDITIONAL LICENSEE
REQUIREMENT:
IN ALL CASES:
“(v) A licensee that supervises an individual is
responsible for the acts and omissions of the
supervised individual.”
(RCNY 175.103(b)(5)(v))
NON-EQUIVALENT TERMINALOGIES
REGARDING RESPONSIBLE INDIVIDUALS
USFDA
INVESTIGATOR
SUBINVESTIGATOR
NYC DOH
AUTHORIZED
USER
SUPERVISED
INDIVIDUAL
JRSC
RESPONSIBLE
INVESTIGATOR
“R.I”
CUMC IRB
“R.I.”
PRINCIPAL
INVESTIGATOR
INVESTIGATOR
SPONSOR
SPONSORINVESTIGATOR
LICENSEE
SPONSOR
SPONSORINVESTIGATOR
WHO CAN ADMINISTER RADIOACTIVE
MATERIAL OR THERAPEUTIC RADIATION?
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)
RCNY 175.103(b)(5)(iv)
WHO CAN ADMINISTER DIAGNOSTIC X-RAY
RADIATION?
Licensed Physician
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
INTERPRETATION OF DIAGNOSTIC STUDIES
X-RAY STUDIES
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)
INVESTIGATIONAL NEW DRUG v.s
RADIOACTIVE DRUGS FOR RESEARCH
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.
RADIOACTIVE DRUG RESEARCH
COMMITTE
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 subcommittee of the IRB.
RADIOACTIVE DRUG RESEARCH
COMMITTEE
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
effects
Annual and total radiation dose commitment have
numerical limits
APPLICATIONS AND CONSENTS
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
study.
The consent must accurately inform the subject of the risk
resulting from receiving the radiation dose associated with
the study
RADIATION SAFETY OFFICER
The Licensee is required to appoint a Radiation
Safety Officer to implement the radiation safety
program
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))
RADIATION SAFETY OFFICER
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
(RCNY 175.103(b)(2)
MISADMINISTRATIONS
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%.
(RCNY 175.02(128))
MISADMINISTRATIONS (contd.)
• Recordable misadministrations - the licensee must
make a record of the medical misadministration
and provide it to City inspectors performing
routine audits and inspections of the License or
Registration upon their request.
• Reportable misadministrations - the licensee must
make a report of the medical misadministration to
all the following: the New York City Department
of Health, Office of Radiological Health; the
patient or the patient’s guardian; the attending or
treating physician. A verbal report must be made
within 24 hours followed by a written report
within 7 days. (RCNY 175.07(e))
MISADMINISTRATIONS(contd.)
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)