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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

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Human subject research

Human Subject Research

Administration of

Radiation and Radioactive Materials


Human subject research
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
FEDERAL /AGREEMENT STATE JURISDICTION to specific Federal and Agreement State Regulation

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


Human subject research
Rules of the City Of New York to specific Federal and Agreement State RegulationArticle 175, Radiation controlSection 175.103 Medical use of radioactive material


Major regulatory requirements
MAJOR REGULATORY REQUIREMENTS: to specific Federal and Agreement State Regulation

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
LICENSING OF RADIOACTIVE MATERIAL to specific Federal and Agreement State Regulation

“(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
CUMC / NYPH / NYSPI to specific Federal and Agreement State RegulationNYC 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
RADIATION SAFETY COMMITTEE to specific Federal and Agreement State Regulation

“(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
CUMC, NYPH & NYSPI JOINT RADIATION SAFETY COMMITTEE to specific Federal and Agreement State Regulation

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
AUTHORIZED USER: DEFINITION to specific Federal and Agreement State Regulation

“(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
AUTHORIZED USER: QUALIFICATIONS to specific Federal and Agreement State Regulation

In NYC the authorized user is to be a physician:

  • 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.

  • 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))


New u s n r c requirements
NEW U.S.N.R.C. REQUIREMENTS to specific Federal and Agreement State Regulation

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
NYC AUTHORIZED USER RESPONSIBILITIES to specific Federal and Agreement State Regulation

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
SUPERVISION: DEFINITION to specific Federal and Agreement State Regulation

“(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
SPECIFIC LICENSEE RESPONSIBILITIES to specific Federal and Agreement State Regulation:

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
ADDITIONAL LICENSEE REQUIREMENT: to specific Federal and Agreement State Regulation

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))



Who can administer radioactive material or therapeutic radiation
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
WHO CAN ADMINISTER DIAGNOSTIC X-RAY RADIATION 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
INTERPRETATION OF DIAGNOSTIC STUDIES RADIATION

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
INVESTIGATIONAL NEW DRUG v.s RADIOACTIVE DRUGS FOR RESEARCH RADIATION

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
RADIOACTIVE DRUG RESEARCH COMMITTE RADIATION

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.


Radioactive drug research committee
RADIOACTIVE DRUG RESEARCH COMMITTEE RADIATION

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
APPLICATIONS AND CONSENTS RADIATION

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
RADIATION SAFETY OFFICER RADIATION

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 officer1
RADIATION SAFETY OFFICER RADIATION

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)


Human subject research

MISADMINISTRATIONS RADIATION

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))


Human subject research

MISADMINISTRATIONS (contd.) RADIATION

  • •  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))


Human subject research

MISADMINISTRATIONS(contd.) RADIATION

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)