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Human Subject Research

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  1. Human Subject Research Administration of Radiation and Radioactive Materials

  2. 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

  3. 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

  4. Rules of the City Of New YorkArticle 175, Radiation controlSection 175.103 Medical use of radioactive material

  5. 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

  6. 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)

  7. 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

  8. 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))

  9. 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.

  10. 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)

  11. AUTHORIZED USER: QUALIFICATIONS 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))

  12. 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.

  13. 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)

  14. 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))

  15. 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))

  16. 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))

  17. NON-EQUIVALENT TERMINALOGIES REGARDING RESPONSIBLE INDIVIDUALS

  18. 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)

  19. 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

  20. 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)

  21. 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.

  22. 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 sub- committee of the IRB.

  23. 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

  24. 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

  25. 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))

  26. 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)

  27. 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))

  28. 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))

  29. 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)