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Current structure of review of Human Research Protocols that involve ionizing radiation. Chaitanya Divgi, MD crdivgi@columbia.edu. Protocol utilizing ionizing radiation in human subjects. Standard of care – NO JRSC review No increase in amount of Ionizing radiation – EXPEDITED JRSC review

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current structure of review of human research protocols that involve ionizing radiation

Current structure of review of Human Research Protocols that involve ionizing radiation

Chaitanya Divgi, MD

crdivgi@columbia.edu

protocol utilizing ionizing radiation in human subjects
Protocol utilizing ionizing radiation in human subjects
  • Standard of care – NO JRSC review
  • No increase in amount of Ionizing radiation – EXPEDITED JRSC review
  • ALL other – JRSC review
points to consider
Points to consider
  • Does the protocol include the use of ionizing radiation?
  • Would the subject have received ionizing radiation if not for the protocol?
  • Would the subject have received less ionizing radiation if not for the protocol?
    • If yes, why does the subject need to receive the additional ionizing radiation?
  • If there are experimental devices/drugs that include ionizing radiation, are there appropriate IND/IDE approvals/exemptions in place?
review algorithm
Review algorithm
  • Back to PI
  • Back to PI
  • Back to PI
  • Back to IRB
  • To IRB
dosimetry review of human research protocols

Dosimetry Review of Human Research Protocols

Thomas L Morgan, Ph.D., CHP

Executive Director, Radiation Safety

Chief Radiation Safety Officer

principles of radiation protection of human subjects
Principles of Radiation Protection of Human Subjects
  • Justification: expected benefits to society exceed the overall societal cost
  • ALARA: total societal detriment from such justifiable activities is ALARA, economic and social factors being taken in to account
  • Limitation: apply individual dose limits to ensure that individuals or groups of individuals do not exceed levels of acceptable risk
scientific review
Scientific Review
  • Why is radiation necessary?
    • “We hypothesize that drug XYZ will accelerate fracture healing. Radiographs will be necessary to assess healing at various time points”
  • How will it be used?
    • “14 lateral and 14 AP radiographs of the wrist will be taken over 52 weeks”
dosimetry review
Dosimetry Review
  • Appropriate studies are being performed (Justification)
  • Radiation dose is the minimum necessary to collect and analyze required data (ALARA & Limitation)
  • Minimum number of subjects are enrolled consistent with the objectives of the study (Limitation)
    • No “fishing” expeditions
dosimetry review1
Dosimetry Review
  • Review data dose data presented and check cited references
  • Suggest corrections as necessary
  • Review risk language on Informed Consent Form
  • Comments returned to P.I.
  • P.I. makes changes and returns for final dosimetry review