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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. 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

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  1. Current structure of review of Human Research Protocols that involve ionizing radiation Chaitanya Divgi, MD crdivgi@columbia.edu

  2. 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

  3. 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?

  4. Review algorithm • Back to PI • Back to PI • Back to PI • Back to IRB • To IRB

  5. Dosimetry Review of Human Research Protocols Thomas L Morgan, Ph.D., CHP Executive Director, Radiation Safety Chief Radiation Safety Officer

  6. 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

  7. 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”

  8. 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

  9. 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

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