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
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Standard of care – NO JRSC review
No increase in amount of Ionizing radiation – EXPEDITED JRSC review
ALL other – JRSC review

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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?

Ionizing radiation
Y/N
• Protocol sent to IRB
• Protocol sent to JRSC
Back to PI
Primary reviewer identified
• Dosimetry review
• Initial review by JRSC Chair
• Primary reviewer assigned by JRSC Chair
• Reviewer within HUS (MD)
• Ad hoc review by additional JRSC members
• Ad hoc Presentation by PI/RI
Back to IRB
• Formal critique presented at HUS
• Approve/Pending /Returned/ Disapprove
To IRB
Back to PI
Back to PI
Back to IRB

Thomas L Morgan, Ph.D., CHP
Executive Director, Radiation Safety
Chief Radiation Safety Officer

Principles of Radiation
Protection of Human Subjects
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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

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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”

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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

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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