Transcript Dosimetry Review of Human Research Protocols

Current structure of
review of Human Research
Protocols that involve ionizing
radiation
Chaitanya Divgi, MD
[email protected]
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
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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
Ionizing radiation
Y/N
Primary
reviewer
identified
Back to IRB
Back to PI
• Protocol sent to IRB
• Protocol sent to JRSC
• 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
• Formal critique presented at HUS
• Approve/Pending/Returned/Disapprove
To IRB
Back to PI
Back to PI
Back to IRB
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
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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
Scientific Review
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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”
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 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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