Current structure of review of Human Research Protocols

that involve ionizing radiation

Chaitanya Divgi, MDcrdivgi@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

ALL other – JRSC review

Points to considerDoes 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 algorithmIonizi

ng radiation Y/N

• Protocol sent to IRB• Protocol sent to JRSC

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

Back to PIBack to IRB

Back to PI

Back to PI

To IRB

Dosimetry Review of Human Research Protocols

Thomas L Morgan, Ph.D., CHPExecutive Director, Radiation SafetyChief Radiation Safety Officer

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 ReviewWhy 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 ReviewAppropriate 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 ReviewReview 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