Current structure of review of Human Research Protocols that involve ionizing radiation Chaitanya Divgi, MD

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 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 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 PI Back to IRB Back to PI 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 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 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