The HUS-RSC evaluates and approves or disapproves all proposed uses of ionizing radiation sources on or in human subjects for investigational or non-routine clinical procedures. This subcommittee reports to the Radiation Safety Committee.
References
Guidance Document for Preparing Studies for Human Use Subcommittee Review
Late Stage Cancer SOP
University of Utah RPR 48-1: Human Use Subcommittee
FAQs
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Call Radiation Safety (801-581-6590) and ask to speak to the HUS Internal Reviewer.
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Call Radiation Safety (801-581-6590) and ask to speak to the HUS Internal Reviewer with any questions.
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When submitted, studies involving research scans are sent to a Responsible User (RU) for review and approval, before being sent to the HUS Internal Reviewer. Studies involving only Standard of Care (SOC) scans are sent directly to HUS internal review. Internal review will typically take up to 3 business days, after which the study is returned to the study team for corrections or sent to HUS committee review. Committee review will typically take up to 5 business days.
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Most approval delays are the result of applications which need to be sent back to the PI for revisions. See "Common Causes for Revisions Request".
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Although there are exceptions, the primary means of obtaining dosimetry reports is by accessing the Online Dosimetry Calculator. Contact Dr. Peter Jenkins if you have any questions about the calculator; contact Radiation Safety (801-581-6590) and ask to speak to the HUS Internal Reviewer regarding any other questions.
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Yes. All human use studies that include radiation procedures must be reviewed.
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Once submitted, you are unable to pull a study back. To have a study sent back to the study team, contact Radiation Safety (801-581-6590) and ask to speak to the HUS Internal Reviewer.
Common Causes for Revision Requests
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- The number/types of ionizing radiation-related scans/ procedures presented in the study document(s) (i.e. Consent Documents, Protocol, and Application for Ionizing Radiation Use in Human Research Studies) are inconsistent.
- The language in the consent document(s) is confusing regarding which scans/ procedures are considered standard of care, and which exceed standard of care.
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- The consent document(s) lack language required by the Guidance Document for Preparing Studies for Human Use Subcommittee Review
- The consent document(s) contain(s) risk language that is not in conformance with the Guidance Document for Preparing Studies for Human Use Subcommittee Review
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These indicators are as follows:
- Scan/procedure(s) are performed only within the research portion of the study
- Scan/procedure(s) are paid by the sponsor
- Scan/procedure(s) are being performed to monitor the safety of the study subject
- Scan/procedure(s) are performed outside of a normal, consistent scan cycle
- Scan/procedure frequency seems excessive
- PI has reservations regarding using the language approved for SOC scans/procedures
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- Validation that the calculation was performed by qualified Medical Physicist (credentials, biosketch, and/or CV are acceptable)
- Effective dose for each individual type of research scan/procedure as well as the cumulative dose for the entire study that accounts for the total number of each type of scan/procedure. Note that the dose estimates should be specific to the equipment and local procedures that are used and they must be provided for each relevant age range of participants in the study (e.g., adult vs. pediatric and specific age ranges for pediatrics). The dosimetry report should include an assessment of all research-related ionizing radiation scans/procedures for either:
- Fixed term study: dosimetry that accounts for all research scans/procedures over the course of the study should be provided, and the consent document(s) should have appropriate language based on this cumulative dosimetry.
- Cycle-based study: dosimetry that accounts for the maximum number of research scans/procedures given in any one year should be provided, and the consent document(s) should have appropriate language based on this dosimetry. The Application for Ionizing Radiation Use in Human Research Studies should also state the cycle frequency.
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- Required document(s) are not attached (e.g. dosimetry report, consent document(s), protocol).
- Required application data has not been completed correctly (e.g. study subject information, scan/procedure schedule).
- Any attachment fails to open, even if not required (this is a cautionary measure to ensure the Committee does not approve documents they cannot see).
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As there is also radiation from the CT component, it needs to be listed as part of the scan.
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The scope of the HUS-RSC involves the review of ionizing-radiation related scans/ procedures in human use studies. Non-ionizing radiation scan/ procedures are not reviewed by the HUS-RSC.