Human Subject Radiation Committee
| HSRC Review |
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The use of radiation for research purposes must be reviewed and approved by the Human Subject Radiation Committee (HSRC) – a subcommittee of The Ohio State University Radiation Safety Committee – in addition to the IRB before research (or changes to research) may be initiated.
Review Requirements
The HSRC evaluates the “research use” of radiation in human subjects. The HSRC does not routinely review research involving radiologic exams or procedures administered for non-research purposes (i.e., performed as part of standard medical care).
Radiation uses requiring HSRC review include the following:
- Radiologic procedures that are administered solely for experimental or research purposes (i.e., would not otherwise be administered)
- Use of an investigational radiologic device or investigational radiopharmaceutical (e.g., contrast agent, radionuclide)
- Use of radiologic procedures when these procedures are the subject of the investigation (e.g., comparison of radiotherapy delivery methods)
- Standard of care procedures that are being altered as part of research
- Radiologic procedures that are administered in addition to those that the participant would receive as part of standard medical care (i.e., “extra” procedures).
The IRBs may also independently request HSRC review (or re-review) for any proposed study involving radiation when questions arise during the review process. For more information, see HRPP policy Research Involving Radiation.
Type of Review
Administrative Review - For research involving total effective doses of 100 millirem (mrem) or less for all proposed radiologic procedures (including repeat exposures) - for all populations except children, pregnant women, or healthy volunteers.
Expedited Review - For research involving either of the following:
- Total effective doses greater than 100 mrem, but not greater than 3000 mrem (3 rem) - for all populations except children, pregnant women,or healthy volunteers
- Total effective doses of 100 mrem or less in healthy volunteers.
Full (Convened) Review - For research involving any of the following:
- Children
- Pregnant women
- Healthy volunteers receiving total effective doses greater than 100 mrem
- Total effective doses of greater than 3000 mrem (3 rem) for all other populations.
Dose Calculations
Radiation exposures for proposed radiologic procedures are calculated using the Dose Calculator made available by the Duke University Radiation Safety Committee. Online instructions are provided. Dose calculations should be included in Appendix V.
Note: These calculations of effective doses are approximations. Values obtained from the calculator may require adjustment during HSRC review to more accurately reflect the radiologic procedures performed at The Ohio State University.
Click here for the Dose Calculator and Instructions.
Risk language appropriate to the radiation exposure will also be provided by the calculator and should be included in the informed consent process and document. “Choose for Me” should be selected as the wording format. The dose calculation worksheet should be printed and submitted with Appendix V.
Additional resources are available at RADAR Medical Procedure Radiation Dose Calculator and Consent Language Generator and Effective Doses in Radiology and Diagnostic Nuclear Medicine: A Catalog.
Submission Instructions
Research submitted for IRB review will be screened by the Office of Responsible Research Practices (ORRP) to determine if HSRC review is also required. ORRP will facilitate HSRC review, when applicable, by forwarding the following materials to the HSRC prior to IRB review:
- Research Protocol
- Application for Initial Review of Human Subjects Research
- Appendix V – Radiation
- Dose calculation worksheet
- All proposed consent, assent, and/or parental permission forms
The principal investigator will be notified of any modifications requested by HSRC for approval. ORRP will forward the final submission to the IRB for review.
Questions or Assistance
Please contact William White at white.79@osu.edu or 614-292-0263 (fax 614-292-7002) for questions or assistance with dose calculations or HSRC review.
