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 OSU 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 research. Such uses include the following:
- Radiologic procedures that are administered solely for experimental or research purposes (i.e., would not otherwise be administered)
- 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 HSRC does not routinely review research involving radiologic exams or procedures that would have been administered for non-research purposes (i.e., performed as part of standard medical care). 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 the OSU HRPP policy Research Involving Radiation.
Type of Review
Administrative Review - For research with an effective dose equivalent of 100 millirem (mrem) or less for all proposed radiologic procedures.
Expedited Review - For research with an effective dose equivalent of greater than 100 mrem, but not greater than 3 rem (3000 mrem), for all proposed radiologic procedures.
Full (Convened) Review - For research involving any of the following:
- An effective dose equivalent of greater than 3 rem for all proposed radiologic procedures (including repeat exposures)
- Children
- Pregnant women
- Healthy volunteers.
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.
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.
Click here for the Dose Calculator and Instructions.
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 614-292-1284 for questions or assistance with the dose calculator or HSRC review.
