Human Subject Radiation Committee
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. The university has obtained a variance for conducting research involving radiation in the state of Ohio. For more information, see the Variance Letter (June 2014) from the Ohio Department of Health.
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:
- 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.
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.
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.
Risk language appropriate to the radiation exposure will 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 option. A copy of the Duke worksheet, which provides dose calculations and recommended consent language, must be uploaded into the Buck-IRB system.
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.
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 appropriate, by forwarding applicable sections of the submission and relevant materials (e.g., protocol, Duke dose calculation worksheet) to the HSRC prior to IRB review.
Alternatively, researchers may complete the Radiation Pre-Submission Worksheet. This form may be sent directly to the HSRC (see below) for review prior to submitting to the IRB or used as a guide for completing the radiation-related questions within Buck-IRB.
The principal investigator will be notified of any modifications requested by the HSRC for approval. Once approved, ORRP will forward the submission for IRB review.
Questions or Assistance
Please contact George Hinkle at firstname.lastname@example.org or 614-247-6403 for questions or assistance with dose calculations or HSRC review.
George H. Hinkle, RPh, MS, BCNP
Radiation Safety Officer
Environmental Health & Safety