Human Subjects and Radiation

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.

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. 

Radiation exposures for proposed radiologic procedures are calculated using the Dose Calculator made available by RADAR, Inc. 

• 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. A copy of the RADAR, Inc. worksheet, which provides dose calculations and recommended consent language, must be provided for HSRC review.
• An additional resource is available at Effective Doses in Radiology and Diagnostic Nuclear Medicine: A Catalog.

Requests for HSRC review should be emailed directly to the HSRC contacts noted below using the subject line “HSRC Review – IRB Protocol.” Emails must contain the following: 

• Principle Investigator’s Full Name and Research Study Title
• The appropriate protocol templates along with Appendix O-Radiation. All are available in the Huron System Library [IRB > Library > Templates]. Note:
  • Include the study ID and study title on the Appendix O-form.
  • The biomedical and cancer, or the behavioral and social sciences template must be used for all investigator-initiated research studies written and designed by an Ohio State investigator.
  • A site supplement protocol template must be completed for studies written or developed in collaboration with a company when the company requires the use of their template. Both the company’s template and the supplement must be provided.
• A copy of the RADAR, Inc. dose calculation. If the RADAR form is not applicable, please provide additional documentation to support effective dose calculations. (i.e., publications)
• A copy of the informed consent form template that includes risk language appropriate to the radiation exposure provided by the RADAR, Inc. calculator.
• The HSRC contact will notify the study team of any needed clarifications or revisions. Once HSRC approval is received, a copy of the HSRC approval letter should be uploaded into the Huron IRB system submission.

• Dramane Konate, Radiation & Research Safety
  konate.7@osu.edu
• Alicia McGough, Medical Health Physicist
  mcgough.14@osu.edu