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.
For research involving total effective doses of 500 millirem (mrem) or less for all proposed radiologic procedures (including repeat exposures) – for all populations.
For research involving either of the following:
- total effective doses greater than 500 mrem, but not greater than 5000 mrem (5 rem) – for all populations except children and pregnant women
Full (Convened) Review
For research involving any of the following:
- children receiving total effective doses greater than 500 mrem
- pregnant women receiving total effective doses greater than 500 mrem
- total effective doses of greater than 5000 mrem (5 rem) for all other populations
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 uploaded into the Buck-IRB system.
- An additional resource is available at 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, RADAR, Inc. 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.
Contact Dramane Konate, Radiation Safety Officer, for questions or assistance with dose calculations or HSRC review.