Radioactive materials and radiation-producing devices play an important role in medical research and teaching, as well as in the diagnosis and treatment of disease at Rush University. The use of these materials and devices is authorized and governed by federal, state and local regulations, in addition to policies and procedures established by the university and its associated medical facilities.
Because radiation can be potentially hazardous to human health, Rush has established its Radiation Safety Program, which supports the safe use of these tools by establishing structures and procedures to ensure that: any hazards associated with the use of radioactive materials or radiation-producing devices are minimized; and that all uses of these materials and devices are in compliance with applicable regulatory requirements.
Rush University Medical Center’s Radiation Safety Program operates under the direction of Radiation Safety Officer (RSO) William White and Assistant Radiation Officer Heather Merchantz. Mark Supanich, PhD, chairs the program’s broad-based Radiation Safety Committee (RSC), as required by the state of Illinois. All routine clinical and research laboratory aspects of ionizing radiation use are managed by the RSO under the RSC’s oversight. Procedures governing the use of radioactive materials and analytical X-ray devices at Rush University, as well as manuals, handbooks and applications for principal investigators (PIs) requesting the use of radioactive material in research labs can be found on Inside Rush.
In addition, lead-apron garments for X-ray use must be inventoried and inspected on an annual basis. Questions and inquiries for lead apron garments should be directed to LeadApron_Check@rush.edu.
The RSC also is responsible for overseeing all uses of radioactive material. Therefore, all clinical and non-clinical uses of ionizing radiation for research purposes must be reviewed and approved by the RSC. All research studies using ionizing radiation for treatment, guidance or localization, screening or treatment-response assessment must be submitted to the RSC for radiation safety review. If the use of ionizing radiation is determined to be consistent with the prevailing Standard of Care (SOC), no further review is necessary. However, If the use of ionizing radiation differs from the standard of care or presents unknown or increased radiation risks, a designee of the RSC will review the protocol and informed-consent document and provide model radiation-risk consent language if required. Some protocols, such as new uses of radioactive materials, may require full RSC review.
Investigators and research teams at Rush primarily use ionizing radiation for X-rays, CT scans, radiation oncology and external radiation beams as they relate to clinical trials. Every research study is led by a project manager who determines the team’s department-specific training. The Rush Learning Hub also provides training modules that may be required initially and/or annually as determined by the RSO. Research teams may ask the RSC to arrange for specific types of research training, or the RSC may reach out to researchers with training requests. In any case, two-way communication remains a constant, and investigators and teams are always welcome to reach out to the RSC at radiation_safety@rush.edu.
The RSC delegates responsibility to a subset of RSC members to review clinical-research use of ionizing radiation. The review process is designed to ensure that the radiation risks associated with participating in various types of research are presented in language that is clear and easy for participants to understand. Any use of radiation in a research study requires researchers to fill out a Radiation Safety Review smart form by logging into the Rush Research Portal. This is a web-based form with branching logic that walks investigators and their teams through the process of submitting required information to be reviewed by the RSC designee.
The various standard types of RSC-recommended radiation-risk language to include in informed consents for studies using ionizing radiation (differing in dose or physiological effect from the standard of care for individuals not participating in the research) are given below. A guidance document on completing the RSC Smart Form in the portal follows the model consent language.
To complete the RSC smart form on the Rush Research Portal, you’ll follow the following steps.
Answering Yes to question 6.0 – “Does this study use ionizing radiation (such as X-ray, CT, fluoroscopy, radioactive materials, or radiation therapy)?” – will open the Radiation Safety module for completion and activate the Create Radiation Safety button in your left task bar.
To create a new Radiation Safety application, click on the Create Radiation Safety button on the left task bar.
If the dose differs (i.e., lower, higher, different location, more frequently, different administration route) from the SOC, check Yes. If the dose does not differ, check No and complete the final application questions for review.
A good rule of thumb for determining CT imaging SOC: 1X every 3 months is a typical SOC regime for CT imaging.
Typically, a single chest X-ray is SOC. More than one X-ray would be an increase in radiation dose.
Think about the campus location where the procedure will occur to determine the type of radiation. For example, if the procedure will occur on the 4th or 5th floor of the Tower, it will most likely be an image-guided intervention.
You may select more than one type. Based on your choices above, the application will branch out correspondingly. Choosing Brachytherapy, Diagnostic Radioisotope, External Beam Therapy or Therapeutic Radioisotope choices branch to reveal:
Only one radio button may be selected on this screen.
If there is not an approved authorized user listed or if you don’t see the user you need, email radiation_safety@rush.edu.
Radiation Dose Calculations are determined from the radiation dose and subject information entered. You will be asked if you accept the calculated average excess risk.
These questions provide the template ICF language to use. Please adapt it to your study, and enter the final version into the text box and your ICF for use.
Please enter a few sentences about what the radiation is. Denoting the page number in the protocol where radiation is discussed would be useful. Also, include the page number of the schedule of events here.
This question provides the template ICF language to use. Please adapt it to your study, and enter the final version into the text box and your ICF for use.
It is possible to select more than one type of ionizing radiation used in your study that deviates from the SOC. This will send you down individual pathways as above.
Some pathways will inform you that a Radiation Safety Committee member needs to review the protocol to suggest the appropriate Informed Consent Form (ICF) language. Different language is presented for different-use scenarios as you navigate the module. These ICF language suggestions will be communicated directly to the individual submitting via the Rush Research Portal. Please adapt the recommended language specifically to your study.