Any human research protocol involving the administration of ionizing radiation to subjects due to their participation in the protocol (solely) must be reviewed and approved by the Radiation Safety Committee (RSC).
RSC will only review protocols formally submitted to the Institutional Review Board (IRB) within the WRG-HS module.
Research Requiring RSC Approval
- 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
- Standard of care procedures (SOC) that are being altered as part of the research
- Radiologic procedures administered in addition to those the participant would receive as part of standard medical care (i.e., “extra” procedures).
- Studies that involve using radioisotopes or other sources of ionizing radiation (e.g., x-ray machines, nuclear medicine scans, fluoroscopy, bone densitometry, CT, PET-CT, cardiac catheterization, radiation therapy, etc.) for purposes other than the standard of care.
The following is a list of typically used procedures or terms involving ionizing radiation:
DEXA or DXAp
Nuclear medicine scan
Note: RSC approval must be received prior to the commencement of the research project.
Request for Research Subject Dosimetry
Request for Research Subject Dosimetry is located within the WRG-RS.
How to obtain RSC approval?
The RSC submission and review process takes place within the Weill Research Getaway Research Safety module (also known as WRG-RS)
Step 1: Obtain dosimetry by completing the Radiation Safety Dosimetry Request within the WRG-RS module.
Step 2: Select Clinical Safety Application for IBC/RSC - Initial.
Step 3: Enter the protocol title (must be the same as Human Subjects (IRB) protocol).
Step 4: Enter the name of the PI and click Continue. A new window will appear.
Note that your name will appear by default. If you’re entering this on behalf of a PI, please update their name.
Step 5: Open the Clinical Safety Application for IBC/RSC, select from the drop down menu: RSC-Radiation Safety
Human Subjects Application.
Step 6: Link the RSC Application to corresponding Human Subjects (IRB) protocol.
Step 7: The following documents must be available in Human Subjects module within the Weill Research Getaway:
Full written Clinical Protocol and Dosimetry Report(s). Missing documents will impact the RSC review timeline.
Note: Any Informed Consent Forms (ICFs) require the recomended Radiation Safety Committee language available below.
However, it is not required to submit the ICFs to the RSC for review. The WCM Institutional Review Board will ensure
that the required radiation risk language is incorporated into the ICF(s) before providing final IRB approval.
Step 8: The Principal Investigator (PI) must submit the RSC-Radiation Safety Human Subjects Application to the RSC for review.
- Procedures that are Standard of Care (SOC) for the study cohort do not require RSC review or approval.
- MRI and ultrasound procedures do not require RSC review or approval.
Changes that Could Impact the RSC Approval
Changes that could potentially impact the initial RSC approval may include, but are not limited to changes in one of the following: age of subjects, patient population, radiation dose or models used to estimate radiation dose, wording in protocol consents and assents related to administration of radiation, regimen for administration of radiation, and change of the PI. Investigators are responsible for obtaining RSC approval prior to initiating these changes, following the same submission process within the WRG-RS by creating the amendment to previously approved application.
For further assistance contact us at firstname.lastname@example.org.
Radiation Risk Language for Consent Forms
Communication of risk to research subjects is an essential part of the consent form. The risk must be communicated in easily understood language. Most risk factors are derived from data involving uniform exposure of the whole body. However, most exposures to research subjects are limited to a part of the body or, in the case of radiopharmaceuticals, result in non-homogeneous exposure to the whole body.
RSC Links & Resources