Any human research protocol involving the administration of ionizing radiation to subjects as a result of their participation in the protocol (solely) must be reviewed and approved by the Radiation Safety Committee (RSC).
RSC will only review protocols that have been formally submitted to the Institutional Review Board (IRB) within the WRG-HS module.
The following is a list of typically used procedures or terms involving ionizing radiation:
DEXA or DXA
Nuclear medicine scan
Note: RSC approval must be received prior to the commencement of the research project.
Request for Research Subject Dosimetry is located within the WRG-RS.
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:
Clinical Protocol and Informed Consent Form(s). Missing documents will impact the RSC review timeline.
Step 8: Informed Consent Form (must contain the mandatory radiation safety language available below.
Step 9: Submit the RSC-Radiation Safety Human Subjects Application to the RSC for review.
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.
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Communication of risk to research subjects is an essential part of the consent form. It is important that the risk 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 of the whole body.