Human Research Radiation Safety

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.

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 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).
  • Studies that involve the use of 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:

X-ray

Radiograph

CT scans

DEXA or DXA

pQCT

Nuclear medicine scan

PET scan

FDG scan

Bone scan

MUGA

Angiogram

 

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:

            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.

  • 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.

Radiation Risk Language for Consent Forms

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.

Radiation Risk Language for Consent Form

RSC Links & Resources

WRG Instructions how to submit the RSC Application

Instructions how to obtain access to WRG-RS