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) via the eIRB.
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:
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
Request for Research Subject Dosimetry: Contact the Office of Health Physics at email@example.com for assistance prior to submitting the protocol to the IRB or to Radiology for review.
How to obtain RSC approval?
If your IRB protocol requires RSC review, submit the following documents to firstname.lastname@example.org
a) Cover letter stating the non-SOC procedure(s) and frequency performed
b) PDF of the completed IRB protocol
c) ICF (must contain the mandatory radiation safety language as outlined below)
- 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.
RSC Links & Resources