Version Date: 09/2020
PO Box 245101
Tucson, AZ 85724-5101
Voice: (520) 626-6850
FAX: (520) 626-2583
rlss.arizona.edu
Informed Consent Form Radiation Risk Language
University of Arizona Radiation Safety Committee Human Use Subcommittee model risk language.
Bone Scan: Bone scans are used to determine the presence and/or extent of certain abnormalities in your
bones and require the injection of a small amount of radioactive substance into your vein. The radioactivity
injected in your body will expose you to radiation. The amount of radiation is small, so your radiation exposure
is low, and the risk is considered small. There is a chance that you may experience discomfort, pain or swelling
at the injection site and, as is the case with any injection, there is an increased risk of infection at the site.
Diagnostic x-ray (Radiography): Diagnostic x-rays may be repeated if required by the study, or if
clinically indicated by your doctor. Such procedures as described above in this consent form are to evaluate
your disease. The total radiation dose you will receive from the x-rays in this study are small and the risks
are negligible.
CT scan: There is a potential risk from the radiation exposure received from a CT scan, but this risk from
a single CT scan is considered small. Sometimes, an intravenous (in the vein) contrast dye is given with a CT
scan. This contrast dye is iodine based. A person who has allergies is more likely to have an allergic reaction
to the dye. This reaction may be mild, such as skin rash or hives, to severe, such as breathing difficulties or
shock. You will be closely monitored and treated should an allergic reaction occur. A severe allergic reaction
would require immediate medical treatment and could result in permanent disability or death. You should
discuss any history of allergies or concerns with your doctor. You may also experience discomfort related to
lying still in an enclosed space for a prolonged period.
PET Scan (Positron Emission Tomography) : A PET scan is a nuclear imaging test that scans your body
and produces images for detecting abnormalities such as cancer. Before the scan, a radiopharmaceutical is
injected into your vein which helps visualize your body function in the PET scan. The amount of radiation to
your body from this scan is considered low and the risk is considered small. There is a chance that you may
experience discomfort, pain or swelling at the injection site and, as is the case with any injection, there is an
increased risk of infection at the site.
Fluoroscopy: Fluoroscopy carries some risks, as do other X-ray procedures. Fluoroscopy is an x-ray
imaging procedure and it used to image physiological motion in the body or for imaging a catheter insertion
and manipulation (to direct the movement of a catheter through blood vessels, bile ducts or the urinary
system). The radiation dose the patient receives varies depending on the individual procedure. Fluoroscopy
can result in relatively high radiation doses, especially for complex interventional procedures which require
fluoroscopy be administered for a long period of time. Radiation-related risks associated with fluoroscopy
include:
o skin injuries, which are rare and usually happen only during prolonged or complicated procedures or
when there are problems during the procedure, and
o radiation-induced cancers; this risk is considered small.
Mammogram: The risks to you associated with mammograms are small. Some discomfort can be
associated with mammograms because of breast compression. Mammograms also require exposure to a small
amount of radiation and the risk is considered small.
Version Date: 09/2020
PO Box 245101
Tucson, AZ 85724-5101
Voice: (520) 626-6850
FAX: (520) 626-2583
rlss.arizona.edu
MUGA scan: The MUGA heart scan takes images of the beating heart to see how well your heart is
pumping blood. It will be done using a radioactive tracer. The radioactive tracer will be injected through a
needle placed in the vein of your arm. The amount of radiation is very low and the risk is considered very
small. The radiology staff will check you closely for an allergic reaction, which is rare but could be life-
threatening. There is a chance that you may experience discomfort, pain or swelling at the injection site and,
as is the case with any injection, there is an increased risk of infection at the site.
MRI scan: Having an MRI (Magnetic Resonance Imaging) scan involves lying still on a table that slides
into a tunnel slightly wider than your body. People who feel uncomfortable in confined spaces may feel
uncomfortable in the narrow cylinder. If you feel uncomfortable in confined spaces, please tell your study
doctor. Your study doctor may give you a medication to make you feel more comfortable.
An intravenous (in the vein) contrast dye is given with an MRI. Some people can have allergic reactions to
the dye put in their veins for these tests. The allergic reactions can cause itching or rash. More serious allergic
reactions can cause difficulty breathing, dangerously low blood pressure, or kidney damage. Some patients
with kidney disease may have a severe reaction of skin thickening, joint pain and/or swelling, and in rare
cases, lung and heart problems and even death.
MRI uses powerful magnets to make images. Therefore, people with certain metal implants, such as
pacemakers, should not have an MRI. If you have an implant or any metal in your body, please check with
your study care doctor to know whether you can have an MRI or not. For people without metal implants, there
are no known health risks associated with exposure to the magnet. As images are taken, a loud banging noise
is produced. Earplugs or headphones will be available if needed. The MRI can be stopped at any time at your
request, but the scan may not be complete.