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Example Statements of Risk Language for Consent Forms for Diagnostic Imaging

Radiation exposure is SOLELY a result of being in the research study (i.e., insurance is NOT paying for the procedure)

This research study involves exposure to radiation from the [name procedure(s)].  Therefore you will receive a radiation dose.  This radiation dose is not necessary for your medical care and will occur only as a result of your participation in the study.  At doses much higher than you will receive, radiation is known to increase the risk of developing cancer after many years.  At the doses you will receive, it is very likely that you will see no effects at all.

Radiation exposure, IF IT DOES OCCUR, would be SOLELY a result of being in the research study

This research study may involve exposure to radiation from the [name procedure(s)].  Therefore, you may receive a radiation dose.  This radiation dose would not be necessary for your medical care and would occur only as a result of your participation in the study.  At doses much higher than you would receive, radiation is known to increase the risk of developing cancer after many years.  At the doses you would receive, it is very likely that you would see no effects at all.

Some or all of radiation exposure MAY POSSIBLY occur even if the subject doesn't participate in the research study

This research study involves exposure to radiation from the [name procedure(s)] and therefore you will receive a radiation dose.  You may have some or all of these procedures even if you do not participate in this study.  At doses much higher than you will receive, radiation is known to increase the risk of developing cancer after many years.  At the doses you will receive, it is very likely that you will see no effects at all.

 

Example Statements of Risk Language for Consent Forms for HIGHER DOSE Diagnostic Imaging (e.g., numerous CTs, extensive fluoroscopy use)


If acute biological effects, such as skin reddining or hair loss, are possible, additional risk language may need to be added to the standard risk language.

Skin Reddening (Erythema) from Cardiac Catheterization or Similar Procedures

It is possible that skin reddening or other alterations to the skin’s appearance may occur if you are exposed to enough radiation during this procedure or if you recently had another catheterization procedures.  This reddening may occur at any place on your chest or back.  You should contact your doctor in the event that you observe any change to the appearance of your skin.

Skin Reddening (Erythema) and Hair Loss (Epilation) from Numerous CTs of Head

It is possible that skin reddening or hair loss may occur if you are exposed to enough radiation during the CT scans of your head.  You should contact your doctor in the event that you observe any change to the appearance of your skin or hair. 

If you need assistance with determining the correct risk language to use or have any questions, please contact:

William Davidson
 wed@ehrs.upenn.edu
215-898-2133