Basic Consent Language

Below are some suggestions for consent language to communicate the risk from radiation exposure. These statements should not be considered complete by themselves. Please note that effective dose values should be summed for all procedures involving radiation exposure. Make sure that values are expressed in the appropriate units (use rem; 1 rem = 1000mrem) in the consent form statement.

Effective Dose up to 1 Rem

"This research study involves exposure to radiation from (name the studies to be performed). The risk of this (these) procedure(s) is small and is similar to that received from clinical x-ray and nuclear medicine studies. The amount of radiation exposure that you will receive from this (these) procedure(s) is equivalent to a uniform whole body exposure of (_______) millirem. This is equal to (_______ times or _____% of) the amount of background radiation that the average person in the United States receives each year (annual background = 360 millirem)."

Effective Dose Between 1 and 3 Rem

"This research study involves exposure to radiation from (name the studies to be performed). The amount of radiation that you will receive from this (these) procedure(s) is equivalent to a uniform whole body dose of (_____) rem. This is equal to (_____)% of the yearly radiation exposure limit allowed for a radiation worker (5 rem)."

Effective Dose Between 3 and 5 Rem

"This research study involves exposure to radiation from (names of the studies to be performed). The amount of radiation that you will receive from this (these) procedure(s) is equivalent to a uniform whole body exposure of (_____) rem. This is equal to (_____% of or times) the yearly radiation exposure limit allowed for a radiation worker (5 rem). The risk from this radiation exposure is considered to be comparable to other everyday risks."

Effective Dose Greater Than 5 Rem

"This research study involves exposure to radiation from (names of the studies to be performed). The amount of radiation exposure you will receive from this (these) procedure(s) is equivalent to a uniform whole body dose of (_____) rem. The parts of your body that will get the most radiation are (investigator: list any organ with a dose that exceeds 15 rem). This is equal to (_____) times the annual radiation exposure limit allowed for a radiation worker (5 rem) and is greater than the amount of radiation that you would get if you were having any of the usual x-rays or scans done on sick patients. There may be a very small chance that the radiation could cause a cancer. The excess cancer risk from the radiation is estimated to be about (_____)% where the lifetime cancer risk is about 20%. The benefit(s) for your participation is (are) __________________________________."

To fill in the excess cancer blank above, use the following:

0.04% per rem (eg. 5 rem: = 0.2% and 10 rem: = 0.4%)

Medical Physicist

Peter Jenkins, PhD, CHP, DABR
Department of Radiology30 North 1900 East #1A071Salt Lake City, Utah 84132-2140Phone: (801) 585-0235Email:peter.jenkins@hsc.utah.edu

Peter Jenkins, PhD, CHP, DABR

Department of Radiology
30 North 1900 East #1A071
Salt Lake City, Utah 84132-2140
Phone: (801) 585-0235
Email:peter.jenkins@hsc.utah.edu