How should the risks of radiation be reflected in the consent form?
Standard Statements of Risk for Consent Forms Involving DIAGNOSTIC Uses of Radiation and Radioactive Material Language for protocols involving exposures below 10,000 mrem effective dose: This research study involves exposure to radiation from a [name procedure(s)] and 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. Language for protocols involving exposures above 10,000 mrem effective dose: Statements of risk from diagnostic uses resulting in greater than 10,000 will be approved on a case-by-case basis. Note: If biological effects are anticipated from the radiation, regardless of the effective dose, then a statement about the biological effect must be include
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