Shared decision-making: is it time to obtain informed consent before radiologic examinations utilizing ionizing radiation? Legal and ethical implications.

Concerns about the possibility of developing cancer due to diagnostic imaging examinations utilizing ionizing radiation exposure are increasing. Research studies of survivors of atomic bomb explosions, nuclear reactor accidents, and other unanticipated exposures to similar radiation have led to varying conclusions regarding the stochastic effects of radiation exposure. That high doses of ionizing radiation cause cancer in humans is generally accepted, but the question of whether diagnostic levels of radiation cause cancer continues to be hotly debated. It cannot be denied that overexposure to ionizing radiation beyond a certain threshold, which has not been exactly determined, does generate cancer. This causes a dilemma: what should patients be informed about the possibility that a CT or similar examination might cause cancer later in life? At present, there is no consensus in the radiology community as to whether informed consent must be obtained from a patient before the patient undergoes a CT or similar examination. The author analyzes whether there is a legal duty mandating radiologists to obtain such informed consent but also, irrespective of the law, whether there an ethical duty that compels radiologists to inform patients of potential adverse effects of ionizing radiation. Over the past decade, there has been a noticeable shift from a benevolent, paternalistic approach to medical care to an autonomy-based, shared-decision-making approach, whereby patient and physician work as partners in determining what is medically best for the patient. Radiologists should discuss the benefits and hazards of imaging with their patients.