Barriers to Informed Consent In Medical Imaging


Informed Consent A new era of informed consent may be upon the medical imaging field.

Current studies suggest that 95 percent of patients are not informed of any radiation risk prior to a medical imaging exam, according to Richard C. Semelka, M.D., Department of Radiology, University of North Carolina-Chapel Hill and colleagues. While this figure may come as a surprise, James A. Brink, M.D., Department of Diagnostic Radiology, Yale University School of Medicine and colleagues believe that informed consent has lost its true intent.

“. …We must return to the value of education rather than legal documentation,” Brink said. He and his colleagues maintain that a relatively new standard—the prudent patient doctrine—should be used instead of informed consent. The doctrine would emphasize providing information to the patient in order to facilitate educated decision making and an opportunity to communicate with the primary physician prior to the medical procedure.

Informed Consent AMA Guidelines

According to the American Medical Association (AMA), informed consent “is a process of communication between a patient and physician that results in the patient’s authorization or agreement to undergo a specific medical intervention.” The communication process is both an ethical obligation and legal requirement, which includes

  • The patient’s diagnosis, if known;
  • The nature and purpose of a proposed treatment or procedure;
  • The risks and benefits of a proposed treatment or procedure;
  • Alternatives (regardless of their cost or the extent to which the treatment options are covered by health insurance);
  • The risks and benefits of the alternative treatment or procedure; and
  • The risks and benefits of not receiving or undergoing a treatment or procedure.

So why create a new standard now? If the standards for disclosure and communication with the patient, set by the AMA, are not being met, what purpose would a prudent patient doctrine serve?

Barriers to Informed Consent Unique to Medical Imaging

With medical imaging and consequent radiation exposure, risk levels vary based on patient age, weight and types of cancer. In addition, the specific risks of exposure are uncertain. Here is where informed consent breaks down, if one is held to a legal standard.

“To be entered into a legally binding covenant, the benefits and risks must be clearly stated, unequivocal and easily measured,” said Brink et al.  The risks of medical radiation exposure do not meet these criteria.

Another problem with informed consent is the inability to definitively link a patient’s cancer, which affects 40 percent of U.S. citizens, with radiation exposure. Causing undue patient anxiety is another challenge that informed consent may induce.

Radiologists May Balk at Verbal Informed Consent

Semelka et al suggested the possibility that U.S. agencies might follow Europe’s lead and impose radiation consent regulations on the radiology community. They suggested the need for “at least verbal informed consent detailing risks … for all procedures of 1 mSv or greater.”

They noted that radiologists may balk at the requirement and suggested distribution of pamphlets explaining the risks of medical radiation as a starting point. Technologists or radiologic physician assistants could present the risks and benefits, with radiologists providing backup. (We’ll leave the ethical implications of this approach aside for now.)

Brink called for radiologists to embrace a patient-centered, informed decision-making approach and concluded that “informed decision making trumps informed consent.”

Sounds like word play to me. What do you think?

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