Informed Consent

July 1, 2012 | Healthcare Risk, Quality, & Safety Guidance

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“They didn’t give me any time to process what they were having me sign. I had to sign in three places, the print was tiny, and I couldn’t read any of the paragraphs. There was no way I could understand what I was signing,” reports a woman who underwent surgery to remove a major vein in her leg (Forman). The patient went on to say that she was lying on a hospital gurney without her reading glasses only shortly before she was to undergo surgery when she was presented with a consent form to read and sign. The preoperative visit with her surgeon, she reported, focused mostly on the benefits of the surgery, not the risks.

In the United States, obtaining a patient’s informed consent to medical or surgical treatment is established and guided by professional ethical codes, statutes, regulations, and case law and is addressed in accreditation standards. Even so, failure to obtain informed consent is one of the most common allegations in medical malpractice suits. (Glabman)

Although consent forms are widely used, studies show that most patients do not read them, and 60% of those who do read them do not understand what is presented in the forms (Saw et al.). Patients also have misconceptions about the purpose of the consent forms they sign. Postsurgical interviews of women who signed consent forms in hospitals in England revealed that some patients felt that the consent form allowed physicians to do what the form specified, even if it was not what the patient wanted (Habiba et al.).

Although evidence-based medical information is increasingly available to patients, many patients, especially those whose healthcare literacy is low, have difficulty understanding clinical options and making informed choices. Even patients who appear to understand the nature and risks of proposed treatment cannot answer basic questions about the medical care they consented to or already received. (NQF; Bergler et al.) Often, patients are unable to recall what they were told during the informed consent process about the risks of proposed interventions (Cassileth et al.).

It is clear that clinicians and patients need time and resources to enable them to engage in meaningful discussion about proposed treatment. Without adequate informed consent, patients are at risk of adverse health consequences; providers and clinicians consequently are at risk of liability exposure. Although risk managers in healthcare organizations have worked diligently to educate and support their institutions and...

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