The importance of informed consent
Informed consent is the process of informing a patient about the risks of, and alternatives to, a specific procedure. When done properly, the process can help set a patient’s expectations to a manageable and realistic level and help them decide if the procedure is worth the risk by educating the patient about possible complications that may occur.
Informed consent is a cornerstone of medical ethics and basic legal principles, says Sandra M. DiVarco, BSN, RN, JD, partner at McDermott, Will & Emery LLP in Chicago, Illinois. “The ability for a patient to consent to treatment, and to refuse treatment, is a fundamental expression of self-determination. If a patient is competent to make their own decisions, the expectation is that they are able to do so and are provided with sufficient information to make those decisions on an ‘informed’ basis.”
Failure to obtain consent for medical treatment can risk claims of battery (e.g., touching another without permission or consent) and lack of informed consent risks claims of medical negligence, she adds. Although state law varies slightly on how consent is obtained and may include specific requirements, these general principles apply nationwide.
As such, procedure-specific forms are often used in the informed consent process. These documents aim not only to educates the patient, but also to reduce liability risk.
However, informed consent forms often lack consistency and specificity or are just out of date, says Michael Callahan, senior counsel in the healthcare practice group at Katten Muchin Rosenman LLP in Illinois. A generic consent form that simply has the patient sign to affirm they have been told all the risks and consequences of a procedure is insufficient. The form should spell out this information in detail.
Additionally, Callahan says informed consent extends beyond the forms. “There is supposed to be a discussion that takes place with the provider for any type of procedure that's being done, whether it's under anesthesia or not under anesthesia. And then that way the patient can make an informed judgment.”
However, the timing and interactivity of those discussions, if they occur at all, has historically been inconsistent, he adds.
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