Informed consent is a process of communication between a patient and their healthcare provider that leads to an agreement or permission for care, treatment, or services. It is an ethical and legal obligation of medical practitioners in the US and originates from the patients right to direct what happens to their body. The following are the key elements of informed consent:
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Patient education: The healthcare provider educates the patient about the risks, benefits, and alternatives of a given procedure or intervention.
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Patient competence: The patient must be competent to make a voluntary decision about whether to undergo the procedure or intervention.
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Patient understanding: The patient must have a clear appreciation and understanding of the facts, implications, and consequences of an action.
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Patient agreement: The patient must voluntarily confirm their willingness to participate in a particular clinical trial or undergo a specific medical intervention.
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Documentation: Informed consent is documented by means of a written, signed, and dated informed consent form.
The informed consent process makes sure that the healthcare provider has given the patient information about their condition along with testing and treatment options before they decide what to do. The information provided can include the name of the condition, the name of the procedure or treatment that the healthcare provider recommends, risks and benefits of the treatment or procedure, and risks and benefits of other options, including not getting the treatment or procedure. Informed consent is not just the signing of a form, but rather a thorough process of communication between patient and provider. It is a shared responsibility between the patient and their healthcare provider, and healthcare providers are obliged to inform the patient in the best way they know how.
