Informed consent is the process of providing a patient with all of the information they need to make a decision about their medical care, and then obtaining their voluntary agreement to that care. Informed consent is essential to protect patient autonomy and to ensure that patients are receiving care that is in their best interests.

Elements of informed consent

The elements of informed consent include:

• Disclosure: The healthcare provider must disclose to the patient all of the relevant information about their medical condition and the treatment options available to them. This information should be clear, concise, and easy to understand. It should also be available in multiple languages.
• Comprehension: The healthcare provider must assess the patient’s understanding of the information that has been disclosed to them. The healthcare provider should answer any questions that the patient has and should make sure that the patient understands the risks, benefits, and alternatives to the proposed treatment.
• Voluntariness: The patient’s consent must be voluntary. This means that the patient must be able to make their own decision about their care without being coerced or pressured.

Clinical example

Here is a clinical example of what can happen when some elements of informed consent are not adhered to:

A 65-year-old man is admitted to the hospital with a heart attack. The cardiologist recommends that the patient undergo an angioplasty and stent placement to open up the blocked artery in his heart. The patient is reluctant to agree to the procedure because he has heard that it is risky. However, the cardiologist assures him that the procedure is safe and that it is the best way to treat his heart attack. The patient eventually agrees to the procedure.

During the angioplasty, the patient experiences a complication and suffers a stroke. The patient is now paralyzed on the left side of his body. He is also unable to speak.

The patient’s family is devastated. They are angry at the cardiologist for not fully explaining the risks of the procedure to their father. They also believe that the cardiologist pressured their father into agreeing to the procedure.

The patient’s family files a lawsuit against the cardiologist for medical malpractice. The lawsuit alleges that the cardiologist did not obtain informed consent from the patient before performing the angioplasty.

The case goes to trial. The jury finds that the cardiologist did not adequately disclose the risks of the angioplasty to the patient. The jury also finds that the cardiologist pressured the patient into agreeing to the procedure. The jury awards the patient’s family a large sum of money in damages.

How to ensure that informed consent is obtained

Healthcare providers can take a number of steps to ensure that informed consent is obtained:

• Provide the patient with written information about their medical condition and the treatment options available to them. This information should be clear, concise, and easy to understand. It should also be available in multiple languages.
• Have a conversation with the patient about their medical condition and the treatment options available to them. This conversation should be patient-centered and should focus on the patient’s individual needs and preferences.
• Answer all of the patient’s questions honestly and thoroughly.
• Make sure that the patient understands the risks, benefits, and alternatives to the proposed treatment.
• Give the patient enough time to make a decision about their care.
• Respect the patient’s right to refuse treatment.

By following these steps, healthcare providers can help to ensure that patients are making informed decisions about their medical care.