Most operations and other medical procedures have some risk and the possibility of adverse side effects. Doctors must obtain informed consent from patients before proceeding. A patient wounded during a procedure without informed consent may sue the doctor for negligence, even if the injury was a usual risk in the situation.
The goal of informed consent is to give patients the ability to make their own decisions about whether or not to undergo a certain surgery or course of treatment. In practice, patients typically sign a consent form that addresses the risks of an operation, although this is not always sufficient. The doctor must explain the potential dangers to the patient to ensure the patient understands them. If you are a victim of medical malpractice, learn about your legal options today.
When is informed consent required?
Not every healthcare treatment circumstance calls for obtaining informed consent from a patient by a doctor or other healthcare provider. Procedures and circumstances that require informed consent, according to the US Department of Health and Human Services, include:
- most surgeries
- cancer treatments like chemotherapy and radiation
- most advanced or complex medical tests and procedures, including biopsy and endoscopy
- corticosteroid therapy or opioid therapy, and other high-risk treatments
- administration of most vaccines
- certain blood tests, including genetic testing.
What risks must be disclosed?
A doctor is not required to inform a patient about every potential outcome of a procedure or treatment. To establish what facts and risks must be revealed and addressed with the patient, most states use one of two standards:
- Would other doctors have revealed the risks?
In areas where this first criterion is used, an injured patient suing a doctor must engage a medical expert to show that other competent doctors would have warned the patient of this risk. The doctor being sued will additionally bring in an expert to testify that a competent doctor would not have necessarily communicated the risk to the patient.
In the end, the essence of the debate is usually whether the danger was statistically likely enough to warrant notification. Even if a particular negative event is a remote possibility, it does not need disclosure – even if that terrible result occurs.
- Would a normal patient have made a different decision if they had been aware of the risk?
In states that apply this second test, judges consider whether a normal patient with the plaintiff’s medical history and conditions would have changed his or her opinion about the treatment if the risk had been communicated. In contrast to states that adhere to the first norm, a doctor must also inform a patient of plausible alternate options, even if the doctor only suggests one.