Informed Consent: What Is It?

Hospital operationInformed consent is a legal doctrine that describes a physician's obligation to provide information and a patient's obligation to consent to medical treatment based on the information provided. It does not necessarily require a formal signed agreement, although that is becoming more common.

Background and History of Informed Consent

This relatively new concept was developed after World War II and incorporated into the Nuremburg Code to ensure that people would be treated ethically by medical providers, in contrast to the unethical medical experiments conducted by doctors in Nazi Germany. The basis was the principle that adults have a fundamental right to determine what others can do to their bodies. Although the initial focus of the Nuremburg Code may have been to protect experimental subjects, it also applies to relationships between doctors and patients.

In short, if a patient receives treatment that he or she did not agree to, the doctor providing that treatment has violated the patient's legal rights.

Of course, obtaining or giving informed consent is more complex and raises numerous questions. For example, how does a doctor know when a patient has enough information to make a decision? Informed consent laws seldom define "enough." Does a doctor have to provide information only about the risk of a proposed treatment or procedure, or is he or she required to provide additional information? Is it even possible for the ordinary layperson to fully understand a proposed course of treatment and then give consent in medically complex situations? In theory, answers to these questions are incorporated into the standard of care for providing medical care.

The standard of care for informed consent is that providers should supply the level of information that a "reasonably prudent" doctor or other provider in Ohio would give a patient about a proposed treatment. However, this raises additional questions that further complicate issues arising from informed consent (or its absence).

Patient Options for Informed Consent

As noted above, patients can either sign a form or give verbal consent to a medical provider's proposed treatment. This is known as "express consent" because the patient expressly consented to the treatment after discussing it with the provider. However, consent can be provided in other ways.

For example, a patient could be unable to consent because he or she was anesthetized. If a surgeon needed to perform a procedure on such a patient to save his or her life or prevent serious complications, the doctor could do so even if the patient had not consented to the emergency procedure. By consenting to the original surgery, the patient gave implied consent for any other procedures that became needed during the course of the surgery.

Informed consent, either express or implied, is an often murky issue. Numerous situations don't allow a doctor or provider to obtain either implied or express consent. For example, if a patient arrives at a hospital emergency department unconscious after a car crash, hospital staff will be unable to obtain implied or express consent.

Although an emergency department would not withhold treatment if informed consent was not possible as in the scenario described above, each instance must be evaluated individually. Moreover, a provider must consider whether providing information would cause a patient emotional trauma or other harm. In short, informed consent can be more complicated than a doctor simply giving information and a patient agreeing to a course of treatment.

Informed Consent and Medical Malpractice

This imprecision is one reason why lack of informed consent is seldom a cause of medical malpractice lawsuits. According to a report published on the Medscape website, only 3 percent of medical malpractice lawsuits are the result of failure to obtain informed consent properly. Moreover, a successful lawsuit could not be based solely on lack of informed consent. A plaintiff would also need to show that there were harmful consequences because of the unauthorized treatment. Additionally, the plaintiff would have to demonstrate that if the risks had been fully disclosed, he or she would not have agreed to the procedure.

Patients who believe that they were harmed because they did not give informed consent, either because it was never offered or the risks and outcomes were never fully described, should consult an Ohio medical malpractice lawyer to learn more about their rights and options.