Informed Consent for

Procedures

2

Rebecca Ginzburg

The primacy of a patient’s personal autonomy is the foundation of most modern professional guidelines and case law

concerning informed consent. Because every individual has

the right to determine what happens to his or her own body,

the individual must ultimately make decisions about which

medical procedures he or she will undergo. For that individual’s decision to be meaningful, it must be made with

full information about the procedure.

In the context of neonates, the notion of personal

autonomy is more attenuated, but the requirements of

informed consent are no less stringent. The law of every

state in the United States requires the parent or legal guardian’s consent before a minor receives medical treatment

(with certain exceptions, such as in emergencies and treatment of “mature” or “emancipated” minors, e.g., a pregnant

minor) (1–3). The presumption, then, is that parents or

legal guardians will make treatment decisions based on the

information provided by the treating physician. If the information disclosed is inadequate, inaccurate, or unclear, the

parent or guardian is not placed in an optimal position to

make a treatment decision.

Legal Consequences of Failure to

Provide Adequate Disclosure

Failure to provide adequate informed consent may give rise

to claims of negligence, assault, and inadequate informed

consent (4–7).

Negligence: To establish negligence, a plaintiff (usually

a patient or patient’s next of kin or guardian) must show that

the health care provider(s) had a duty to the patient, that the

provider breached that duty, that the patient suffered an

injury, and that the breach caused the injury. A health care

provider has duties to his or her patients. In the neonatal

intensive care unit (NICU), these duties arise because the

patient’s well-being has been entrusted to the NICU health

care team, directed by a physician, based on the team’s

superior medical knowledge and, either explicitly or implicitly, the team’s ability to provide the requested treatment. A

priority physician duty is to explain disease process, prognosis, and the range of possible treatments with their individual risks and benefits. Although a treating physician may

delegate the responsibility for obtaining informed consent,

he or she needs to keep in mind that when the treating physician fails to ensure that parents or guardians are provided

with all the information that they require to make a decision, in a language and manner that the parents or guardians fully understand, the treating physician fails to fulfill

his or her duty to the patient. If injury results that was not

covered in the informed consent process, the treating physician may be liable for this injury, as may other members of

the health care team who were involved in the performance

of the procedure (8,9).

A plaintiff may (alternatively or additionally) make a

medical malpractice claim for failure to provide adequate

disclosure. Medical malpractice is a type of negligence, so

the elements required for a prima facie case are the same. The

plaintiff must show that the health care provider owed the

patient a duty, that the provider breached this duty, that

the patient suffered an injury, and that the breach caused

the injury. The duty to the patient is, again, based on the

provider–patient relationship. To show that a provider

breached this duty, the standard of care must be established; when the alleged breach was a failure to obtain

informed consent, the standard may depend on the disclosure that a “reasonable” physician would make or that a

“reasonable” patient would find material (these standards

are discussed in more detail below).

A medical malpractice suit may succeed when a patient

(or the patient’s parent or guardian) did not receive adequate

disclosure and the patient was injured during the procedure,

even if the physician performed the procedure competently.

If further disclosure would have resulted in a decision that

the patient would not undergo the procedure, there has

been malpractice because the health care team failed to disclose all material facts. The treating physician would then

be liable for all injuries resulting from the procedure (10).

Battery: Battery is unwanted physical contact. In some

states, a physician or other health care provider may face a

medical battery claim if he or she treats a patient without first

getting informed consent or gets consent that does not adequately cover all aspects of the treatment (4). Except in an

emergency no procedure other than the one(s) to which the

parent or guardian has agreed may be performed. This includes