Chapter 2 ■ Informed Consent for Procedures 19

a modification to a procedure that is beyond the scope of

the consent (11). It is immaterial whether the provider’s

intention was to help the patient, whether the procedure

was successful, or whether the health care provider was otherwise negligent (12,13). Although damages may be more

difficult to prove when the alleged battery was a successful

procedure, courts may assess punitive damages (which may

not be covered by malpractice insurance) and licensing

boards may levy their own penalties (4).

Inadequate Informed Consent: Some state laws also

provide for a separate cause of action for failure to secure

informed consent (14–16). To prove such a claim, the

plaintiff must generally show that the physician or designee

failed to inform the patient, parent, or guardian of a material fact relating to the proposed treatment; that consent to

the treatment was given without awareness of the material

fact; that a reasonably prudent patient, parent, or guardian,

in a similar circumstance, would have refused to consent to

the treatment if informed of such material fact; and that

injuries resulted from the treatment. Like a medical malpractice claim, a failure to secure informed consent claim

may succeed even if the procedure was performed without

negligence or there is insufficient evidence to support a battery claim (4,17).

Specific and General Informed Consent

There are two kinds of informed consent: general and specific. A patient, parent, or guardian may give a general

informed consent (sometimes called a “blanket consent”)

when the patient is admitted to the hospital and will

require ongoing clinical intervention by a number of

health care providers. The patient, parents, or guardians

may be kept informed of the specifics of procedures during

the hospital stay, but they may not be informed of every

intervention. A general informed consent will cover routine medical care that a patient may receive while in the

hospital, such as drawing blood or administering a nonexperimental medication. The hospital administration will

define what constitutes routine care, depending on community and professional standards. The procedures considered routine may also vary depending on the hospital unit

to which a patient is admitted.

In the NICU, specific informed consent is required

when a procedure falls outside of routine intensive care provided to most patients in the unit. Examples of nonroutine

procedures might be surgery for a congenital or acquired

defect, renal dialysis, and extracorporeal membrane oxygenation. In such nonroutine cases, parents or guardians must

receive sufficient information specific to the procedure to

permit them to make a fully informed decision.

It is important to document both general and specific

informed consent. In the case of general informed consent,

the patient, parent, or guardian is likely to be asked to sign a

written consent; these consents should be retained with the

patient’s records. For specific informed consents, a written

or oral disclosure (in many cases, both) is required. In the

case of oral disclosure, the individual obtaining consent

should summarize in the patient chart, in reasonable detail,

the information provided. If consent is obtained by telephone, a witness should listen to the telephone conversation and co-sign the summary in the patient chart.

What is Adequate Disclosure?

Disclosures about proposed procedures should be presented

in terms and in a language that the patient, parents, or

guardians can fully understand. At minimum, the treating

physician should ensure that the following are explained:

1. the procedure;

2. the long- and short-term risks and benefits of the procedure;

3. the alternatives, including doing nothing; and

4. the long- and short-term risks and benefits of the alternatives and doing nothing.

Disclosures should include information about the frequency and severity of the adverse potential consequences

and the likelihood, duration, and degree of anticipated benefits from the treatment(s). There is a potential to overload

the consentee with information; the patient, parent, or

guardian does not need to hear every possible risk, especially if the problem is extremely unlikely to occur.

However, the provider should consider the disclosure carefully when there is a low risk of a problem materializing but

the consequences are death or severe morbidity.

U.S. state courts have generally endorsed one of two

approaches to determine whether a disclosure is sufficient:

the physician-centered approach and the patient-centered

approach. The physician-centered approach measures the

disclosure against the accepted practice among other physicians; it asks what a reasonable physician would disclose. At

trial, the court would expect testimony of medical experts to

establish the standard disclosure for a given procedure (4,18).

The patient-centered approach considers what information a reasonable patient (or patient’s parents or legal guardians) would regard as significant to deciding whether to go

forward with the procedure (19,20). At trial, a medical

expert’s testimony might be valuable to explain the kinds of

risks attendant to a procedure; however, expert testimony

would not be necessary to show whether a particular fact was

material to making the decision whether to proceed (21).

Neither approach is without its problems. The physiciancentered approach is problematic because the standard disclosure may not actually include sufficient information. In

addition, a disclosure sufficient for one patient, parent, or

guardian may not be sufficient for another; by failing to take

into account the patient’s unique circumstances, the physician may fail to protect the patient’s autonomy (21). The