The doctrine of “informed consent” within the context of physician-patient relationships goes far back into English Common Law. As early as 1767, doctors were charged with the tort of “battery” (the non-consensual touching of one person by another) if they had not gained the consent of their patients prior to performing a surgery or procedure.[1]

The doctrine of informed consent requires a patient be knowledgeable and voluntarily consent before surgery and invasive procedures are performed. It is the legal embodiment of the concept that each individual has the right to make decisions affecting his or her well-being. In Pennsylvania failure to obtain informed consent from a patient may subject a health care practitioner to liability under the legal theory of battery.

Pennsylvania Act 135 requires a patient’s full, knowing, and voluntary consent prior to performing or administering the following procedures: 

• Surgery, including administration of related anesthesia;
• Radiation and chemotherapy;
• Blood transfusions;
• Insertion of a surgical device or appliance; and
• Experimental medications or devices, or use of approved medication or devices in an experimental manner.

A patient is considered “informed” under Act 135 when the patient is provided a description of the procedure and the risks and alternatives that a reasonably prudent patient would need to consider to make an informed decision.[2]  The physician has the sole responsibility to disclose the risks and alternatives that a reasonable person in the patient’s situation would consider significant in deciding to undergo the proposed treatment. 

There are exceptions when a physician may provide treatment without obtaining an informed consent: 

• An emergency which prevents consulting the patient;
• In the case of a minor when, in the physician’s judgment, an attempt to secure the consent of the parent or legal guardian would result in delay of treatment which would increase the risk to the minor’s life or health (25 P.S. 10104).

In these cases the physician should document in the patient’s medical record the reason for failing to obtain consent.

A competent adult patient may choose not to have a particular condition treated, even if not treating the disease or condition means that the patient may die. U.S. courts have increasingly affirmed the right of patients to reject treatment.  Consequently, informed consent laws now include the concept of informed refusal.  This means that the physician must inform the patient of the risks or consequences of refusing treatment or diagnostic tests. [3]  It is the policy of CKHS that: 

• the refusal of the patient will be respected
• the patient’s refusal of treatment must be documented in the medical record and;
• the physician will document that the potential consequences of refusal have been thoroughly explained to the patient.

A patient who is incompetent cannot legally consent to hospitalization or to medical treatment. In Pennsylvania, an “incompetent” adult is defined as a “person who, because of infirmities of old age, mental deficiency or retardation, drug addiction, or inebriety….lacks sufficient capacity to make or communicate responsible decision concerning his person or property” (20 Pa. C.S.A. 5501).

In such cases, consent may be provide by a competent member of the patient’s immediate family, with the order of preference being: spouse, parent, adult child, sibling, a court appointed or patient designated guardian or representative, or a person authorized by Statute to give consent when consent is required.

If you have any questions please contact Risk Management at (610) 447-2995 (15-2995 or (610) 284-8156 (12-8156).