On June 12, 2019, the Pennsylvania General Assembly introduced Senate Bill No. 761. The Bill allows a physician to delegate the task of obtaining a patient’s informed consent to a qualified assistant. This Act was sponsored as a legislative response to a 2017 Pennsylvania Supreme Court decision which had ruled against delegation of this task by a physician.

In a 2017 ruling, the Pennsylvania Supreme Court held in Shinal v. Toms (162 A.3d 429, 2017) that the duty to obtain informed consent belongs solely to the physician performing the procedure. The court’s reasoning was based on the theory that informed consent requires direct communication between patient and physician. This direct communication contemplates a back-and-forth, face-to-face exchange that allows a patient to be informed and willing to consent.

Critics of the Shinal decision have stated that physicians now must be involved with every aspect of informing their patients and obtaining their consent. This has the potential to increase the risk of harm to seriously ill patients whose access to physicians’ critical services could be delayed by Shinal’s more stringent interpretation of the informed consent requirement.

As a legislative response to Shinal, Senate Bill No. 761 restores a multi-party or team-based approach by providing physicians with the flexibility to delegate the task of obtaining informed consent to other qualified healthcare providers.

Senate Bill No. 761 would amend the MCARE Act to allow a physician to delegate the task of obtaining informed consent to a “qualified practitioner.” This individual must be knowledgeable about the proposed procedure and the patient’s condition. Of course, although a physician may delegate the task of informed consent to another “qualified practitioner,” the physician remains responsible for the care of the patient.

The Bill defines a “qualified practitioner” as

“any physician participating in a residency or fellowship training program, physician assistant, nurse practitioner, midwife or registered nurse.”

In 2002, Pennsylvania codified the procedure of informed consent by enacting the Medical Care Availability and Reduction of Error (MCARE) Act (the “Act”). Under the Act, a patient who undergoes certain medical procedures, including surgery, must be given a description of the procedure, as well as information regarding the risks and alternatives that a reasonably prudent patient would require to make an informed decision prior to undergoing such a procedure.

The primary purpose of SB 761 is to enable physicians “to determine when to employ the assistance of other qualified practitioners within a framework that still ensures patients are protected and have access to information they need to make informed decisions ….”