Informed Consent in Pennsylvania: Recent Changes

August 31st, 2017

In a recent Pennsylvania Supreme Court case focused on informed consent for medical procedures, the Court ruled that a physician may not delegate the duty to obtain a patient’s informed consent.

This case was a medical malpractice case and does not address consent in the research context. Investigators conducting research in Pennsylvania may want to discuss with their legal counsel the impact of this decision on their consent process.

In this case, Shinal v. Toms, a patient sued her physician for medical malpractice after brain surgery. Before the surgery, the physician assistant provided the patient with information about the procedure and obtained the signed informed consent. The patient claimed that her consent was not valid because it was not obtained by her physician. In its decision, the Court explained that informed consent requires direct communication between a physician and patient, and contemplates a back-and-forth, face-to-face exchange, which might include questions that the patient feels the physician must answer personally before the patient feels informed and becomes willing to consent. This duty to obtain informed consent belongs solely to the physician.

The Court referenced the Medical Care Availability and Reduction of Error (MCARE) Act, which states that “except in emergencies, a physician owes a duty to a patient to obtain the informed consent of the patient or the patient’s authorized representative” prior to conducting five listed medical procedures, including administering an experimental medication, using an experimental device or using an approved medication or device in an experimental manner (40 P.S. § 1303.504). The Court stated that under the plain language of this section, the duty to obtain a patient’s informed consent for the listed procedures belongs to the physician.

Schulman IRB provides this update for information purposes only and not for the purpose of providing legal advice. Schulman will promptly review any informed consent modifications or other study changes that are required related to this ruling.

For more information, contact your Study Manager or call 513-761-4100.


Reference: Shinal v. Toms, 2017 WL 2655387 (Pa. June 20, 2017).