Informed consent is a process designed to protect the rights and welfare of a patient while providing a description of risks, alternatives, and any/all pertinent information that may alter a patient’s willingness to participate.
Effective June 20, 2017 the Pennsylvania Supreme Court ruled the obligation of obtaining informed consent from a patient is solely the duty of the treating physician, and may not be delegated to another individual regardless of qualification. Additionally, the Court overruled any previous proceedings that may “permit a physician to fulfill through an intermediary the duty to provide sufficient information to obtain a patient’s informed consent.”
The Court argued “Informed consent requires direct communication between 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. The duty to obtain the patient’s informed consent belongs solely to the physician.”
Under Pennsylvania Act 135, also known as the Medical Care Availability and Reduction of Error (MCARE) Act of 2002, it is the:
- Duty of physicians. 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 the following procedures:
- Performing surgery, including the related administration of anesthesia
- Administering radiation or chemotherapy
- Administering a blood transfusion
- Inserting a surgical device or appliance
- Administering an experimental medication, using an experimental device or using an approved medication or device in an experimental manner
- Description of procedure. Consent is informed if the patient has been given a description of a procedure set forth in subsection (a) and the risks and alternatives that a reasonably prudent patient would require to make an informed decision as to that procedure. The physician shall be entitled to present evidence of the description of that procedure and those risks and alternatives that a physician acting in accordance with accepted medical standards of medical practice would provide.
The Court asserted that the plain language of Pennsylvania Act 135 placed the responsibility of obtaining informed consent from a patient resides solely with the physician. However, the Court further specified the above section also requires the physician to provide the necessary information to obtain an informed consent from the patient.
The full impact of the Pennsylvania Supreme Court’s decision to mandate informed consent must be obtained by the physician remains unclear in a research setting.
Please share your thoughts on the new on the ruling from the Pennsylvania Supreme Court and how it may impact the informed consent process in research.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.
