Originally posted June 21, 2018
N Engl J Med 2018; 378:2433-2438
Here are a few excerpts:
In 2017, the Pennsylvania Supreme Court ruled that informed consent must be obtained directly by the treating physician. The authors discuss the potential implications of this ruling and argue that a team-based approach to consent is better for patients and physicians.
Implications in Pennsylvania and Beyond
Shinal has already had a profound effect in Pennsylvania, where it represents a substantial departure from typical consent practice. More than half the physicians who responded to a recent survey conducted by the Pennsylvania Medical Society (PAMED) reported a change in the informed-consent process in their work setting; of that group, the vast majority expressed discontent with the effect of the new approach on patient flow and the way patients are served. Medical centers throughout the state have changed their consent policies, precluding nonphysicians from obtaining patient consent to the procedures specified in the MCARE Act and sometimes restricting the involvement of physician trainees. Some Pennsylvania institutions have also applied the Shinal holding to research, in light of the reference in the MCARE Act to experimental products and uses, despite the clear policy of the Food and Drug Administration (FDA) allowing investigators to involve other staff in the consent process.
Selected State Informed-Consent Laws.
Although the Shinal decision is not binding outside of Pennsylvania, cases bearing on critical ethical dimensions of consent have a history of influence beyond their own jurisdictions.
The information is here.