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It’s a long standing medico-legal principle that before a patient undergoes a non-emergent procedure, he must understand the risks, benefits, and options, and provide consent. This is informed consent.

It’s also a long standing medico-legal principle that informed consent is more than a signature on a piece of paper. It’s a process. Done right, the patient is given an opportunity to ask questions and receive answers to his satisfaction. The piece of paper and the signature merely documents the process that occurred.

Legislatures and courts have not been overly prescriptive in the details of informed consent. To paraphrase former Supreme Court Justice Potter Stewart when asked to define obscenity, he answered you know it when you see it. Likewise with informed consent.

The Supreme Court of Pennsylvania recently rendered a ruling which is reverberating across the state – with potential to propagate across the country. It ruled that a physician cannot delegate obtaining informed consent to a physician assistant or any other qualified assistant. In other words, informed consent is a duty that cannot be passed on to your staff.

In this case, Shinal v. Toms, the plaintiff argued the surgeon had failed to provide informed consent related to removing a non-malignant brain tumor. The trial court provided instructions to the jury allowing them to consider information provided by the surgeon’s physician assistant as part of the informed consent process. The trial court found in favor of the surgeon.

The case was appealed. The Superior Court (next level of appeal above trial court) agreed with the trial court’s instruction and held that information provided by a surgeon’s qualified staff could be considered part of the informed consent process.

The plaintiffs appealed again.

In June 2017, the Pennsylvania Supreme Court concluded that informed consent is a duty belonging solely to the physician performing the surgery or treatment. It cannot be delegated. The Court buttressed its conclusion on its belief that without direct dialogue, a physician cannot be confident the patient understood the risks, benefits, and options. A physician who conducts the process himself ensures the patient’s consent is truly informed.

While I appreciate how using ancillary personnel for the informed process could fall short in specific cases, I think the solution is not a blanket ruling mandating physicians be front and center for every part of the informed consent process. The one commodity physicians are missing is time. They are always rushed. Why not have ancillary personnel discuss the generic risks, benefits, and options? To the extent a patient has individualized questions, they can be posed directly to the physician. This would be a better use of everyone’s time.

Also, there are unanswered questions.

What if the physician makes a 20 minute video for informed consent for a procedure. The patient sees the entire video. The patient takes a test after the procedure demonstrating full understanding. Will that suffice? If not, why not?

Some believe the informed consent process will actually deteriorate with the new rule in Pennsylvania. Is it better to get a 20 minute back and forth with a PA, or a 3 minute back and forth with a rushed surgeon? What do you think? Share your comments below.

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