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Informed Consent? Sure. We’ve Got All the Time in the World…

01/15/18 9:32 AM

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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Posted by Medical Justice | in Legal | 8 Comments »

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AriJoseph HortonBrian Kent MDretiredmdArmando Russo, MD Recent comment authors
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Marguerite Barnett
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Marguerite Barnett

Hmmm, this is a good question. i personally have never abrogated informed consent to another person because i just don’t see how someone can do the thorough job i can but then i have the luxury to spend a full hour on my pre-op visits because i refuse to deal with insurance companies who decide i am only worthy of x amount of $s(which they cut down every year). In the aesthetic business each person is so unique and the ways of “fixing them” can vary tremendously depending on their expectations, their health and their anatomy that there are almost… Read more »

james summers
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james summers

I usually do all the consenting myself so that I know what I said, and I include a statement in my report that I did speak to the patient about specific complications of a particular procedure. The notion that a signed generic consent form constitutes “informed” consent is laughable in my mind. I have thought of writing specific consent forms for particular procedures I perform, but I find that the generic forms most people use are worthless.

Damien Joy
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Damien Joy

With NON-emergent,I would EXPECT the surgeon HAD spent a good deal of time in officer hospital room,explaining EVERYTHING. I am guessing it is THE PROCESS of getting a signature. Any surgeon who relies on anyone, other than himself, to DISCUSS IN DETAIL,the surgical plans and risks/benefits,is foolish.However,it is the administrative garbage insisting that the surgeon be present for a signature. This delays cases, and serves no purpose.Even when I had brought a pile of CONSENT FORMS to my office, and had patients sign after I had finished explaining ALL,these forms, sent with the patient, always were “lost”. The policy was… Read more »

Armando Russo, MD
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Armando Russo, MD

I agree with my colleagues that it is the responsibility of the surgeon performing the procedure to engage the patient in an informed consent process. With elective surgery I have found that it is helpful to do it over a couple of visits. The final visit is a preop visit wherein the “i”s are dotted and the “t”s are crossed. Now for a sobering bit of reality. I do not remember the citation, but about 25 years ago a urologist thought he had a foolproof informed consent process. He videotaped the process – with the patient’s permission – of course.… Read more »

retiredmd
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retiredmd

This very issue came up at least two decades ago from a similar case. Our hospital’s corporate parent insisted that we get the informed consent signed. I always obtained my own informed consents, but deferred the paperwork signage to the nursing staff. I agree that paperwork consents would get lost from the office to the OR. That sometimes meant that I had to run out to the day surgery area and get the form signed myself. It took an extra couple of minutes to get the paperwork done, but the major part of the informed consent was already done in… Read more »

Brian Kent MD
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Reading the comments above, it is obvious that there is no fool proof method of providing informed consent. Even if you are conscientious in trying to inform the patient to the best of your ability, there is always a “legal theory” that you didn’t. Politicians place more value in preserving the right of the patient to take a legal pot shot at the doctor than curbing lawsuit abuse and maintaining a fair workplace environment for physicians. This reflects the non-existent political power of doctors. As doctors retire in droves in the years ahead, and medical school applicants decline, the politicians… Read more »

Joseph Horton
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Joseph Horton

With few exceptions, I second all of retiredmd’s comments. I’ve always gotten my own consents for a couple reasons: 1) If I do it, I know what’s been said. If someone else gets it, I can only guess, and I hate guessing. And 2) it gives the patient another chance to ask questions. No one has ever abused that. For that matter, I always gave patients my home number. Likewise never abused. About 10 years ago, I was one of three defendants in a med mal case in Hershey, Pennsylvania. The plaintiff’s attorney tried to hang his hat on the… Read more »

Ari
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Ari

Jeff, I don’t agree with you. As surgeons, we always have, or must make, sufficient time to give non-emergent informed consent ourselves. We may not be able to list “all” the possible risks, but the simple act of creating face-to-face time helps ward off the evil spirits of lawsuits, in my opinion. I typically tell my patients that “…if I have not frightened you at least a little bit with the informed consent process, then I have not done my job…” I really don’t believe that informed consent, or the lack of its completeness, is the root of most med/mal… Read more »