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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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 infinite ways of going through the informed consent. i’ve thought about videoing this process but find the body language i get from patients tells me an amazing amount of whether they understand what we are discussing or not. i don’t know how to get around it other than to stand up to those who try to tell us how best to run medicine/surgery.
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.
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 to keep pt. in holding area until staff member saw surgeon!? People have to realize that getting pt. from holding, to O.R.,then “lined, and prepped” can take an hour!!!??? That,in it self’,is a disgrace, but the notion that a staff member has to witness is just another tear-down of our position. Why not just add a statement that the staff can ask the patient,”Did the surgeon explain everything to you?”… Now,this won’t fix all the problems because, in my experience, there will always be a percentage of patients that will SAY NO!!!,even when you have…they are nervous and just want to see you. I am rambling so I will end by summarizing:yes,THE SURGEON should always explain the case to the patient. It is asinine to think that the surgeon needs a staff member to ASSURE this was done! So,I would come to Holding,say,”Mr. Smith,didn’t I explain everything in the office, and they would say yes…sign,and I would waste 30-60 minutes waiting while patient is brought to the O.R.,delaying me, and all who follow my case!!! I often thank GOD,I don’t have to deal with the utter stupidity of the “system”!!! any longer.
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. There was a surgical complication and the patient sued. Certainly, a videotaped “consent” would be bullet proof. Until……..the patient testified,,,,,,,,,that she “was too anxious to understand that there could be complications.” Verdict for the plaintiff because the patient lacked capacity to consent! I rest my case………..
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 the office. On the offhand chance that the patient had an additional question, I asked at the paperwork signing in day surgery I would ask them if they had any extra questions.
I also asked patients immediately prior to procedures if they had any other questions. If they did, it was full stop, and take the time to answer questions. The extra few minutes of care that it takes to answer a patient’s questions beforehand saves the physician from dealing with years of time preparing for and being in court.
As far as video taped informed consents, those have also had holes blown in them because invariably some complication would occur that was not covered in the video. Instant loss for the physician because the informed consent had not informed the patient of that particular risk. The best policy after studying these issues for years is to say to the patient that there are risks to everything including crossing the street, but the risks are low, never zero, and we will do everything we can to keep them that way. Then actually walk the walk not just talk the talk.
Also never ever discuss or make fun of patients within their earshot whether they are awake or not. Also don’t do that with staff members because the patient could be a relative or someone that the know. HIPAA has a funny way of being violated in small towns, and sometimes large ones.
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 will shake their head and blame everyone but themselves.
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 informed consent, inter alia. He just assumed that the PA had been then getting the consent and would have pursued that line of inquiry to create doubt in the jury’s mind. The PA’s testimony was videotaped: he had a lymphoma and was dying; it was clear that he would not survive to testify in open court.
Tom, the PA, politely cut his legs off: “Oh no, sir, Dr. Horton is very particular about his consents and gets all of them himself. We never do–he wouldn’t allow it.” Or words to that effect.
Myself, I have a standard disclaimer that I used and once I came up with it, never– and I mean ~never~ –varied from it. After discussing the indications, techniques, indications and alternatives–all of them, religiously–I said, “Mr. [ ], in order for you to give informed consent, you have to be informed [stress the word “informed”] that although it is unlikely, it is always possible for complications, potentially serious, even life-threatening [stress “life-threatening] ones to result from what we plan to do. Do you have any questions?” Always exactly those words–no more, no fewer.
Most patients answered that they didn’t have any questions. About 1 in 20 did, and I talked with them about any and all concerns they had, until they ran out of them. And then I’d ask again if they wanted me to proceed. Yes or no. If no, it’s not personal, it’s business. I’d figure out what else might be done for them, including referring them to someone else. If yes, the documentation I put into the chart was also the same:
“Spoke with patient and discussed the techniques, indications, alternatives, and risks of procedure. Patient wishes us to proceed.” Not “consents to surgery,” but “wishes us to proceed.”
Which brings up another point: who came up with the words, “informed consent”? What they mean to me is “I want to do this operation on you. OK with you if I do it?” OK, I give my [reluctant or enthusiastic] consent. Go ahead.
Isn’t a better mindset for the patient to ~ask~ you to treat him?
“All the time in the world….” YES!! That’s what you have to have in order to obtain an informed ~request,~ which is what I told patients they’d have to give me in order for me to take care of them. As far as I’m concerned, surgery was only one step in the process. Diagnosing, talking with patient/family was another step, and a necessary one. And so was follow-up.
Astor the 20 minute video question, I think that’s a great idea, and if done well, can be used as foreplay potentially to shorten the discussion time necessary. But if you’re too rushed to have a proper discussion with the patient beforehand, maybe you have too many patients. And not enough patience.
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 lawsuits. It goes without saying (I’ll say it anyhow) that patient (or family) anger at anything other than a robotically-perfect outcome (immortality, perhaps?!), mass quantities of vulture attorneys, unmitigated societal greed, ubiquitous blame, and the permissible and self-interested courts are the problems.
I believe that the informed consent process is used as just one tool in some med/mal claims, but it is not the key aspect in most cases.
I wish all a happy Easter and Passover.