Medically Reviewed On: May 07, 2008

DAVID MARKS, MD: Hi, and welcome to our webcast. I'm Dr. David Marks. Very often you can't get doctors and lawyers in the same room together, but today I'm happy to have two lawyers help me talk about informed consent, because it's a confusing topic.

Joining me is, first, Aytan Bellin. He's a healthcare attorney in New York City. Welcome.

AYTAN BELLIN, JD: Thank you.

DAVID MARKS, MD: Next to him is David Hoffman. He's also a healthcare attorney in New York City. Thanks for being here.

DAVID HOFFMAN, JD: Nice to be here.

DAVID MARKS, MD: There's not going to be any doctor-lawyer jokes here.

DAVID HOFFMAN, JD: I hope not.

AYTAN BELLIN, JD: We try to avoid that.

DAVID MARKS, MD: Good. We've all given informed consent to be here. Now, what exactly is informed consent? This is a term that's bandied about a lot.

DAVID HOFFMAN, JD: Informed consent is really a process. It's a process by which a physician will tell a patient the risks, benefits and alternatives of a particular treatment that the physician wishes the patient to go through. So for example, if you're going to undergo surgery, the physician will tell the patient there's an X percent risk that the operation won't work or that you'll suffer some complication. The benefit is that you'll be all better -- your hernia will be taken care of, for example -- and he might tell you that there are alternatives -- you know, wearing a truss, I guess, although I don't think that that's the standard treatment anymore. But that's basically what informed consent is. It can take either written form or oral form.

DAVID MARKS, MD: Why did this come about to begin with?

DAVID HOFFMAN, JD: It really all started out of the law of assault and battery. The notion was that even a physician has no right to even touch your body without your permission. You have sanctity in your body, and if a doctor was going to do something to you, he or she ought to be doing that with your consent. But consent alone really doesn't mean anything, because when you're discussing performing a medical procedure, if the patient hasn't had the procedure explained to them -- not just explained in medical terms, explained in terms that the patient can understand so that they can decide, "Do I really want this surgery? How am I going to feel if at the end of the surgery I have numbness, or I lose the use of a limb, or if I wind up with a worse cardiac condition than I started off with?" The idea of informed consent is really embodied in the "informed" part; that is, that the patient should really know what they're getting themselves into.

DAVID MARKS, MD: Of course, "informed" means information, and doctors have a lot more information than they can ever give to patients. The list of potential complications for any procedure is this long. Is it fair to say that a patient can actually be informed when they give consent, be fully informed?

AYTAN BELLIN, JD: I think physicians have a responsibility to give their patients information that the patients can understand, that a reasonable person would be able to understand. It's difficult for physicians sometimes because they are so busy at their jobs, seeing many patients, and sometimes the complications and the information is difficult to explain, but I think that in most circumstances it is possible. They may not be able to go to the really small details, but they'll be able to give the general picture.

DAVID HOFFMAN, JD: In fact, you don't want a doctor to be going into the minutiae. Informed consent really doesn't mean anything if all the physician does is tell you everything that could possibly happen to you in the course of a procedure, because in reality that list would start with the most minor possibility and end with death in almost every case.

DAVID MARKS, MD: And it would scare the patient.

DAVID HOFFMAN, JD: Right. It is not the physician's objective to just protect themselves. Lots of physicians see informed consent as a way of avoiding legal liability. But in reality, as a matter of professional practice standards, informed consent is the physician's way of bringing the patient into the process. To do that, the physician has to exercise a measure of skill, just as he or she has to in actually performing the procedure. So the physician has to identify what are the probably or what are the reasonable risks of this procedure, and what are the legitimate alternatives?

DAVID MARKS, MD: Can you give me an example that you've heard about or that you've seen where there may have been a problem with the information or the consent that was given?

AYTAN BELLIN, JD: Very often -- I shouldn't say very often -- but often, when patients come into hospitals, let's say for a surgery, they're given a pile of forms upon their intake, and in that pile of forms is what's called an informed consent form. Usually these forms say something to the effect, "I have been informed by my physician of all the risks, benefits and alternatives of this treatment, and I consent to the treatment." Usually the form does not list what exactly the treatment was, what the physician told the patient, and often, unfortunately, the patient really isn't told anything.

DAVID MARKS, MD: Give an example, a real-life example.

DAVID HOFFMAN, JD: A patient going in for prostate treatment, something that's been in the news a lot lately -- there are three major modes of treating prostate cancer. You can do seed implantation, you can do generalized radiation treatment, and you can do surgery. Each of those alternatives has risks attached to it in terms of complications of the surgery, and then have complications that are an inevitable outcome of the procedure. For example, open surgery can result impotency or urinary incontinence. If the patient doesn't know that, but is just told that surgery provides the greatest potential for a cure, but they don't know that there are these lifestyle complications, they're not making an informed decision. It's interesting, what closes out in most informed consent forms -- really what they are are consent forms; the "informed" part, the information, comes from the doctor -- the last phrase in most of these forms is, "The doctor has answered all of my questions," and that's the essence of informed consent.

DAVID MARKS, MD: That brings up another question. When that form is put in front of you with all the small type in it, what should a patient ask themselves before they actually put their signature on that form?

AYTAN BELLIN, JD: They should ask themselves whether they actually have spoken to their physician about the treatment that they're about to undergo, and whether they have any questions and whether the risks, benefits and alternatives of the procedure have been explained to them.

DAVID HOFFMAN, JD: No one should ever sign a consent form as you're being rolled into the operating room. If anyone is handing you a consent form to be signed as you're being rolled into the operating room, that's time to stand up for your rights.

DAVID MARKS, MD: I've seen that happen many time through my training.

AYTAN BELLIN, JD: That should never happen.

DAVID MARKS, MD: Even on an emergency basis?

AYTAN BELLIN, JD: In an emergency situation, there's not a requirement to obtain informed consent. I mean, you could think of a situation where a patient is being brought in through the emergency room who has been knocked unconscious in a car accident and is bleeding from the chest or has had all sorts of other injuries, and they need to be taken into the operating room immediately. In that situation the law recognizes that informed consent would be impossible to obtain given the emergency situation, and therefore you don't have to get it.

DAVID HOFFMAN, JD: The law provides, in those situations, what's called "implied consent," where the presumption is that anyone who has been in an accident or has developed a serious medical condition wants to live.

DAVID MARKS, MD: There are lots of things that are done on a daily basis -- x-rays, blood tests. People don't get or give informed consent for these things. Should they?

DAVID HOFFMAN, JD: The general rule is that a signed consent form is required for invasive procedures, so obviously that would cover surgery. That would cover a radiologic procedure if they're injecting some sort of material into your body. Those are the kinds of procedures where a written consent form is required. But the concept of informed consent, both as an ethical principle and as a requirement of professional practice standards, that applies to everything, so that if you're going in for an x-ray, the doctor ought to at least be telling you, "This is a procedure that involves exposure to radiation, but I think it's in your best interest."

AYTAN BELLIN, JD: As a practical matter I'm not sure that that actually happens in every circumstance, but it should happen. An important thing for people to realize and for physicians to realize is that a mere signature on an informed consent form does not satisfy the requirement that there be informed consent. So if you as a patient have gone in and signed a piece of paper that says, "I consent to the operation," that doesn't necessarily protect the physician. He has not obtained your informed consent merely because he or she has gotten you to sign a piece of paper.

DAVID MARKS, MD: So the bottom line is?

AYTAN BELLIN, JD: The bottom line is that the only way that informed consent has been obtained is if you have spoken to your physician, and the physician has explained the risks, benefits and alternatives of the treatment to you and you've had an opportunity to ask him or her questions, and they've answered them to your satisfaction.

DAVID MARKS, MD: Great. Thank you both very much. Communication is obviously the key. Don't sign an informed consent unless you've spoken to your doctor.

I'm Dr. David Marks. See you next time.