Losing Informed Consent

May 29, 2014

Informed consent is more than just a signed consent form, says ethics blogger Paul Burcher, MD, PhD, who weighs in on a different way to think about this practice.

A couple of weeks ago, I was the faculty attending on Labor and Delivery. We were inducing a woman with severe preeclampsia and an IUGR fetus. Things went well until she was five centimeters dilated, at which point the fetal tracing went rapidly from category one to category three.

I quickly explained the situation to the patient with a resident and a nurse in the room. She heard the reasons I was recommending a cesarean section, a brief discussion of its risks, and an even briefer discussion of the alternatives (continue labor, placing the fetus at risk of permanent injury or death). She had no questions, and since she had already signed a cesarean consent at the beginning of the induction, we proceeded to the operating room to perform a cesarean. 

"Informed consent isn’t about a signed consent form, it’s about seeking out what information is important to our patients and providing it to them."

- Paul Burcher, MD, PhD

The patient needed general anesthesia because she had a low platelet count. During the induction of anesthesia but before intubation, the circulating nurse announced that she couldn’t find the “informed consent” and that we could not proceed. My response involved a reference to bull manure and the comment that informed consent had just happened and that she had witnessed it herself. The anesthesiologist agreed, and the cesarean section occurred without delay.

The (Non)Ambiguous Nature of Informed Consent

This case exemplifies the ambiguity around “informed consent.” The nurse was referring to a document-a signed piece of paper. I was referencing a conversation-a process involving sharing information and answering questions. From a legal perspective, informed consent seems to represent the document. From an ethical perspective, however, it is the process, not the paper, that embodies informed consent. Of course, ultimately, both have a role to play, and in the case of a significant procedure, it is best to have both sides of this informed consent coin documented.

However, I suggest that the signed document represents an artifact-a physical symbol that two parties agree that the real nature of informed consent has been fulfilled. The piece of paper is derivative. A signed document that lacks the ethical underpinning of a complete and valid consent discussion is meaningless. A lawyer would probably give a slightly different answer, but this is an ethics blog, not a discussion of medical malpractice.

So if the signed document is not an essential aspect of informed consent, but rather evidence of the process that has supposed to have had occurred, what represents the essential elements of informed consent? The standard answer is really not bad: all relevant information regarding the procedure, its risks, and alternatives have been discussed, and the patient’s questions have been answered. But the devil is always in the details and. in this case, the detail of importance is how we define relevant.

What’s Relevant?

My take is that relevant is, of course, in relation to the patient, not the physician, and that ultimately it requires some knowledge of the patient, or an opportunity for the patient to express what she deems relevant to adequately determine what is required to obtain consent in any particular circumstance. As a counterexample, I would reject the notion that it is possible to obtain adequate consent by having our patients watch generic videos on the various surgical procedures we perform, and then have them sign consent forms after this. (I once toured a practice that used this method for obtaining consents.) While a video may be a helpful adjunct to a face-to-face encounter with the surgeon, it may contain information that some patients would judge to be irrelevant to their decision-making and, similarly, to lack crucial information for others.

To illustrate what I mean by relevant, I am reminded of a debate about informed consent between two bioethicists. One was arguing that informed consent needed to include a list of every possible risk and benefit that was conceivable, whereas the other only wanted to know whether her surgeon was skilled and whether the surgeon recommended this particular procedure as the best option for her condition. My contention is that they are both right, but only for themselves. They were both articulating what the relevant information was that they need-I would not universalize either of their characterizations of informed consent. What instead I would universalize is the need to seek out what our patients consider relevant and to provide that information to them.

From an ethical perspective, we can’t lose “informed consent” once obtained simply by losing the paper that symbolically represents the process of obtaining consent. But we can certainly fail to adequately obtain consent, and the surest way of doing this is failing to listen to our patients and failing to provide the relevant information that they seek.