Reader Question

Nurses must judge quality of consent to be a witness

Question: We’ve recently become aware that some of our nurses are uncomfortable with witnessing a patient’s informed consent when they don’t think the patient truly understands what he has been told, or that the physician has not adequately conveyed the risks. Is this the nurse’s call to make or should he or she merely attest to witnessing the exchange? We even found a couple instances in which a nurse signed as the witness but added a note (presumably to cover herself) that she was unsure the patient understood. How should we address this problem?

Answer: You’ve got a problem. If your nurses are so uncomfortable with the quality of the informed consent process that they don’t want to sign as a witness, you should consider that a red flag that you have some serious work to do, suggests Lew Lefko, JD, MPH, a health care attorney with the firm of Haynes & Boone in Dallas. Their concerns must be significant if they have come to your attention, so you might find even more reason for concern once you investigate.

And the nurse who added her own note to indicate that the informed consent process was inadequate is handling the situation incorrectly, he says. You must put a stop to that practice immediately, he urges.

But first, Lefko answers a key question: When the nurse signs as a witness to the informed consent process, is he or she expressing approval of the content or merely confirming that an exchange took place? Lefko says the answer is that the witness signature indicates that the informed consent was valid and sufficient in that person’s eyes. Merely signing off, with no concern to what actually transpired, is not acceptable.

"When you sign, you’re attesting to the consent process — that the patient understood the information, was provided the full picture and all the other factors that go into the process," he says. "If the nurse does not have confidence in that process, it is appropriate to step in and halt the procedure."

But you should hope it never comes to that because the clinicians can address the nurse’s concerns. Whatever the problem between the physician and the nurse, adding a note to the witness signature is never the right solution, Lefko says.

He explains that in many states, adding such a note to the medical record creates a "rebuttable presumption" that the doctor was negligent in performing the duty to disclose. That’s the exact opposite of what normally occurs when the witness affirms that a valid informed consent process took place. In that situation, the record creates a presumption that the process was done correctly and the plaintiff must prove otherwise.

"A note in the record saying she had concerns creates the presumption that something was wrong and now you’re going to have to prove otherwise. It puts the burden on you, which is the opposite of where you should be on this question," he says.

So what should a nurse do if he or she is uneasy about signing as the witness? Lefko says the first step should be discussing the concerns with the physician, and ideally that should happen as the informed consent process is ongoing, not at the last minute when it’s time to sign the forms. If necessary, the nurse should seek the aid of an intermediary, such as a nursing supervisor or another physician.

While he says nurses should stand up for the patient when appropriate, Lefko suggests that risk managers also educate them about how their perception of the informed consent might be skewed sometimes. For instance, the nurse might not be aware of all the discussions between the patient and the doctor, or there may be cultural factors at work that can affect how the informed consent process is carried out. Some Asian cultures, he notes, depend on a family decision for such matters and not a traditional one-on-one discussion.

"It’s good for the nurse to speak up when she has concerns, but they also need to understand that her first impression might not be entirely valid," Lefko says. "Sometimes, the concerns can be dispelled by just pulling the doctor aside to ask, and the doctor might provide an acceptable explanation for why the informed consent process was handled the way it was."