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Dr. MedLaw explains the importance of discussing risks, benefits, and alternatives in a manner that patients fully understand when obtaining patient consent.

From our earliest days in medical school, we learned that treatment requires a patient’s informed consent. What is less often taught is how to obtain that consent in a manner that withstands legal scrutiny. Let’s take a look at some points to consider:

What Is the Legal Role of Consent?

Ethically, informed consent safeguards patient autonomy and underpins today’s model of shared decision-making. A century ago, in a more paternalistic era, consent assumed patient agreement with a physician’s recommendation. That assumption no longer holds; the process is now viewed as mutual and interactive.

Legally, treating a competent (or represented) patient without permission constitutes battery. Physicians’ good intentions are irrelevant except in dire emergencies in which consent is impossible to obtain. The principle is simple: If a patient can be asked, a patient should be asked. A discussion of consent and documentation of the patient’s voluntary and knowing agreement to the proposed care in a signed and witnessed consent form, therefore, function as the physician’s shield.

The duty to ensure that the patient adequately understands the proposed care and has agreed to it is not delegable. We may recall, as interns, getting consent forms signed by patients we would not be treating, but that was only procedural.  It was always the physician’s obligation to review the facts with the patient and obtain agreement before proceeding. Similarly, using informational videos is now popular, but only a first step. The physician must still verify that the video was understood.

Are Consents Only for Invasive Procedures?

By statute, the answer is “yes” for care that requires the patient to actually sign a consent form. However, in the modern setting of shared decision-making, any proposed treatment should be considered subject to the requirement of consent.

When you think about it, that’s what you’re doing when you recommend a diuretic to your patient with hypertension and tell them that it has been shown to be effective, but may cause dizziness, which they need to be careful about, and then say, “OK?” before issuing the prescription. You may not be getting a signed form, but you do want a note in the chart that records the conversation, showing that risks and benefits were explained and patient agreement was obtained.

What Must Consent Cover?

The general rule is that patients must be informed, in terms they can understand, about the risks and benefits of the proposed care and any clinically acceptable alternatives, but what is actually necessary to be said?

There are two models of requirements:

1. What a reasonable doctor physician under similar circumstances would reveal.
2. What a reasonable patient would want to know about the proposed care.

The first, followed by a majority of states, focuses on the physician’s fiduciary duty of disclosure. The second, often referred to as a materiality standard, focuses on the patient’s need for specific information to make their decision.

However, are these practically different in practice? For example, in New York, a patient suing due to a lack of informed consent must show that a reasonable physician would have informed them of a risk that then harmed them. However, in Alaska, a patient must show that they were not told relevant facts that a reasonable patient evaluating the proposed care would want to know. But wouldn’t a reasonable physician explain likely risks, and wouldn’t a reasonable patient want to know about them?

Every physician should therefore know the applicable standard in their state; however, when actually speaking to a patient, they should reverse-engineer what they would want a judge, juror, or medical board examiner—someone who, in their own life, is a layperson—to see that they said.

What Should Be Covered in a Consenting Note?

This is the physician’s only opportunity to demonstrate to a later evaluator that they actually informed the patient about the proposed care. Rote statements such as “Risks, benefits, and alternatives were discussed,” or even worse, “R/B/A discussion done,” squander that opportunity.

On the other hand, busy physicians do not have the time to write long exegeses about a 10-minute talk with their patient who has a cataract.

The issue is to be succinct yet personalized enough to demonstrate that this discussion with the patient actually fulfilled your duty to inform them before they agreed.

Start with the risks that you actually discussed. If you say “including” (but never “including but not limited to,” since you are not a lawyer drafting a contract, and this language will only put off a later evaluator) before the ones that you state in the note, you leave yourself the leeway to later say that you discussed other issues, so some defense attorneys recommend that. However, the plaintiff’s attorney will then just ask why you did not write down the issue that eventually harmed their patient, and when you fumble and say that you don’t remember, their response will be the legal equivalent of “Sure.” Basically, if something was worth saying to the patient, it is worth including in the note. You can always put in the priority that you mentioned an issue—for example, that itchiness was likely but death was virtually nil—but you will not be sorry that you spent an extra line saying what you said.

You should also state the actual benefits that you balanced against the risks. For example, it could be assumed that you suggested laparoscopic cholecystectomy as a benefit to the patient’s health, but what you told them about success rates and recovery times is what matters to their willingness to go ahead.

Finally, be specific as to what you said about any alternatives, including why they are less preferable than the approach you are recommending.

It is also essential to not just record what you recited, but how you listened to the patient and responded to them. This is because patients are usually not medically trained, and even if they are, they likely have less expertise in your area than you do. Asking if what you said is clear as you go along and then asking at the end if they have any questions are essential to determining whether they are actually being informed. Therefore, you want to document that you did it and use appropriate language when you do so. “Patient verbalized understanding” or “Patient denied questions” is not what you want read to a jury or seen by a medical board. You want to document something like the following: “During the discussion, I asked Ms. Patient if she had any questions before we went further, and she said that she did not. At the end of the discussion, she said that she understood what we had covered and had no questions.”

The Consent Form

The signed consent form will be presented as proof that the patient accepted the proposed care after the discussion, so it should facially stand as valid.

First, it should be in colloquial language and a readable font. The key to defensibility is that someone like the patient, when actually reviewing the form prior to care, could read and understand what they were signing. Dense legalese in small, packed font loses all its intended protective value when it is later set aside by a court as having never been knowingly agreed to.

The procedure should also not just be named on the form but briefly explained (eg, “Endoscopic retrograde cholangiopancreatography: insertion of a thin tube through the mouth to the intestine and dye injection to visualize bile ducts”) to eliminate a claim that the patient did not understand the medical name of the procedure and how it related to what they had discussed with the physician.

Even if the physician is using a facility’s consent form, it is preferable to avoid having it signed in the physician’s office, both because a patient may then claim that they had second thoughts but did not feel free to state them and because there is an apparent conflict of interest if the physician has a member of their own staff act as the witness to the patient signing for work that the physician will be paid to do. The discussion of consent should be handled and documented in the physician’s office, and the form should actually be signed by the patient and witnessed by a facility staff member on the day of the procedure.

Of course, on the day of the procedure, the physician should not just say “This is what we talked about 2 weeks ago. Sign here.” There should be a quick review of what the procedure entails, and the physician should then specifically ask if the patient is still willing to proceed.

Obtaining Consent When Using a Translator

The consent process depends on the physician and the patient understanding each other; therefore, another issue that often arises is how to obtain valid consent when the patient has limited English proficiency and a translator is used. Because the physician cannot speak the language in question, how can they be sure that what they said or what the patient responded was correctly stated?

The answer is to act reasonably.

The physician should expect that the length of the translation and the patient’s response will be as expected if they were speaking directly to the patient. A translation that is significantly shorter or longer, a patient’s response that seems discordant with the statement, or the patient appearing confused should prompt the physician to ask the translator exactly what was said.

A consent form in English signed by a patient who does not speak English is also inherently problematic. Therefore, if no form in the patient’s native language is available, the translator should review the form with the patient and indicate this with their signature on the form.

What If the Patient Declines the Consenting Discussion?

A final issue to consider is when a competent patient, either due to personal preference or cultural reasons, declines to be informed and simply wants to consent.

In this situation, you want to be somewhat persistent, thanking the patient for their faith in your medical judgment while also stating that you want them to know the facts. If they are adamant, however, they cannot be compelled to listen, and you should document in your note that the discussion was declined, that note itself demonstrating that you fulfilled your fiduciary duty to respect their autonomy, but that they voluntarily waived that protection.

Summary

To be defensible against a later challenge, obtaining consent should be based on a discussion of risks, benefits, and alternatives that the physician ensures are actually understood by the patient. This discussion may, depending on the jurisdiction, be based on a reasonable physician or reasonable patient standard, but the two will likely overlap in a practical sense. The patient’s agreement with treatment should then be documented on a form that is clear and understandable, with no room for ambiguity regarding an interim change of mind or a potential conflict of interest. If a translator is used, the physician should assess whether the process seems reasonable even if they cannot understand the language used, and the form itself should be translated as well. A patient may, as an aspect of their autonomy, decline a discussion of consent and defer to the physician’s judgment, but the physician should document that the discussion was offered.

Any views and opinions expressed are those of the author(s) and/or participants and do not necessarily reflect the views, policy, or position of Physician’s Weekly, their employees, and affiliates.