Things I Wish I’d Known From the Beginning: Informed Consent

“Can you go get the consent?”

New interns and their more seasoned senior residents are asked this almost every day. So let’s talk about this for a minute and what that question really means…

What you are being asked to do.

The hospital requires a signature on a consent form (always printed with very small font and several pages long). This part of the consent process that has a long history guided primarily by legal counsel for hospitals and, yes, you need to get the signature. But…

The signed form isn’t the consent.

Maybe I should say that again….

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So what is?

Photo credit – from a great article on disclosing the presence of learners in the OR

There are five things that must be present for informed consent. If any of them is missing, it’s not informed consent.

The patient must have the capacity and ability to understand. (No intoxication, translation when needed, etc).

The patient must actually understand. (This means you have to confirm they understood with a conversation – Can they explain it to another family member? Do they have questions?)

The person performing the procedure (or their designee) must describe the procedure and must discuss alternatives, risks (and how likely they are) and the expected benefits (and how likely they are).

The patient has to agree without coercion. (If you aren’t sure about this, don’t proceed)

The consent has to be documented.

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There are questions that every intern would like to ask about this process but can’t/won’t. Here are a few that come to mind…

What if you’ve never performed (or even seen) the procedure yourself? It’s hard to get truly informed consent if you aren’t competent in doing the procedure. But – you know (intellectually) the alternatives, the potential risks and benefits, and the “big picture” of the procedure. Particularly for complicated procedures, you can assume that the attending has discussed these (and therefore is the person who actually got the consent!). Here’s a way to make this easy… “Hello, I’m Dr [xxx}. I know that Dr. Attending has already talked to you about your surgery. I’m here to go over the alternatives, risks and benefits again – to make sure you don’t have any questions I can take back to Dr. Attending for you.”

p.s. If you are “Dr. Attending” in this scenario, you are the one who is ultimately responsible for the informed consent (and liable if it’s not done properly).

Is it important to get the consent just before the procedure? No, in fact it makes it legally more sound and much more efficient to document informed consent when you first see the patient. For elective or semi-elective surgery, it takes no time at all for “Dr. Attending” to put this phrase (or one like it) in their clinic (or ED) note: The procedure including alternatives, risks, and benefits was discussed with the patient, all questions were answered, and informed consent was obtained. This documentation often holds more water than the signed form (at least according to most attorneys I’ve talked to). Best yet – do both. Get the consent form signed at the same time! It’s easy to scan into the medical record to be there for the day of surgery, which is a win-win for almost everyone involved.  

What if It feels like you are scaring the patient/family when you review the list of the possible complications? First of all, that’s a normal feeling. But we have to learn to handle the anxiety that is always part of this process. In addition to trying to be really calm and supportive, here’s how I handle that: “When we decide about doing surgery, we always ask which is riskier… to do it or not do it. For you, we’ve decided together that it’s risker not to do the surgery… which is why you are here. But because there are risks, I want to make sure you understand them and we can talk about them before the operation.”

What if they don’t speak English but the family says they can translate for you? It’s not informed consent unless it’s translated into their language by a professional medical translator. Imagine the shoe on the other foot. What if your best friend the artist was travelling in a country where none of the doctors or nurses spoke English and they needed surgery? They would be terrified and so would any family member who was with them (even – or maybe especially – if they were being asked to translate). Don’t cut this corner. Please.

Isn’t this blog post oversimplified?

Yes!

Informed consent is a fascinating and rapidly changing area of medical ethics. I hope I’ve hit the critical highpoints and addressed a few unspoken questions many trainees have, but it’s unquestionably a “30,000-foot view”.

p.s. If you have more questions, even ones that seem naïve, please comment on this post or email me (if you don’t want them to be public).

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Here are some other great resources to learn more:

American College of Surgeons educational pdf on informed consent

ACS and Association of Surgical Education student curriculum on informed consent

Informed Consent for Academic Surgeons: A Curriculum-Based Update (with links to all the slides for the course!)

Whose Decision Is It? Teaching Students and Physicians About Informed Consent

Informed Consent and Shared Decision Making in Obstetrics and Gynecology

Fantastic You Tube video on obtaining informed consent

Treating Patients as Partners, by Way of Informed Consent – column by Pauline W. Chen in the New York Times

 

 

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