Informed Consent - What Does it Really Mean?

Have you ever wondered how to get the most out of informed consent and informed refusal at your medical practice? If so, this blog is for you.

PSIC recently hosted a series of complimentary risk management webinars. In May, Linda Hay, JD, of Hay & Oldenburg, LLC presented on informed consent and informed refusal. In case you missed it, here are a few of the responses Ms. Hay provided to questions posed by attendees:

Do I, as the practitioner, have to personally witness a consent form?

No, but you are ultimately responsible for thoroughly explaining the procedure, the risks, the alternatives, etc. Therefore, you must actively perform those functions.

Additionally, while a practitioner’s signature is not typically required on the consent form, it can help to show that you were the one who went through everything with the patient and that you answered their questions.

If a patient refuses a procedure do they have to sign something? If so, what should they sign?  

It is always preferable to have patients sign off to confirm they were aware of the risks and alternatives of refusing a procedure. Signing a specific document such as an informed refusal form that identifies risks is the strongest evidence in these cases.

Since informed refusal can be more uncommon than informed consent, you may face situations where a form is not readily available. In such cases, it is essential to make a detailed note in the patient’s chart on the discussions, the advisement of the risks of refusal and any questions the patient may have had.

Because procedure refusal has the potential for dire consequences, you should consider consulting with a risk specialist or legal counsel to make sure your practice is handling these situations appropriately.

All of these steps can also be helpful if you must later make a difficult decision as to whether you should continue care of a patient whose continuous refusal compromises the standard of care.

Can I discharge a patient if they will not agree to sign a consent form?

Yes, but typically patients must be in stable condition on discharge. This, again, is a situation where detailed documentation of the steps leading to such a decision will serve you well if a complaint arises.

Remember, professionalism in communications with a patient on discharge is critically important.

Can I discharge a patient for refusing to have a procedure I recommend?

Yes. Even a simple act of refusal to take x-rays, if left unheeded, can compromise the ability to provide proper care.

Informed consent risk management

In addition to the above information, implementing core risk management principles of informed consent is strongly encouraged. These principles should include:  

  1. Using layman’s terms to improve patient understanding without compromising the message.
  2. Writing informed consent forms in the primary language of the patient.
  3. Avoiding long sentences and paragraphs in informed consent forms.
  4. Using patient educational resources and printouts to further explain procedures.
  5. Assessing patient understanding throughout the process.
  6. Encouraging questions.
  7. Documenting the discussion process.

For more information on this topic, PSIC’s complete webinar Informed Consent and Informed Refusal: How to Know When Enough is Enough is now available online. 

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