A doctor looks at a form that his patient is writing on.

Altering Informed Consent Forms

If an Informed Consent form needs to be changed for a specific situation, only the provider should be able to make a change.

You already know that Informed Consent forms are a must. But what if a patient wants to change language on your existing form? Can he or she simply cross out the language they don’t like and write their own language in its place?

In a word: No. While you may want to make your patient happy and feel comfortable signing the form, from a risk management standpoint, this is not a good practice to allow or encourage. First, let’s talk about informed consent basics.

Informed Consent Basics

  • Procedure specific informed consent forms are recommended.
  • The provider who is performing the procedure is responsible for securing the informed consent.
  • Informed consent is not just a form; it is a conversation as well with the patient having the opportunity to ask questions.

What If a Patient Won’t Sign the Form as Written?

  • It is the provider’s responsibility to explain to the patient why the form is written the way it is, why it says what it says and advise that no changes can be made. 
  • In some facilities, the forms are preapproved by boards, etc. All providers should be aware of the process the forms undergo in order to be used in the first place and aware of what their actions regarding changes could initiate.
  • If a change is deemed necessary by the provider based on specific circumstances, it is the provider who should change the form and then have the patient and provider initial the changes made by the provider. Document why the changes were made by both parties so that if/when the records are reviewed in the future, a clear thought process of what was happening can be determined.

For more information on the topic of informed consent, access our free webinar: Informed Consent and Refusal: How to Know When Enough is Enough

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