Understanding Informed Consent

Have you ever walked into your doctor's office and been handed a stack of papers to sign? The answer is most likely yes.

Among the papers, you probably found insurance information requests and HIPAA information about the privacy and security of your records. Included, too, may have been an "informed consent" document.

patient signing document
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What Is Informed Consent?

The concept of informed consent is based on state laws. It requires your doctor to provide information about the benefits, risks, and alternatives of any test, procedure, or treatment that they recommend before it is performed. It also requires you to sign a document which states your doctor has provided that information.

Too many patients sign the informed consent form without full comprehension of the risks and benefits of those tests, ​procedures, and treatments. They may not have asked enough questions, or they may not have done any additional research prior to signing the documents. An empowered patient knows that the informed consent document rarely needs to be signed on the spot.

You've likely heard this advice before: "Don't sign anything until you know what you are signing." That also applies to informed consent documents.

If you are asked to sign an informed consent document, follow these guidelines:

  • First, understand that your signature on the form tells your doctor that she has permission to go forward with her recommended treatment, test, or procedure. It makes no sense to give a doctor permission to do anything to you until you understand why it's being done, what else could be done instead, and what could possibly happen to you during the process. All of that requires a research and decision-making process. If you have unanswered questions, be sure to take the time to get answers you need.
  • There is no rule that says you must sign the form when it's handed to you. Some doctors include the informed consent form among the documents that must be signed by patients before they see the doctor. If that happens to you, then just hang on to it until you are satisfied you have the information you need.
  • When your doctor describes the tests, procedures, benefits, and risks to you, take the time to repeat them back to him as you understand them. That will give the doctor the ability to clarify any information you may not understand correctly.
  • Finally, recognize that your signature on the form provides no guarantees that the treatment, test, or procedure will relieve or cure you, or that you are removing any risk. Unfortunately, medical treatment can never provide a guarantee. But your understanding of why you need the test or treatment, how it will happen, and what the risks and alternatives are, will support its chances of being successful.

It's true that "informed" and "understands" are two different concepts. An empowered patient expects both.

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  1. Gossman W, Thornton I, Hipskind JE. Informed Consent. [Updated 2020 Feb 18]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK430827/