There is a disconnect between health care providers and patients.  Informed consent means different things to each of these groups.

Let's start with some internet definitions of informed consent:

American Cancer Society:

Informed consent is a process of communication between you and your health care provider that often leads to agreement or permission for care, treatment, or services.  Every patient has the right to get information and ask questions before procedures and treatments.  If adult patients are mentally able to make their own decisions, medical care cannot begin unless they give informed consent.

American Medical Association

Informed consent to medical treatment is fundamental in both ethics and law.  Patients have the right to receive information and ask questions about recommended treatments so that they can make well-considered decisions about care.  Successful communication in the patient-physician relationship fosters trust and supports shared decision making.

Wikipedia

Informed consent is a principle in medical ethics and medical law that a patient should have sufficient information before making their own free decisions about their medical care.

You can see from these definitions that informed consent all contain communication.  Communication, be it verbal or written, is the way informed consent is supposed to occur. Let's now look at the elements of informed consent—the fundamental parts that should be included in any informed consent.

Basic Informed Consent

First, patients have the right to receive information—but information about what exactly?  We believe, at a minimum, that truly informed consent should include information about the proposed medical treatment or medical procedure.  But what information is important so you, as a patient, can decide?  The basic information we believe that should be provided include:

• What will happen if you decline the proposed treatment / procedure?
• What exactly is the treatment / procedure?
• What alternatives are there to the proposed treatment / procedure?
• Will the treatment / procedure hurt?
• How will we control the pain from the treatment / procedure?
• What are the potential complications?
• What do you do to prevent complications?
• How often do these complications occur?
• If complications occur what is the treatment?
• How often has the provider has performed the treatment / procedure?
• What were the outcomes of patients the provider has treated?

Without the basic information patients are often left at a deficit because they do not know what they do not know.  I have seen and heard doctors simply say something like, “we are going to fix you up—sign the form.”

Full Informed Consent

Second, patients have the right to ask questions about the proposed medical treatment or medical procedure.  But what questions you ask depend upon the information you are first provided. Questions you might consider are:

• How is the treatment / procedure going to affect me?
• What alternative treatment / procedure is safer?
• Has the provider performed the treatment / procedure before?
• How often have “complications” occurred in patients you have treated?
• What were the ultimate outcomes of the treatment / procedure?
• How much does the treatment / procedure cost?
• Will my medical insurance pay for the treatment / procedure?

Who is Protected by Informed Consent

The typical printed informed consent form that patients sign includes a list of what may occur during the proposed treatment / procedure.  A simple example might be when a patient, signing a consent form for general anesthesia, will include something like:

I understand that the probability of significant harm from anesthesia is minimal.  Occasionally anesthesia may be associated with the occurrence of nausea, vomiting, dizziness, drowsiness, headache, depression, numbness, dental damage, sore throat urinary retention and changes in smell and taste for a brief time.  Some potential risks which are less likely to occur include but are not limited to, infection; breathing problems· unexpected reaction to drugs; serious rapid increase in body temperature; failure to recover from anesthesia, including death.

When something goes awry in any given treatment / procedure the provider will point to the consent form and say something akin to, "We told you this might happen, you knew it could happen, it happened, and now you are unhappy it happened."

Now let's add a little bit to our story.  Let's assume the person signed the above consent for general anesthesia.  The person dies.  That person was told they might die, they knew they could die, they died, and the surviving family is not happy about it.  Now let's add one tiny bit of information to our story—the drug used to anesthetize the patient was the wrong drug and that wrong drug caused the patient's death.

Make no mistake about it—informed consent protects the person (doctor, nurse, technician), and oftentimes the entity (clinic or hospital), providing the treatment / procedure. 

Does Informed Consent Allow for Negligence

In the above general anesthesia example, the anesthesiologist used the wrong drug to anesthetize the patient and caused his death.  This is negligence!  But the informed consent said the patient might die and some might argue that because the patient knew he may die, the informed consent somehow lets the doctor off the hook.  Nonsense!  Did the consent form say anything about the patient knowing about the anesthesiologist using the wrong drug—no!  It is a matter of law that people cannot consent to allow others to commit negligence. 

Informed Consent Law in Utah

In a medical malpractice case the jury will ultimately decide whether the informed consent was truly informed.  The Utah Jury Instruction on informed consent states:

CV319 Written consent defense.

A written consent is a defense to a claim for failure to obtain informed consent, unless:

[(1) [Name of plaintiff] proves by a preponderance of the evidence that the person giving consent lacked the capacity to do so.]

[(2) [Name of plaintiff] proves by clear and convincing evidence that [name of defendant] obtained the consent by fraudulent misrepresentation or fraudulent failure to state facts important to a reasonable person in making decisions about health care.]

There is no waiver for negligence and informed consent has no bearing on whether negligence occurred.  Defense attorneys often stand up at trial and wave around the informed consent and claim the negligently harmed patient knew it could happen, it happened, so …. Give the doctor a pass.  Again, nonsense!

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