What is “Informed Consent”?

June 7, 2012
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How Informed is Informed Consent?

It depends. The term Informed Consent means that you have been told of the reason for a procedure, the alternatives to the procedure, the risks and benefits, and the likelihood that the procedure will be helpful. The term applies not only to medical care that you need but also to clinical trials in which you are participating.

Informed Consent is key to patient autonomy and empowerment involving a two-way process of physician input and the patient’s understanding of what she has been told. Integral to the process is giving time for the patient to consider her options, formulate questions, and ask for additional information. The idea behind Informed Consent is that one has the right to know what is being done to his body, and the right to refuse treatment if he chooses. Informed Consent signifies that the patient is sharing in the decisions being made for his treatment.

The term is a bit of a misnomer, for a patent can decline to give consent to the physician’s treatment plan. A better term would be “informed decision-making.”

Most people do not ask enough questions about their procedure.

Key to the patient’s comprehension of her options is knowing the questions to ask when presented with the physician’s proposal. If asked by the patient to do so, healthcare advocates often intervene to assure that their client does indeed fully understand the information given.

Components of Informed Consent include one’s diagnosis and prognosis, alternative treatment plans, and the advantages and disadvantages of all options. If health literacy is an issue, and it often is, information is required to be communicated at the patient’s level of understanding, avoiding medical-eze and legal-eze.

Your doctor must explain why he believes the procedure needs to be done.

The steps of the procedure must be described.

The risks of the treatment must be explained, including any health care quality issues that exist.

Your doctor must tell you what to expect while you recover from the operation.

You must be told about alternative treatments.

You must be told what might happen if you refuse the treatment.

Your doctor must explain why the procedure will benefit you, and what the likelihood is that the operation will be successful.

You must be told the cost range of the procedure, and given a breakdown if you ask for it.

You must be told what will be involved in your care after the procedure, and shown how to perform any tasks needing to be done after you are home. If home health care assistance will be needed, a case manager, if asked, will inform you of how it can be obtained and paid for.

Your doctor must explain any residual effects from the operation.

You must be told when you can expect to resume normal activities.

You may have as many conversations as you need with any member of your medical team until you are comfortable with your knowledge and ability to make an informed decision that is right for you.

You may alter the Informed Consent document to more precisely reflect what you know.

All of the above must be given to you in writing before you sign anything.

So how can the components of Informed Consent not be met?

First, realize that due to time constraints and a physician’s “need to know” orientation, you typically are given generalized information that is often a template extended to all patients with your disease. Additional information is often not volunteered. You may be encouraged to ask questions, but most healthcare consumers do not have the extreme medical sophistication needed to know what questions to ask. This is where your patient advocate can be extremely helpful.

Sometimes the language may mislead you. Watch out for phrases that are vague or overly generalized. The information you are given may be sugar-coated. For instance, when a doctor or nurse uses the word “discomfort,” what they mean is PAIN. If you are told that success is “likely,” ask for specific percentages. “Likely” often is code for a 50/50 chance. You might want better odds than that. Ask what the historical success of the operation has been in the past, and when there have been complications, a description of the most frequent types.

Ask how many times the physician has performed the procedure. You want someone who frequently performs the operation proposed to be done to you.

Is there any reason you should not have the procedure? There almost always is, but is there a slight risk, or a “significant” risk? “Significant” in medical-eze means “almost certain to happen.”

Ask to see how the procedure is described to your insurance company. You hope to see the same explanation to your insurer that you are given (although you may have to have the language translated out of medical-eze or legal-eze so that it is understandable). Talk it over with your hospital case manager, if relevant, and/or your insurance company’s case manager.

Get everything in writing. Scrutinize it, and ask a trusted friend, family member, or your advocate to also read it for any ambiguity. If you don’t like something on the document you have been asked to sign, feel free to mark it so that it reflects your preference, and ask the physician to initial it.

Finally, repeat back what you understand you have been told and ask your doctor to confirm or amplify your knowledge.

Further reading: The American Medical Association discusses this standard in depth.

20 Responses to What is “Informed Consent”?

  1. Debi Qurk on June 8, 2012 at 1:02 am

    Thanks Claudia.
    The information is so thorough.
    I myself was a patient last week. I was not even asked for my identifying data, and a sticker was ‘slapped’ on my gown identifying me. (not verified).
    I asked many questions about my procedure, mostly because none of it was given to me prior (as above in your informed consent). I believe most patients would not know ( I am a medical professional).
    No risks were explained to me.
    I was shocked! I was in the best place in Seattle to have medical care. I was in the place that got the highest grade from the Leap Frog Group on Safety. Yet,……none of the above occured.~!!
    I was given a piece of paper with list of what I should do once I got home.
    No instructions from the RN.
    It has been 7 days and I am still awaiting a follow-up phone call to see how I am doing.
    This is where the system has gone….I have been in it for 34 years, and I am in shock! I feel fortunate that I have an understanding and a knowledge base so I can protect myself.

    • Claudia K. Nichols on June 14, 2012 at 7:14 pm

      Debi, clearly you were blind-sided by how a hospital bureaucracy works. It’s interesting that an ethical principle that is taken extremely seriously by the AMA is treated so casually in actual practice.

  2. Betty Curtis on June 10, 2012 at 7:17 pm

    THANKS for your presented information !
    I certainly agree that this issue needs to be addressed, and fine-tuned.
    The specialized terms, acronyms etc, used by medical facilities, are often confusing to the patient. If physicians, and medical personnel want a clear dialogue with patient, they will have to respect the fact that few patients will be able to assimilate full meaning of specialized terms. I understand these terms are helpful for those who work daily with medical info, but they
    can be confusing, and even misleading , for those unfamiliar with them.

    When you are a caregiver standing in admissions line at an emergency entrance, and they want you to sign some fine-print papers, you are often
    left without options. I have been in that position, knowing what the patient did not want. I asked if I could write out what exceptions I knew were the patient’s choices, and have it stapled to the paper they wanted me
    to sign, as the patient could not sign the papers theirself. They allowed it, stapled my statement to the admissions paper, then told me it would not have any legal value, as I was not a blood relative. Of course, when we were again home we took care of that, and wrote out a statement we could have notarized.

    • Claudia K. Nichols on June 14, 2012 at 7:19 pm

      Betty, the situation you describe is so difficult. An emergency admission does not permit advance check-in so that the patient can carefully review how the hospital proposes to treat her. And yes, the “medical-eze” needs to be jettisoned so that what the doctor says makes sense!

  3. Ann Fonfa on June 12, 2012 at 2:24 pm

    It is sad that not all that much has changed in the medical system in the last 20 years – it has been clear that such change is GLACIALLY slow. Most of us do not know what questions to ask – I have suggested since 1993 that medical professionals provide written Q&A (FAQ) so that many of our potential questions are clearly answered (there are so many diseases, it is absurd to think anyone knows all they need to about the one they are currently being diagnosed with, and many cannot afford to hire a Health Coach or Navigator). Many of us, myself included, do not really complain when later we realize we were not fully informed prior to a procedure. My spouse told me he resented being asked to sign a ‘consent’ form prior to his first colonoscopy, as he sat on the table wearing a gown. He expressed to me that he felt they took advantage of his confusion, embarrassment, and fears by not asking him to sign while a) fully dressed, b) in the waiting room, and c) perhaps before the actual date of event.
    I am the founder of nonprofit Annie Appleseed Project for those with cancer and questions about natural strategies.

  4. Claudia K. Nichols on June 14, 2012 at 7:25 pm

    Ann, you are so right. I don’t know if the medical staff were deliberately taking advantage of his vulnerability – the callous behavior we often witness from this tribe is the result of great stress and ultimate stakes – but what your husband described was a horrible way to obtain his consent. Clearly, one isn’t given any time to explore options or discuss risks and complications when you’re about to undergo the procedure. I’m so glad you’ve founded the Annie Appleseed Project. I’ll definitely check it out.

  5. […] following article, What is “Informed Consent”? by Claudia Nichols and posted on Pilot Health Advocates website is written from the perspective of […]

  6. Carmen on July 24, 2012 at 6:46 pm

    Great assessment. Patients are also entitled to know how the study went. Reporting of study outcomes is required, but not often provided on clinicaltrials.gov. It would be great to learn of any incidental findings that arise during a research study too, e.g. if other positive benefits arose from the study compound that were unexpected.

  7. Heda on September 1, 2012 at 9:04 pm

    I had a Lumber Puncture done in the ER after a CT of my head confirmed a bad infection in my left maxilla sinus. I did not sign any consent form. The risks and dangers were not disclosed. I was not even asked to change into a gown. No history taken.
    I was shuffled out the door only 2.5 hours after the LP. Not even kept for the 4 hours required. And not even kept for the 2 days for them to get the results of the culture back.
    I had to look up all the information regarding complications on the internet.
    When I was returned back to an ER shortly after the LP was done because I am drowsy and I cannot feel my limbs I was denied medical help.

    • Arizona Nurse on December 1, 2012 at 3:31 pm

      This totally does not surprise me. I have also worked in ED depts and that is another area that patients are treated horribly.

  8. Arizona Nurse on December 1, 2012 at 3:29 pm

    I see abuses every single day of patients in the surgery dept. They take total advantage of patients. It makes me sick. When brought to the attention of the manager and director, I am labeled the “troublemaker” they say I worry about things too much. “so what who cares, just get them to sign it” I’ve seen nurses attempt to answer pt questions that the surgeon should be answering. It all makes me want to vomit at what healthcare has become today.

    • Claudia K. Nichols on August 9, 2013 at 6:13 am

      Yes, there is often a conflict between providing quality healthcare and an entity’s financial self-interest.

  9. Diane on January 31, 2013 at 3:44 am

    Another issue in obtaining an informed decision is timing…for example, if a person is given a diagnosis of a malignancy, he or she is going to be emotionally affected and most likely will not be able to take in, understand and evaluate information being given, at that time, regarding treatment options and all the accompanying information. Unfortunately, it is often done at that time.

    • Claudia K. Nichols on June 8, 2013 at 10:42 pm

      Diane, great insight, and an issue I haven’t seen addressed except within the context of “fluctuating capacity” and “sundowning, ” both of which typically occur in patients with previously diagnosed neurologic disease. To my knowledge there is virtually no consideration of timing outside of the above conditions. I’m not sure how well informed consent is addressed even within these diagnosed populations.

  10. Resource on April 27, 2013 at 9:02 am

    agreed

  11. Odilia Noxon on June 7, 2013 at 3:04 pm

    There is no coherent, consistent and widely accepted definition of alternative medicine. Often referred to as complementary and alternative medicine, or simply as CAM,alternative medicine resists easy definition because the health systems and practices to which it refers are diffuse and its boundaries are poorly defined.

    <http://www.healthmedicinebook.com/index.php

  12. google advertising tools on June 22, 2014 at 2:04 pm

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    • Claudia K. Nichols on October 29, 2015 at 5:24 pm

      The Alliance of Professional Health Advocates Linked In forum is the best discussion resource I know. I believe you must join the Alliance, but it is a good investment not only for practicing advocates but for interested health care consumers who wish to develop their own basic navigational skills. Please see http://APHAdvocates.org/, and good luck!

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  14. Claudia K. Nichols on October 29, 2015 at 5:24 pm

    CC ~ much appreciated!

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