Do You Understand “Informed Consent?”

February 1st, 2012


By , BSN, RN

Across the blogosphere, this past week or so, terms like patient advocacy, patient education, and informed consent have appeared more times than I can count. On Twitter and Facebook nurses are talking, decrying, in fact, that a nurse in Arizona was seemingly fired for furthering the client’s education on a surgical procedure they were about to undergo.

According to reports, the patient had already agreed to the surgery. However, when the nurse assessed the patient’s understanding of the procedure and the post-surgical recovery she found the client didn’t really understand all their options. The nurse proceeded to provide teaching materials and request a case management consult. One of the biggest issues in this case, one that should concern patients and everyone on healthcare teams everywhere, is informed consent. What is it, what should it encompass, and who is responsible?

Informed Consent

Informed consent is a person’s agreement to allow something to happen, such as surgery or an invasive diagnostic procedure, based on a full disclosure of risks, benefits, alternatives and consequences of refusal. Informed consent creates a legal duty for the physician and/or healthcare provider to disclose material facts in terms the client can reasonably understand to make an informed choice. Ok, that’s pretty much a textbook definition.

We have said it is a legal duty between the doctor or healthcare provider and the patient. All legal duties come with legal paperwork, so once that consent form is signed it’s full steam ahead for whatever the patient has agreed to, right?

It is not that easy. To quote the American Medical Association (AMA) “Informed consent is more than simply getting a patient to sign a written consent form.” This process should be a specific communication between the patient and physician about what the doctor wants to do, possible complications, and likely outcomes. In other words, they need to sit down and talk and there should be documentation that echo’s what is discussed. The following factors are required for informed consent:

  1. A brief, complete explanation of the procedure or treatment must be given.
  2. Names and qualifications of persons performing and assisting in the procedure should be provided.
  3. A description of the serious harm, including death, which may occur as a result of the procedure, as well as anticipated pain and/or discomfort, should be provided.
  4. An explanation of alternative therapies to the proposed procedure should be provided, as well as the risks of doing nothing.
  5. The client must be advised or his or her right to refuse the procedure or treatment without discontinuing other supportive care.
  6. The client may refuse the procedure or treatment even after it has begun.

Now, what the physician describes and what the form says may not be exact, but as stated earlier, it should echo it.

Nursing’s Role in Informed Consent

Because nurses do not perform surgery or direct medical procedures, in most situations, obtaining clients’ informed consent does not fall within the nursing duty. Even though the nurse often assumes the responsibility for witnessing the client’s signature on the consent forms, the nurse is not legally responsible for obtaining the informed consent.

What that means is you, as the RN, are merely collecting the signature, not responsible for the information included on the form or provided by the physician. You are like a notary when you sign it yourself. You are simply verifying that the patient signed the consent voluntarily.

That’s the legal standard, but the ethical standard, the moral standard is a little more complicated. When you hand the patient that form you should ask, “Do you understand the procedure you are agreeing to?” If they say no, or provide a description that is fuzzy, or if, as the nurse, you suspect they don’t really get it, you must notify someone. Call the physician, talk to your nursing supervisor, let someone else know that there is a lack of understanding on the patient’s part and don’t let them sign until that has been clarified.

The reality is lots of people, healthcare workers included, get lost in the explanations. As they teach us all in nursing and medical school, the worst time to talk to a patient is right after they have been given a diagnosis. They often just don’t hear you because their minds are wrapping around the fact they have kidney disease, or cancer or whatever else. They nod, they agree to things, but they don’t really hear.

Also, many people hesitate to question their physicians. Either it is generational, or cultural or they don’t want to appear stupid, but patients often just say ok without asking further questions of the doctor. It is often reported that nurses are easier to approach, plus we are the caregivers at the bedside 24/7. We are the familiar faces, the hand holders, and the teachers. According to JCAHO (Joint Commission on the Accreditation of Healthcare Organizations), in their Accreditation Manual for Hospitals under patient rights and responsibilities: “Nursing staff and other professionals who routinely obtain signatures on consent forms shall take reasonable steps to ensure that the benefits, risks and alternatives of any procedure to be performed on a patient has been explained to the patient or patient representative or surrogate by the physician before obtaining signatures.”

Informed consent is NOT the form. It is the explanation leading to understanding of the proposed procedure or treatment by the patient. What defines “reasonable” and what steps a nurse may take to “ensure” patient comprehension differs from place to place. It is defined by individual states’ nursing scopes of practice and by each facility’s scope of practice and standard protocols for nurses.

Who May Give Informed Consent?

  • If the patient is competent, the patient has the right to consent to, or refuse, the treatment. Generally, it is assumed that an adult patient presenting for treatment is competent, unless there is evidence to the contrary. “Competency” is generally defined as the ability to understand the nature and consequences of the illness and the proposed treatment and alternative to treatment and the ability to make a reasoned decision in this regard. The law presumes the competency of every person 18 years of age or older.
  • Parents are usually the legal guardians for pediatric patients and will sign the consent forms. If the parents are divorced the parent with legal custody must give consent.
  • Sometimes, getting informed consent is difficult, for example, the client is unconscious. Then, consent can be obtained from a person legally authorized to give it on the patient’s behalf, like a wife or husband.
  • In emergency situations, if it is impossible to obtain consent from the client or an authorized person, the procedure required to benefit or save the patient’s life may be done without liability for failure to obtain consent. In such cases the law assumes the client would wish to be treated.
  • Psychiatric clients must also give consent. They retain the right to refuse treatment until a court has legally determined that they are incompetent to decide for themselves.

Final Thoughts

While the nurse is not technically, or even legally, responsible for providing the information necessary for informed consent there is an ethical responsibility to look out for the patient’s best interest. The nurse’s role is both as a witness and as the patient’s advocate. As patient advocate, it is our responsibility to ask questions of the patient to determine whether he or she has received sufficient information to make an informed decision. That is a significant role and one we should never take lightly.

4 Responses to “Do You Understand “Informed Consent?””

  1. Carol Gino Says:

    Jennifer, another really good piece in the nuances of nurse/patient relationships. I’m completely disheartened by the corporate greed or ignorance of the “business of healthcare” and at the same time, very heartened by the quality of the responses from the nurses who have chosen to speak up about Amanda. But of course, it’s because we all know it’s not only about Amanda, it’s about all of us.
    For so many years, nurses have stood silently by as their doctor/corporate husbands have played God while those patients we have been entrusted to care for have been helpless children who didn’t even understand enough of the language or jargon to speak up for themselves. I’m heartened because now with the increased education, and courage we’ve discovered we have, we’ve found the voice with which to say “Foul.” Not fair. WE can’t allow this any longer. And in doing that, we have become strong enough to help our patients. Doesn’t this whole thing smack of the time before civil rights or feminism? Where is the voice of our organization who requires more from us and yet supports us less? Aren’t they required to grow with us? If not, what are they for? And whose got our back?

  2. Greg Mercer, MSN Says:

    Jennifer, thank you for this timely piece. It seems that too many harried and cynical providers have let our dysfunctional health care system beat down their expectations – providing Informed Consent can thus become a process of obtaining a signature to eliminate culpability related to Informed Consent. Very different things: substance versus appearance, integrity versus “everyone does it” rationalization.
    If we lack sufficient time for adequate Informed Consent, as often seems the case, it is our professional and ethical obligation to address the issue. It is entirely unethical practice to take on more work than can be done to minimim standards, in order to make more money. We must advocate for improved operational efficiency and communications – health systems badly lag behind other industries in both. We must also advocate for adequate staffing to permit minimal standards of care without such pressure that errors and short-cuts mount. Quality care is not just an individual provider responsibility, but also one at the institutional, industry, and regulatory levels. Americans can no longer afford to permit waste, errors and sub-standard care, by minimizing or ignoring these pressing problems.

  3. Lynn Hadaway Says:

    Thanks for this great information. All nurses need to read this and I plan to link to it on my Facebook page. I would also ask that you write a similar piece for nurses who are the ones to obtain informed consent for the procedures they are performing. In my specialty this is very important as nurses are inserting PICCs. Now nurses are beginning to insert percutaneous central venous catheter through the jugular and subclavian sites. Nurse practitioners are doing surgical procedures to insert tunneled cuffed catheters and implanted ports. These nurses are responsible for obtaining the informed consent in these situations. We researched this extensively while updating the Infusion Nursing Standards of Practice and found that the person performing the procedure should be the one to obtain the consent.

  4. Jennifer Olin Says:

    Thank your for your kind words and that great suggestion. We will absolutely look at information pertaining to nurses who are performing procedures and what they must pursue in providing informed consent.

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