Lippincott Nursing Pocket Card - October 2021

Informed Consent

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Definition

Informed consent is a process of communication between a patient and a health care provider that results in the patient’s agreement to undergo a procedure or treatment. It is both a legal and ethical obligation. The provider educates the patient about the benefits, risks, and alternatives of the intervention. Informed consent is required for invasive procedures, procedures requiring sedatives or anesthesia, non-surgical procedures that carry risk (i.e., blood transfusion), and procedures involving radiation. Nurses are key participants in the informed consent process, in both educating the patient and verifying understanding.

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Background

  • The concept of informed consent in healthcare usually calls to mind the written contractual acknowledgement form signed by a patient or legal representative in advance of a procedure. 
  • Legal restrictions on who can obtain informed consent varies by state, making it vital for nurses to be aware of the policy where they practice.
  • Informed consent is also a process, extending beyond the paperwork, in which nurses must fully understand their legal, moral, and ethical roles.
 
Historical Perspective
  • Paternalism played a significant role in the history of informed consent, as it allowed the surgeon, nurse, or family members to set aside patient preferences in care and assumed that others would make the most beneficial choices on behalf of the patient.
  • In the past, some considered it undesirable to discuss the possible risks or negative outcomes with patients for fear that it would increase their anxiety or make them less likely to consent to life-saving procedures.
 
Ethical and Moral Considerations
  • Autonomy: the moral right of the patient to make their own decisions
    • Nurses and physicians can support patient autonomy by using neutral language and not emphasizing benefits over risks.
    • The trusted roles of physicians and nurses make it imperative that they exercise discretion and fairly represent balanced information to patients, particularly during the consent process.
  • Self-determination: the ethical principle which supports providing patients with the facts necessary to make a rational decision on their own behalf

Patient Education

  • Nurses are empowered to assess and understand their patient’s cognitive abilities, knowledge of their condition, and learning styles, allowing for appropriate interactions and successful nurse-patient education.
  • Nurses perform most patient education at the bedside, filling trusted roles as patient caregiver, advocate, educator, and steward.
  • During bedside care, nurses may be asked by both the patient and family to answer questions related to upcoming procedures and surgeries, and move from informing, to genuinely educating about upcoming procedures and tests.
  • Consideration must be made to factors such as pain, anxiety, the disease in question, and therapeutic interventions, as these may hinder the meaningful participation of patients in the decision-making process.

Informed Consent

  • At its core, informed consent requires patients be aware of the risks, benefits, and alternatives of the proposed surgery, intervention, or treatment and be given an opportunity to ask questions.
  • The process of informed consent is complex, may require the participation of multiple parties, and usually begins well in advance of the point of obtaining a signature on a form.
  • The signed and witnessed informed consent form is the legal obligation of the physician or advanced practice provider performing the procedure in question.
  • Nurses are usually charged with verifying the informed consent paperwork has been obtained just prior to surgery or procedures.
  • Consent should never be considered a waiver of liability.
  • Patients have the right to know who is performing their procedure, as well as how many times the person has successfully completed this procedure.
  • If the nurse believes the patient has not been fully informed or has less than a full understanding of the proposed treatment, the nurse must act as a patient advocate to ensure that the patient receives the necessary information.
Terminology
  • Informed decision-making: Can only be completed by a patient with the mental capabilities to understand the decision to accept or reject the medical treatment being offered.
  • Decisional capacity: A patient who is unconscious, disoriented, or delusional may have a surrogate decision-maker assume authority for providing informed consent on their behalf.
  • Healthcare surrogate: A person designated by the patient to make healthcare decisions should the patient become incapacitated.
  • Substituted judgement: In the event that a patient lacks the capacity to make decisions on their own, statutes in many states allow for the assignment of a proxy to make decisions, who must consider any and all known wishes of the patient.

Refusal of consent

  • It is within the rights of the autonomous patient to refuse a recommended treatment.
  • A competent patient may verbally withdraw consent at any time, and refuse to continue a treatment pathway, even in the presence of a signed consent form.
References:
 
Axson, S. A., Giordano, N. A., Hermann, R. M., & Ulrich, C. M. (2019). Evaluating nurse understanding and participation in the informed consent process. Nursing Ethics, 26(4), 1050-1061. https://doi.org/10.1177/0969733017740175
 
Menendez, J.B. (2013). Informed consent: Essential legal and ethical principles for nurses. JONA's Healthcare Law, Ethics and Regulation, 15(4), 145-146. https://www.doi.org/10.1097/NHL.0000000000000019   
 
Ryan, M. & Sinha, M.S. (2021, July 8). Informed procedural consent. UpToDate. https://www.uptodate.com/contents/informed-procedural-consent