Informed Consent: A Form or a Conversation?

August 2019 Issue

  1. Clark C. Smith, MD, MPH Associate Professor, Director of Interventional Spine; Department of Rehabilitation and Regenerative Medicine; Columbia University Co-author
  2. David C. Miller, MD, MA Director of Clinical Research, Centers for Pain Management Co-author


Modern medicine moves fast. Although it is important to stay up to date with the latest medications, technologies, and procedural techniques, it is also necessary to stay informed about social, political, and legal issues that may affect medical practice, including evolving concepts related to informed consent. Although specific treatment outcomes cannot be guaranteed, patients must receive adequate information to enable informed decision making. This article will detail the history of informed consent, essential components of informed consent, and medical-legal issues that may affect your practice.


Although specific treatment outcomes cannot be guaranteed, patients must receive adequate information to enable informed decision making.


Initially, the demand for standards and regulation in the informed consent process grew in response to outrage over unethical medical research that had been conducted without patients’ consent or approval.[1] For example, in 1932, the Tuskegee syphilis experiment enrolled 622 African American men in a study that examined the effects of untreated syphilis. In this study, inoculated subjects were not informed as to the nature of the study or risks of participation, and they were not offered treatment at the conclusion of the study. Numerous examples of egregious human experimentation taking place in Germany during World War II and carried out in the name of research came to light. Since then, an international movement has worked to improve the informed consent process for both research and clinical care.[2] In an effort to protect patient autonomy, various domestic cases have further defined the required elements and application of the informed consent process.

Informed consent describes the formal process of communication between a patient and medical provider that results in the patient’s authorization or agreement to undergo a specific medical intervention. The AMA Code of Medical Ethics identifies six basic elements:[3]

  1. Diagnosis
  2. Determination of the capacity of the patient to consent
  3. Disclosure of the nature of the procedure including risks, benefits, and estimation of the likelihood of outcomes
  4. Alternatives to the proposed treatment including their risks and outcomes
  5. Comprehension of relevant information
  6. Consent obtained without coercion or duress

A discussion of risks, benefits, and alternatives should be provided for the procedure in question, including alternative therapeutic options and avoidance of therapeutic modalities. The provider should also attempt to disclose the probability of a successful outcome, how success is defined, and the probability of adverse events.[3],[4] Those components are listed in Figure 1.

Some exceptions where obtaining conventional informed consent may not be possible include emergency, incompetency, therapeutic privilege, and waiver. In the vast majority of cases, however, a proper informed consent is required, and in certain cases, it may be necessary to enlist the support of surrogate decision makers. Cases in which informed consent is not obtained may demonstrate a lack of compassion from the physician caregiver. Furthermore, physicians who fail to obtain proper consent may face civil charges of battery (intentional unpermitted act that results in harm to another), malpractice, and other charges that could lead to loss of license, fines, and even imprisonment.[1]

Figure 1: Informed Consent[3],[4]

Components of Informed Consent
  • Disclose the patient’s diagnosis.
  • Determine the patient’s competence and ability to give consent.
  • Disclose the probability of a successful outcome with the proposed treatment.
  • Determine what would constitute a successful outcome for the patient.
  • Disclose the probability of adverse events.
  • Determine which adverse events are more likely for the patient.
  • Disclose the probability for success for alternative treatments.
  • Determine which alternative treatments are available for the patient.
  • Disclose the probability of adverse events with alternatives.
  • Disclose the probability of success and adverse events with no treatment.
  • Determine whether the patient comprehends the information.
  • Determine whether the patient is truly and voluntarily consenting.

Litigation has incrementally defined the physicians’ role and requirements in the informed consent process.[1] In many practices, informed consent may be obtained by the attending physician, a midlevel provider, or a resident. Some states have limited who is permitted to obtain patient consent for proposed interventions or treatment. A 2017 Pennsylvania case ruled that only the physician performing the procedure should obtain consent.[5] Another legal issue is the question of whether physicians must divulge the nature and extent of their personal experience performing a procedure. Johnson v. Kokemoor established that a physician must divulge his or her experience and refer the patient to a tertiary care center with more experienced physicians, if needed.[6] Another pertinent issue is the optimal timing of consent (minutes versus days prior to the intervention). Ideally, patients would receive information adequately in advance of their procedure to allow them to review the proposed procedure and alternatives, process the information, and formulate questions. Other considerations might include providing a variety of enhanced consent aids (oral, written, figures, models, videos) and how to produce bias-free and reputable consent forms that are effective in crossing broad educational, cultural, and social barriers.

Patients experiencing chronic pain may need to be approached as a particularly vulnerable population because the promise of relief may overwhelm their normal ability to process information and thoughtfully weigh the risks and benefits of a proposed procedure. Physicians may have an even greater burden to ensure that patients are aware of the potential risks associated with any proposed procedure.

Legal precedent may result in a localized evolution of the informed consent process. However, recalling the required elements of consent should suffice in most cases and prevent consent-related complaints.

No longer can physicians assume a paternalistic approach to information disclosure. Failure to properly obtain informed consent is one of the top reasons that physicians are sued.[7] Although no medical provider is immune to litigation, promoting good relationships with patients and engaging in a detailed informed consent process may lessen the risk of litigation following an adverse outcome.[7] When attempting to fulfill the patient standard for consent, a physician should consider what relevant information is required for the average patient to be able to make an informed decision. In the physician standard for consent, the burden changes to what a reasonable physician would expect should be disclosed. The standard (physician or patient) varies from state to state and can change over time but should be considered when providing information.

For some practitioners, the informed consent process is a bureaucratic obligation. Unfortunately, this approach results in an important discussion, losing its central position in establishing our professionalism and affirming the patient’s autonomy. The informed consent process deserves to be reimagined as a key link in the doctor–patient relationship, where mutual respect and information exchange lay the foundation for informed choice and shared decision making. Physicians should periodically review legal decisions within their jurisdiction and state regulations for any substantive changes in informed consent and be prepared to modify their current practices to conform to state and federal law.

References

  1. Appelbaum PS, Lidz CW, Meisel A. Informed consent: legal theory and clinical practice. Fairlawn, NJ: Oxford University Press. 1987.
  2. Berg JW, Appelbaum PS, Lidz CW, et al. Informed consent: legal theory and clinical practice, second edition. New York, NY: Oxford University Press. 2001.
  3. American Medical Association. Informed consent. https://www.ama-assn.org/delivering-care/informed-consent. Accessed June 6, 2019.
  4. Spatz H, Krumholz B, Moulton B. The new era of informed consent: getting to a reasonable patient standard through shared decision making. JAMA. 2016;315(19):20632064. https://doi.org/10.1001/jama.2016.3070
  5. Shinal v. Toms, 162 A.3d 429 (Penn. 2017).
  6. Johnson v. Kokemoor, 545 N.W.2d 495 (Wis. 1996).
  7. Roberts, Richard G. Seven reasons family doctors get sued and how to reduce your risk. Fam Pract Manag. 2003;20(4):443–451.

Tags: consent, patient relationships, safety

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