Medical Informed Consent

by Shaylona Kirk, MD

The following is an ABN literature review as of July, 2010 and should not be interpreted as legal advice on medical informed consent.

Definition

Informed consent is the process by which patients are educated about the elements of a medical choice and/or procedure and then make an informed, knowledgeable, and voluntary decision about the health care they are to receive (or refuse).

Informed Consent

Patient Criteria
In order for consent to be valid:

  • A patient must be competent/have decision-making capacity: While general incompetence can be determined only by a court of law, healthcare providers must ensure that patients have the capacity to make good decisions about their care. The patient should be able to understand the material presented to them, including the benefits, risks and alternatives, and have the ability to make a rational decision in light of their values.
  • A decision must be voluntary: The patient should not be unduly influenced by family members, healthcare professionals, or other agents, and should not be impaired by medications or uncontrolled stress when giving informed consent.
  • A competent patient can withdraw informed consent at any time. Healthcare professionals must respect a patient’s revocation of initial consent.
  • A competent person may decline any treatment – no matter how strongly recommended by the healthcare team. Health care professionals must honor the patient’s decisions, whether for or against the suggested treatment.

Physician/provider criteria
The American Medical Association lists important elements of the information component of informed consent. Physicians must disclose to their patients:

  • the patient’s diagnosis, if known;
  • the nature and purpose of the treatment or procedure;
  • risks and benefits of the proposed treatment or procedure;
  • reasonable alternatives;
  • relevant risks, benefits, uncertainties of each alternative;
  • the risks and benefits of not undergoing a treatment or procedure.

It can be daunting to decide which risks should be presented to the patient. A general rule is that any severe risks, and any frequently occurring though less severe risks, should always be discussed.

The consent form, although helpful for documentation, is not sufficient for informed consent; discussion must occur. The physician or another professional directly involved with the proposed intervention should conduct the informed consent discussion. The language used in the discussion should be at the level of understanding of the individual patient. In addition to conversing with the patient about the topics listed above, physicians can provide recommendations and share their reasoning with the patient. In every discussion the physician should allow time to answer any questions the patient may have. At the end of the conversation, the physician should determine whether the patient comprehends the information he or she has been presented. Asking the patient to explain to the physician the key points of the discussion can assist in determining the patient’s comprehension.

Exceptions to obtaining informed consent

  • Emergencies: In urgent cases, when death or serious physical harm may result from inaction, and a patient’s preferences are unknown, informed consent is presumed.
  • Patient waiver: The patient may elect to sign a waiver, allowing the decision to rest with the physician or another individual of the patient’s choosing. In some instances the waiver may be verbal and witnessed rather than written.
  • Therapeutic privilege: This doctrine allows the physician to withhold information if the disclosure of the information will actually harm the patient. This option should be used rarely, since it is legally and ethically risky. State precedent would govern, and could vary widely from state-to-state. The physician should document very well if choosing to rely on therapeutic privilege to withhold information. If doubt exists, disclose. (Klove et al. 217-218)

Ethics and Informed Consent

The principle of patient autonomy, or self-determination, is widely seen as justifying the practice of informed consent (Berry 68). Other considerations that favor informed consent include an increase in the patient’s confidence, the promotion of fair relationships between patients and physicians, a decrease in coercion and neglect, and the inclusion of patient input on aspects of the decision that go beyond the strictly medical facts (Steinberg 1570).

While the principle of autonomy seems to indicate that physicians should always provide complete disclosure to every competent patient, the principles of beneficence and non-maleficence (other important principles in healthcare settings) seem to indicate that there are occasionally times when partial disclosure or no disclosure may be appropriate. This stems from the perceptions that some patients do not handle bad news well and that in some cultures disclosing bad news to the patient is unacceptable (Steinberg 1569). Since patients vary in their need for information to facilitate choice, “the most ethically defensible approach is to tailor and navigate the information according to the needs and desires of each individual patient in a sensitive and empathetic manner” (Steinberg 1568). To do that, physicians must talk with their patients and understand their perspective.

The manner in which the informed consent process has evolved concerns some ethicists. Instead of fostering a dialog between the physician and patient, the informed consent process can potentially interfere with the relationship if the focus is placed on completion of forms and decreasing legal liability. Ideally, the process should include ongoing conversation and a trusting partnership between the physician and patient. “The ultimate goal of informed consent should be the respect for patient’s autonomy combined with acting in his benefit” (Steinberg 1571).

Legal Basis for Informed Consent

Slater v Baker and Stapleton (1767): Physicians have long been required to obtain consent for treatment. The first recorded legal decision of this nature was the case of Slater v Baker and Stapleton. In this case the court established that physicians should obtain consent from patients before surgery and could be held legally liable if they did not. “The Slater court did not allow, however, for nuances as to whether or not consent was indeed obtained; consent either existed or it did not” (Klove, DiBoise, Pang & Yarbrough 214).

Schloendorff v. Society of New York Hospital (1914): In this case the physician removed tumor from a patient who had only consented to an examination and had refused an operation. Justice Benjamin Cardozo, of the New York Court of Appeals, wrote, “Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault, for which he is liable in damages” (Berry 65). This case established the necessity of voluntary approval for each specific proposed procedure. The decision did not, however, require the physician to fully inform the patient of all relevant information, leading commentators to argue that “Consent freely given but without proper information is meaningless” (Klove et al. 214).

Salgo v. Leland Stanford Jr. University Board of Trustees (1957): The phrase “informed consent” was coined in this California Court of Appeals decision. The decision specified that a physician could be held liable for failing to provide facts about a proposed treatment that are necessary for a patient to make an informed decision. The decision also stated, however, that the physician must exercise discretion when deciding what risks to disclose in order to protect patient well-being (Berry 65).

Originally, failure to obtain informed consent was considered by the courts as an allegation of battery, but it is now typically considered under the theory of negligence. In order for negligence to be established the injured party must establish: “1) the physician owed a duty to the patient to obtain his or her informed consent, 2) the physician breached that duty, 3) the physician’s breach directly and proximately caused the patient’s injury, and 4) the patient suffered compensable harm” (Klove et al. 213).

In the event that a case goes to court, appropriate documentation of the informed consent process can be used as evidence that the physician properly informed a patient about a procedure and that consent was valid. Informed consent forms can be helpful to satisfy legal requirements and make documentation more efficient, but they may have a negative impact on the physician-patient relationship. In particular, there is some concern that the informed consent process has evolved into a largely legalistic process. The use of consent forms has been criticized since they “appear to be aimed at limiting liability rather than facilitating comprehension” (Berry 78). The focus seems to be on risk communication and not on informed medical decision-making. Many healthcare professionals and ethicists believe that if more time were spent educating and interacting with the patient, these practices would actually provide more protection against malpractice lawsuits than informed consent documentation does.

Court rulings have suggested that the physician’s duty to disclose risk increases as the magnitude of the risk increases, but there are no specific guidelines or suggestions about how to measure risk. All severe risks (such as death or paralysis) should always be disclosed, even if unlikely. All risks that occur frequently should always be disclosed. (Paterick, Carson, Allen, & Paterick 315).

Full disclosure cannot be expected because the number of risks and consequences from even simple procedures is large. It would be difficult for the physician to identify every single risk possible, and the patient would have a hard time comprehending the great amount of information involved. Although courts do not expect full disclosure, they don’t specify what should be disclosed. “There does not appear to be a standard of disclosure to which physicians can adhere to avoid liability with certitude” (Paterick, Carson, Allen, & Paterick 315). That there is no specific formula for risk disclosure is understandable, requiring physicians to be especially attuned to their patients’ needs and interests. (See “Standards”, below, for some general guidance.)

Physicians should educate themselves about their own states’ laws about medical informed consent.

Standards

Determining what information and how much information is adequate for informed consent is a matter of some difficulty. The states are divided almost equally between the concept of reasonable physician standards and reasonable patient standards for disclosure.

  • Reasonable physician standard (also known as the “malpractice standard” or “professional standard”): This standard is based on what a typical or “reasonably prudent” physician would disclose about a particular intervention. This standard allows the physician to determine what information is appropriate to disclose. Although this standard allows for the most knowledgeable party to determine the materiality of the information disclosed, a physician’s determination of what is material may be very different from what the patient needs or wants to hear.
  • Reasonable patient standard (also known as the “material risk standard” or “materiality standard”): This standard is based on what information a hypothetical, “reasonable” patient considers significant or feels the need to know in order to be an informed participant in the decision. The advantage of this standard is that the patient, who ultimately bears the consequences, determines what information is relevant. However, since the standard is generally based upon a hypothetical patient, the specifics of the disclosure may not be what the actual patient would choose.
  • Subjective standard: This is a less common form of the material risk standard. This standard is based on what a particular patient needs or wants to know and understand in order to make an informed decision. This standard is the most challenging to incorporate into practice, since it requires tailoring information to each patient.

In order to facilitate truly informed decision-making, some states have begun to develop “shared-decision making” legislation. Decision aids, such as videos, can be provided to patients, allowing them to more fully understand the treatment and incorporate their own values and preferences into the decision. Bills proposing to mandate shared decision-making have been introduced at the federal level in both the House and Senate (Pope 75).

Other Issues

  • The informed consent process is meant to empower patients, but it seems unlikely patients will truly be in control since they do not have the same level of knowledge and education as their physicians. Often patients, even intelligent and well-educated ones, have difficulty understanding the complex medical information presented to them when it involves personal bad news (Steinberg 1570). In addition, elderly patients often present unique problems regarding informed consent. Arizona has “vulnerable adult” statues that might come into play where an elderly person does not have capacity to make an informed decision.
  • Even if a patient does understand the information presented, this does not guarantee that the patient will use the information appropriately and beneficially when making a decision (Steinberg 1570).
  • Depending on how the information is presented, physicians can easily persuade or manipulate naïve patients to consent to the approach that the physician favors (Steinberg 1571).
  • Studies have found that providing additional written information, audiovisual/multimedia programs, extended discussions, or test/feedback techniques all improve patient comprehension in medical informed consent, especially regarding risks and general knowledge about the procedure. This suggests that communication interventions are effective and should be promoted (Schenker, Fernandez, Sudore, & Schillinger).

The Bottom Line

No single paradigm fits all patients. It may be the case that some patients do not want the autonomy they have been given or don’t want it at times. Supporting patients who chose to involve themselves in their medical decision making or those who choose to give up that decision-making responsibility is still respecting their autonomy. Physicians should evaluate each situation individually and gain an understanding of the level of responsibility the patient wants to assume in the decision-making process at any particular point in time. Such discussions require time, empathy and understanding and should be well documented. (Paterick, Carson, Allen, & Paterick 318).

References

American Medical Association. “Informed consent.” Available from: URL: http://www.ama-assn.org/ama/pub/physician-resources/legal-topics/patient.... Accessed 28 June 2010.

Berry, Roberta M. “Informed Consent Law, Ethics, and Practice: From Infancy to Reflective Adolescence.” HEC Forum 17.1 (2005): 64-81.
http://www.springerlink.com/content/g03g1q02426346np/

Goldstein, Melissa M. “Health Information Technology and the Idea of Informed Consent.” Journal of Law, Medicine & Ethics (Spring 2010): 27-35.
http://www3.interscience.wiley.com/journal/123334066/abstract?CRETRY=1&S...

Klove, Carole, DiBoise, Sarah J., Pang, Betty, Yarbrough, William C. “Informed Consent: Ethical and Legal Aspects.” Thoracic Surgery Clinics 15.2 (2005): 213-219.
http://www.ncbi.nlm.nih.gov/pubmed/15999519
Paterick, Timothy J., Carson, Geoff V., Allen, Marjorie C., and Paterick, Timothy E. “Medical Informed Consent: General Considerations for Physicians.” Mayo Clinic Proceedings 83.3 (2008): 313-319.
http://www.ncbi.nlm.nih.gov/pubmed/18315998

Pope, Thaddeus Mason. “Legal Briefing: Informed Consent.” The Journal of Clinical Ethics 21.1 (2010): 72-82.
http://www.ncbi.nlm.nih.gov/pubmed/20465078

Schenker, Yael, Fernandez, Alicia, Sudore, Rebecca, and Schillinger, Dean. “Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: A Systematic Review.” Medical Decision Making (2010).
http://mdm.sagepub.com/cgi/content/abstract/0272989X10364247v1

Steinberg, Avraham. “Disclosure of Information and Informed Consent: Ethical and Practical Considerations.” Journal of Child Neurology 24.12 (2009): 1568-1571.
http://jcn.sagepub.com/cgi/content/abstract/24/12/1568

Whitney, Simon N., McGuire, Amy L., and McCullough, Laurence B. “A Typology of Shared Decision Making, Informed Consent, and Simple Consent.” Annals of Internal Medicine 140.1 (2003): 54-59.
http://www.annals.org/content/140/1/54.abstract