Providing informed consent is a bedrock of ethical medical practice -- and a physician’s failure to provide proper informed consent is grounds for legal action. But, determining what constitutes proper informed consent is nuanced. The understanding is different in law, medicine, and bioethics.
Generally, the “informed consent” package involves advising the patient of comparative benefits as well as risks of medical interventions, along with disclosing available alternatives. This means the content must be patient-specific, as every patient's risks, benefits, and personal considerations differ. The key question becomes determining what standards a physician should use in deciding what to disclose.
The Bioethical Model
While the Beauchamps and Childres Bioethical model (highlighting patient autonomy, the duty of beneficence (doing good), non-maleficence (not harming), and justice) applies, specifics are left to the physician. The UNESCO Declaration of Bioethics and Human Rights explains:
Risks and Benefits: “In applying and advancing scientific knowledge, medical practice, and associated technologies, direct and indirect benefits to patients, research participants, and other affected individuals should be maximized, and any possible harm to such individuals should be minimized.” [emphasis added]
The Medical Model
As taught to would-be physicians and employed in medical practice, informed consent is a multi-step process, establishing:
- The Patient’s Competence or Capacity - the consenting individual has demonstrated the mental ability to understand the information and appreciate the consequences of their decision.
- Disclosing Adequate Information - including all relevant information needed for the individual to make an informed decision, conveyed in a manner understandable by the patient. This typically includes risks and potential side effects, including possible complications or adverse outcomes, benefits or expected outcomes, and available alternative therapies.
- Freedom from Coercion or Undue Influence
- Providing Authorization to Proceed
- Documentation of the Consent process
The Legal Model
The legal focus of informed consent is twofold.
First, the patient’s right to bodily autonomy was recognized as a legal maxim enunciated in 1914 (recognized in Britain as early as 1767).
“Every human being of adult years and sound mind has the 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…”
Consent insulates the physician from liability for assault and battery, which are intentional torts involving violating the patients’ bodily integrity. An extreme example would be sexual abuse under the cover of “consented for” medical treatment.
“When a person intentionally causes harmful or offensive contact with another person, the act is battery. However, if the plaintiff expressly consented to such an act or gave implied consent … they are not liable.”
The second consideration pertains to obtaining the patient’s informed consent for a specific medical intervention. Determining what to disclose requires the provider to assess both the probability and severity of risks, balanced against the likely benefits treatment will provide for this particular patient. Additionally, the patient must be informed of feasible alternative therapies.
The two legal claims are distinct, and a physician can be sued for malpractice, a type of negligence, for failing to provide informed consent, and for battery, an intentional tort.
“To succeed on an informed consent [a malpractice] claim, the plaintiff must establish that the physician breached the standard of care by failing to disclose the material risks associated with the treatment or procedure…, thereby precluding the plaintiff from making an informed decision about whether to undertake a particular procedure or course of treatment.”
The Scope of Disclosure
While determining the scope of adequate informed consent initially vests with the physician or provider, they cannot decide for the patient what is in their best interest. Instead, the provider must provide sufficient information to allow the patient to make their own choice.
“It is the prerogative of the patient, not the physician, to determine for him[/her]self the direction in which his interests seem to lie…”
The legal standard is not what the doctor or other providers consider proper (nor the general practice in the medical community, as in other malpractice cases). Instead, the standard is what a reasonable person in the patient’s position would need to know to make an informed choice. [1]
To prevail. However, plaintiffs have another hurdle: they must prove they would have chosen differently had they been fully informed, often called “but/for causation.”
“that means that the plaintiff must prove that she would not have agreed to the treatment or procedure had the physician made a proper disclosure of the risks and alternatives associated with the treatment or procedure.”
The Physician’s Legal Obligation
The legal standard governing informed consent leaves physicians somewhat naked – they must forecast what this patient would need to know to make an informed decision for a determination made by independent lay persons (juries) years down the road.
Yet, a scorched-earth-disclose-everything policy is not the answer, and not every risk must or should be disclosed.
“Some [courts] have said "full" disclosure [is required], a norm we are unwilling to adopt literally. It seems prohibitive and unrealistic to expect physicians to discuss every risk of proposed treatment with their patients—no matter how small or remote… In our view, … [t]he scope of the physician's communications to the patient, then, must be measured by the patient's need.”
Materiality
The ultimate decision required of a provider is assessing the materiality of the risks and whether and to what extent revelation to the patient is necessary to make an informed choice.
"[a] risk is … material when a reasonable person, in what the physician knows or should know to be the patient's position, would be likely to attach significance to the risk …. in deciding whether or not to forego the proposed therapy…..” - Canterbury v. Spence.
There is no bright line separating the significant from the insignificant. “The legal answer must abide by a rule of reason: Viewed from the point at which he had to decide, would the patient have decided differently had he known something he did not know?"
Risks in Context
Let’s consider whether disclosures of Guillain-Barré syndrome (GBS) risks from flu vaccination are warranted.
GBS is a rare but potentially serious auto-immune response [2] which can result in paralysis but is generally temporary. However, simply because GBS is a recognized risk of a potentially serious consequence from vaccines is NOT necessarily a reason to require disclosure or to recommend abstention from vaccination.
Assessing the scope or necessity of disclosure involves a three-fold balancing approach:
- assessing the overall risks of flu against the overall vaccine benefits
- comparing the risk of GBS from vaccination compared to GBS from flu
- comparing the risks of GBS from immunization compared to GBS if not vaccinated.
While a physician might consider it adequate to disclose that "Your chance of getting GBS from the flu is far greater than your chance of getting GBS from the vaccine," lawyers likely would want more. But from a policy perspective, given the comparative de minimus risks of GBS from the vaccine and the significant risks of flu deaths – especially in the elderly, it might be argued that no disclosure is necessary (and might be counterproductive), at least to populations at high risk of serious consequences of flu.
Consider:
- The flu vaccine minimizes serious consequences, including death.
- The risk of deaths from flu in the elderly, who account for 90% of global influenza deaths, significantly more dangerous than COVID, is about 120 per million cases,.
- The risk of GBS from the influenza vaccine is one case per million.
- Influenza-related GBS is 17x higher than the risks of GBS from vaccines.
Informed Consent Requirements Should Not Be a Scare Tactic
STAT writes,
“Kennedy wants future vaccine communications to focus on “informed consent,” by which he means giving people information about the adverse events associated with vaccines.”
With this deeper understanding of informed consent, one wonders why -- and for what purpose -- the federal government is rewording its influenza or measles vaccine messages. As I write, flu deaths are worryingly on the increase:
“For the first time since the beginning of the pandemic, more people in the U.S. died of influenza than from COVID-19 in the week ending on Jan. 25”
- Centers for Disease Control and Prevention
[1]the physician retains some privilege to determine whether the conveyance of “very slight” risks might unreasonably deter the patient from treatment.
[2] GBS is a rare neurological disorder where a person’s immune system mistakenly attacks part of its peripheral nervous system.
