What is informed consent?
Law and medical ethics dictate that medical professionals must obtain informed consent from their patients before beginning a treatment or procedure. Informed consent is based on 1) the patient understanding their treatment options and 2) the patient making a free choice. This requirement is meant to protect patients against unwanted medical interventions and to ensure that they are an active participant in their own medical care (1). For certain invasive or risky procedures, a signed consent form is required, but in many cases, informed consent can be obtained in an informal discussion (2).
How Do Doctors Obtain Informed Consent?
A physician must do the following things during a conversation about informed consent:
- Describe the proposed procedure/treatment
- Discuss alternatives to the proposed intervention
- Explain the potential benefits and risks of each possible decision
- Ensure that the patient understands the information they have provided
- Ask the patient whether they agree with the recommended course of action
During this discussion, the doctor must avoid coercive behavior and make it clear that the patient is a voluntary participant in treatment. In their explanations to the patient, they should also define any confusing medical jargon, offer translation services if they are needed, etc.
Just because a patient has provided informed consent for something does not mean that they cannot later change their mind. For example, a patient who initially agreed to chemotherapy may later decide to discontinue treatment (3). Rather than a one-time event, informed consent is a process that should evolve if a patient changes their mind or if a certain course of action becomes more or less risky (1).
Are There Any Exceptions to Informed Consent?
In certain cases, physicians may not be required to obtain a patient’s full, informed consent. If there is an emergency during which a patient is unconscious or there is no time to have a discussion about various courses of action, physicians can use “presumed consent” in their decision making. In other words, they can perform procedures that could save a patient’s life or prevent serious harm, under the assumption that the patient would agree if they were able to (3).
Another exemption is made for patients who are deemed “incompetent” – that is, they lack the ability to make an informed, rational decision. The purpose of this designation is to protect people with cognitive impairments or severe mental health issues from harming themselves because they do not fully appreciate the risks and benefits of a given course of action. Conditions that may cause doctors to call into question a patient’s competence include dementia, stroke, schizophrenia, severe depression, and bipolar disorder. Patients must be evaluated on a case-by-case basis – these conditions are not in of themselves justification for designating a patient as incompetent. For example, someone with mild dementia may still be capable of understanding their current situation and making medical decisions. In determining whether a patient is competent, physicians must assess their ability to:
- Communicate a decision
- Understand the relevant information
- Understand the potential consequences of different courses of action,
- Reason through different treatment options
In particularly complex cases or those involving mental health issues, physicians may request a psychiatric consultation.
If a patient is determined to be incompetent, doctors must then consult with a substitute decision-maker (4). Usually, this is a close family member, such as a spouse or sibling (5).
In certain cases, a patient’s ability to consent may change over time. Some types of incompetence are temporary, such as delusion caused by fever. Other patients’ competence may fluctuate; for example, some people may have periods of lucidity followed by periods of serious confusion. If physicians notice a change in behavior or understanding, they should regularly reassess their patient. If they perform as a competent patient would when lucid, then they should be allowed to make decisions about their own health. When they are not lucid, however, they should still be considered incompetent.
Generally, children are considered to be incapable of providing informed consent. Instead, a parent or guardian will be asked to provide “informed permission.” It is important to note, however, that minors may be able to provide informed consent for certain matters related to reproductive health, mental health, and substance abuse (3).
I remember signing a consent form. Does that mean I have no basis for a lawsuit?
Signing a consent form does not necessarily prevent you from pursuing a medical malpractice lawsuit. Sometimes patients simply sign consent forms agreeing to treatment. Others prove that medical professionals told patients about certain risks, treatments, or procedures. These consent forms do not allow doctors, nurses, or other medical personnel to provide negligent care. Medical personnel can and should be held accountable for any instance of medical malpractice.
Informed Consent, Medical Malpractice, and Birth Injuries
Sometimes, doctors fail to obtain informed consent. Failure to obtain informed consent is a type of medical malpractice. Legal standards for evaluating whether a physician obtained informed consent vary somewhat by jurisdiction. Some use the “reasonable physician” standard, which considers what an average physician would disclose to their patients. Others use the newer, more stringent “reasonable person” standard. This takes into account what a reasonable person would want to know if they were in the position of the patient in question (3). Regardless of which standard your jurisdiction uses, you have the option of pursuing legal action against a medical professional who did not get your informed consent for a procedure.
At Reiter & Walsh ABC Law Centers, we focus exclusively on malpractice cases involving pregnancy, birth, and the neonatal period. When investigating a case, we always consider whether medical professionals obtained informed consent. Sometimes they have not, with serious consequences.
Example of a Case Involving Informed Consent
One of our clients delivered a baby via VBAC or a vaginal birth after Cesarean section. In some cases, VBAC can be relatively safe, but she had multiple risk factors that should have been a cause for concern, and prompted clinicians to encourage her to instead have another C-section. Among others, these risk factors included morbid obesity, the fact that her prior C-section incision had been sewn shut via single layer closure, and that her baby appeared to be unusually large. Despite these warning signs, a clinician told her that she had a good chance of having a safe VBAC. She consented, but it was not an informed consent. Moreover, the risk continued to increase throughout her pregnancy. Upon admission to labor, she was dilated only 3cm, which further lowered the likelihood of a safe VBAC by about 20%. At this point, the healthcare professionals managing her labor should have reevaluated her and discouraged her from going through with the VBAC. This did not happen. As a result, her child was born with hypoxic-ischemic encephalopathy (HIE), which later manifested in cognitive impairments and severe spastic quadriplegic cerebral palsy.
If you believe that your doctor did not obtain your informed consent for an action they took during your pregnancy or while you were giving birth, or your informed permission for a treatment given to an infant, please reach out today for a free case review. We have numerous testimonials and multi-million dollar verdicts and settlements that attest to our success, and you pay nothing unless we win your case.
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- American Congress of Obstetricians and Gynecologists: Informed Consent
- Canadian Medical Association Journal: Informed consent for clinical treatment
- University of Washington School of Medicine: Informed Consent
- New England Journal of Medicine: Assessment of Patients’ Competence to Consent to Treatment
- ScienceDirect: Surrogate decision-maker