Before starting medical treatment, providers must obtain informed consent from patients. The informed consent process requires providers to disclose what will happen during the procedure, plus the risks, benefits, and alternative treatment options so patients are adequately informed before agreeing to care.
Informed consent is legally required in most cases. Grounded in medical ethics, it also establishes trust with patients and supports patient autonomy in choosing the treatment that's right for them. Failing to obtain informed consent before treatment could lead to costly medical malpractice claims.
In this article, we'll break down how informed consent works, why it's so important, and how to obtain it.
Informed consent is when a medical provider explains the risks, benefits, and alternative treatments to a patient before providing care, using clear communication so the patient can make an informed decision. The patient can then decide what happens to their own body and whether or not they want to proceed with treatment.
Four elements must be present for a patient to provide meaningful informed consent to medical treatment:
Obtaining a patient's informed consent is ethically required for medical providers, reflects core ethical principles, and is part of their ethical obligations within health care. Here are some of the ways informed consent supports ethical medical care:
Informed consent is so important in healthcare because it preserves patients' bodily autonomy as a basic right of every human being. While the medical provider offers their expert opinion, the patient is ultimately the one who decides whether or not to proceed with treatment.
An early legal milestone came in 1914, when Schloendorff v. Society established that a competent adult has the right to decide what is done to their body.
Getting informed consent is legally required for most medical procedures, with a few exceptions. If a medical provider fails to get informed consent, it could lead to a medical malpractice claim. Malpractice claims can lead to costly lawsuits and cause damage to your reputation in medical practice.
The informed consent process also builds trust between provider and patient, which supports patient engagement and a patient centered approach for better health outcomes, including when a patient is declining treatment. Before a procedure starts, patients know exactly what to expect, why it's necessary, and any possible side effects they may experience. In modern care, it has evolved from a signature into a decision making process rather than a formality.
Informed consent is legally required for surgeries and other invasive procedures, including chemotherapy, blood transfusions, anesthesia, and biopsies, just to name a few examples. The informed consent process is required regardless of whether the procedure happens in a hospital or in an office setting.
According to the US Department of Health and Human Services, informed consent is also legally required for medical research. In human research, federal regulations govern when researchers must provide consent. An institutional review board oversees protocols and participant protections under human research protections. Consent materials must clearly state when a project is research. Depending on the applicable rules, consent is generally not required for de-identified samples.
Exact informed consent laws vary from state to state. Roughly half of the US states use the "reasonable person" standard, while the other half use the "professional practice" standard.
The "reasonable person" standard considers what a typical patient would need to know to make an informed decision about their medical care. The "professional practice" standard considers what other doctors in the same state and specialty would tell their patients before the procedure.
If a medical provider does not share enough information to reach these standards before the patient makes a medical decision, it could be grounds for a medical malpractice lawsuit.
There are a few exceptions to informed consent law. In these situations, a healthcare provider can perform treatment without getting the patient's consent first.
Exceptions to informed consent requirements include:
There are three types of informed consent:
Not all consent types will work for all procedures. For example, written consent is required for most surgeries and high-risk procedures. Properly completed informed consent forms help show that the patient understood the procedure, benefits, alternatives, and associated risks before choosing to proceed. A signed consent form does not replace documenting the informed consent discussion in the medical record. This documentation can also help reduce legal liability if a malpractice claim arises.
However, there are some situations where implied or oral consent may be appropriate. For example, an informed consent discussion may be enough to proceed with low-risk diagnostic tests. Implied consent should only be used for simple, routine procedures.
When in doubt, providers should err on the side of caution and obtain written, express consent to reduce their legal risk.
Here's a step-by-step breakdown of the informed consent process:
The Joint Commission expects documentation of the core elements of informed consent.
One study found that only 26.4% of consent forms documented the required elements, reinforcing the need for better records.
Today, many routine medical appointments happen using telemedicine tools. According to the American Medical Association, 71.4% of physicians use telehealth in their practice weekly as of 2024.
While these appointments usually do not contain high-risk treatments, it's still important to obtain consent. In most cases, the patient should complete a short digital consent form before the appointment starts.
The provider should also mention any viable alternatives to telehealth at the beginning of the appointment, so patients can decide if they would rather meet in person.
Informed consent is particularly important for any medical research or clinical trials with human research participants. Unfortunately, subjects aren't always fully informed on studies before they begin. An analysis of clinical trials over 30 years found that the percentage of participants who understood different components of informed consent ranged from 52.1% to 75.8%.
Clinicians should explain the study in detail to subjects before it begins. The consent must clearly identify the activity as research and provide specific contact information for questions. Consent discussions should include information about the proposed treatment, the study's goals, possible risks, and whether samples or data may be reused so participants can decide if they want to take part in future research. Subjects must sign a written consent form before the study starts.
Participation in medical research studies should be completely voluntary. Subjects should be mentally competent, and should be able to end their participation at any time, with limited exceptions such as a minimal risk waiver, which helps prevent exploitation of human subjects.
Yes, patients can withdraw consent or begin declining treatment at any time during a medical treatment, subject to safety limits. This can happen by verbally asking the provider to stop, or by withdrawing their consent in writing. The patient does not have to provide a reason for withdrawing their consent.
If a patient decides to withdraw their consent, the provider must explain the risks involved in stopping treatment. Many medical providers require patients to sign a form when they revoke consent confirming that they understand the risks involved and were adequately informed about those risks.
Of course, there are some situations where stopping treatment isn't safe. In this situation, providers are legally and ethically required to stabilize the patient, but should not move forward with the treatment.
For example, if a patient revokes consent in the middle of a surgery, the provider would need to close open wounds and stop any active bleeding. In this situation, the patient is usually discharged against medical advice. Every step of the process, including completing a medical incident report, should be fully documented to minimize legal risk.
The patient also needs to have full decision-making capacity to revoke treatment. Anesthesia or severe pain could result in impaired decision-making capacity. In this case, the provider should consult with family members or other surrogate decision-makers.
Healthcare providers often face challenges when getting patient informed consent. These include:
If a medical provider doesn't get informed consent before performing treatment, the patient may have grounds to file a medical malpractice lawsuit.
A court ruled that providers can face malpractice exposure when patients were not adequately informed before treatment.
Malpractice cases often take years to resolve and can damage your reputation, even if you're ultimately not found at fault. Malpractice cases can also be very expensive to resolve. However, a good medical malpractice insurance policy covers many of these costs, including defense costs.
The risks are particularly high if you fail to obtain informed consent for high-risk surgical procedures. In this case, inadequate disclosure can create legal risk and threaten patient safety if the patient experiences long-term consequences or side effects from a procedure they didn't want or fully understand.
If a medical provider is accused of failing to obtain consent, there are four things the prosecution must prove to win a medical malpractice lawsuit:
Essentially, the patient's legal team must prove that if the patient had been fully informed about the risks of the treatment, they would have chosen an alternative course.
Most medical malpractice cases are settled out of court. However, a small percentage of cases go to trial. If you are found at fault, you could be responsible for paying damages and the patient's medical bills.
Consistent informed consent procedures help prevent medical malpractice lawsuits. Use these best practices to make sure your team obtains the consent you need from every patient.
The definition of informed consent is when a medical provider explains the benefits, risks, and alternatives of a procedure so the patient can make an informed decision.
The 4 principles of informed consent are information disclosure, competence, comprehension, and voluntariness.
Informed consent is important because it ensures patients have autonomy and control over their medical care. It's also legally required for most invasive procedures.
Mistakes can happen to any medical provider, even if you are diligent with your informed consent process. That's why you need a reliable medical malpractice insurance policy to protect you.
Indigo offers medical malpractice coverage for physicians across a wide range of specialties. Our AI-powered quoting engine tailors pricing to your practice. We also pair you with a trusted defense team in the event of a claim.
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