Informed consent is an ethical and legal requirement for medical treatment. You must understand and agree to testing and treatment before it can proceed. This is a basic ethical concept in medicine — but in practice, it can be more complicated. Some elements and examples of informed consent are outlined below.
You have the right to fully understand and agree to any medical procedure or treatment you receive before it proceeds. Informed consent is your understanding and agreement. Your healthcare provider is responsible for effectively communicating with you about your condition and your testing and treatment options. They must obtain your informed consent before proceeding with any option.
Informed consent is one of the nine core principles of the American Medical Association’s Code of Medical Ethics. Opinion 2.1.1 in the Code of Medical Ethics states, “Informed consent to medical treatment is fundamental in both ethics and law. Patients have the right to receive information and ask questions about recommended treatments so that they can make well-considered decisions about care.”
Informed consent is an ethical concept first, a legal concept second, and finally, a formal administrative process. In the United States, informed consent laws vary by state and by circumstances. Some cases require a signed document indicating your informed consent, while others only require a verbal agreement. But in all cases, healthcare providers have to keep some record of the process.
Consent codes and laws protect both caregivers and care receivers. They help establish trust in your caregiver while respecting your autonomy as a care seeker. They help to prevent misunderstandings and lapses in communication that could lead to you being unhappy with the care that you receive. They make sure that you understand what to expect, including the chances of less-than-optimal outcomes.
Most healthcare providers have good intentions to treat care seekers ethically, including being honest about their options, their risks and their prognosis. But sometimes practical limitations and human error thwart these intentions. That’s where formal processes and laws can help. These processes and laws have evolved over time to take into account some of the stumbling blocks we’ve met along the way.
Scenarios like these have required healthcare providers to revise their approach.
Laws vary, but in general, informed consent applies whenever you’re accepting a risk. Many medical procedures carry a low risk of complications or a moderate risk of minor side effects. In addition to protecting your body, you also have the right to protect your privacy. The principles of informed consent protect all of these rights. In practice, procedures that are likely to require signed consent include:
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Stakeholders generally agree that informed consent requires these four conditions:
In order for you to make an “informed choice,” your healthcare provider must disclose:
Your healthcare provider may use a variety of media to communicate about your condition, including oral communication, written pamphlets, infographics and videos. They should ensure that the wording is accessible for non-medical people to understand. If you aren’t fluent in the same language, they must provide a qualified translator to communicate with you and obtain your informed consent.
No. A signed document may be one required part of the informed consent process. But it’s not the beginning or the end. Healthcare providers must also document the full communication process leading up to it, including allowing time for you to ask questions and to think about it. You can also change your mind at any time. Signing your consent doesn’t obligate you to continue with the original plan.
Informed consent as described above isn’t practical or appropriate in every situation. Some of the recognized exceptions to the rule include:
A note from Cleveland Clinic
Informed consent is a core principle of ethics in medical care. It acknowledges your freedom and independence to understand and choose what happens to your body and information about your body. Different laws have been written to uphold this principle in different places and circumstances. These laws continue to evolve as our understanding and practice of informed consent also evolve.
In practice, informed consent is a shared responsibility between you and your healthcare provider. They’re obliged to inform you in the best way they know how. You may also seek additional information from credible sources to reinforce your understanding. Our health library is a great place to begin your research, with introductory information on a wide variety of medical conditions and procedures.
Last reviewed by a Cleveland Clinic medical professional on 10/01/2022.
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