Informed Consent—What Is It?

In any code of medical ethics, informed consent is a bedrock principle—the solid foundation upon which all other principles of the medical profession should rest.

Informed consent, in the context of medical treatment or medical research, transcends the unspoken ethical responsibilities of the patient-physician relationship. It is, in fact, a legal obligation.

Seen from the legal perspective, informed consent in a medical setting entails the bodily integrity of the individual patient or research subject. It is grounded in the idea of an individual’s personal autonomy—that is, their capacity for self‐determination and self‐governance.

What this means in practice is that a patient or research subject must be given sufficient information about any and all pending treatments, including the risks and benefits of those treatments, the existence and availability of any alternative treatments, the patient’s role in treatment, and the patient’s right to refuse treatment.

The concept of informed consent extends beyond healthcare intervention into medical research as well as into the protection of private medical information.

While the parameters of informed consent vary from country to country and, in the US, from state to state, the conceptual framework of informed consent is universal.

A patient’s consent to all treatments must be voluntary, with “no coercion or unfair persuasion and inducements.”

The patient must have a clear understanding of all the facts and consequences of treatments.

The patient must be in full possession of their reasoning faculties and be free from any impairments that may preclude them from making sound judgments. Examples of such impairments include, but are not limited to, intellectual or emotional immaturity, severe intellectual disabilities, severe mental disorders, post-traumatic stress disorder, and dementia.

If an individual is unable to give or withhold informed consent, someone else may be authorized to do so on the individual’s behalf. Parents or legal guardians give or withhold informed consent for a child, and conservators commonly do the same for individuals who are unable to handle their personal affairs due to their mental capacity, age, or physical disability.

The doctrine of implied consent permits treatment in limited cases, such as when an unconscious person would die without immediate intervention.

Informed consent is codified in international treaties as well as in both national and international law and is widely considered to be a key element for the protection and welfare of patients and research participants.

Before receiving informed consent to proceed with treatment, a medical professional must meet certain criteria by engaging in educational interactions with the patient or patient’s advocate.

These criteria include an explanation of clinical conditions, a clear and detailed description of proposed treatments, an assessment of potential benefits and risks of that treatment and follow-up care, alternative treatment options, and a discussion about the risks or benefits of having no treatment.

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