What is Informed Consent?

Mary McMahon
Mary McMahon

Informed consent is a concept in the medical community which supports the idea that patients should be fully informed at all stages of medical treatment and medical trials. There are two aspects to informed consent: a conversation with a care provider or researcher, and a form which must be signed to indicate that the conversation has occurred. Informed consent is a very important part of modern medical practice and research, and it is designed to protect both patients and doctors.

A patient should know that experimental treatment is conducted at their own risk.
A patient should know that experimental treatment is conducted at their own risk.

The concept of the need for informed consent arose from the Nuremberg Trials held after the Second World War, when the court was subjected to detailed descriptions of experiments carried out by the Nazis in concentration camps. This testimony was used as evidence to convict and punish researchers who had performed such experiments, and it also raised ethical issues for medical practitioners. As a result, many nations started adopting some version of an informed consent law.

Informed consent forms require a signature noting that the participant understands the risks.
Informed consent forms require a signature noting that the participant understands the risks.

The idea behind informed consent is that it is very important for patients and research subjects to be actively involved in their care, participating in the decision making process with a full awareness of any potential consequences of a treatment. Informed consent laws place a heavy emphasis on the value of individual human rights and autonomy by insisting that informed consent be obtained for medical procedures. In the event that someone is physically or mentally incapable of consent, a representative may be permitted to authorize certain procedures.

Informed consent is a very important part of medical practice and research.
Informed consent is a very important part of medical practice and research.

In an informed consent discussion, a doctor will discuss the patient's condition and possible treatment options, along with the option the doctor recommends. The patient will be informed about the possible outcomes, results, and complications of any treatment, including a decision not to treat the condition, and the patient is invited to ask questions for clarification. As a general rule, doctors are encouraged to use plain, clear language so that patients understand the conversation.

Informed consent requires that the doctor clearly explain the patient's condition as well as possible treatment options and side effects.
Informed consent requires that the doctor clearly explain the patient's condition as well as possible treatment options and side effects.

Once the patient has been briefed and asked to make a decision, the patient will be asked to sign an informed consent form for major procedures. In other instances, a doctor may note the patient's consent in the patient's chart, which serves as a legal document. If the patient later has a dispute with the doctor, the evidence of informed consent will be brought forward as evidence.

Failure to obtain informed consent in a non-emergency situation may expose the doctor to assault and battery charges.
Failure to obtain informed consent in a non-emergency situation may expose the doctor to assault and battery charges.

There are some instances in which informed consent is assumed, due to the circumstances of the situation. For example, if someone goes to donate blood, after he or she has filled out the necessary forms, the nurse or technician taking the donation will not always ask if it is OK to stick the needle into the donor, because the assumption is that consent was given by simply showing up to donate. Also, if someone comes into a hospital in very bad condition without identification or a proxy, medical personnel will treat the patient as they see fit, with the goal of stabilizing the patient so that he or she will live.

Informed consent is sometimes assumed, such as when a person decides to donate blood.
Informed consent is sometimes assumed, such as when a person decides to donate blood.
Patients participating in medical trials must give their informed consent.
Patients participating in medical trials must give their informed consent.
Mary McMahon
Mary McMahon

Ever since she began contributing to the site several years ago, Mary has embraced the exciting challenge of being a wiseGEEK researcher and writer. Mary has a liberal arts degree from Goddard College and spends her free time reading, cooking, and exploring the great outdoors.

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Discussion Comments

lavenderdang

if the patient refuses the surgery, they must sign what form?

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