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Informed Consent

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Informed Consent

Overview

Before providing treatment to patients, doctors and healthcare providers are required to obtain the patient’s consent.  The consent has to be “informed consent”, which essentially means obtaining the patient’s written consent to proceed informing him of the potential benefits, risks, and alternatives involved in any surgical procedure, medical procedure, or other course of treatment.  In short, Informed consent is the process by which fully informed patients can participate in choices about their healthcare.

Failure to Obtain Informed Consent

The concept has its origin in the principle that a patient has the right to prevent unauthorized contact with his or her person.  A failure to obtain informed consent is a form of medical negligence, and if injuries result as a result of this breach, the patient may have a legal claim for damages.  In some cases, informed consent is an absolute necessity.  For example, when new medical treatments or experiments that receive federal funding are tried, informed consent must be obtained from any human participant or subject.

Types of Consent

Informed consent may be express or implied.  Express consent can be when given in writing or verbally.  In case of written consent, it should include the name of the health care professional who discussed the proposed treatment with the patient, the name of the health care provider who is to perform the procedure, and the date, time and location where the consent form was signed.  Implied consent is when consent is understood from the circumstances surrounding the procedure or treatment.  This is sufficient in treatments involving relatively simple, non-invasive procedures.  Consent is also usually implied for necessary procedures a surgeon might perform in the course of a surgical procedure to which the patient did consent.  In emergency situations too, where the doctor may not have the time to wait till the patient gives consent, consent may be implied. In cases where the patient is unconscious or unable to communicate also, consent may be implied under the reasoning that the patient would have consented to the emergency treatment.

Physician’s Role

It is always better for the physician himself, instead of the nurse or healthcare provider, to discuss the treatment and obtain the patient’s informed consent. On the first hand, the physician should ensure that the patient understands what he is hearing. The physician should discuss: (i) if known, the patient's diagnosis;  (ii) The nature and purpose of the proposed treatment or procedure, as well as the procedure's likelihood of success;  (iii) The benefits and risks of the proposed treatment or procedure; (iv) The alternatives to the proposed treatment or procedure; (v) Alternatives to the treatment or procedure should be discussed regardless of their cost and regardless of whether they will likely be covered by the patient's health insurance; (vi) The risks and benefits of an alternative treatment or procedure; (vii) The risks and benefits of not receiving or undergoing any treatment or procedure.

Patient’s Role

The patient’s role does not extend beyond listening to the physician carefully and trying to understand what is being told and to require additional information if he/she feels the necessity.

Consent of Incompetent Individuals and Minors

In case of incompetent individuals, an appointed guardian authorized to take medical decisions has to give informed consent on that individual’s behalf.  As far as minors are concerned, parents can give informed consent on the minor’s behalf.

How much Information can be Considered Adequate

The best approach to the question of how much information is enough is one that meets both one’s  professional obligation to provide the best care and respects the patient as a person with the right to a voice in health care decisions. The adequacy of the information is determined on the basis of the following three standards:

Reasonable physician standard: This standard allows the physician to determine what information is appropriate to disclose.  However, it is probably not enough, since most research in this area shows that the typical physician tells the patient very little. This standard is also generally considered inconsistent with the goals of informed consent as the focus is on the physician rather than on what the patient needs to know.

Reasonable patient standard: This standard focuses on considering what a patient would need to know in order to understand the decision at hand.
Subjective standard: This standard is the most challenging to incorporate into practice, since it requires tailoring information to each patient.

A Recent Decision

New Jersey Superior Court Judge considered a lawsuit involving informed consent for an abortion procedure.  The pregnant woman argued that the doctor ought to have told her that the “fetus or embryo is a living being.”  Holding that this is asking “for more than impartial medical information,” the judge found the doctor not negligent.

Conclusion

It is the right of every patient to get complete information on all treatments or procedures to which they are or might be subjected.  Failure to provide the information can subject the health care providers to legal liability.

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