Research and Governance

Research and Governance



Research and Governance

Introduction

Informed consent is a legal document in all 50 states, prepared as an agreement for treatment, nontreatment, or for an invasive procedure that requires physicians to disclose the benefits, risks, and alternatives to said treatment, nontreatment, or procedure. It is the method by which a fully informed, rational patient may be involved in choices about her health care.

Informed consent stems from the legal and ethical right the patient has to decide what is done to her body, and from the physician's ethical duty to make sure that the patient is involved in decisions about her own health care. The process of securing informed consent has three phases, all of which involve information exchange between doctor and patient and are part of patient education. First, in words the patient can understand, the physician must convey the details of a planned procedure or treatment, its potential benefits and serious risks, and any feasible alternatives. The patient should be presented with information on the most likely outcomes of the treatment. Second, the physician must evaluate whether or not the person has understood what has been said, must ascertain that the risks have been accepted, and that the patient is giving consent to proceed with the procedure or treatment with full knowledge and forethought. Finally, the patient must sign the consent form, which documents in generic format the major points of consideration. The only exception to this is securing informed consent during extreme emergencies.

Informed consent stems from the legal and ethical right an individual has to decide what is done to her body, and from the physician's ethical duty to make sure that individuals are involved in decisions about their own health care. The process of securing informed consent has three phases, all of which involve information exchange between doctor and patient and are part of patient education. First, in words an individual can understand, the physician must convey the details of a planned procedure or treatment, its potential benefits and serious risks, and any feasible alternatives. The patient should be presented with information on the most likely outcomes of the treatment. Second, the physician must evaluate whether or not the person has understood what has been said, must ascertain that the risks have been accepted, and that the patient is giving consent to proceed with the procedure or treatment with full knowledge and forethought. Finally, the individual must sign the consent form, which documents in generic format the major points of consideration. The only exception to this is securing informed consent during extreme emergencies.

It is critical that a patient receive enough information on which to base informed consent, and that the consent is wholly voluntary and has not been forced in any way. It is the responsibility of the physician who discusses the particulars with the patient to detail the conversation in the medical record. A physician may, at her discretion, appoint another member of the health care team to obtain the patient's signature on the consent ...