In many situations where medical care or treatment is provided to an individual, medical professionals are required to obtain the patient's "informed consent." Although the specific definition of informed consent may vary from state to state, it means essentially that a physician (or other medical provider) must tell a patient all of the potential benefits, risks, and alternatives involved in any surgical procedure, medical procedure, or other course of treatment, and must obtain the patient's written consent to proceed.
The concept of informed consent is based on the principle that a patient has the right to prevent unauthorized contact with his or her person and, thus, a physician has a duty to disclose information to the patient so that he or she can make a reasoned decision regarding treatment, based on an understanding of the treatment to be provided.
In many situations, the failure to obtain informed consent is a form of medical negligence, and may even give rise to a cause of action for battery. In certain situations, informed consent is an absolute necessity. For example, in any medical trials or experiments that receive federal funding, informed consent must be obtained from any human participant or subject.
The Role of the Physician
Physicians themselves, rather than a representative, nurse, or other related health care professional, are the best choice to speak to patients about informed consent. In discussing the matter with a patient, the physician should cover:
A physician should also ensure that patients understand what they're hearing. In fact, some hospitals now require physicians to participate in courses on communication skills.
The patient, or the patient's legally authorized representative consenting to the treatment on the patient's behalf, must sign and date the informed consent documents, and must be given a copy of the informed consent documents once they are signed and dated. A copy of those documents should also be placed in the patient's file.
The Role of the Patient
Although a physician is required to inform a patient about benefits, risks, and alternative treatments, patients must also play a part in the informed consent process. Patients must listen to the physician and should ask questions of the physician if they do not understand, or if they would like more detailed information.
Types of Consent: Express and Implied
Informed consent may be either "express" or "implied." Express consent is given in writing or verbally. If a patient's consent is written, 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.
Consent not given by a patient in writing or verbally, but understood from the circumstances surrounding the procedure or treatment at issue, is known as implied consent. Consent may be implied when, for instance, a patient presents him or herself for a relatively simple, non-invasive procedure. 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.
Situations in Which Informed Consent May Not be Necessary
Situations Not Involving Medical Procedures or Treatment. Not all situations require that informed consent be given. For example, although listening to a heartbeat through a stethoscope may be considered a "treatment" or "procedure," to some people (especially those who are uncomfortable in physician's offices), it's rare that a physician and patient would have a lengthy discussion about the benefits and risks of listening to a heartbeat using that device.
Emergency Situations: In emergency situations, there is not always time to obtain a patient's informed consent, or the patient may be unconscious and unable to communicate. If an emergency involves risk to the patient's life or the patient is unable to communicate, consent may be implied under the rationale that the patient would have consented to emergency treatment.