The interactive process by which an individual gains an understanding of what will be involved in receiving a medical or surgical procedure or treatment is called informed consent. In most cases, the process is focused primarily on the individual who is considering the proposed procedure or treatment. In certain circumstances, however, such as emergencies or situations where the individual is physically, mentally or legally incompetent to participate in the informed consent process, another person may be the primary decision maker. This person may be a family member or someone whom the individual has designated for health care decision making through a document called a durable power of attorney.
Although the exact content included in informed consent varies from individual to individual and from situation to situation, the following components should be included:
It is the responsibility of the physician to present all information necessary for informed consent to the individual and involved family members in a way that is understood by them. This includes the use of words, phrases and language that they understand. If necessary, an interpreter should be involved. In addition, other members of the health care team, such as nurses, may clarify information and answer questions regarding the information presented by the physician.
Throughout the entire process, questions are encouraged to help ensure full understanding of all aspects of the proposed procedure or treatment. For this reason, more than one discussion with the physician and other health care professionals may be required. Throughout the dialogue, the goal remains the same - to provide the individual with the information necessary to make the best decision given their individual condition and personal circumstances.
For many procedures and treatments, informed consent includes signing a written consent form. The content of this document should include the information as described above, and should be consistent with the discussions which have taken place between the physician, other health care professionals and the individual. The written consent should not be signed until all questions have been answered fully. By signing, however, the individual does not in any way give up the right to ask additional questions or to withdraw consent at any time. The consent form is also signed by the physician and, in some cases, a third party witness. Once signed, the informed consent document becomes part of the individual's permanent medical record. A copy of the signed form is provided to the individual, upon request.