What is Informed Consent?

Informed Consent

More on Informed Consent:

An agreement to do something or to allow something to happen, made with complete knowledge of all relevant facts, such as the risks involved or any available alternatives. For example, a patient may give informed consent to medical treatment only after the healthcare professional has disclosed all possible risks involved in accepting or rejecting the treatment. A healthcare provider or facility may be held responsible for an injury caused by an undisclosed risk. In another context, a person accused of committing a crime cannot give up his constitutional rights–for example, to remain silent or to talk with an attorney–unless and until he has been informed of those rights, usually via the well-known Miranda warnings.

(from NOLO.COM)

A medical practitioner may also be legally liable if a patient does not give “informed consent” to a medical procedure that results in a harm to the patient, even if the procedure is performed properly. For example, if a doctor does not tell a patient that a surgical procedure has a 50% chance of causing paralysis, the patient does not have the necessary information to make an informed choice to either have or refuse the operation. If the patient has the operation, and is paralyzed as a result, the doctor may be liable even if the operation was performed flawlessly, as the patient might have refused the surgery if the risks were known. For a health care provider to obtain informed consent, the information must be provided to the patient in a timely manner and in accordance with the accepted standard of practice among members of the profession with similar training and experience. (from www.a2lawyer.com)

Legislation governing the requirements of, and conditions under which, consent must be obtained varies greatly from State to State. General guidelines, such as those proposed by the AMA require patients to be informed of the nature of their condition and the proposed procedure, the purpose of the procedure, the risks and benefits of the proposed treatments, the probability of the anticipated risks and benefits, alternatives to the treatment and the associated risks and benefits, and the risks and benefits of not receiving the treatment or procedure (from http://www.ahrq.gov/clinic/ptsafety/chap48.htm)

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.
from (http://www.flmedicalmalpractice.com)

“Nurses may be liable for professional negligence or battery when they know or should have known (by checking the medical record) that a physician did not obtain INFORMED CONSENT and the nurse did nothing about it.”
From the Book: Legal and Ethical Issues By Susan Westrick Killion, Katherine Dempski

“Nursing staff and other professionals who routinely obtain signatures on consent forms shall take reasonable steps to ensure that the benefits, risks and alternatives of any procedure to be performed on a patient has been explained to the patient or patient representative or surrogate by the physician before obtaining signatures.”
From: Joint Commission on the Accreditation of Healthcare Organizations Comprehensive Accreditation Manual for Hospitals – Patient Rights and Responsibilities

Obtaining the signature on the consent form is not the same as obtaining the consent.
This is an administrative duty by the nurse only. It’s done after the informed consent is actually obtained by physician. The signature means that the Nurse witnessed the patient sign the form. Informed consent is NOT the form. It is the explanation leading to understanding of all the material information by the patient including all of their rights not to have the treatment. In informed consent cases that are brought to court, there is usually a signed form. But the patient can claimed that some important information had been omitted that would have caused the patient to change his/her mind about undergoing the procedure. If that point is on the form, the case can be said that the claim is unmerited as the patient was to read the informed consent form before signing. The better evidence of informed consent is a progress note by the provider who spoke with the patient. This documentation is often in office records and not in the facility records as MDs often call the patient and explain the procedure and obtain consent by phone from their offices.  – an extrapolation of several conversations and writings from attorneys and legal nurse consultants – Ken Thomas, RN