Health Law Institute Lecture Series: The Status of Informed Consent and Informed Refusal Laws

On October 28, Alane Repa, RN, BSN, MS, JD, presented to law students and legal and medical professionals the status of current laws on informed consent and refusal in the United States.

She summarized the history of informed consent laws and explained that these laws stem from the doctrines of negligence, breach of contract, misrepresentation, fraud, and deceit.   In the United States, treatment without informed consent is battery.

A patient may give consent two ways.  An oral agreement to the procedure or an affirmation given in writing, signified by a signature, is referred to as express consent.  When a patient presents himself for a relatively simple, non-invasive procedure, that patient gives implied consent.  An example of implied consent occurred in the famous O’Brien v. Cunard S.S. Co. (1891) case, in which doctors administered vaccines to hundreds of passengers before they boarded a ship, and the passengers impliedly consented to the shot by simply sticking out their arms and awaiting their turn.

Ms. Repa outlined the necessary components for a valid consent form: name and signature of patient or legal representative, name of the hospital, name of the procedure(s), names of all practitioners performing the procedure and individual significant tasks if there is more than one practitioner, risks, benefits, alternative procedures and treatments and their risks, date and time consent is obtained, statement that procedure was explained to the patient or legal representative, signature of person who witnesses the consent, and the name and signature of the person who explains the procedure to the patient or legal representative.

With respect to the substantive nature of the disclosure, many, but not all, states rely on a standard of what a “reasonable physician” would provide.  Most laws emphasize the need to tailor the information to each patient in addition to covering all the material risks. Other states utilize a patient-based standard that focuses on what a “reasonable patient” would need to know in order to make an informed decision.

Hospitals failing to provide valid consent forms put themselves at risk of citations by the Center for Medicare and Medicaid Services (“CMS”).  A CMS surveyor will typically review medical records and interview patients and/or hospital personnel to determine whether a hospital has routinely complied with its policies on informed consent.  Surveyors look for hospital policies that address the patient’s right to make informed decisions about their medical procedures.

In Illinois, informed consent is required for physicians who are acting in non-emergency situations prior to performing surgical or operative procedures.  Any instance where incisions, excisions, or sutures must be performed on the patient also requires informed consent.  In addition, doctors must give accurate and truthful answers to those patients who inquire about their education and experience. 

Informed consent is not required in emergency situations when the patient is unconscious, (or adequate time for communication does not exist), when such procedures would put the patient’s life at risk, when there is risk of significant emotional harm, and when the individual is deemed incompetent.  Additionally, a patient’s decision for treatment may be denied in situations where care would be futile.

Effective delivery of informed consent has barriers.  These barriers include the lack of clinician time, confusion among clinicians about when informed consent is needed, caution among doctors about disclosing too much information, the perception among patients that informed consent is simply a legal release, patient unawareness and cultural issues, poor quality of educational materials and consent forms, patient inability to comprehend information on the consent form, and clinician inability to detect the patient’s lack of comprehension.  Ms. Repa stressed that successful informed consent procedures requires a balancing of the interest in an efficient process versus the interest of preserving a patient’s rights.

To improve informed consent, Ms. Repa suggested practitioners redesign the consent forms to include only simple sentences, at a 6th to 8th-grade reading level, which are written in the patient’s first language.  She also suggested clinicians use a “teach back” method during the discussion, which would ensure that the clinician and the patient are on the same page and encourage the patient to ask questions.

Informed refusal is the other side of informed consent.  Here, patients that demonstrate understanding have the right to refuse a test or procedure.  So long as the patient understands the seriousness of his/her conditions, the full range of risks (including death) and disclosure of what is likely to happen if the patient declines a procedure, health care professionals must respect the patient’s refusal.  In the case Mother Doe v. St. Joseph Hospital (1993), the Illinois Appellate Court ruled that a mother’s decision to refuse a cesarean section, even if doing so may have been harmful to the fetus, must be honored by the hospital personnel.

To conclude, Ms. Repa outlined that the informed consent doctrine could be expanding.  A Delaware Supreme Court case, Shapira v. Christian Care Health Services, Inc. (2014), relied on a 1997 decision that held material risks and alternatives include a doctor’s inexperience with a procedure, a hospital being understaffed on the day of the procedure, and the existence of a nearby hospital in which the procedure could also be performed.  This ruling demonstrates that patient rights, rather than hospital efficiency, will likely become more robust as hospitals revise informed consent procedures.

If you missed the lecture, you can view it HERE!

 

Haley Guion is a current student at DePaul University College of Law.  Ms. Guion received her Bachelor of Arts in English and Certificates in Religious Studies and European Studies from the University of Wisconsin.  She will complete her J.D. degree with a certificate in health care law in 2015.