Informed Consent: More Than Just a Signed Paper.....
The general public and our patients generally have a good idea of what ‘consent’ means, thanks in part to publicity surrounding the #MeToo movement, but what does consent mean to health care providers? Especially those who perform invasive procedures? At its most basic, consent simply means permission to engage in some type of activity that otherwise may be illegal or unethical. For example, asking permission from a friend to borrow a car is legal and ethical, but taking the car and using it without permission is theft. In the realm of medicine, consent means permission to have a procedure or diagnostic test performed on a patient that, without permission, would constitute assault and battery; yet, many providers forget that true informed consent is more than just seeking permission.
To understand the concept of informed consent today, we must look to history to demonstrate how changes in the practices of law and medicine have shaped the consent process. The first mentions of assault and battery being committed by a physician did not occur until the beginnings of English common law. Prior to that, physicians rarely discussed procedures, their risks and benefits, and potential outcomes. In Medieval times, physicians were encouraged to manipulate and deceit patients in order to achieve successful surgical outcomes. By the early 20thcentury, numerous civil and criminal trial illuminated deficiencies in the consent process and altered not only the physician-patient relationship, but surgical practices as well. Outcomes of some of these trials include declaration that patients have a right to know inevitable risks of procedures, physicians cannot misrepresent procedures, parents cannot make martyrs of their children and must act in the child’s best interest, patients cannot be consented under duress, and patients have a right to refuse treatments. So how do we navigate what is now arguably the most litigious aspect of medicine? I recommend the following:
Step 1, Inform: Begin discussions of a potential procedure or diagnostic test as soon as possible. The more time a patient has had to think, research, and ask questions, the more informed they will be. These discussions should happen in an appropriate setting in a language the patient prefers to receive their medical information in. During this time the patient’s competency should be assessed and it should be determined whether or not the patient has the ability to make an informed decision. The consent process should never happen in the operative area as this can be perceived as persuading the patient to agree.
Step 2, Decide: Patients should be given information on what their diagnosis (or suspected diagnosis) is, what information supports that diagnosis, what the proposed is, it’s potential risk, benefits, and alternatives (including therapeutic monitoring), what the potential outcomes are, who will be performing the procedure, and how the patient’s life may be affected. Only those who are a part of the procedure team and who are familiar with the procedure should be having an informed consent discussion.
Step 3, Document: In many legal cases where the informed consent process is in question, a signed consent form was of minimal use to a clinician’s defense. Of most help is a clinical encounter note documenting the informed consent process with mentions of the name of the proposed procedure, risks and benefits discussed, and even mentions of the conversation including those who were present, questions asked, overall feelings, and the outcome of the conversation.